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88–248 PDF 2014

THE FUNGAL MENINGITIS OUTBREAK: COULD IT 

HAVE BEEN PREVENTED? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

SECOND SESSION 

NOVEMBER 14, 2012 

Serial No. 112–181 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

CLIFF STEARNS, Florida 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

Vice Chairman 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

CHARLES F. BASS, New Hampshire 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

CLIFF STEARNS, Florida 

Chairman 

LEE TERRY, Nebraska 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

KATHY CASTOR, Florida 

EDWARD J. MARKEY, Massachusetts 

GENE GREEN, Texas 

DONNA M. CHRISTENSEN, Virgin Islands 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Cliff Stearns, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 1 

Prepared statement .......................................................................................... 4 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, opening statement ...................................................................................... 6 

Hon. Edward J. Markey, a Representative in Congress from the Commonwealth of Massachusetts, opening statement .................................................... 7 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 8 

Prepared statement .......................................................................................... 10 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 11 

Prepared statement .......................................................................................... 12 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 13 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 14 

Hon. H. Morgan Griffith, a Representative in Congress from the Commonwealth of Virginia, opening statement ............................................................... 15 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 15 

Hon. Lee Terry, a Representative in Congress from the State of Nebraska, 

prepared statement .............................................................................................. 113 

WITNESSES

Joyce J. Lovelace, Wife of Eddie C. Lovelace ........................................................ 17 

Prepared statement .......................................................................................... 20 

Barry J. Cadden, President, Co-Owner, and Director of Pharmacy, New England Compounding Center ................................................................................... 30 

Prepared statement 1

Margaret A. Hamburg, Commissioner, Food and Drug Administration ............. 33 

Prepared statement .......................................................................................... 35 

Lauren Smith, Interim Commissioner, Massachusetts Cepartment of Public 

Health ................................................................................................................... 51 

Prepared statement .......................................................................................... 53 

SUBMITTED MATERIAL

Subcommittee exhibit binder .................................................................................. 114 

1Mr. Cadden did not present a statement for the record. 

(1) 

THE FUNGAL MENINGITIS OUTBREAK: COULD 

IT HAVE BEEN PREVENTED? 

WEDNESDAY, NOVEMBER 14, 2012 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:04 a.m., in room 

2123, Rayburn House Office Building, Hon. Cliff Stearns (chairman 

of the subcommittee) presiding. 

Members present: Representatives Stearns, Terry, Murphy, Burgess, Blackburn, Gingrey, Scalise, Gardner, Griffith, Barton, Upton 

(ex officio), DeGette, Schakowsky, Castor, Markey, Green, 

Christensen, Dingell, and Waxman (ex officio). 

Also present: Representative Whitfield. 

Staff present: Sean Bunyun, Communications Director; Anita 

Bradley, Senior Policy Advisor to Chairman Emeritus; Karen 

Christian, Deputy Chief Counsel, Oversight; Debbee Keller, Press 

Secretary; Katie Novaria, Legislative Clerk; Andrew Powaleny, 

Deputy Press Secretary; Krista Rosenthall, Counsel to Chairman 

Emeritus; Alan Slobodin, Deputy Chief Counsel, Oversight; Peter 

Spencer, Professional Staff Member, Oversight; John Stone, Counsel, Oversight; Tom Wilbur, Staff Assistant; Phil Barnett, Democratic Staff Director; Tiffany Benjamin, Democratic Senior Counsel; 

Stacia Cardille, Democratic Deputy Chief Counsel; Brian Cohen, 

Democratic Investigations Staff Director and Senior Policy Advisor; 

Eric Flamm, Democratic FDA Detailee; Kiren Gopal, Democratic 

Counsel; Elizabeth Letter, Democratic Assistant Press Secretary; 

Karen Nelson, Democratic Deputy Committee Staff Director, 

Health; Stephen Salsbury, Democratic Staff Assistant; Rachel Sher, 

Democratic Senior Counsel; Roger Sherman, Democratic Chief 

Counsel. 

OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

Mr. STEARNS. Good morning everybody, and the committee will 

come to order. 

My colleagues, we convene this hearing of the Oversight and Investigations Subcommittee to examine the recent outbreak of 

fungal meningitis linked to contaminated products made by the 

New England Compounding Center, or NECC. 

I want to extend my deepest condolences to everyone who has 

lost a loved one in this tragedy. Thirty-two people have died, including three within my congressional district, one in Marion 

2 

County. One of the persons lived right up the street from me. And 

well over 400 people have been sickened, making this one of the 

worst public health disasters ever caused by a contaminated drug 

in this country. 

After a tragedy like this, the first question we all ask is, Could 

this have been prevented? After an examination of documents produced by the Massachusetts Board of Pharmacy and the U.S. Food 

and Drug Administration, the answer appears to be yes. 

Before this outbreak, FDA had conducted three series of inspections of NECC, each based on a separate set of allegations or 

events. The Massachusetts Board of Pharmacy’s history with 

NECC is even more extensive, involving at least 12 separate complaints concerning NECC or its pharmacist, Mr. Cadden, since 

NECC opened in 1998. 

Over the course of these inspections, regulators noted the same 

kinds of problems at issue in the current outbreak, problems with 

sterility in violation of its own license. For example, back in 2002, 

several adverse events were reported to FDA involving patients 

who had received steroid injections made by the NECC. FDA followed up and inspected the company. Just 6 months after that inspection, patients were again hospitalized after receiving NECC’s 

injections in what case can only be seen as a warning, just a simple 

warning of things to come. The patients infected in 2002 displayed 

meningitis-like symptoms. The product in question was the very 

same product connected to the current outbreak. In that case, the 

NECC drug was contaminated with bacteria. 

After the 2002 meningitis cases, officials from FDA and the State 

pharmacy board met in 2003 to review NECC’s conduct. Now, during this meeting, the FDA made a prophetic statement. The FDA 

stated that there was ‘‘the potential for serious public health consequences if NECC’s compounding practices, in particular those relating to sterile products, are not improved.’’ 

Even though FDA was clearly aware of the risks posed by 

NECC’s compounding practices, the agency was simply slow to act. 

In fact, it took FDA 4 years after finding problems with the 

NECC’s sterility practices and violations of the Food, Drug and 

Cosmetic Act to issue a simple warning letter. The company challenged the charges FDA made in the 2006 warning letter. It took 

FDA another 2 years to respond to the company’s claims. When 

FDA finally responded in 2008, 6 years after the agency first inspected the NECC, it directed the company to correct the violations 

and warned that it would follow up with future inspections. But 

the FDA never did so. FDA didn’t even follow up after the Colorado 

Board of Pharmacy notified the agency in 2011 that the NECC was 

again sending its drugs to out-of-State hospitals without first receiving patient prescriptions. FDA didn’t even refer this complaint 

to the Massachusetts board for follow up. We are left to wonder 

what would have happened if FDA had investigated or at least informed the Massachusetts Board of the Colorado of this complaint. 

It is possible that this outbreak very well might have been prevented. 

My colleagues, we are joined today by Joyce Lovelace, whose husband, Eddie, passed away in September. Mrs. Lovelace, we sincerely thank you for sharing your story with us today. I pledge that 

3 

we will get to the bottom of this so we can ensure that this outbreak, things like this never ever occur again. 

We are also joined by Commissioner Hamburg of the FDA and 

Commissioner Smith of the Massachusetts Department of Public 

Health. I am interested in learning whether they think this outbreak could have been prevented and whether their agencies did 

enough to stop it. 

This committee has a long history of conducting bipartisan oversight, and this investigation is no exception. So it is my sincere 

hope that this hearing will serve and it is an opportunity to determine the reasons why such a history as this does not repeat itself. 

[The prepared statement of Mr. Stearns follows:] 

4 


88248.001
5 


88248.002
6 

Mr. STEARNS. And with that, I give the remaining time to Chairman Emeritus Joe Barton. 

Mr. BARTON. I think your time has expired, Mr. Chairman. 

Mr. STEARNS. OK, well, then we will go to—— 

Mr. BARTON. If there is time at some point—— 

Mr. STEARNS. I think we will go to the ranking member, Ms. 

DeGette, who is recognized for 4 minutes. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you very much, Mr. Chairman. And I do 

appreciate your taking the time to have this hearing on the very 

day that we return from the recess because this is such an important public health issue, and we are acting in a bipartisan way. I 

am also glad about that. 

The contaminated steroid injection sold by the New England 

Compounding Company have caused 438 cases of fungal meningitis 

spanning 19 States. Thirty-two people have died, and I am afraid 

that number could continue to climb. 

We have four witnesses today to help us examine how this could 

have happened, and I am very eager to hear from the FDA and the 

Massachusetts Board of Registration and Pharmacy, the agencies 

with primary regulatory authority over NECC, just how we got 

here. I want to hear from Mr. Barry Cadden about how on Earth 

his company could have been so irresponsible causing the deaths 

of so many Americans. And I’m looking forward to hearing from 

Mrs. Lovelace, who, as you heard, is the wife of one of the first victims in this tragedy. 

I want to join with Mr. Stearns, Mrs. Lovelace, in expressing my 

deep, deep sadness for your loss, and I really want to thank you 

today. It can’t be easy. 

And Congressman Whitfield, thank you so much for accompanying her today. I know this is hard for you, but it is important. 

Mr. Chairman, the facts that we have uncovered so far in this 

investigation reveal frightening failures on multiple levels, and this 

is one of those real cases where there is a lot of blame to go around 

for a lot of people. 

Mr. Cadden repeatedly failed to ensure that NECC and its sister 

companies were following appropriate safety rules and guidelines. 

Again and again, reports of problems with the facility were brought 

to the attention of the Massachusetts Board of Registration and 

Pharmacy, which failed to act. The board was informed of problems, via complaints or even from its own inspections, in 1999, 

2002, 2003, 2004 and even just this past summer. But somehow, 

NECC was able to keep its license, avoid significant penalties and 

continue its operations until tragedy struck all across the Nation. 

We also need to hear an explanation from the FDA. Just like the 

Massachusetts board, FDA inspectors and officials were repeatedly 

informed of problems at NECC, but the strongest action taken by 

the FDA was a warning letter sent to the company in 2006, a letter 

that appeared to have very little effect. The FDA tells us that they 

were hobbled by questions about whether they had the legal authority to address the problems at the NECC. 

7 

If this is true, Mr. Chairman, this is a problem that demands 

this full committee’s immediate attention. We need to clarify the 

Food, Drug and Cosmetics Act, which apparently limits the FDA’s 

jurisdiction over compounding pharmacies, and we need to make 

sure that for these large pharmacies like this, that they have the 

ability to act and to act quickly on behalf of patients. 

Over 30 people have died from this meningitis outbreak because 

too many signals about the risk were missed. One of those signals, 

as the chairman said, came from my home State of Colorado. In 

2011, the Colorado State Board of Pharmacy determined that 

NECC was distributing unlicensed and unregistered drugs in the 

State and issued a cease-and-desist order. But this was not all the 

Colorado officials could do, and it was not enough to stop NECC’s 

action. Colorado officials notified the Massachusetts Board of Pharmacy, and Massachusetts did nothing. The Colorado Board of Pharmacy did the right thing, but the system failed. NECC did not improve its operation. The FDA did not act. And Massachusetts did 

not act. 

Now, Mr. Chairman, for a long time, we have all had sort of a 

Norman Rockwell vision of the pharmacists who manufacture the 

drugs our families rely on, the kindly old gentleman in the white 

coat in the back of the store mixing the prescriptions for the little 

child with the illness. Unfortunately, this tragedy makes clear that 

large corporate compounding pharmacies are operating unchecked 

by appropriate safeguards, even as American families trust their 

lives. So we need to work together now, Mr. Chairman, to make 

sure this crisis is not repeated. And I will yield the remainder of 

my time to Mr. Markey from Massachusetts. 

OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF MASSACHUSETTS 

Mr. MARKEY. I thank the gentlelady. 

New England Compounding Center is in my district in Framingham. My deepest condolences go to all victims and their families. 

NECC was no stranger to Federal and State regulators. It had 

been the subject of eerily similar safety complaints in 1999, 2001 

and 2002. Yet, in 2002, NECC’s owner, Barry Cadden was appointed to the State’s task force charged with developing new regulations for compounding pharmacies. And in June of 2006, the 

State board waived sanctions. 

My report, which I have completed on this issue, shows that even 

before the current outbreak there were at least 23 deaths, 86 serious injuries associated with unsafe compounding pharmacy practices. 

To Jerry Cohen, Melanie Norwood, and Joyce Lovelace, I want to 

commit to you and to all of the victims that I will not stop until 

we make sure that these industries are safe. 

I thank you for your courage. We have to make sure that this 

never happens again. 

I yield back. 

Mr. STEARNS. Thank you. 

The gentleman yields back. 

8 

I recognize the full chair of the committee, the distinguished gentleman from Michigan, Mr. Upton. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Thank you. 

You know, when we first began this investigation over a month 

ago, we knew that people were sick, and we knew that people had 

died and were dying due to contaminated medicine made by the 

New England Compounding Center. 

One of my constituents, too, a grandmother from Cass County, 

lost her life tragically to these contaminated drugs. 

The loss of innocent lives is tragic enough, but what makes this 

tragedy worse is the fact that it seems that these deaths and illnesses could have been prevented. The NECC was not unknown to 

its regulators. It was not operating under the shadow of darkness. 

The NECC plant is about a 30-minute drive from the FDA’s New 

England District Office, and the FDA and NECC’s State regulator, 

the Massachusetts Board of Pharmacy, had inspected NECC’s facility a number of times since the company opened its doors back in 

1998. 

FDA even issued a warning letter to the NECC in 2006, and the 

Massachusetts Board of Pharmacy entered into a consent agreement with the company that same year. 

I was stunned and angered to learn that inspection of the NECC 

by the FDA and the Massachusetts Board over 10 years ago identified contamination in the very same drug at issue in the current 

outbreak. The reason for that inspection? Patients had been hospitalized with meningitis-like symptoms. 10 years later, we are in 

the midst of an unthinkable worst-case scenario. The body count is 

growing by the day, and hundreds, hundreds have fallen ill. Inexcusable. 

Today we are going to hear from the Massachusetts Department 

of Public Health and the FDA about their history and the NECC 

and why they treated the company the way that they did. Why did 

State and Federal regulators feel confident that this company could 

make drugs safely after repeatedly finding that the company’s 

drugs were contaminated back in 2002? After observing multiple 

violations of the Food, Drug and Cosmetic Act leading up to the 

FDA’s 2006 warning letter, why did the agency fail to conduct a 

single follow-up inspection? 

The committee expects the cooperation of the FDA, the Massachusetts Board and the company as we try to uncover the facts as 

to ensure that this never happens again. Thirty-two innocent 

Americans have died during this outbreak, and the public deserves 

to know what went wrong. I thank Dr. Smith and Dr. Hamburg for 

agreeing to testify today. The Massachusetts Board in particular 

has provided thousands of pages of documents relating to the 

NECC. 

Thank you, Dr. Smith, for making yourself and your staff available to the committee. I wish I could say the same about the FDA. 

Commissioner Hamburg, the FDA still has not provided the key 

timeline information requested by the committee more than a 

month ago. The FDA has not provided its communications relating 

9 

to the NECC. FDA needs to focus on protecting public health by 

cooperating with its authorizing committee. We are going to insist 

today on a firm timetable from you as to when you can produce 

those documents and the rest of the requested information. The 

sooner that the FDA cooperates, the sooner we can determine what 

went wrong and what we need to do to fix it so it doesn’t happen 

again. 

Mrs. Lovelace, our hearts are with you. They really are. We appreciate your testimony during this very, very tough time, and I 

yield the balance of my time to Mr. Barton. 

[The prepared statement of Mr. Upton follows:] 

10 


88248.003
11 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Mr. Chairman. 

You have heard the old saying, you can bring a horse to water, 

but you can’t make it drink. Well, you can take a regulator to a 

problem, but you can’t make it regulate. 

And we have got numerous cases in the last 10 to 15 years of 

State and Federal regulators being made aware of problems at this 

particular company, and they go out and investigate, or they ask 

for documentation, and then they issue some sort of a general reprimand or, in some cases, do nothing at all. 

It is an absolute tragedy without any question that 32 people 

have died, and it is very unlikely that that is going to be the end 

of the death toll. 

We have got to get our regulatory authority, both at the State 

and Federal level, when you have what appears to be a back bad 

actor like this company, you have got to get the regulators to use 

the authority that the States have given them and the Congress 

has given them to stop these practices. 

And if you read the reports of both the majority and the minority 

staff that was prepared for this hearing, there are repeated instances of where an inspector just walking through could see obviously contamination in the various batches of this particular product, and it has been going on for 10 to 15 years. 

So I want to thank Chairman Upton and Subcommittee Chairman Stearns and Ranking Member Waxman and DeGette for, on 

a bipartisan basis, immediately calling for this hearing, immediately asking that the facts be made present, and let’s find out 

what the facts are and then do what is necessary to put a stop to 

this once and for all. 

With that, Mr. Chairman, I yield back. 

[The prepared statement of Mr. Barton follows:] 

12 


88248.004
13 

Mr. STEARNS. The gentleman yields back. 

I recognize the ranking member of the full committee, the gentleman from California, Mr. Waxman, for 5 minutes. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

I want to thank you for holding this hearing and working with 

the Democrats in making this a bipartisan hearing. We are convening in the midst of an ongoing public health tragedy. The New 

England Compounding Center shipped across State lines over 

17,000 vials of a steroid, an untold number of which were contaminated with a dangerous fungus, these injections have so far killed 

32 people and sickened 438 people with meningitis. This is a tragedy that has brought unspeakable devastation to so many families. 

That is why I’m very grateful, Mrs. Lovelace, for you being here 

today. It takes a lot of courage for you to come forward and speak 

about this, but it is important that you do so. 

The facts that we have learned to date are very, very troubling. 

First of all, let’s not lose sight of the wrongdoer as we go around 

blaming regulators. The regulators deserve blame, but the primary 

blame, in my mind, is the company. We had to subpoena the 

former President of the NECC, Barry Cadden, to be here to testify 

about how this company handled the matter. And what we learned 

was that even 10 years ago, people who are regulating the company 

found that there were sloppy practices that could lead to a public 

health problem. In fact, the FDA 10 years ago knew that there 

could be a possible meningitis outbreak, and it wasn’t corrected by 

the company. 

And the company went about its ways, I suppose always telling 

people that they are going to behave better, they are going to 

change their ways. Well, that doesn’t mean we don’t insist on regulators watching out for the public interest. 

And I am pleased that both sides of the aisle are talking about 

the need for regulation, and what we need to do is straighten out 

who has what responsibility to be sure it is clear. 

The Massachusetts Board of Registration and Pharmacy and 

other State regulators and health care providers identified the 

problem at the company. The Massachusetts Board inspected the 

facility after the outbreak. They found a horrifying list of problems, 

and it is shameful that those that ran this facility allowed this to 

happen. 

The Massachusetts Board had primary jurisdiction, no one questions, that the State had primary jurisdiction to regulate the company. They were informed numerous times of problems. They even 

did their own investigation identifying serious issues, but the board 

never took actions tough enough to stop the New England 

Compounding Center from putting consumers at risk. 

And finally, we have FDA. FDA was informed of the problems. 

They conducted investigations. They raised concerns about the 

NECC, but the most aggressive action the agency took was a warning letter in 2006. That letter and previous attempts by the FDA 

to inspect and review NECC’s actions were met with stubborn reVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
14 

fusals and a challenge to FDA’s authority. Well, the FDA is questioning their authority. Congress acted specifically in 1997 to limit 

the authority of the FDA and there was a Supreme Court case that 

left the FDA in doubt as to exactly the authority it had left. 

This tragedy demands action from this Congress. Mr. Markey 

has a bill that is a good start. I think we want to work during this 

lame duck session to pass bipartisan legislation that preserves 

compounding pharmacies’ abilities to operate safely in appropriate 

situations, yet gives FDA the clear and effective authority to prevent compounders from becoming dangerous drug manufacturers, 

like the NECC. 

Mr. Chairman, I want to yield the balance of my time to Mr. Dingell. 

Mr. STEARNS. The gentleman from Michigan is recognized for the 

balance of the time, but with the consent, unanimous consent, that 

you could have additional 2 minutes and we have additional two 

speakers that will speak each a minute a piece after you, if that 

is by unanimous consent accepted. 

Mr. DINGELL. I’m not about to make it difficult, and I do thank 

you for the courtesy, Mr. Chairman. 

Mr. STEARNS. With unanimous consent, so ordered. 

And the gentleman, distinguished chairman emeritus of the full 

committee under the majority and the Dean of the House, is recognized 3 minutes. 

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. Mr. Chairman, I thank you for your courtesy. I 

commend you for holding this hearing, and I’m very pleased with 

the speed with which the committee has responded. 

I ask unanimous consent to revise and extend my remarks, and 

I note that my home State of Michigan leads the country in the 

number of cases related to this fungal meningitis outbreak with 

129 patients affected and 9 deaths. These individuals and their 

families deserve answers as to how this was able to occur. We also 

need to ensure our people that the pharmaceuticals that they purchase are safe. It is clear that the New England Compounding Center, which has a long history of sterility issues and significant other 

problems, was not properly regulated by either Federal or State authorities and that the sitting on the border between of the two authorities, they were able to disregard their responsibilities and lead 

us into a bad situation. 

It is further clear that NECC blatantly chose not to address deficiencies and violations found by FDA and the Massachusetts Board 

of Pharmacy and additionally compounded these steroids without 

patient-specific prescriptions as required by Massachusetts State 

law. 

While I recognize that compounding serves an important public 

health purpose, I am concerned that NECC was operating at such 

a volume as to be outside what may properly be considered traditionally pharmacy compounding and may instead be properly classified as a drug manufacturer and engaged in drug manufacturing. 

15 

Warnings were given on many occasions to all concerned, and we 

are going to have to see to it that that situation does not again obtain. 

I would note that we have sort of the classic system of the tragedy of the commons before us, where what belongs to everybody or 

more than one appears to belong to no one, and as a result, neither 

agency responsible for its actions dealt with the problems. 

I’m sure this committee hopes and intends to work with all of us 

together on both sides of the aisle to find out how new FDA authorities can address the issue before us with proper expansions of 

regulatory authority and what additional statutory authority may 

be needed to prevent future outbreaks like the one from which we 

are now suffering. 

I am fearful, Mr. Chairman, that this problem is something 

which will require fairly strong legislation, but I’m satisfied it is 

fairly easily done. 

I thank you for your courtesy to me, and I yield back the balance 

of my time. 

Mr. STEARNS. I thank the distinguished gentleman and now recognize the gentleman from Virginia, Mr. Griffith, for 1 minute. 

OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF VIRGINIA 

Mr. GRIFFITH. Thank you, Mr. Chairman, and thank you so much 

for holding this hearing. 

Like so many others who have spoken, my area in the Roanoke 

Valley and the New River Valleys of Virginia have been particularly hard hit. We have had two fatalities, and I was on the phone 

this morning with the father of the youngest victim to date in the 

United States, a young man who just turned 16 when he was 

stricken down. He has the advantages of age, but they don’t know 

what his end result will be. On the Friday before he was stricken, 

he caught, as a sophomore, caught three interceptions in a football 

game, ran one back for a touchdown, just a great athlete, this gives 

him some advantages, but how will his life be changed? We don’t 

know. 

Our job here is to find out why this happened and then to make 

sure that it doesn’t happen again. And I look forward to working 

with everyone to make sure that we get to the bottom of this in 

a bipartisan fashion and also want to thank Mrs. Lovelace for 

being here today and express sorrow for your loss. 

With that, Mr. Chairman, I yield to Mrs. Blackburn. 

Mr. STEARNS. The gentlelady from Tennessee is recognized for 1 

minute. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. Thank you, Mr. Chairman, I am appreciative 

of the work that you and your staff have done and the manner in 

which we have moved forward so quickly on this issue. 

And I do want to welcome our witnesses. 

16 

And Mrs. Lovelace, we do welcome you. We are appreciative that 

you would take your time to join us. 

According to the CDC, 81 Tennesseans have been affected with 

fungal meningitis, and 13 Tennesseans have lost their life. This is 

something that is of tremendous concern to us, and it is because 

of this and on behalf of my constituents and those families that 

have been adversely impacted by this fungal meningitis outbreak, 

I am interested to hear why the FDA did not pursue any enforcement actions against NECC, despite having emphasized nearly a 

decade ago, nearly a decade ago, the potential for serious public 

health consequences. These are answers that we are looking for. 

They are questions that we have each approached during our comments, and I look forward to the hearing. 

I yield back. 

Mr. STEARNS. The gentlelady yields back. 

We are now ready to have our first panel. Our first panel is Mrs. 

Joyce Lovelace. She is the wife of the late honorable Eddie C. 

Lovelace. Judge Lovelace served as a circuit judge for the 40th Judicial Circuit in Kentucky’s Clinton, Cumberland and Monroe 

Counties. 

Judge Lovelace was the first confirmed death as a result of the 

fungal contamination from steroid injections. 

Before Mrs. Lovelace begins her testimony, I would like to recognize her congressman, the distinguished gentleman from Kentucky, 

who is also chairman of the Energy and Power Subcommittee and 

represents the First District of Kentucky, for an introduction of 

Mrs. Lovelace. 

Mr. WHITFIELD. Chairman Stearns, thank you very much, and 

Ranking Member DeGette and all of the members of this committee. 

We genuinely appreciate your being here to investigate this very 

important issue. 

I feel very fortunate to be here with Joyce Lovelace today, not 

only because she is a constituent but because, ever since I have 

been a Member of Congress, Joyce and her husband, Eddie, have 

been very good friends of mine. They lived in Albany, Kentucky. 

We talk about statistics and figures, and yet when you look at the 

individual lives involved, it makes all the difference in the world. 

Joyce and Eddie were married almost 56 years. He died on September the 17th, 2012, as a result of complications from the contaminated steroid injection that caused fungal meningitis and 

which is the focus of this hearing. He was 78 years old, but I might 

say that most people who met him thought he was 50 years old because he walked 3 or 4 miles every day. He was a circuit judge, 

was one of the leading legal scholars in Kentucky, had also served 

as a chief prosecutor, a county attorney, and he was one of those 

people involved in every aspect of the community of Albany. So we 

will all miss Eddie Lovelace, and we will never forget him. 

And at this time, I want to thank Joyce very much for being willing to share her story and Eddie’s story with the committee. And 

Joyce, thank you very much for being here with us this morning. 

Mr. STEARNS. I thank my colleague for that fine introduction. 

17 

STATEMENT OF JOYCE J. LOVELACE, WIFE OF EDDIE C. 

LOVELACE 

Mr. STEARNS. Ms. Lovelace, you are aware that the committee is 

holding an investigative hearing and when doing so has had the 

practice of taking testimony under oath. 

Do you have any objection to testifying under oath? 

Mrs. LOVELACE. No. 

Mr. STEARNS. The chair then advises you that under the Rules 

of this House and the rules of the committee, you are entitled to 

be advised by your counsel. Do you desire to be advised by counsel 

during your testimony today? 

Mrs. LOVELACE. I’m fine. 

Mr. STEARNS. In that case, if you are able to stand—if not, then 

please raise your right hand, and I will swear you in. 

[Witness sworn.] 

Mr. STEARNS. You are now under oath and subject to the penalties set forth in Title 18, Section 1001 of the United States Code. 

We welcome you today and your can now give your 5-minute summary opening statement if you would. 

Mrs. LOVELACE. Thank you, Mr. Chairman and members of the 

committee. I’m very much encouraged by what I have heard from 

you today, that you do plan to move on this and to investigate this 

matter. That is basically what my family and I desire, is to get to 

the bottom of this and make sure that it never happens to another 

family because we have lived a nightmare. We will be living this 

nightmare for ages to come. It is something that probably we will 

never really be able to get closure because it was such a useless 

thing that happened to my husband. 

I don’t have any notes. My husband hated notes. Obviously, he 

can’t be here, and I’m here on his behalf. So I’m just speaking from 

the heart, and I think he would not want me to have notes. He 

never read, he always spoke. 

I was fortunate enough to have been married to this amazing 

man for nearly 56 years. And I won’t say that it was always pleasant or smooth or anything, and I don’t think any marriages are, 

but we worked together in his office. We were married when he 

was in law school. And I worked and helped him make his way 

through law school, and then we moved to Albany and made our 

home there. And he immediately began to get involved in civic matters, community matters. He taught Sunday school 42 years. He 

was still teaching when he passed away. He was a gifted speaker. 

Really, I just want these people to know what kind of a person 

that has perished because of their lack of concern. My family is bitter. We are angry. We’re heartbroken. We’re devastated. And I just 

come here begging you to do something about the matter. 

I cannot say enough good about him. He was bigger than life in 

any setting that you put him in. And I worked in his office alongside of him, so I’ve seen all sides and have seen him interact with 

all classes of people in all situations. And he had a gift of working 

with people. He was compassionate. He wanted to help the people 

that needed it. He always wanted the victim in any to be taken 

care of and given full consideration. And it’s ironic that he winds 

up the victim in this. 

18 

Our family, I can’t begin to tell you what I have lost, my 

soulmate, my partner, words don’t, can’t describe. Our older grandchildren. He was their anchor, their rock. They looked to him for 

advice. He guided the older ones through college and helped them 

decide what steps or what direction that they wanted to take. Our 

oldest granddaughter became an attorney based upon her appreciation I think for him and the work that he did. And he had 2 more 

years left in his term as judge. He planned to complete that term 

and go in practice with our granddaughter and help her get started. Now she has no one. 

Our younger grandchildren have lost the best playmate they ever 

had. He played anything that our grandchildren asked him. They 

could dress him up. They could do anything, and he was happy to 

do it. They all wanted Papaw, our youngest granddaughter asked 

him, even when gas prices were so high, and they still are, asked 

him, you drive me around Pops and let me just read. And he would 

get her in the car, and he would drive and let her read her books. 

She is now in the sixth grade, and she is an avid reader. But these 

are some of the things that we are going to miss. 

He had a very legal mind. He studied the law. Every weekend, 

on Friday, he wanted all the opinions of the appellate courts printed out and that was his weekends, reading. He would get kind of 

miffed at us if we didn’t get it done because that would ruin his 

weekend. 

Now he wasn’t a sick individual. He was healthy. He walked 3 

miles every morning before I would even get out of bed. He wanted 

to stay active. He didn’t have the appearance of a 78-year-old man 

until about the second injection, and then we began to see the difference, for he had walked those streets every morning, he was 

stumbling, he was losing his balance, he fell often. He began to 

have headaches, which he never had before. And I was really concerned at his appearance. He had the look of someone who might 

have cancer. He had a physical examination just maybe 2 weeks 

before he fell sick, before he became sick, and they found nothing 

wrong. The only problems he had were kidney stones and allergies, 

neither of which I think would have taken his life. 

On the 11th of September, he began to have numbness in his 

hand, and we begged him to go to the emergency room, and he declined. That evening, he had a bad headache, and then he told me 

that two fingers on his hand were not right. He couldn’t use those 

two fingers. Then it became his fist; he couldn’t. But he still would 

not go to the emergency room. He just was an individual that was 

not sick that much, and he wasn’t going to go to doctors. He just 

didn’t go until he had to. 

The next morning, of course, he had been up, and when I got up, 

he was hollering for me in the kitchen. He had a horrible look on 

his face. I will never forget that expression. And he said, my legs 

don’t work. He said, I’ve been out twice to get my paper, and I’ve 

fallen twice. Our daughter is a nurse, and I called her and she took 

him to the emergency room. 

I believe they did a CT scan there, and it didn’t show anything, 

but based on his symptoms they transferred him to the Vanderbilt 

in Nashville. To back up, he had had a car accident in March, the 

last of March and had injured his lumbar and cervical spine. And 

19 

he had gone through his physical therapy. He had done everything 

the doctors had told him to do in an effort to try to get better. To 

be able to work was number one on his mind, to get back on the 

job. He was transferred—he was referred to a Dr. Abrams, a neurosurgeon at St. Thomas, and that’s where he received these injections at the St. Thomas Neurosurgical Outpatient Center. They admitted him to Vanderbilt on the 12th. He immediately, just within 

a day or two, started declining fast, I mean rapidly. His speech became slurred. He lost the use, he had no grip in his left hand. He 

could not move his left foot. He had no eye-hand coordination. He 

could not feed himself. It was a nightmare to see this man who was 

perfectly healthy one moment and then just so quickly going downhill, and everything the doctors were doing for him didn’t—was to 

no avail. The medicine, whatever they did, it was not helping him 

in the least. And he just declined so rapidly, that on the 17th, he 

passed away. 

And people, it was not an easy death that we witnessed. And 

these are human beings that these committees, the FDA, the 

NECC, whoever is responsible. I want them to know their lack of 

attention to their duties cost my husband his life, cost my family, 

caused them a loss that we will never recover from. And if you 

don’t do your job, it may not appear to be anything to you, but you 

are affecting human lives, valuable human lives. My husband was 

valuable to us. And I cannot beg you enough, bipartisan, I don’t 

care what party, work together—— 

Mr. STEARNS. We will do. 

Mrs. LOVELACE. And please legislate this so no other family has 

to go through what we have. 

[The prepared statement of Mrs. Lovelace follows:] 

20 


88248.005
21 


88248.006
22 


88248.007
23 


88248.008
24 


88248.009
25 


88248.010
26 

Mr. STEARNS. Mrs. Lovelace, thank you very much for your 

poignant testimony, your statement. 

I’m just going to ask two questions, short, brief. But the first one 

is, when you found out that your husband was the first of many 

to be linked to this contaminated product distributed by the NECC, 

do you remember when that was, how long after he died? And secondly, who was it that informed you about this? 

Mrs. LOVELACE. He passed away on September the 17th, and we 

went ahead with the funeral services and everything, thinking that 

he had a stroke because that was their diagnosis. On the third of 

October, I believe it was, we began to hear about the contamination 

from these injections. 

Mr. STEARNS. From the press? Who told—— 

Mrs. LOVELACE. Yes, through the press. My son-in-law, I think, 

was the first that read it or heard it. On October the 5th, I received 

a call from a reporter from the Nashville Tennessean, and he told 

me that a spokesperson at Vanderbilt had issued a statement that 

a 78-year-old man had died from the contaminated steroids. 

Mr. STEARNS. So the first you heard about it was from the Vanderbilt hospital. 

Mrs. LOVELACE. The first I heard that was from—— 

Mr. STEARNS. So no one from the FDA or the Center For Disease 

Control, did they ever contact you? 

Mrs. LOVELACE. No. St. Thomas did not contact me. 

Mr. STEARNS. So you actually heard about it through a press report? 

Mrs. LOVELACE. Correct. 

Mr. STEARNS. And no one from the State of Tennessee contacted 

you? 

Mrs. LOVELACE. No. 

Mr. STEARNS. Did they subsequently, after you heard through 

the press, did the State of Tennessee or FDA or the Centers for 

Disease Control? 

Mrs. LOVELACE. I was on the Internet to try to find something 

about it, and I found a phone number on there, and I called it. 

Mr. STEARNS. So you initiated it? 

Mrs. LOVELACE. Yes. 

Mr. STEARNS. No one from outside came to you? 

Mrs. LOVELACE. No one. 

Mr. STEARNS. Even after the press reports and the Vanderbilt 

Hospital, did the doctor call you? 

Mrs. LOVELACE. No, but Vanderbilt didn’t know about him having the injection. It was over at St. Thomas. Now, on the 25th— 

and bear in mind that his funeral was the 21st—on the 25th someone from St. Thomas called my cellphone and asked how Mr. Eddie 

was doing from his procedure. And I was really taken aback because we had just buried him. And I told her so. And well, she was 

so sorry; what happened? And I said, they believed he had a stroke. 

So then, the next day, a different lady from the same place called 

wanting to know what his symptoms were, how long he had the 

symptoms and whether or not we had an autopsy performed. And 

neither person mentioned contamination, meningitis, anything like 

that. 

27 

Mr. STEARNS. You know, it is a possibility what you say, a 

stroke, there might have been people that had died because of the 

contamination prior to your husband that were elderly and they attributed to a stroke. 

Mrs. LOVELACE. It is very possible. 

Mr. STEARNS. We will never know. I think my last concern is, is 

the feeling I have that you had no contact with the FDA and these 

other folks that I mentioned. I think if you, they did contact you, 

and told you about it, I think what you would say to them is, why 

didn’t you stop it? 

Mrs. LOVELACE. Right. 

Mr. STEARNS. And obviously, if you had to talk to Mr. Cadden, 

who is the CEO of NECC, you could say, how in the world would 

you be so oblivious to the lack of quality control and all the notices 

that you got prior to your manufacturing of this large number of 

drugs? So those are the questions I want to ask you. I want to 

thank you again for your courage to come here, and I recognize the 

ranking member, Ms. DeGette from Colorado. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

I just want to follow up, Mrs. Lovelace, on some of the things the 

chairman was saying, because when they went over to inspect 

NECC, they found vials with little black stuff in them, and they 

found insects near the areas and terrible, terrible working conditions. And you know, sometimes in this committee, we have seen 

this before with food manufacturers, and we all sit here and we 

say, ‘‘How could this happen in the 21st century in the most civilized country in the world?’’ And the reason why it is so important 

that you came today—and it is so hard for you, I am sure—is because it is easy for regulators and for Congress people to talk about 

this in the abstract and for every—for you being here, there are 

hundreds of people around the country who have either lost loved 

ones who were just as cherished to them as your husband was to 

you and—or they are sick and they are still sick. 

So I just want to let you know, it makes a big difference for you 

to come here today. And I want to thank you for doing it. It is not 

easy, I know. And I also want to let you know that we are—with 

some of the food safety issues that we identified a few years ago, 

we actually did pass legislation that clarified it. And so as hard as 

this is and how senseless and unnecessary as this is, I will guarantee you that I will be working with Mr. Upton and the entire 

committee, Democrats and Republicans, to make sure we clarify 

this. 

And I think one of the problems as well as just sloppiness on the 

part of the Massachusetts regulatory agency and the FDA, the 

other problem was this gray area in the compounding pharmaceutical law, where the FDA wasn’t really sure if they had jurisdiction or they’d be sued in court. We can fix that, and I can guarantee you we will fix that. And when we do fix that, unlike these 

regulators, we will call you and let you know. 

So thank you very much for coming, and I yield back the balance 

of my time. 

Mr. STEARNS. The gentlelady yields. 

28 

We will open the floor for additional questions. Just to remind 

members the second panel is Barry Cadden, who is the CEO of 

NECC, as well as we have the third panel. 

So would anyone like to ask a question? Mr. Burgess is recognized from Texas. 

Mr. BURGESS. Thank you, Mr. Chairman. 

And Mrs. Lovelace, I do appreciate your being here and sharing 

your story with us. You made the comment that your husband was 

important to your family. I just stress that he is important to this 

committee as well. 

And just like the ranking member, when she was talking about 

some of the food safety investigation, we have done, your story, as 

you were relating it, was just so similar to, in this very room, 

maybe 2 years ago, we heard a similar story about salmonella, and 

the family actually learned about it, that the lost of their loved one, 

they learned about it through the newspaper that maybe it was the 

tomatoes in the salad or wherever the contaminant was from and 

the same thing, the place where things were grown, there were obvious areas where there was contamination going on. 

We have read the memos, and we understand the litany of problems that existed at this manufacturer. 

Can I just ask you a couple of questions to clarify in my mind 

the timeline that the clinical course that your husband had? He 

had the automobile accident, and roughly when was that? 

Mrs. LOVELACE. March 30th of this year. 

Mr. BURGESS. And then his treatment at the outpatient facility 

for the steroid injections, he had two of those. 

Mrs. LOVELACE. Three. 

Mr. BURGESS. Three. And so I guess the last one would have occurred when? 

Mrs. LOVELACE. August 31st. 

Mr. BURGESS. And his illness began. 

Mrs. LOVELACE. The 11th, it really began before, but it was really magnified on the 11th. 

Mr. BURGESS. So roughly not quite 2 weeks afterwards. 

Mrs. LOVELACE. Uh-huh. 

Mr. BURGESS. And when he was admitted to the hospital, when 

was transferred to Vanderbilt, when did that occur? 

Mrs. LOVELACE. That was on the 12th, the morning of the 12th. 

Mr. BURGESS. So he had a pretty rapid decline in his clinical 

course. 

Mrs. LOVELACE. He did. 

Mr. BURGESS. Did the doctors know in, coming into Vanderbilt, 

that he had had previous outpatient therapy at the other facility? 

Mrs. LOVELACE. No, I don’t believe they did. Our daughter accompanied him to the hospital, and I don’t believe that that was 

in his history when he was admitted. 

Mr. BURGESS. It may not have occurred to anyone to ask, and obviously, now, in retrospect, this all becomes very intertwined. This 

is tough, what you have been through; we don’t have an opportunity to talk to them, but I suspect it is tough for the doctors involved as well—— 

Mrs. LOVELACE. I am sure it is. 

29 

Mr. BURGESS. For the doctors that provided the steroid injection, 

as well as the doctors that were treating, not knowing what they 

were up against. 

Mrs. LOVELACE. I am amazed that they were ordering medicine 

from someone that had that reputation. 

Mr. BURGESS. That is part of our problem, that information may 

not have gotten to where it needed to get. 

Well, again, we appreciate your courage and your strength for 

being here, relating it to us today. It is an important part of this 

story, and I certainly look forward to what we can do for you in 

the future. Thank you. 

Mrs. LOVELACE. Thank you very much. 

Mr. STEARNS. Anyone else who wishes to ask a question? Anyone 

on this side? Short question. 

Mr. MURPHY. Just a short comment here. I thank you for being 

here because of the statement you made about the importance of 

the organizations involved that are supposed to be inspecting. 

Clearly, there is a lot of information that they knew that this 

compounding pharmacy had problems. And whatever the issue 

was, as you are keenly aware, surely you have searched so many 

times, how could someone stop and say, it is not my job, it is not 

in my job description, it doesn’t matter? It is so important that you 

hear—and I am sure it is difficult, I am sure it is tragic—but it 

is still, I thank you for having the energy for being here and help 

people put a face on this. There is a role of these agencies, and at 

no time should ever someone say, this is a gray area, I don’t want 

to overstep the boundaries, because the fact that people did that 

ended up in a tragic loss. So I thank you for having the courage 

to be here and helping to put a face on it. 

Mr. STEARNS. I thank the gentleman. 

And with that, Mrs. Lovelace, thank you very much for your testimony. 

Mrs. LOVELACE. You are welcome. 

Mr. STEARNS. And we thank our colleague Mr. Whitfield for his 

time, too. 

And with that, we will call up the second panel. 

Mr. Cadden is asked to come to the desk. 

Mr. Cadden, my understanding is that Mr. Cadden authorized 

his counsel to advise the committee that he will rely on his Constitutional right not to testify at today’s hearing. I believe that this 

privilege should be personally exercised before the members as we 

have done in the past, and that is why we have requested that he 

appear today before us. 

I request that, given the importance of his testimony, he reconsider his decision to invoke his Fifth Amendment rights, especially 

because the families of the people who have lost their lives after 

receiving a contaminated injection made by his company, the New 

England Compounding Center, those who are sick and those who 

have received injections, are waiting to see if they, too, will get 

sick, they deserve some answers today. 

Mr. Cadden, I ask you to consider, to reconsider and tell this 

committee and the people watching this hearing how this tragedy 

has happened. 

30 

STATEMENT OF BARRY J. CADDEN, PRESIDENT, CO–OWNER 

AND DIRECTOR OF PHARMACY, NEW ENGLAND 

COMPOUNDING CENTER 

Mr. STEARNS. Mr. Cadden, are you aware that the subcommittee 

is holding this investigative hearing and, in doing so, we have the 

practice of taking testimony under oath? 

Mr. CADDEN. On advise of counsel, I respectfully decline to answer on the basis of my Constitutional right—— 

Mr. STEARNS. First of all, Mr. Cadden, you just need a yes or no 

for this question. 

Mr. TERRY. Put the microphone on. 

Mr. STEARNS. Put your microphone on. So we are just asking you 

basically, you understand we have the practice of taking testimony 

under oath. You understand that. And do you have any objection 

to testifying under oath? 

Mr. CADDEN. No. 

Mr. STEARNS. The chair also advises you that, under the Rules 

of the House and the rules of the committee, you are entitled to be 

advised by counsel. Do you desire to be advised by counsel during 

your testimony today? 

Mr. CADDEN. Yes, I do. 

Mr. STEARNS. In that case, would you be so kind as to identify 

your counsel for our record. 

Mr. CADDEN. Mr. Attorney Bruce Singal and Steven Ross. 

Mr. STEARNS. And Mr. Steven Ross. 

OK, Mr. Ross do you want to come and sit at the front here? 

Mr. ROSS. We are fine. 

Mr. STEARNS. At this time, we are going to swear you in. Please 

raise your right hand, and I will swear you in. 

[Witness sworn.] 

Mr. STEARNS. Thank you, Mr. Cadden. 

I will recognize myself for the first part of the question. 

Mr. Cadden, are you the one—are you one of the owners of the 

New England Compounding Center, or NECC, the company that 

distributed contaminated injectables to medical clinics, doctor’s offices, and hospitals across this country? 

Mr. CADDEN. On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution. 

Mr. STEARNS. Mr. Cadden, 32 people have died, 400 people are 

infected, and scores of others who were injected with medicine your 

company compounded are waiting, holding their breath to see if 

they will get sick from the products you have made. 

You have been the director of pharmacy at the NECC since it 

opened. You were responsible for ensuring that the products were 

safe and sterile. Mr. Cadden, what explanation can you give the 

families who have lost their loved ones and those who are gravely 

ill for the actions of your company? 

Mr. CADDEN. Mr. Chairman, on advice of counsel, I respectfully 

decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution. 

Mr. STEARNS. The Massachusetts Board found that you released 

two lots of the injectable drugs at issue in this meningitis outbreak 

31 

before you received the lab tests as to whether the drugs were sterile. They also found black particulate matter within the injectables. 

The FDA found greenish-black matter in the vials. 

Mr. Cadden, there is no question there was a massive failure of 

sterilization at your facility. For the sake of protecting the public 

health and preventing something like this from ever happening 

again and to provide some explanation to grieving families, can you 

please tell us what was the breakdown that led to the contamination and the meningitis outbreak? 

Mr. CADDEN. Mr. Chairman, on the advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and 

privileges, including the Fifth Amendment to the United States 

Constitution. 

Mr. STEARNS. I now recognize the ranking member, Ms. DeGette, 

for questions. 

Ms. DEGETTE. Mr. Cadden, we just heard from Joyce Lovelace. 

Joyce Lovelace’s husband Eddie was the first one who was found 

to have died of fungal meningitis from one of your company’s products. He was a judge. He was a husband of 56 years. He was a father, a grandfather. He was getting ready in 2 years to leave the 

bench so he could go into law practice with his oldest granddaughter. 

And there are a number of other victims around the country now 

who have either died or become terribly ill as a result of your product. 

And the chairman talked about some of the findings that they 

found just this year in your company, the greenish-black foreign 

matter inside the vials. There were also things like a leaking boiler 

next to the clean room that created a pool of water, which creates 

a breeding ground for bacteria; an air-conditioning system that 

turned off at night despite requirements that the clean rooms had 

a consistent temperature. Your own environmental monitoring program showed violative levels of bacteria and mold in clean rooms 

between January and September of this year. 

When FDA inspectors looked at NECC’s sister company, 

Ameridose, they found the same kind of thing. They reported that 

there were insects in or near areas where sterile products were 

packaged, stored, and manufactured. They even saw a bird flying 

inside an area where there are supposed to be sterile packages. 

So I guess I would ask you—I would ask you, what do you say 

to all of these patients and all of these families that have been devastated—devastated by these contaminated products that your 

company has produced? 

Mr. CADDEN. On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges, including the Fifth Amendment to the United States Constitution. 

Ms. DEGETTE. Mr. Chairman, I think it is clear that the witness 

does intend to exercise his Fifth Amendment rights, and, with that, 

I think I will not ask any more questions. We won’t have any more 

on this side. 

Thank you. 

Mr. STEARNS. I thank the ranking member. 

32 

Let me be clear, Mr. Cadden. Again, are you refusing to answer 

the questions on the basis of the protections afforded to you under 

the Fifth Amendment to the United States Constitution? 

Mr. CADDEN. On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges. 

Mr. STEARNS. Will you invoke your Fifth Amendment rights in 

response to all questions today? 

Mr. CADDEN. Yes. 

Mr. STEARNS. Then you are excused from the witness table at 

this time. But I would advise you that you remain subject to the 

process of the committee and that if the committee needs are such, 

then we shall recall you. 

Mr. CADDEN. Thank you, Mr. Chairman. 

Mr. STEARNS. Yes. 

Now, my colleagues, we will call up the third panel. 

My colleagues, we have on the third panel Commissioner Margaret A. Hamburg. Margaret A. Hamburg became the 21st Commissioner of Food and Drug on May 18th, 2009. Prior to assuming 

her role as Commissioner, Dr. Hamburg was a senior scientist at 

the Nuclear Threat Initiative. She also served as the Assistant Secretary for Policy and Evaluation in the U.S. Department of Health 

and Human Services and as commissioner of the New York City 

Department of Health and Mental Hygiene. 

We also have the interim commissioner, Lauren A. Smith. 

Lauren A. Smith has been the interim commissioner of the Massachusetts Department of Public Health since October 25th, 2012. 

And prior to assuming that position, Dr. Smith served as the medical director and chief medical officer of the department. 

Let me welcome you to the committee. And let me ask you, you 

are aware that the committee is holding an investigative hearing, 

and when doing so, it has had the practice of taking testimony 

under oath. Do either one of you have an objection to taking testimony under oath? 

Ms. HAMBURG. No. 

Ms. SMITH. No. 

Mr. STEARNS. The chair then advises you that under the rules of 

the House and the rules of the committee, you are entitled to be 

advised by counsel. Do you desire to be advised by counsel during 

your testimony today? 

Ms. SMITH. No. 

Ms. HAMBURG. No. 

Mr. STEARNS. In that case, if you would please rise and raise 

your right hand, I will swear you in. 

[Witnesses sworn.] 

Mr. STEARNS. You are now under oath and subject to the penalties set forth in Title 18, Section 1001 of the United States Code. 

You may now give a 5-minute summary of your written statement. 

Dr. Hamburg? 

33 

STATEMENTS OF MARGARET A. HAMBURG, COMMISSIONER, 

FOOD AND DRUG ADMINISTRATION, AND LAUREN SMITH, 

INTERIM COMMISSIONER, MASSACHUSETTS DEPARTMENT 

OF PUBLIC HEALTH 

STATEMENT OF MARGARET A. HAMBURG 

Ms. HAMBURG. Mr. Chairman and members of the subcommittee, 

I am Dr. Margaret Hamburg, Commissioner of the Food and Drug 

Administration. And I am joined by Howard Sklamberg, Deputy 

Associate Commissioner for Regulatory Affairs. 

Thank you for this opportunity to testify about the tragic fungal 

meningitis outbreak associated with an injectable steroid product 

distributed by NECC and for our safety concerns related to 

compounding and the legislation that is needed to prevent such incidents from happening again. 

I want to begin by offering my deepest sympathies to the patients affected by this outbreak and their families. This event has 

had devastating effects on patients across the country, such as 

Eddie Lovelace, Judge Lovelace, many of whom were likely unaware that they were being treated with a compounded product not 

reviewed or approved by the FDA. 

Our foremost goal is the protection of the health of the public. 

Since the onset of this outbreak, we have targeted FDA resources, 

from experts in our headquarters to inspectors and scientists in 

district offices and labs across the country, to do everything we can 

to stem the toll of this terrible event. Together with CDC and the 

States, we have sought to identify potentially contaminated products and ensure that they are removed from the market and do not 

reach patients. We have collected and analyzed hundreds of samples from the relevant firms, as well as from medical facilities and 

State and local agencies, to isolate the cause and determine the extent of the contamination. 

We are working daily to ensure timely, clear, and accurate information is disseminated about the findings of our investigation, 

what products are affected, and what providers should do with any 

products still on their shelves. And we are working to alleviate existing drug shortages exacerbated by product recalls. 

We have also been reviewing actions taken in the past with regard to NECC. From our review thus far, we have no reason to believe that any of the specific actions in question, a more timely 

issuance of the 2006 warning letter, or inspectional follow-up, 

would have prevented this recent tragedy. 

What we do know is that stronger, clearer authority would enable more effective regulation of the drug-compounding industry, 

especially when it has been evolving so significantly. As it is, our 

authority over compounding is limited, unclear, and contested. And 

in the face of differing views in Congress and the courts about 

FDA’s authority and continuing challenges by industry, the agency 

has struggled with how to chart an effective course to protect the 

public health. 

We recognize that traditional compounding provides an important service for patients who, for example, can’t swallow a pill or 

are allergic to an ingredient in a drug product. But the industry 

has evolved well beyond the neighborhood pharmacist. In parVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00037 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
34 

ticular, the movement by many hospitals to outsource pharmacy 

compounding has created a market for compounding operations 

that produce drugs that reach far larger numbers of patients. 

When these facilities operate well, they may serve an important 

function in terms of safety and efficiency. However, when they fail 

to follow safety and quality standards, many patients may be 

harmed. 

Our best information is that there are thousands of other 

compounders out there producing what should be sterile products 

made to exacting standards, and, thus, many other firms with the 

potential to generate a tragedy like this. 

The current oversight framework, in attempting to draw a bright 

line between compounders and manufacturers, fails to address the 

complex issues raised by a changing industry. Additionally, gaps 

and ambiguities in the law have hampered our ability to act to protect patients and to prevent rather than just react to safety concerns. 

I am committed to working with Congress and other stakeholders 

to design a system of rational, risk-based regulation that takes into 

account both the Federal and the State roles. As I outlined in my 

testimony, we have developed a proposed framework that would 

tier the degree of oversight to the risk posed by the type of product 

and practices. Traditional compounding would remain the purview 

of the States. The higher risk posed by nontraditional compounding 

would be addressed by Federal standards, including standards for 

quality control. 

And under this framework, certain products carrying the highest 

risk could not be compounded. They could only be produced by entities willing to meet the standards currently required of drug manufacturers. 

We would like to explore with you authorities that would be important to support this new regulatory paradigm, including clear 

authority to access records, mandatory reporting of adverse events, 

additional registration requirements to facilitate appropriate oversight and coordination with State regulators, clear label statements 

to allow prescribers and consumers the opportunity to make informed judgments, and adequate funding to support the inspections 

and other oversight activities outlined in this framework. 

And because a key piece of any plan involving oversight of pharmacy compounders will continue to be performed at the State level, 

we must work closely with our State partners as we develop the 

framework for new authorities. Consequently, FDA will be inviting 

representatives from all 50 States to participate in a full-day meeting on December 19th to facilitate these important discussions. 

We have a collective opportunity and responsibility to help prevent future tragedies. If we fail to act, this type of incident will 

happen again. It is a matter of when, not if. If we fail to act now, 

it will only be a matter of time until we are all back in this room, 

sadly, asking why more people have died and what could have been 

done to prevent it. 

I am happy to answer any questions you may have. 

Mr. STEARNS. I thank you. 

[The prepared statement of Ms. Hamburg follows:] 

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Mr. STEARNS. Dr. Smith, for your summary of your opening 

statement? 

STATEMENT OF LAUREN SMITH 

Ms. SMITH. Thank you, Chairman Stearns, Ranking Member 

DeGette, and members of the committee. Thank you very much for 

having me here today. My name is Dr. Lauren Smith, and I am the 

interim commissioner of the Massachusetts Department of Public 

Health. 

I have to also begin by saying that my thoughts are with the victims and families affected by this tragic outbreak and with Mrs. 

Lovelace, whose moving testimony only strengthens my resolve to 

ensure that no other family has to suffer what she aptly described 

as the heartbreak that hers has. As a mother, a pediatrician, and 

a public health leader, I have devoted my life and career to protecting the health of others. These events evoke in me the same 

sense of outrage as they do for you and the rest of the public. For 

many of you, I know this hits very close to home. 

For the past 2 months, our department, along with the FDA, has 

conducted a joint investigation of New England Compounding Center, the source of this devastating fungal meningitis outbreak that 

has sickened hundreds and killed 31 people across the country. We 

have also investigated and shut down NECC’s sister company. 

NECC knowingly disregarded sterility tests, prepared medicine 

in unsanitary conditions, and violated their pharmacy license, endangering thousands of lives as a result. NECC bears the responsibility for the harm that they have caused with these actions. 

I was given the responsibility, as interim commissioner, less than 

3 weeks ago to lead my department through this crisis, and, like 

you, I have been trying to put together the pieces of the puzzle. 

First licensed by Massachusetts in 1998, NECC and its owner, 

Barry Cadden, have since been the subject of numerous complaints, 

resulting in a series of investigations by the State and the FDA. 

These investigations led to the Board of Pharmacy’s proposed reprimand and probation in 2004. This proposal was inexplicably 

weakened in 2006, allowing NECC to continue to operate without 

disciplinary actions, pending an independent evaluation of its 

progress under a consent agreement. The Board of Pharmacy’s failure to take decisive disciplinary action in 2006 on these complaints 

has contributed to these tragic events. 

In April of 2006, the Board of Pharmacy’s staff learned that the 

principal of PSI, the evaluator for NECC, had been convicted of 

Federal crimes that resulted in 18 people being blinded. However, 

the staff did not share this information with board members before 

they accepted the report from PSI validating NECC’s compliance 

with the consent agreement. These same staff members failed to 

act on a July 2012 report from the Colorado Board of Pharmacy 

that NECC had violated both Colorado and Massachusetts pharmacy regulations. These staff have been removed from their jobs. 

Poor judgment, missed opportunities, and a lack of appropriate 

action allowed NECC to continue on this troubling path. We acknowledge that these lapses—some of which were preventable, but 

all are unacceptable. 

52 

From the early days of this outbreak, our department has acted 

swiftly and decisively. We secured a surrender of NECC’s license, 

shut down its operations, and forced a total recall of all NECC 

products. We moved to permanently revoke NECC’s license as well 

as the licenses of the three principal pharmacists who oversaw 

their operations. We also secured the suspension of operations of 

Ameridose and Alaunus, two other drug manufacturers owned by 

Barry Cadden, which, as you know, have been found to have similar substandard practices. 

While taking these strong and necessary actions, we have reexamined our own State regulations regarding compounding pharmacies. Although our regulations are comparable to those in most 

States, they need to be strengthened to address the realities of this 

evolving industry. 

On November 1st, Massachusetts enacted a series of emergency 

regulations to bring greater scrutiny to this industry and require 

sterile compounding pharmacies to report both volume and distribution information to us. Licensed pharmacies will also have to 

report when they are the subject of any State or Federal investigations. We have also begun unannounced inspections of all sterile 

compounding pharmacies in Massachusetts. Teams are conducting 

these inspections even as we speak. 

To further strengthen our oversight over sterile compounding 

pharmacies, we must explore changes to the law. We have created 

a special commission to review best practices in other States and 

to identify stronger mechanisms for oversight for these pharmacies 

in Massachusetts. 

As we work to raise standards in our State, we urge Congress 

to act to strengthen Federal oversight. Congressman Markey’s 

leadership on this issue is laudable and would address some of the 

regulatory black holes that exist between State and Federal oversight. 

As a pediatrician who has cared for acutely ill children and their 

families for almost 20 years, I must say that I understand the trust 

that patients place in our healthcare system. We must use these 

tragic events as an impetus to work together—public health leaders, public health officials, and legislators—to institute reforms to 

restore this trust and to ensure that something like this does not 

ever happen again. 

We will keep the victims and their families always in our 

thoughts—they are not numbers, they are not statistics, but real 

people with real lives—as we work to identify responsibility and to 

implement policies and practices that can be effective and lasting. 

Thank you. I appreciate the committee’s interest in this matter, 

and I am grateful to you for acting so swiftly to have us come here 

to discuss it. 

[The prepared statement of Ms. Smith follows:] 

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Mr. STEARNS. Thank you, Dr. Smith. 

Commissioner Hamburg, the title of this hearing is ‘‘The Fungal 

Meningitis Outbreak: Could It Have Been Prevented?’’ 

Now, your testimony is 16 pages long. There is one sentence on 

FDA oversight on the New England Compounding Center prior to 

the outbreak. Now, this was—this is an investigative hearing. This 

was a complete and utter failure on the part of your agency and— 

Dr. Smith in her testimony admitted—and the State Board of 

Pharmacy. The committee’s memorandum that we did, we had 25 

pages laying this out. Yet you devoted just 1 sentence of your 16 

pages in your opening statement that even talked about this oversight. 

Over the years, the FDA repeatedly—repeatedly documented numerous problems at the NECC. Many of these problems are similar, if not identical, to the same problems which caused this outbreak. The agency ultimately issued a warning letter in 2006, 6 

years ago, stating that if the company did not alter its practices, 

FDA would seize its product or issue an injunction and effectively 

shut down NECC. 

Now, we heard Dr. Smith; you heard her testimony this morning. 

She talked about the mistakes they made and what they are going 

to do to correct it. You are here with your opening statement, you 

are practicing plausible deniability is what you are practicing. 

When FDA issued the 2006 warning letter, did FDA have the authority to do what it said—namely, seize the drugs and shut down 

the committee—the company? Yes or no? 

Ms. HAMBURG. I think it is important—the fact is—— 

Mr. STEARNS. No, the question is, did you have the authority—— 

Ms. HAMBURG [continuing]. The one letter did not involve sterility failures, and it was not in relation to the kinds of problems 

that we are addressing now. 

Mr. STEARNS. So you are saying your letter was an empty threat? 

Ms. HAMBURG. You know, I think one of the great challenges—— 

Mr. STEARNS. No, the real question is, did you think you had the 

authority—— 

Mr. WAXMAN. It wasn’t her letter. 

Ms. DEGETTE. It wasn’t her letter. 

Mr. STEARNS. Well, not your letter, personally, but—— 

Ms. HAMBURG. I think it is important to understand that I was 

not at—— 

Mr. STEARNS. No, I understand that and I appreciate that. 

Ms. HAMBURG [continuing]. The FDA at the time and that—— 

Mr. STEARNS. And I am just staying that the frustration we have 

is—— 

Ms. HAMBURG [continuing]. The warning letter and the inspection it was based on had to do with a different set of complaints 

than sterility failures—— 

Mr. STEARNS. Let me rephrase the question. Do you think the 

FDA had the authority to shut down NECC? Yes or no? 

Ms. HAMBURG. I think that is a very, very complex question and 

that the legal framework—— 

Mr. STEARNS. So you can’t answer that question now? 

Ms. HAMBURG [continuing]. For FDA activities is—— 

Mr. STEARNS. OK, let me ask another question. 

61 

Ms. HAMBURG [continuing]. Very, very unclear—— 

Mr. STEARNS. If you are not going to answer this question—— 

Ms. HAMBURG [continuing]. Contested, and limited. 

Mr. STEARNS. [continuing]. Let me ask you—— 

Mr. WAXMAN. May she answer the question? 

Mr. STEARNS. Well, she is not answering the question, Mr. Waxman. 

Mr. WAXMAN. She is trying. 

Mr. STEARNS. Well, I had asked her ‘‘yes or no,’’ and she won’t 

answer the question. 

Ms. DEGETTE. She can’t. 

Mr. STEARNS. This is my—my questions can be asked. You can 

ask your question. 

Ms. HAMBURG. You know, I think that the answer to your question is that, even on much smaller regulatory actions, the FDA authority to act was contested. Even going into NECC to do that inspection in 2004—— 

Mr. STEARNS. OK. Let me interrupt you—— 

Ms. HAMBURG [continuing]. We did not get access to the records 

immediately. 

Mr. STEARNS. I am asking the questions, and I only have so 

much time. 

You issued the letter in 2006. You said you were going to shut 

it down if they didn’t improve on their quality assurance. Was that 

an empty threat? 

Ms. HAMBURG. The—— 

Mr. STEARNS. Did the FDA think they had the jurisdiction, they 

had the responsibility to shut it down? 

Ms. HAMBURG. The warning letter concerned, first and foremost, 

an issue that had to do with making copies of a commercially available drug. 

Mr. STEARNS. We have a different interpretation—— 

Ms. HAMBURG. It was a different issue. 

Mr. STEARNS [continuing]. Of my question. Let me interrupt you 

and ask you another question. 

When the FDA inspected the NECC in 2002—that is 10 years 

ago—there was evidence that people had been infected by contaminated NECC products. Some of those people were experiencing 

meningitis-like symptoms. 

What proof did the company provide then that it had corrected 

these problems? 

Ms. HAMBURG. Well, as I think you understand from the documents we provided and the information that has been discussed, it 

was—we went in and we found problems, and we worked closely 

with the Massachusetts Board of Pharmacy to address them. But 

it was determined that the primary responsibility for overseeing 

NECC was Massachusetts because they were operating as a compound pharmacy—— 

Mr. STEARNS. So you were deferring to the State of Massachusetts? 

Ms. HAMBURG. Well, we worked with the State. We—— 

Mr. STEARNS. OK. 

Ms. HAMBURG [continuing]. Tried to provide help and assistance. 

Mr. STEARNS. All right. 

62 

Ms. HAMBURG. But the responsibility for assuring—— 

Mr. STEARNS. So it is not your job; it is the State of Massachusetts’. OK. 

Ms. HAMBURG [continuing]. Compliance with sterility issues was, 

in fact—— 

Mr. STEARNS. Let me ask this last question. 

Ms. HAMBURG [continuing]. Not our direct responsibility. 

Mr. STEARNS. Before the current outbreak, the last time FDA inspected the NECC was in January of 2005, which led to the warning letter. The warning letter stated that FDA may conduct followup inspections to ensure that the NECC was in compliance. 

There was not a single follow-up inspection that occurred after 

2005; is that correct? Yes or no? 

Ms. HAMBURG. That—— 

Mr. STEARNS. Do you want me to repeat the question? There was 

not a single follow-up inspection that occurred after 2005. 

Ms. HAMBURG. We did not do—— 

Mr. STEARNS. OK. 

Ms. HAMBURG. Again, I have to—— 

Mr. STEARNS. OK. That is a ‘‘yes.’’ 

Ms. HAMBURG [continuing]. Make clear that I was not 

present—— 

Mr. STEARNS. All right, let me finish. 

Ms. HAMBURG [continuing]. At the FDA at the time. 

Mr. STEARNS. After noting—— 

Ms. HAMBURG. And it is my understanding—— 

Mr. STEARNS. OK. 

Ms. HAMBURG [continuing]. And I cannot speak—— 

Mr. STEARNS. OK. 

Ms. HAMBURG [continuing]. To all of the issues that were involved there, but—— 

Mr. STEARNS. You are taking my time. Let me finish. 

After noting violations upon violation—violations upon violation 

in 2002 through 2005, why did the FDA feel confident that the 

NECC would correct its violations and obey the law? I mean, you 

had from 2002 to 2005 all these violations. What made you think 

that they would correct them? And not you, personally; I understand you weren’t there. 

Ms. HAMBURG. With respect to the first violations concerning the 

sterility issues, those were very serious concerns. We acted aggressively, in partnership with the State of Massachusetts. 

But the day-to-day responsibility for overseeing the practice and 

remediating the sterility failures were taken on by the State of 

Massachusetts, who had the primary day-to-day oversight of this 

compounding pharmacy. A consent decree was reached in 2006, 

and we had understood, as had the Massachusetts Board of Pharmacy, that they were appropriately addressing those sterility concerns. 

We had gone in in relation to a different complaint from a company about the copying of an FDA drug. And in that instance—we 

went in in relation to the manufacture of a specific product, trypan 

blue—it was not an issue of sterility failure or the conditions in the 

facility, but it was a practice that we felt they should not be pursuing, and that was what we were trying to address. 

63 

Mr. STEARNS. My time has expired, and I recognize the ranking 

member from Colorado, Ms. DeGette. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Dr. Hamburg, I want to try to clarify what is going on here, so 

I would appreciate short answers also. 

Now, most of the FDA inspections into this manufacturer, NECC, 

were about 10 years ago, correct? And that was under the FDA 

under the Bush administration, correct? 

Ms. HAMBURG. That is correct. 

Ms. DEGETTE. OK. Now, in 1997—I was actually here then—the 

FDA Modernization Act excluded the small—well, it excluded drug 

compounders, for the most part; is that correct? 

Ms. HAMBURG. That is correct. If a pharmacy was operating in 

accordance with certain conditions, then they were excluded. 

Ms. DEGETTE. So the FDA didn’t have authority over those types 

of compounders, correct? 

Ms. HAMBURG. That is correct. 

Ms. DEGETTE. So after the 1997 act was passed, when the FDA 

received complaints about drug compounding, it had to go over the 

hurdle of determining whether those conditions had been met or 

not before the FDA was determined to even have authority; is that 

correct? 

Ms. HAMBURG. Correct. 

Ms. DEGETTE. So what happened here is that the FDA was contacted in 2002 about some problems. They went into NECC, they 

found some problems, and there was a whole series of investigative 

efforts after that, correct? 

Ms. HAMBURG. Yes. 

Ms. DEGETTE. And one of the issues in this case and in other 

cases was whether the FDA even had authority to be investigating 

complaints, whether or not this particular manufacturer fell under 

the appropriate criteria, right? 

Ms. HAMBURG. With respect to the public health threat that was 

identified in 2002, we went in and aggressively investigated and 

worked with the State of Massachusetts to get those contaminated 

products recalled to prevent ongoing damage to patients. Then, because this was a compounding pharmacy, with the primary responsibility for oversight resting with the Massachusetts State Board of 

Pharmacy, they were responsible for the efforts—— 

Ms. DEGETTE. ‘‘They’’? Who is ‘‘they’’? 

Ms. HAMBURG. The Massachusetts State Board of Pharmacy. 

Ms. DEGETTE. Massachusetts was primarily responsible because 

it was a compounding pharmacy, right? 

Ms. HAMBURG. Because it was a compounding pharmacy. 

Ms. DEGETTE. OK. So, in other cases, not particularly NECC but 

in other cases, when the FDA tried to assert jurisdiction over 

compounding pharmacies in similar situations, they were actually 

sued in court, the FDA was sued in court by these companies, saying the FDA didn’t have jurisdiction over these pharmacies, correct? 

Ms. HAMBURG. That is correct. 

Ms. DEGETTE. And, in fact, there is a court case that covers part 

of the whole country that says the FDA doesn’t have jurisdiction; 

is that right? 

64 

Ms. HAMBURG. The challenge we have today is that there is a 

patchwork of legal authorities that really oversee the regulatory actions that we can take. We have a split circuit court decision. There 

is a map that we have that shows that, you know, unfortunately, 

we have unclear, fragmented legal regulatory frameworks that 

make it very hard to understand how best to exercise enforcement. 

Ms. DEGETTE. Well, and so if you have an emergency like this, 

if you have an emergency like this, sometimes what you are afraid 

of is—you are going to act aggressively, but you are afraid that you 

are going to be hauled into court. And that is why oftentimes you 

go to the State regulatory agency; is that correct? 

Ms. HAMBURG. Absolutely. The fact that we have unclear, limited, and contested authorities and ambiguities in the law and a 

crazy quilt of legal authority has required us to be very reactive, 

responding to those serious public health threats, and selective. 

And, of course, every effort is resource-intensive, as you say, and 

often will end up in litigation. 

Ms. DEGETTE. OK, so let me ask you this: If Congress clarified 

what we meant in the 1997 act with these large compounding 

pharmacies, that we, yes, indeed, intend to give the FDA jurisdiction, that will help you be able to protect these patients better by 

either doing inspections to prevent these problems in the first place 

or by requiring quick recalls; is that correct? 

Ms. HAMBURG. Absolutely. 

Ms. DEGETTE. Thank you. 

Ms. HAMBURG. We clearly need additional authority. 

Ms. DEGETTE. I just want to ask a really quick question of Dr. 

Smith. 

I really appreciate the efforts that you are making since you took 

over. But, again, most of these things that happened—in fact, all 

of these things that happened—happened before your tenure, Dr. 

Smith. 

And I guess I would like to know—and in reading all the documents and all of the history of this, it is obvious to me that the 

ball was dropped, and dropped in a big way, by the Massachusetts 

regulators. And so my question is, what is Massachusetts doing 

now to make sure this never happens again? 

Ms. SMITH. Well, I agree with you that there were certainly 

missed opportunities and lapses of judgment that demonstrate significant irresponsibility. And we have taken action with the staff 

that demonstrated that. 

In terms of what we are doing now, I think the highlight would 

be the enactment of the emergency regulations, importantly, which 

would require sterile compounding pharmacies to produce information regarding volume and distribution—the volume issue being so 

important because if you are making numerous batches, thousands 

of vials of material, then effectively you are acting more like a 

manufacturer than the more traditional compounder. 

We also require pharmacies to provide information on any State 

or Federal investigations that concern them. That would allow us 

to have known that your State’s board of pharmacy had, in fact, 

issued a cease-and-desist to NECC in April of 2011 for this same 

issue of providing bulk prescriptions that were not patient-specific. 

65 

And, lastly, we have done the—convening a special commission 

to really understand what are the best practices in strengthening 

the oversight of this evolving industry. 

We clearly are committed to making sure that this doesn’t happen again, and we want to do everything in our power to do that. 

Ms. DEGETTE. Thank you. 

Thank you very much, Mr. Chairman. I appreciate your indulgence. 

Mr. STEARNS. The chairman of the full committee, Mr. Upton, 

the gentleman from Michigan. 

Mr. UPTON. Thank you, Mr. Chairman. 

I just want to remind all of us here that this committee has a 

very long tradition, even before John Dingell, of working with 

strong members to identify problems in this country, to expose 

that, and then coming back with legislation to fix it so it doesn’t 

happen again. 

And one of those, as we all review this case and see what was 

there—the recent inspection, the visible black particulate, the 

tacky mats, the leaking boiler, the bird flying around—I mean, it 

is just, what gives? I mean, if this was found just recently—and it 

is our understanding that there were similar types of contamination in earlier years—what is the problem without—what is the 

problem by not shutting down something like this until it is corrected? 

And if you don’t have the authority, then we need to make sure 

that it is there. And it seems pretty reasonable to me that, in fact, 

you did have the authority to not only have unannounced inspections but to come in and correct it so that it didn’t get to this stage. 

Certainly, with the deaths of people across the country and the 

questions that are raised today, as part of the tradition of this committee, we have to have the right information to find out if something is off track or whatever. 

And I guess one of the concerns that I have is that, in a bipartisan letter that was sent nearly a month ago, we asked the FDA 

for documents, for internal communications, to find out what discussions were going on, what was the feedback from the company. 

And it is my understanding that to date we have some emails that 

have come back but not anywhere close to what we ought to have 

as we really try to move an investigation forward and try to get 

to the very bottom of this and make sure that it never can happen 

again. 

And I would ask Commissioner Hamburg if we can have a commitment from you, as it relates back to the letter that we sent on 

October 17th, that we get the full cooperation from your staff so 

that we can come back and ask questions and really try to get to 

the bottom of this to identify where are the problems. Because, 

clearly, they were there, right? 

Ms. HAMBURG. We will work very hard with you. We appreciate 

the work this committee is undertaking. We have tried to get you 

documents in a timely way. We have, you know, so far been able 

to get you—— 

Mr. UPTON. Not very many. 

Ms. HAMBURG [continuing]. You know, the 2,000 pages of documents. But, unfortunately, we are also pursuing the active public 

66 

health investigation response, and many of the same people that 

are involved, have the right expertise and knowledge of the issues, 

are working on that at the same time that we are trying to get you 

that information. 

And of course, as Congresswoman DeGette pointed out, this concerns activities, some of it going back many years to a different administration and different employees at the FDA. So we are going 

through, trying to get all those documents, and we will be continuing to provide you with the information you have requested. 

Mr. UPTON. Well, I just want to say, I had a long discussion last 

month during the break with my colleague from Michigan, Mr. 

Dingell. Very frustrated about what was going on. Wanting to get 

to the bottom of this, wanting to make—you know, as we all think 

about the FDA’s proper role, I mean, this would be it. I mean, as 

we all identify facilities in our own districts—I know that when I 

go visit, it is clean as a whistle. It really is. The people are proud 

to have the jobs that they have. It is as sterile as you can imagine. 

And I can’t, you know, for the life of me, as we read about this 

information from eyewitness accounts and inspections that were 

there before, and to have it go on and on and on without a followup, without—I mean, that is not—that is not what anyone is expecting the FDA to do. When you find this stuff, it needs to stop. 

And, as Americans, we demand that for manufacturing here. We 

also expect it to happen overseas. And your inspections in China 

and other places, that the products that are being produced are 

safe, not only for Americans but all humans. And when we—you 

know, we get terribly frustrated. 

I know you tried to call me yesterday afternoon. It was my first 

day back. And we are going to continue to communicate, I can assure you. 

But we want to get to the bottom of this. We want to find out 

what really did break down and where are the questions that have 

to be answered so that, in fact, you do have the baseball bat to go 

after these companies that are—it is not right. And this is not 

going to be the last hearing, because we don’t have the information 

that we need to proceed. 

So I would like to get just—I know my time is expiring, but we 

would like to get a commitment from you that, in fact, you will be 

totally responsive to the questions that are asked by Republicans 

and Democrats so that we can figure out where this train got off 

the track so that we can put it on and we can assure every person 

in this country that, in fact, the FDA is working as it should. 

And we shouldn’t have to hear the stories that we did earlier this 

morning with Mrs. Lovelace and our constituents, whatever State 

that they are in. And I would like to get that from you and just 

assure you that we are not—this is not a one-time deal. We are 

going to get to the bottom of it. 

Ms. HAMBURG. You have my absolute commitment that we will 

continue to work with you and all of your requests for additional 

information. 

You have also touched on a very important point that I want to 

underscore, though, which is that we have responsibilities for oversight of manufacturers and drug facilities in this country and 

around the world, but our authorities to provide oversight of drug 

67 

manufacturers is very different than our authority to oversee 

compounding pharmacies, which are, in fact, exempted from important aspects of FDA law. 

And there is, you know, this disconnect between different legal 

requirements in different parts of the country, as well. We have 

ambiguous, fragmented, unclear, and contested authorities in this 

particular realm of pharmacy and drug manufacturing practice. 

And that is what our opportunity is now and what our responsibility, I think, is, to work together to really create new legislative 

authority that defines the best approaches, that gives us the broader authorities that we need to address this growing arena of what 

we call ‘‘nontraditional compounding’’ that involves larger volume, 

more complex products, including sterile products, and broader distribution, potentially putting more patients at risk. 

And there are gaps in the oversight authorities of the States, 

who have primary responsibility for overseeing compounding pharmacies, and the FDA. And we need to make sure that we have a 

seamless system that protects patients. 

Mr. STEARNS. The gentleman from California, Mr. Waxman, is 

recognized for 5 minutes. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

I want to commend Chairman Upton for his statements and his 

questions because I think this committee needs to respond on a bipartisan basis. 

And I think we need to correct the law, and we ought to try to 

do it before we leave at the end of this year for this simple reason: 

When you get into the next year, some of these interest groups are 

going to gear up to stop legislation. They will say that we really 

don’t need to have the FDA look at these compounders. FDA regulates the manufacturers, but the compounders are going to be regulated at the State level. 

Now, you are being criticized, Dr. Hamburg, as the head of the 

FDA, for the problems that were primarily the responsibility of the 

State of Massachusetts. And often we hear on this committee, ‘‘We 

ought to let the States handle things, not the Federal Government.’’ 

In fact, I want to express some sympathy for you at FDA because 

you are in a no-win situation. When the FDA asked for more data 

to determine whether a drug is safe and effective, or takes enforcement action for violations of good manufacturing practices, the 

agency is accused of being a job-killer, an over-regulator. But now 

when something terrible happens, we hear that something went 

wrong and everybody is quick to jump on you for not doing enough. 

Now, if we expect you to do more, we better be sure that the statutory law gives you enough authority to do your job, if we want you 

to do the job and not the State to do the job. 

And let me be very critical of the State. The State of Massachusetts dropped the ball. They entered into a consent decree with the 

company and said—it was a weaker consent decree than they originally started with, and said, oh, you ought to get an independent 

inspector. So the company hired an independent inspector. And 

then the independent inspector came back and said, everything is 

fine. And then there were questions about whether this was really 

an inspector that was independent, which is a good thing to keep 

68 

in mind when we say, let the companies decide who to pick to investigate themselves. 

So let’s look at what we can do now. How many compounding 

pharmacies are there in the United States? 

Ms. HAMBURG. You know, we don’t know the exact number because they are not required to register, and so, you know, we are 

really uncertain. But there are thousands of pharmacies that do 

compounding. We think that there are about 7,500 pharmacies that 

do more so-called advanced compounding and about 3,000 facilities 

that are doing sterile compounding. 

Mr. WAXMAN. Now, compare that to manufacturers where there 

is no question that you have the jurisdiction to inspect them and 

to approve their drugs and to recall their drugs. How many manufacturers are there—manufacturing facilities compared to the 

compounding facilities? 

Ms. HAMBURG. You know, there are about 5,600 manufacturers 

that we provide oversight for, including regular inspections. And 

there is a broader array of facilities that we also oversee in that 

context. 

Mr. WAXMAN. Well, in 1997 Congress attempted to codify an 

FDA regulatory system with respect to these compounding pharmacies, but then the Supreme Court later invalidated a part of that 

law, raising the question of whether the rest of the law is still in 

force. 

Some have argued the FDA still has the ability to cobble together 

other authorities to act to prevent this tragedy caused by NECC. 

I don’t know if that was a realistic possibility or not. What I do 

know is that, at the very least, there is a dangerous lack of clarity 

in FDA’s authority here, and we should fix that. 

Do you think there is a lack of clarity? 

Ms. HAMBURG. I think there is an enormous lack of clarity, and 

I think we should seize this opportunity to address it. We—— 

Mr. WAXMAN. What authority and enforcement tools does the 

FDA need to better enable you at the FDA to take effective action 

when you discover problems at compounding pharmacies? 

Ms. HAMBURG. Well, we feel that there needs to be a risk-based 

framework that enables us to play our critical role in overseeing 

drugs that are going to the American people. Compounding has an 

important role in addressing medical needs, and traditional 

compounding is probably best overseen at the level of the State, 

though it should always be undertaken by a licensed pharmacist or 

physician and in accordance with a prescription for a patient for a 

specific medical need. 

Mr. WAXMAN. We—— 

Ms. HAMBURG. But there is this area of nontraditional 

compounding, where we think really there needs to be focused attention and new legislation. 

Mr. WAXMAN. Now, all pharmaceuticals that are compounded 

don’t need to be regulated by the FDA, because the traditional way 

we think of it is a pharmacist putting together a prescription for 

somebody who has a special need. But now we have an example of 

a company that is shipping it all over the country. They are making a drug and they are shipping—they are like a manufacturer of 

the drug. 

69 

What we need from you is very specific authorities that you must 

have to be able to deal with this. And the second thing we need 

to recognize is your budget. Because if we give you authority and 

there are thousands of compounding pharmacies, your agency I 

can’t imagine has the resources to regulate every single one of 

them, and we need to—you need to rely on the States to complement the FDA’s oversight. Is that a fair statement, that you rely 

on the States? 

Ms. HAMBURG. That is a fair statement. 

And with respect to the authorities, I did outline in the testimony. But we clearly believe that for nontraditional compounders 

there should be Federal standards that would establish basic safety 

measures, including sterility controls. Could be enforced by the 

State or by the FDA, but those need to exist. 

Then we need standards, new authorities around registration, so 

we know who is out there and what they are making. We need to 

be able to review records—— 

Mr. WAXMAN. Let me—you are absolutely right. 

And I want to say to Chairman Upton and, for the record, all the 

members of this committee that we need to get this information. 

We have to get the right balance. We ought to do it before we leave 

at the end of the year and make it very clear that we are not just 

saying, ‘‘You are at fault, you are at fault, somebody else is at 

fault.’’ We are going to be held responsible, as Members of Congress, to make sure the law is clear and that the agency has the 

ability and resources to do the job that everybody expects you 

should have done. And we want to make sure that you are able to 

do it. 

Thank you, Mr. Chairman. 

Mr. STEARNS. The gentleman’s time has expired. 

The gentleman from Texas is recognized for 5 minutes. 

Mr. BARTON. Thank you, Mr. Chairman. 

I mean, we have a tragedy of significant proportions here. Thirtytwo people have died; probably more will. We have a bipartisan investigation before this subcommittee. And we understand that, you 

know, business as usual is not acceptable. 

Having said that, apparently the FDA has decided this is something that they can use to be able to get more authority to regulate 

or inspect certain transactions that compounding pharmacies do. If 

there really is a lack of regulatory authority at some level, then 

that is a legitimate policy recommendation. But if there is not a 

lack of regulatory authority in existence in State and Federal law 

right now, then it is unnecessary. 

And my first question is to both Dr. Hamburg and Dr. Smith. 

Are you all both stating that under current State and Federal law 

neither the State nor the FDA had the authority to seize these 

drugs or to shut this company down? 

Ms. HAMBURG. I think it is important to understand—— 

Mr. BARTON. I want a—I don’t need a long—I think it is important. If the State of Massachusetts doesn’t have the authority and 

the FDA doesn’t have the authority, that is one thing. But we have 

a warning letter, 2006, issued by the FDA. Now, this is before you 

were the Commissioner. It says, ‘‘Failure to promptly correct these 

deviations may result in additional regulatory action without furVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00073 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
70 

ther notice, including seizure or injunction against you and your 

firm.’’ So, in 2006, in the FDA’s warning letter, it was the thought 

at that time that the FDA had sufficient authority. 

And Dr. Smith, on behalf of the Massachusetts—she has only 

been on the job 3 weeks, so we can’t hold her liable for what happened, you know, 10 years ago, 6 years ago, 7 years ago. But I 

don’t think there is any question that if Massachusetts felt there 

was a violation, they had the authority to shut it down. 

So, you know, I think we ought to work on using the authority 

that we have, as opposed to trying to get additional authority at 

the Federal level. 

The FDA went in and inspected this particular company on at 

least two different occasions and, as far as I can tell, other than 

issuing one warning letter, didn’t do anything at all. 

Ms. HAMBURG. The truth is that in the initial inspections, we 

worked very closely with the Massachusetts Board of Pharmacy, 

which has the responsibility for licensure and oversight on a dayto-day basis of compounding pharmacies, but—— 

Mr. BARTON. So, again, go back and answer my question. 

Ms. HAMBURG [continuing]. We acted to make sure that the contaminated product was recalled and not continuing to put people 

at risk. Our first priority was—— 

Mr. BARTON. So you are saying the FDA did have the authority 

or did not have the authority? 

Ms. HAMBURG. We worked closely with Massachusetts, who 

had—— 

Mr. BARTON. Can you ever give a straight answer to the question? 

Ms. HAMBURG [continuing]. The primary responsibility for the 

oversight of that facility. 

Mr. BARTON. Either you do or you don’t. 

Ms. HAMBURG. I think, you know, what is very clear is that—— 

Mr. BARTON. What is very clear is that you don’t want to answer 

the question. 

Ms. HAMBURG. No, it is complicated, and that is reflected here. 

But the responsibilities are different. What FDA has clear and 

strong responsibility for and oversight of—— 

Mr. BARTON. Let me ask Dr. Smith. 

Ms. HAMBURG [continuing]. Is drug manufacturers. 

Mr. BARTON. Dr. Smith, does your State—— 

Ms. HAMBURG. These are held to a different standard. 

Compounding pharmacies are—— 

Mr. BARTON. Does your State agency have the authority to shut 

this company down if you see a clear violation of the law, yes or 

no? 

Ms. SMITH. Yes, it does. 

Mr. BARTON. OK. 

Ms. SMITH. And, in fact, we—— 

Mr. BARTON. Thank you. Now, if you—— 

Ms. HAMBURG. But the State of Massachusetts—— 

Mr. BARTON. At least you got—— 

Ms. HAMBURG [continuing]. Has the oversight responsibility for 

compounding pharmacies on a day-to-day basis. FDA has a different set of authorities. 

71 

And the challenge is that these authorities, as evidenced by that 

map, are fragmented. And what enforcement actions we can take 

have to be seen through different lenses in different parts of the 

country. 

Mr. BARTON. All right. 

Ms. HAMBURG. We don’t have clear—— 

Mr. BARTON. I am going to try one more time, Dr. Hamburg. 

Under current law, does the Food and Drug Administration of the 

United States of America have authority over adulterated drugs? 

Ms. HAMBURG. We have authority over adulterated drugs, 

and—— 

Mr. BARTON. Thank you. 

Ms. HAMBURG [continuing]. We can take actions in relation to 

that. 

Mr. BARTON. OK. 

Mr. DINGELL. May the Congressman from Texas have 1 additional minute? And I would ask that he would yield to me. 

Mr. STEARNS. By unanimous consent, so ordered. 

Mr. BARTON. And I would be happy to yield to my good friend, 

the gentleman from Michigan. 

Mr. DINGELL. I thank my friend. 

Commissioner, two agencies here have dropped the ball. The 

Massachusetts agency has had to fire its head because it didn’t do 

its job. Your agency—and I don’t want you to be defensive; I just 

want you to recognize a hard fact. Your agency did not use your 

power to define who is a manufacturer. Here you have an agency 

that is—that in just one has sold over 17,000 doses in something 

like 23 States. 

Don’t you have the authority to define who is a manufacturer 

and who is a compounder? And if you do, why didn’t you do it? 

Ms. HAMBURG. The problem is that the current legal regulatory 

framework says either you are a compounder or you are a manufacturer, and there, in fact, is—— 

Mr. DINGELL. And you may define both, may you not? You have 

that authority, and you did not do it. 

Ms. HAMBURG. I—— 

Mr. DINGELL. And I thank the gentleman for yielding. 

Ms. HAMBURG. The concern, though, is that if it is all or nothing 

that way, then these facilities, if they were defined as manufacturers—— 

Mr. DINGELL. Commissioner, we are trying to solve the problem. 

This is not an issue of where you are here to defend yourself. If 

you choose to do that, you are going to have a very hard time in 

this committee. We do not tolerate that kind of foolishness, and I 

would assure you that you are putting your head in the noose. 

I would urge you to just cooperate with us and with my good 

friend and give us the answers that we need—— 

Mr. BARTON. All right. Now—— 

Mr. DINGELL [continuing]. So that you can address your problems—— 

Mr. BARTON [continuing]. If I can reclaim the time I no longer 

have—— 

72 

Mr. STEARNS. Just to recognize where we are, we had a unanimous consent to give Mr. Dingell 1 minute, and the time now belongs to Mr. Barton. 

Mr. BARTON. I am just going to—— 

Mr. STEARNS. If you would finish up and we will move on to—— 

Mr. BARTON. Yes, I will be quick. 

I want to be explicitly clear. If there really is a regulatory gap— 

based on the record that I have reviewed, I don’t believe there is. 

But if there is, I suggest there is a bipartisan coalition on this subcommittee and full committee that will move legislation to correct 

it. 

If, however, there is no regulatory gap, I also think there is a bipartisan coalition on this subcommittee and full committee to work 

to make sure that the State and the Federal agencies with jurisdiction work together to solve this problem and to prevent it from 

happening in the future. 

And, with that, Mr. Chairman, I yield back. 

Mr. STEARNS. Yield back. 

And I want to thank the dean of the House of Representatives 

for his taking the initiative to really get the Commissioner to answer the question that both Mr. Barton and myself and others have 

asked, is whether you have the jurisdiction, and I think the answer 

is yes. 

Ms. HAMBURG. No—— 

Mr. STEARNS. We recognize for 5 minutes Mr. Dingell. 

Mr. DINGELL. I thank you, Mr. Chairman. 

Commissioner, I would appreciate ‘‘yes’’ or ‘‘no’’ answers here. 

Do you have sufficient authority to inspect compounding pharmacies, yes or no? 

Ms. HAMBURG. No. 

Mr. DINGELL. Would you please submit is to us what authorities 

you need so that we can see to it that it is done? 

Do you have the authority to access all records when inspecting 

a compounding pharmacy, yes or no? 

Ms. HAMBURG. No. 

Mr. DINGELL. Please submit to us the information on what you 

need so we can see to it that that is given to you. 

Do you have authority to require compounding authorities to— 

rather, compounding pharmacies to register with FDA, yes or no? 

Ms. HAMBURG. No. 

Mr. DINGELL. Would you please submit to us the authorities that 

are needed so that we can address that problem? 

All right. Do you have the authority to require compounding 

pharmacies to report adverse events to FDA, yes or no? 

Ms. HAMBURG. No. 

Mr. STEARNS. Would you please submit to us what authorities 

you need in that area? 

You heard earlier my question about whether or not you have 

the authority to define who is a compounding pharmacy and who 

is a manufacturer. Do you have authority to do that or not, yes or 

no? 

Ms. HAMBURG. Yes, on a very technical level. 

Mr. DINGELL. All right. If you need some reform of that authority, please submit that information to us. 

73 

Ms. HAMBURG. We definitely do. 

Mr. DINGELL. Commissioner, do you have authority to require 

compounding pharmacies to follow good compounding or something 

equivalent to good manufacturing practices, yes or no? 

Ms. HAMBURG. No, we do not. 

Mr. DINGELL. Would you please submit to us the authority that 

you require? 

Now, this question to both you and to Dr. Smith: Do you have 

sufficient authority between your agencies, State agencies and the 

Federal agencies, to assure that you are able to coordinate your authorities and to achieve the necessary controls over both manufacturers and compounding pharmacies? 

Ms. HAMBURG. I believe we do not. 

Mr. DINGELL. You do not. 

What is your view on that, Dr. Smith? Yes or no? 

Ms. SMITH. We don’t regulate or oversee manufacturing, so—— 

Mr. DINGELL. OK, but can you define a compounding pharmacy 

so that you can define your authority? We have here something 

where a major problem fell between the cracks. Please submit the 

answer to us for the purposes of the record. 

Now, again, to the Commissioner, do you have authority to require compounding pharmacies to indicate on the label of their 

product that the product was compounded and not approved by 

FDA, yes or no? 

Ms. HAMBURG. We do not. 

Mr. DINGELL. Would you please submit the authority—the authority that you need? 

Commissioner, it does not sound to me like FDA has authorities 

to oversee compounding pharmacies, and there is a question of 

your authority to define who is a compounding pharmacy. Do you 

have efficient—do you have sufficient authority to oversee 

compounding pharmacies now, yes or no? 

Ms. HAMBURG. We do not, no. 

Mr. DINGELL. OK. Please submit to us your suggestions for that 

authority to be given. 

Do you—would you submit to the committee any additional authorities that I have not been able to define here this morning that 

we should address to you? 

Now, Commissioner Hamburg, your agency is in receipt of two 

letters dated October 9 and 16, 2012, from my office regarding this 

situation. When will you submit to us a response to those letters 

so that we can have that information available to us as the committee proceeds? 

Ms. HAMBURG. We will get you those responses as soon as possible. 

Mr. DINGELL. As soon as you can. 

Mr. Chairman, with thanks, I return to you 24 minutes. 

Mr. STEARNS. I think—— 

Mr. DINGELL. One more question, Mr. Chairman. Those two letters, I would ask that they be inserted in the record and the response that will be received by the committee. 

Mr. STEARNS. We have seen those letters. By unanimous consent, 

so ordered. 

Mr. DINGELL. Thank you. 

74 

Mr. STEARNS. And I thank the gentleman from Michigan. 

The gentleman from Nebraska, Mr. Terry, is recognized for 5 

minutes. 

Mr. TERRY. Thank you, Mr. Chairman. 

Here—I want to follow through on some of the gentleman from 

Michigan, Mr. Dingell’s questions because I really do think that is 

at the heart of us trying to figure out where our jurisdiction lies 

or doesn’t lie with the FDA and our role. 

So I have toured compounding facilities in my district, which 

usually are small operations. In the part of a current pharmacy, 

somebody brings in a prescription that is unique, they compound 

it, and it is for that patient. That is compounding. 

And I don’t think the FDA would want—and that is a question 

for a different day—the jurisdiction to go into every pharmacy that 

has compounding abilities to make something specific for one of 

their clients. And that is why that has been reserved, I assume, in 

those discussions, the gentlelady from Colorado, of why it was put 

in the States’ hands that are best able to do that. 

So now when we focus on the New England Compounding Center, it may have called itself ‘‘compounding center,’’ but it was a 

large manufacturing. We know that through its past violations that 

have come to the attention of both the State pharmacy board and 

the FDA in the past. So we then have a 2011 incident in Denver 

where pallets of a drug was found; a Colorado board of pharmacies 

issues a cease and desist. So now what we have is mass manufacturing of a specific drug for nonspecific people. To me, that is the 

definition of ‘‘manufacturing.’’ 

So, Ms. Honorable Hamburg, is the issue, then, that the definition of ‘‘manufacturing’’ within that bill isn’t clear enough for the 

FDA? Because it seems pretty clear, if you are mass producing, you 

are sending it into interstate commerce and it is not for a specific 

patient, that that is not compounding, that is manufacturing. 

Ms. HAMBURG. I think that this has been an evolving industry 

and that we do have a problem that existing law and authority 

is—— 

Mr. TERRY. What specifically—— 

Ms. HAMBURG. It is on or off—— 

Mr. TERRY. Let me interrupt you, since you talk over us. 

I am looking for the specifics in the law that say that there is 

lack of clarity on the definition of ‘‘manufacturing.’’ Because that 

seems to be the hook that you are putting your hat on. Can you 

specify in the act that we have to tighten the definitions? 

Ms. HAMBURG. Currently, as we have discussed, there is huge 

disagreement about the FDA authorities, and the courts have split 

on the interpretation of authorities for compounding—— 

Mr. TERRY. Will you define the parts of the statute that we need 

to focus on regarding tightening the definition of ‘‘manufacturing’’? 

Ms. HAMBURG. The problem is that, with this evolving industry, 

there is a gray area. If we would be to regulate the thousands of 

compounders—— 

Mr. TERRY. That is a great speech. Can you refer me to the part 

of the statute that we need to focus on, yes or no? 

Ms. HAMBURG. I am sorry, could you repeat—— 

75 

Mr. TERRY. Refer me to the appropriate part of the statute that 

lacks the clarity of which you complain. 

Ms. HAMBURG. The FDA has the authority to act against—— 

Mr. TERRY. Manufacturers. 

Ms. HAMBURG [continuing]. Manufacturers. 

Mr. TERRY. And this is generally manufacturers—— 

Ms. HAMBURG. We have the oversight of drug manufacturers, 

and with that comes a set of activities—— 

Mr. TERRY. All right. 

Ms. HAMBURG [continuing]. That do not apply to compounders, 

including the—— 

Mr. TERRY. So you will not refer me to a specific section of which 

you feel lacks clarity. 

One last question for Dr. Smith. 

This is very frustrating, madam. 

Dr. Smith, you are in a really tough place, and you have done 

a great job. You have presented well today. But I am very curious. 

With all of the knowledge that was brought to the State board— 

a colossal failure here. You said you are looking into that and putting the pieces together. I am just curious, is there any evidence 

of a special relationship between the State board and this manufacturer? Because it seems like somebody is covering for somebody. 

Ms. SMITH. Well, we are as concerned about the missed opportunities as you are. And there are numerous, numerous episodes of 

that. We are in the process, as I said, of reviewing just that 

through interviews and through the exhaustive document reviews 

that we are doing and reviewing the documents that we have produced for this committee. It is, you know, thousands and thousands 

of pages. 

So I can’t—I don’t know the answer to your question, but we are 

trying to—— 

Mr. TERRY. Well, I appreciate that you are looking into that. 

Just the last 5 seconds, Madam Honorable Hamburg. Getting 

your testimony at 1:30 a.m., most of us are sleeping then, so I 

guess the whole purpose was to not let us see in advance your testimony. 

I yield back. 

Mr. STEARNS. The gentleman yields back. 

The gentleman from Massachusetts, Mr. Markey, is recognized 

for 5 minutes. 

Mr. MARKEY. Thank you, Mr. Chairman. 

Ms. Hamburg, I have introduced legislation to give the FDA authority to define which compounding pharmacies should be required to register as manufacturers. Would you support that? 

Ms. HAMBURG. We think it is very important that we have additional legislation in this area and that compounders, in fact, register and that it can be defined, what they are doing, what they 

are manufacturing, and what the appropriate regulatory oversight 

would be. 

Mr. MARKEY. I have introduced legislation to give the FDA authority to require compounding pharmacies to compound safe drugs 

using safe practices. Would you support that? 

Ms. HAMBURG. I do support that. 

76 

Mr. MARKEY. I have introduced legislation to give FDA authority 

to conduct the same inspections and request the same documents 

as it can from manufacturers. Do you support that? 

Ms. HAMBURG. It is enormously important that we have the authority to go in and be able to do full inspections and review documents, collect samples, et cetera. 

Mr. MARKEY. I have introduced legislation that requires 

compounding pharmacies to submit reports of adverse reactions or 

safety problems to the FDA. Do you support the FDA having that 

authority? 

Ms. HAMBURG. Yes. It is currently a gap, that adverse events are 

not required to be reported from compounding pharmacies. 

Mr. MARKEY. And I have introduced legislation to require compounded drugs to be labeled. Do you believe that that authority 

should be given to you? 

Ms. HAMBURG. Yes, we do. 

Mr. MARKEY. And I might say, the legislation also allows traditional compounding pharmacies, those which are just doing individual doses to individual patients, to continue to stay under State 

jurisdiction. Do you agree with that? 

Ms. HAMBURG. Traditional compounding, one patient, one prescription—— 

Mr. MARKEY. Yes. 

Ms. HAMBURG [continuing]. Should be overseen by a licensed 

physician or pharmacist, but it does not require the FDA oversight. 

It is this nontraditional compounding area where the volume is 

larger, the distribution is larger, the products are more complex, 

where we think we lack the authorities that we need. And we appreciate that you are introducing legislation, and we will work actively with you—— 

Mr. MARKEY. Thank you. 

Ms. HAMBURG [continuing]. In order to an achieve the important 

goal. 

Mr. MARKEY. I think it is critical, given today’s hearing, given 

what we have heard from the witnesses, the pain that it has 

caused, the regulatory black hole that obviously has to be closed, 

that we pass legislation that gives you these authorities—— 

Ms. HAMBURG. I agree with you. 

Mr. MARKEY [continuing]. So that children will have to look to 

the history books to find that there ever was such a catastrophe as 

is being suffered by hundreds of families across the country right 

now. And so I just hope that we can move quickly on legislation 

to give you that authority because I think you are the cop on the 

beat and we have to make sure that you have the authority which 

you need in order to enforce the law. 

And, Dr. Smith, I want to commend you and Governor Patrick 

for the decisive manner in which you have responded to this tragedy. You have undertaken an aggressive investigation and held the 

companies involved and some members of your staff accountable 

and put in place stringent emergency regulations for compounding 

pharmacies in Massachusetts. 

We have learned that this tragedy was enabled by a regulatory 

black hole that allowed a drug manufacturer, NECC, to masquerade as a pharmacy, producing massive amounts, quantities of 

77 

drugs with little or no Federal oversight, and able to sell these 

vials all across the country to dozens of States without full Federal 

regulation. 

And there were complaints that had been reported as long as 10 

years ago. Starting in 1999 with the first complaint, State regulators repeatedly failed to take strong action, such as withdrawing 

NECC’s license in 2006. The State even waived the company’s proposed probation as long as it got a clean bill of health from an independent evaluator. But when that same independent evaluator was 

convicted of selling unsafe medical sterilization equipment that 

blinded 18 patients, Massachusetts did nothing to make sure the 

clean bill of health that the New England Compounding Center 

had received was reexamined. 

Dr. Smith, have you been able to determine why those decisions 

were made back then through interviews with the staff that were 

there at that time? 

Ms. SMITH. No, we have not. We have done interviews, as you 

allude to, and we have not been able to really understand why they 

made those decisions. In retrospect, clearly there were missed opportunities for the Board of Pharmacy, as you point out, in 2006 

to take decisive action, and it did not. And we are trying to understand that, but we don’t at this point. 

Mr. MARKEY. Are all of those individuals’ emails and other documents from that period available for review? 

Ms. SMITH. Yes. We have—we produced for this committee thousands of—thousands of pages of emails. And those are all being reviewed. 

Mr. MARKEY. Is it possible that some of those emails and documents have been destroyed in the period of time from 2006 and 

prior to today? 

Ms. SMITH. Well, I am not—I wouldn’t be sure of that. I can tell 

you that the numbers of emails from the earlier, prior years are far 

fewer than what we have been able to obtain more recently. 

Mr. MARKEY. So Massachusetts is, in the very near future, going 

to have the strongest compounding pharmacy regulation in the 

country. But that does not protect us, does it, from other States 

having weak laws, which could then sell compounded drugs into 

Massachusetts—— 

Ms. SMITH. That is correct. 

Mr. MARKEY [continuing]. Or the other 49 States? 

So you just heard the list of powers which I asked Dr. Hamburg 

if she would support being given to the FDA. Do you support giving 

the FDA those same powers so that they can be the national cop 

on the beat to protect against one State becoming the place where 

a rogue compounder then terrorizes and harms the rest of the 

country? 

Ms. SMITH. Absolutely. 

Mr. MARKEY. I thank you. I thank all of you for your service. 

And I thank you, Mr. Chairman. 

Mr. STEARNS. I thank the gentleman and recognize Dr. Burgess 

for 5 minutes. 

Mr. BURGESS. I thank the chair for the recognition. 

Dr. Hamburg, again, thank you for being here today. 

78 

Let me ask you, you made a statement a minute ago in response 

to another Member’s question that you favored a risk-based system; is that correct? 

Ms. HAMBURG. We do favor a risk-based—— 

Mr. BURGESS. Let me just stop you for a second, because, I mean, 

this country was—company was bad news from the day it started 

back in the ’90s. They, as is my understanding from looking at the 

materials provided to us, they shipped preprinted prescription 

forms to various clinics around the country in clear violation of 

what they should be doing. 

And then you have—the FDA, not you, but the FDA has assembled a 10- or 15-year history of repeated violations and areas where 

this company has shown itself to be unsafe. So if you want to have 

a risk-based system, this company is too risky. You can’t risk it. 

Don’t do a risk-based system for this company. It is through. And, 

in all honesty, it should have been terminated by the FDA, multiple branch points along the way—2002, 2004, 2006, 2008. We see 

the documents. It should have happened. 

Now, I guess, listening to your testimony today, I must be given 

to believe that what you have been doing is collecting the data set 

so that what Congress finally passed a law to allow you to prevent 

this from happening you would then prevent it. Is that what I am 

understanding? That you lack complete and total authority to do 

anything at all even though you saw this stuff happening? 

Ms. HAMBURG. You know, we worked very hard when the first 

problems at NECC were identified with the State to address them 

aggressively. But our authorities around compounding pharmacies 

are unclear, limited—— 

Mr. BURGESS. Yes, let me stop you. 

Ms. HAMBURG [continuing]. And untested. 

Mr. BURGESS. We have been down this road before—— 

Ms. HAMBURG. We need—— 

Mr. BURGESS [continuing]. And we are not buying it. We are just 

not buying it, Dr. Hamburg, in all honesty. 

You have an evidence binder in front of you. Tab 15, look at it, 

if you will. It is a letter dated October 31st, 2008. We have heard 

other people reference a 2006 letter where the FDA, the FDA, in 

writing to this compounding pharmacy, say, ‘‘Failure to do so may 

result in an enforcement action, including a seizure of the firm’s 

products and/or an injunction against the firm and its principals.’’ 

That is pretty strong language. 

Now, you lacked the authority to do anything and yet you sent 

a letter like this? Was this letter sent in error? You really didn’t 

have that authority, and it was an empty threat; is that what I am 

to understand? 

Ms. HAMBURG. As, you know, was pointed out, I was not present 

at the FDA at the time, and I cannot speak to all of the issues. But 

there—clearly, there was an effort to assert authority—— 

Mr. BURGESS. Well, let me just ask you—— 

Ms. HAMBURG [continuing]. Around an issue that was very different than the issue about sterile compounds—— 

Mr. BURGESS. OK. But this letter was issued in error; is that 

what I am to understand? It was an error, that the FDA sent this, 

79 

even though it was a previous administration, a previous Commissioner? 

Ms. HAMBURG. There were—in 2004, the FDA was asked to take 

a look at an issue that involved a specific product, Trypan Blue, 

and whether or not NECC was making it inappropriately. 

Mr. BURGESS. OK. With all due respect here—and our time is 

limited. I don’t mean to be rude, but we really have to pursue this. 

Did you, did anyone at the FDA, previous Commissioner, previous administration, did anyone get a legal memo from your legal 

department saying, ‘‘Hey, you didn’t have the authority to do that, 

so you better back off’’? Is there such a memo in existence? 

Ms. HAMBURG. There was a lot of internal discussion. The courts 

were split on what our authority—— 

Mr. BURGESS. So was there a memo delivered from the Commissioner? 

Ms. HAMBURG. Well, at that time, there was ongoing litigation, 

and—— 

Mr. BURGESS. May we on the committee have access to those internal memos that said you didn’t have the authority to write that 

letter? 

Ms. HAMBURG. That isn’t what I said, and I apologize if it came 

across that way. What I was saying was that an inspection was 

done in response to a specific complaint, and then, with respect to 

the actions taken, there was ambiguity in the law, ongoing litigation—— 

Mr. BURGESS. Yes, but there is no ambiguity. 

Ms. HAMBURG [continuing]. Discussions within FDA, as I understand it, about—— 

Mr. BURGESS. OK, let me try it from another perspective, if I 

could. 

Ms. HAMBURG [continuing]. What enforcement could be used to 

take action. 

Mr. BURGESS. We all saw on television the company being raided, 

the computers being seized. Did you do that and you didn’t have 

the authority to do that? 

Ms. HAMBURG. In the—I mean, you are asking me about one specific question that had to do with the warning letter, which is a 

very discrete and different problem than what we are talking 

about—— 

Mr. BURGESS. But you assert an authority which you are now 

telling us you don’t have in that letter. Now—— 

Ms. HAMBURG. I think you just need to look at the map and see 

that the authority that is used to oversee compounding pharmacies 

is very fragmented. We have different court decisions applying different legal regulatory frameworks to different parts of the country 

that cannot serve patients well. 

We need to have a strengthened and clarified legal regulatory 

authority that gives us some of the additional authorities over—— 

Mr. BURGESS. OK. Once again, let me just ask you as straightforward and simply as I can, do you have the authority to regulate 

the manufacturer, or if a compound is—of the manufacturer of 

these compounds or if the drug is adulterated in some form? Do 

you have that authority, as it exists today? 

80 

Ms. HAMBURG. We have many more authorities over drug manufacturers than compounding pharmacies. And that limits our ability to effectively ensure the safety and quality—— 

Mr. STEARNS. Dr. Hamburg—— 

Mr. BURGESS. Well, again, let me just ask it in the simplest way 

that I can. How many companies are out there labeled as 

compounding pharmacies that ship 17,000 doses of sterile, preservative-free steroids every year? 

Ms. HAMBURG. The problem is that compounding pharmacies are 

not required—— 

Mr. BURGESS. How many? The question is, how many? 

Ms. HAMBURG [continuing]. To register with us. We don’t know 

how many compounding pharmacies are, in fact, engaging in those 

kinds of practices. 

What we do know is that the industry, though, has evolved and 

that there are an increasing number of nontraditional compounders 

who are acting, for example, with hospitals and clinics—— 

Mr. BURGESS. Look—— 

Ms. HAMBURG [continuing]. Are outsourcing to them—— 

Mr. BURGESS [continuing]. We heard testimony from the widow 

of a victim. And you could tell that there was some bitterness in 

her voice against the company—or, the clinic that had provided the 

steroid injections. ‘‘How could they buy it from someone if they 

weren’t sure?’’ 

But, you know, I am a doctor, you are a doctor, Dr. Smith, you 

are a physician. I mean, you take a vial off the shelf, you make 

some assumptions as to its potency and its sterility. In this country, we stipulate that, because you have done your job at the FDA, 

we don’t have to come and ask additional questions before we administer that to a patient. 

Now you are telling me that that is not the case and that the 

FDA lacks the authority to assert that the safety and effectiveness 

of those medicines that are coming off the shelf is, in fact, valid? 

Ms. HAMBURG. We have the authority with drug manufacturers 

to oversee the safety, efficacy, and manufacturing quality. 

Mr. BURGESS. Correct. 

Ms. HAMBURG. We do not have—— 

Mr. BURGESS. And if you are making 17,000 doses of sterile, preservative-free, injectable steroids every year, you are a manufacturer. There is no other word for it. 

Mr. STEARNS. The gentleman’s time has expired. 

Mr. BURGESS. I thank the gentleman. 

Mr. STEARNS. Let the record show, Dr. Hamburg, he asked you 

a question. You are under oath. You have an obligation to answer 

‘‘yes’’ or ‘‘no.’’ 

Ms. DEGETTE. She tried to answer—— 

Ms. HAMBURG. I was attempting to, and—— 

Mr. STEARNS. And let the record show—— 

Ms. HAMBURG [continuing]. I am sorry if I did not. 

Mr. STEARNS [continuing]. That Dr. Burgess asked you a question time and time again, the same question, and you would not 

answer ‘‘yes’’ or ‘‘no.’’ 

Let me recognize—— 

81 

Ms. HAMBURG. We do not have the authority over compounding 

authorities—— 

Mr. STEARNS. That is—Dr. Hamburg, we understand that. 

Ms. HAMBURG [continuing]. That we have over drug manufacturers. 

Ms. DEGETTE. Wait a minute. 

Mr. STEARNS. The gentlelady from Florida, Ms. Castor, is recognized for 5 minutes. 

Oh, Ms. Schakowsky. Oh, I am sorry. Yes, welcome. 

Ms. SCHAKOWSKY. This is for Dr. Smith. 

In the aftermath of this tragedy, we have learned some troubling 

facts about the Massachusetts Board of Registration and Pharmacy 

and how it dealt with NECC in the past. And it raises some questions about whether the board was too close to NECC and whether 

the board did enough to prevent conflicts of interest from affecting 

its decisions. 

So I wanted to ask you, Dr. Smith, about Sophia Pasedis, one of 

the members of the board. I understand she is gone now; is that 

true? 

Ms. SMITH. No. We have asked her to resign, but she declined. 

Ms. SCHAKOWSKY. So how long has she served on the board? 

Ms. SMITH. I don’t have that in front of me, but it has been for 

several years. She was there in the previous administration. 

Ms. SCHAKOWSKY. And what is her affiliation with NECC or its 

sister companies? 

Ms. SMITH. She had previously worked for NECC. I am sorry— 

she started in the summer of 2004. She had previously worked for 

NECC and then subsequently went to Ameridose, a company that 

was also owned by Mr. Cadden. 

Ms. SCHAKOWSKY. So I understand that she was actually vice 

president of regulatory affairs and compliance at Ameridose. 

Ms. SMITH. Yes. And she is the pharmacy of record there. 

Ms. SCHAKOWSKY. Did Ms. Pasedis adequately recuse herself 

from board actions related to these companies? 

Ms. SMITH. In our review of the minutes of the board meetings, 

it is clear that on several occasions there is a specific indication 

that she did recuse herself. However, there are some minutes that 

don’t—that are silent on the issue, don’t say either way. And because of that, the fact that it was unclear she appropriately recused 

herself—although in interviews she declares that she did—because 

of the lack of clarity, we asked her to resign, which, as I said, she 

declined. 

Ms. SCHAKOWSKY. So I am glad that you attempted to take action to remove her, but there is still a lot of questions about whether her role on the board during much of the time when Massachusetts was receiving complaints softened the actions of the board 

that the board was willing to take against NECC. 

In 2004, after first identifying significant problems at NECC, the 

board proposed a tough consent agreement with real sanctions. But 

something happened in the interim, and the consent decree that 

was actually signed in 2006 was much weaker than in the initial 

proposal. 

82 

Do you know how this happened and why the board proposed 

weaker penalties even after they had received additional reports of 

problems at NECC? 

Ms. SMITH. We don’t know how that happened, and, as I mentioned, we are very interested and have been attempting to find 

that out. Our interviews with board members about that precise 

issue have been—have not yielded definitive information. Most 

simply state that they don’t recall. 

Ms. SCHAKOWSKY. So one of the problems with the 2006 consent 

agreement was that it required NECC to be independently audited 

but then let NECC have significant input into who its independent 

evaluator would be. 

So, Dr. Smith, did NECC participate in the selection of PSI as 

its independent auditor—evaluator? 

Ms. SMITH. Well, we are unsure. We have been reviewing the 

records to, in fact, try to determine who did make the final decision 

regarding who that independent evaluator should be. And it is unclear, from the documents that we have found, who did do that. 

Ms. SCHAKOWSKY. And is it common for a party to help select its 

own evaluator? 

Ms. SMITH. I can’t speak to whether or not it was common. You 

could certainly imagine that that would be problematic. But we 

haven’t been able to determine who, in fact, chose the evaluator. 

Ms. SCHAKOWSKY. Is it still the practice? 

Ms. SMITH. Well, it would be—currently, I am not aware of any 

current actions that are involving an outside evaluator. As we proceed, as I mentioned, we are really looking at both the best practices around other States for the Board of Pharmacy, and so that 

would be the kind of thing we would include. 

Ms. SCHAKOWSKY. Well, let me just say, at the time that PSI was 

selected to act as an independent evaluator, one of its executives, 

Ross Caputo, was facing trial for defrauding the FDA and selling 

unapproved sterilization equipment to hospitals that caused blindness in patients. And he was later convicted. 

So in 2006 your agency sent a letter to NECC telling them that 

they had ‘‘satisfactorily completed,’’ unquote, the conditions of the 

consent agreement based on NECC’s compliance with the follow-up 

actions identified in PSA’s audit report of the company; is that correct? 

Ms. SMITH. That is correct. 

Ms. SCHAKOWSKY. So were any of the Massachusetts Board of 

Registration and Pharmacy staff aware of Mr. Caputo’s Federal 

conviction when they found NECC had satisfactorily completed 

PSI’s recommended actions? 

Ms. SMITH. As far as we can tell through our interviews with 

staff and the board members, they were not made aware of the fact 

that the primary evaluator, Mr. Caputo, had, in fact, been convicted of those Federal crimes. The staff were aware, but, as I have 

mentioned, and shockingly so, they did not share that information 

with the board. 

Ms. SCHAKOWSKY. Well, you know, we have turned up a number 

of problems, but, one, it seems that the NECC was too close to the 

board and its members, and it seems like the board was more inVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00086 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
83 

terested, maybe, in protecting pharmacists than in protecting consumers. 

We have a lot of work to do, but it seems like that some of the 

solutions that we have laid out, at least on the Federal level for 

the FDA, are fairly clear. And I am hoping that at the State level, 

as well, that these problems will be—you will get to the root of 

them. 

Thank you. 

Mr. STEARNS. The gentlelady’s time has expired. 

The gentleman from Pennsylvania, Mr. Murphy, is recognized for 

5 minutes. 

Mr. MURPHY. Thank you. 

Dr. Smith, in your testimony, you had stated that you have uncovered a number of problems where PSI executives and others did 

not provide information to people. You said you have found no evidence to indicate the executive directors or staff attorney of the 

board provided crucial information to the board, and yet the board 

had to vote on something without that information. Am I correct? 

Ms. SMITH. That is right. 

Mr. MURPHY. And you have given a number of other examples 

of a breakdown within the structure and have taken action toward 

people when you found that they were not properly informing or 

following the rules? 

Ms. SMITH. That is correct. 

Mr. MURPHY. OK. Is there anything also within the laws, as you 

understand it, that you have the authority within Massachusetts, 

are required, to pass information up to the FDA on any of these 

problems that occur? 

Ms. SMITH. There is nothing in our practices or our regulations 

that I am aware of that requires that kind of information share. 

Mr. MURPHY. Do you do it anyway? 

Ms. SMITH. Certainly, since this investigation or this episode has 

begun, we have worked in partnership with the FDA and, in fact, 

have done all of the inspections together. That is an area, as I mentioned, when we move forward to determine what sorts of policies 

we should have about information sharing—— 

Mr. MURPHY. Thank you. 

Ms. SMITH [continuing]. Whether it should be required as opposed to on a case-by-case basis. 

Mr. MURPHY. It is helpful internally to identify those breakdowns, too. 

Ms. Hamburg, is there someone at the FDA who routinely reviews State actions and communicates with them from your level 

down to the States when there are problems occurring? Is there 

anybody who reads or reviews anything with the States at all right 

now? 

Ms. HAMBURG. There is not a system in statute—— 

Mr. MURPHY. But is there anybody who does that? 

Ms. HAMBURG [continuing]. Or in practice where there is that 

kind of back-and-forth communication on a routine basis. When 

there is a serious problem, as occurred in this case, you know, we 

mobilize into action very quickly. We have—— 

Mr. MURPHY. Who is it that is mobilized in the FDA to then 

work with States? 

84 

Ms. HAMBURG. Different components of FDA, depending on the 

nature of the problem. 

Mr. MURPHY. Is there a particular person? 

Ms. HAMBURG. We have district offices, and they are sort of the 

first line in terms of identification of a problem—— 

Mr. MURPHY. I am just trying to get some specifics here. 

Ms. HAMBURG [continuing]. And responding—— 

Mr. MURPHY. I am trying to lay out here that Dr. Smith did a 

thorough internal review and found a number of breakdowns that 

people weren’t communicating with one another. 

I am trying to find out within the FDA—regardless of regulations, obviously if someone with the FDA was talking to the States, 

someone has the authority to talk to States. And I am trying to 

find out if you have identified structural changes needed within the 

FDA to make sure you are communicating within FDA that information is coming to your desk for review. Have you made any of 

those changes or reviews? 

Ms. HAMBURG. I think part of the issue here is there are not formalized systems. There certainly are opportunities to improve communication. But it also is a broader issue, that compounding pharmacies—— 

Mr. MURPHY. Hold on. Really, I am trying to help. 

Ms. HAMBURG. Uh-huh. 

Mr. MURPHY. And you are obfuscating. 

Dr. Smith, very cogent leadership, says, if there are problems, 

identify the problems, we went after the problems. I am just trying 

to find out, do you even have—you don’t have to wait for authority 

to find out within the FDA who can have the authority to review 

these things. Do you have it, yes or no? 

Ms. HAMBURG. We—well, I am not sure what authority you 

mean. 

Mr. MURPHY. Well, the authority to review if there are problems 

with the States and manufacturing, et cetera. 

Ms. HAMBURG. We don’t always get the reports is the issue. 

When we do get the reports, then we have our district offices and 

Office of Regulatory Affairs—— 

Mr. MURPHY. OK. Have you met with those people since from the 

district offices to review—— 

Ms. HAMBURG. Yes. 

Mr. MURPHY. OK. Thank—— 

Ms. HAMBURG. We have been working very closely with them. 

And, you know, every day there are issues that involve our working 

with States—— 

Mr. MURPHY. Well, let me ask another area, too, in terms of 

identifying people. In terms of dealing with the definition of 

‘‘compounding pharmacy’’ versus ‘‘manufacturer,’’ who within the 

FDA is responsible for defining that? 

Ms. HAMBURG. Well, the—it is not just in FDA. It is Congress—— 

Mr. MURPHY. But who is it that—who is the keeper of the definition that when you have a question—— 

Ms. HAMBURG. But our—our—— 

Mr. MURPHY. Who? 

Ms. HAMBURG. Our chief counsel’s office is—— 

85 

Mr. MURPHY. Chief counsel. Have you reviewed with chief counsel the definition of ‘‘manufacturing’’ versus ‘‘compounding’’? 

Ms. HAMBURG. I think that everyone agrees that, at the present 

time—— 

Mr. MURPHY. I didn’t ask you that. 

Ms. HAMBURG [continuing]. That the law is not—— 

Mr. MURPHY. Please. Please, please, please. 

Ms. HAMBURG [continuing]. Clear on this. 

Mr. MURPHY. Please. I want to know, have you reviewed with 

someone—you said chief counsel—the definition of ‘‘compounding’’ 

versus ‘‘manufacturing’’? Have you reviewed that with someone? 

When did that take place? 

Ms. HAMBURG. You know, we have had many discussions on it, 

but the problem is—— 

Mr. MURPHY. So has someone reviewed with you a definition of 

‘‘manufacturing’’ versus ‘‘compounding’’? 

Ms. HAMBURG. You know, I think that, really, you know, unfortunately, there is not a clear—— 

Mr. MURPHY. Yes, there is. Because in your authority—if you are 

telling us the crux of your testimony today is you don’t have authority under manufacturing, you therefore must have met with 

someone who told you what the definition of ‘‘manufacturing’’ 

versus ‘‘compounding’’ is. I would like to know who that is. Or is 

it you? 

Ms. HAMBURG. Well, you know, I really do think this is a broader 

issue. I know that you are frustrated by my answers, and I am 

sorry that I can’t just give ‘‘yes’’ or ‘‘no,’’ but this is a very complex 

issue. The courts of our country are split on these issues. 

Mr. MURPHY. Ma’am, that is not complex. Complex is the life 

that the 32 victims’ families have now. That is complex. What you 

have to do is easy, ma’am. Children growing up without parents, 

people without a spouse, living that lonely life, that, I submit to 

you, is complex. 

Leadership is easy if you are willing to accept it. And you are 

not. Dr. Smith took leadership. She went in and cleaned house and 

identified problems. 

What you are telling me is all this smoke and mirrors, that you 

don’t have authority. Go look in the eyes of the victims, and try 

and comfort them with that. Ma’am, that doesn’t work. 

I am asking you a simple question, as everybody else has here. 

And you can’t even tell us if you have talked to someone to come 

up with a definition of ‘‘manufacturing.’’ 

Ms. HAMBURG. No, I have told you we have been working very, 

very hard—— 

Mr. MURPHY. Tell us who—— 

Ms. HAMBURG [continuing]. To try to apply the authorities we 

have to an evolving industry and situations where we do not have 

the authorities we need. We don’t even have registration of the 

compounding facilities to know who they all are. We cannot review 

the record. There are no Federal standards to which the 

compounding pharmacies are held. And the courts have not—— 

Mr. MURPHY. You should be able to provide us with a definition. 

86 

Ms. HAMBURG [continuing]. Been able to agree on what is the 

legal regulatory framework for examination of these problems and 

enforcement actions. 

I care deeply about the patients and the families. The mission of 

the FDA is to promote and protect health. We are as frustrated as 

you are that we don’t have the authorities and the resources—— 

Mr. MURPHY. Then just tell us the definition, ma’am. We will 

move from there. 

I yield back. Thank you. 

Mr. BURGESS [presiding]. The gentleman’s time has expired. 

The chair now recognizes the gentlelady from Florida, Ms. Castor, 5 minutes, for your questions, please. 

Ms. CASTOR. Thank you very much. 

And I appreciate all of us coming together to focus on what we 

can do to prevent tragedies like this from ever happening again. 

Now, I do think it is clear that there is great ambiguity in the 

law. FDA—the law with regard to compounding pharmacies was 

last written in 1997; it is out of date. And from my colleague from 

Texas, there is ambiguity here, great ambiguity. And it has been 

made even more convoluted due to these court cases. And I wish 

we would bring this map up on the screen, as well, so folks watching outside this hearing room could see it. 

See, in 1997 the Congress passed the FDA Modernization Act. 

That law contained a provision, section 503(a), which dictated the 

circumstances under which compounded drugs were new drugs and 

subject to FDA regulation. In that law, Congress explicitly exempted compounders from oversight and regulation as manufacturers. 

So I know that is what they are struggling with in trying to answer 

questions here. 

Then the courts stepped in. And this is where I would like to follow up on Mr. Terry’s question of you, Dr. Hamburg, about exactly 

which section of the act lacks clarity and his request that you direct him to it. We are talking here about the entirety of section 

503(a), aren’t we? 

Ms. HAMBURG. Well, 503(a) applies in some areas of the country 

and not in other areas of the country, which is a very challenging 

situation—— 

Ms. CASTOR. Yes. Let’s look at the map. 

Ms. HAMBURG [continuing]. In terms of our ability to be as effective as possible. 

Ms. CASTOR. Because in 2001, the ninth circuit, whose jurisdiction is the Western States, those red States, ruled that the advertising component of 503(a) was unconstitutional. And then they 

said that the rest of 503(a) is void because it is inextricably tied 

to the advertising component. 

Then, a few years later, in 2008, the fifth circuit court, the blue 

States there to the south, whose jurisdiction includes Texas, Louisiana, and Mississippi, ruled that the unconstitutionality of the 

advertising restrictions did not affect the rest of 503(a). And, unfortunately, the United States Supreme Court did not speak to break 

the tie to provide clarity. 

So, Commissioner Hamburg, what has been the impact on FDA 

in its regulation of compounded drugs as a result of these split 

court decisions? 

87 

Ms. HAMBURG. It has created a very challenging situation where 

we have, you know, contrasting legal regulatory frameworks for our 

actions. 503(a) applies in some places, and it does not—the other 

tool that we have is our compounding guidance that was written 

in 2002, but that doesn’t have the force of law. It just lays out our 

best thinking about how to—— 

Ms. CASTOR. So then the States have primary responsibility over 

compounding—— 

Ms. HAMBURG. It is very clear that States have the day-to-day, 

routine responsibility for overseeing compounding facilities. 

Ms. CASTOR. And then you have an industry that has evolved, 

that now some of the compounders, when you think of the pharmacy on the corner, where it is very important that a lot of our 

neighbors get their customized compounded drug, but some of them 

now are very sophisticated enterprises that are shipping all over 

the place, and they are not—they don’t—they have outgrown the 

1997 law. 

So now we have to decide how we are going to update it to address the sophistication of compounders out there, and then go 

after these bad actors. Because I think the majority of these 

compounders are on the up and up, living up to high standards. 

But the compounding—this is the map from the compounding industry and association, and I am afraid that that has led to some 

of the bad actors being able to take advantage of this situation and 

the gaps in regulatory authority. 

Is that a good summary? Is that an accurate summary? 

Ms. HAMBURG. That is an excellent summary. And I appreciate 

your trying to help me explain this, because it is just an extraordinarily complex situation where, you know, the effort to—— 

Ms. CASTOR. Except I don’t think that it is overly complex. I 

think there is a difference in outlook here on whether you have certain authority. And I think it is clear under the 1997 law and these 

court cases that compounders were exempted and are not manufacturers. 

So we, the Congress, has the responsibility now to act and clarify 

it. And there has to be additional oversight of the States. If the 

States—if they are going to drop the ball and they are not—they 

are going—they are not going to provide proper oversight, then it 

is time for the Feds to step in and give FDA the tools it needs to 

prevent these tragedies from ever happening again. 

Thank you. I yield back. 

Ms. HAMBURG. I don’t know if I am allowed to make a comment, 

but I think, you know, that speaking to the complexity of the issue 

and the changing, evolving industry overlaid on top of a fragmented and ambiguous legal framework, it is important to understand that this notion of sort of black and white, compounder or 

manufacturer, you know, it just is trying to fit a square peg into 

a round hole. 

And, in fact, you know, if the law is examined, it isn’t really adequately defined, but there is this area of outsourcing pharmacies 

that is increasingly important in medical practice. And if we were 

to define all of those pharmacies that hospitals now use—they used 

to make—Dr. Burgess, you would appreciate this. You know, it 

used to be that a hospital would add the potassium chloride to the 

88 

IV bag in their local—in their basement pharmacy or on the floor 

and give it to the patient. Now, both because of volume and, you 

know, concerns about making sure it is made under the best possible practices, that is outsourced to a pharmacy. They are making 

a product in larger volume and often not making it with a patient 

prescription in hand, yet it is, you know, clearly serving an important medical need. 

And if we were to treat them as drug manufacturers, that would 

be simply impossible. They would have to submit an application, a 

formal application, to FDA for review and action. They would have 

to pay fees associated with that, as well. They would have to be 

subject to good manufacturing practice. 

And so I think we want to work together to make sure that we 

have a law that clearly defines critical issues and authorities, that 

enables important patient needs to be addressed, but clarifies the 

different roles and responsibilities, and puts in place some critical 

authorities that are currently missing. 

Mr. BURGESS. I am going to interrupt you there in the interest 

of time. Dr. Gingrey has been waiting patiently. 

And, Dr. Gingrey, you are recognized, 5 minutes for questions, 

sir. 

Mr. GINGREY. Mr. Chairman, thank you very much. 

And, of course, an extremely interesting and important hearing. 

Tragic in so many ways, of the lives lost and the number of cases 

of meningitis as a result of this bad actor. 

Dr. Hamburg, Dr. Smith, pediatricians both, we appreciate your 

being here. 

And some of the questioning, the line of questioning from both 

sides of the dais, both Republicans and Democrats, have being pretty tough, but they have to be. Because if we are going to change 

the law, if we are going to rewrite the Federal Food, Drug, and 

Cosmetic Act, particularly in regard to section 503(a) and the 

vagueness of that section and the conflicting court decisions, then 

we have to get this right. And I have some great concerns that we 

might not get it right, in regard to overreacting in regulating 

compounding pharmacies. 

Every Member of the House of Representatives have drugstores. 

And they are not chain drugstores; a lot of them are just corner 

druggists that do compounding, where a certain product is needed 

by a patient, but maybe the manufactured product, it is in a base 

or something that they are allergic to, so therefore the local pharmacist has to reconstitute that drug—not manufacture a drug; the 

drug is manufactured—and just put it in a different way of giving 

it to the patient. It might even be in a pellet form. Think hormone 

replacement therapy, in some cases, or a cream or a vanishing 

cream or something that the patient is not allergic to. 

So if we get to the point in the line of questioning that Dr. Hamburg received from our longstanding member emeritus, Mr. Dingell, about compounding pharmacies, that worries me a little bit, 

that we might overreact and get to the point that we are not getting at the problem. 

It seems to me that this particular company, this New England 

Compounding Company, was an unusually bad actor, unusually 

egregious. And I would be very surprised if there are not multiple 

89 

lawsuits and, in the final analysis, some folks serving some jail 

time. 

And, you know, again, I can’t understand why—Dr. Smith, I will 

direct this to you. I realize you have only been in this position for 

a few months. And by all appearances and from what I read, you 

are doing a commendable job. But, gosh, this company is going 

back to 1998, and a bright light has been shining on it at least 

since 2002. And there has to be some connection between members 

of this Massachusetts Pharmacy Board, I guess appointed by the 

Governor, I don’t know for what period of time. And I think we 

have some evidence that there was some cross-pollination, where 

maybe even one of these individuals served on the board of the 

New England Compounding Center or one of these sister companies. And, you know, it is just unbelievable. 

The general public is so disgusted with Washington. I mean, you 

look, we are reading about what is going on now at the highest 

level of our military. And this situation where, in the 21st century, 

we have a Food and Drug Administration and we have State pharmacy boards, that something like this could happen. It is, like—it 

is almost beyond belief. 

But it makes me think back to what President Reagan said in 

reference to the Russians and their nuclear stockpile: ‘‘Trust, but 

verify.’’ And that is the responsibility of this committee, this Oversight and Investigations Subcommittee of Energy and Commerce. 

Trust, but verify. And we are not very trusting today, as you can 

tell from our line of questioning. And we shouldn’t be. 

That judge, his widow in the previous panel talked about his contribution to society in the great State of Tennessee. And his life 

was lost, but he was just one of how many? Well, we are talking 

about far too many people. 

So I would just in my last second ask you, Dr. Hamburg—and 

maybe Dr. Smith could comment, as well—do you think that the 

FDA needs, because of this, to all of a sudden have us change the 

law so that you and the FDA, or whoever succeeds you, has this 

broad authority over these little compounding pharmacies all 

across the country who are doing the right thing? They are not 

manufacturing drugs; they are just trying to provide a service, indeed, based on a prescription that has to be written. 

This company was an absolute crooked operation, and they killed 

people. But I don’t think anybody here should get confused between 

them and the typical compounding pharmacist at our corner drugstores all across our districts. 

Ms. HAMBURG. Yes. Well, I think we need a tiered approach, and 

that is what we are proposing in terms of the need for new legislation. I think that, clearly, the traditional compounder working locally is most appropriately overseen by the State. But this isn’t, 

sadly, an isolated incident. This is the worst and most tragic, and 

it should be the last wake-up call to us. But over a period now of, 

you know, almost two decades, there have been problems with 

compounding facilities, compounding pharmacies. 

And I think it reflects this gap in regulatory oversight and the 

fact that we really need a strong, clear, and appropriate legislation. 

We cannot have a crazy quilt where different parts of the country 

are subject to different legal frameworks for oversight. We need a 

90 

tiered system that recognizes the role of traditional compounding 

and the role of the States; nontraditional compounding, which represents higher risks, and there should be Federal standards. 

And we need to look at a set of statutorily based criteria, factors 

that in some combination would put people into this category: the 

type of product or activity, whether it is sterile processing, for example, the amount of product being made, whether it is in interstate commerce, whether it is going directly to the end-user or 

through a third party, and the nature of the anticipatory 

compounding. 

And then there are some things that just simply shouldn’t be 

compounded, that should be manufactured by drug manufacturers 

subject to the full force of FDA authorities. And that would include, 

you know, certain things that you are well familiar with: extended 

release, transdermal, biologics, and other kinds of products that, 

because of the nature of the manufacturing, they really should be 

made in accordance with good manufacturing practice. They should 

be subject to the FDA preapproval review for safety, efficacy, and 

quality manufacturing—— 

Mr. GINGREY. Dr. Hamburg, thank you. I have gone way beyond 

my time, and I really appreciate the chairman’s indulgence. And I 

yield back. 

Mr. STEARNS [presiding]. Sure. 

The gentleman from Texas, Mr. Green, is recognized. 

Mr. GREEN. Thank you, Mr. Chairman. 

I think the questions and the testimony here today showed from 

all three panels the problem we have. The NECC tragedy laid bare 

a regulatory gap that we have between the practice of traditional 

pharmacy compounding and full-scale drug manufacturing. 

There is no debate that we want the Federal Government to license individual pharmacists. That is a State responsibility. Nor is 

there a debate about whether FDA should oversee large-scale manufacturing of drugs, which is I think on a bipartisan basis what we 

have heard. 

There have been overwhelming numbers of signals, though, 

about NECC, which is not your average neighborhood pharmacy. 

Commissioner Smith, how many different States did NECC sell 

their products to? 

Ms. SMITH. I am not sure about all of their products, but in 

terms of—— 

Mr. GREEN. But they did sell it into a lot of States. Did they did 

sell it into Massachusetts? 

Ms. SMITH. Yes, they did. Twenty-three, I believe, is where 

they—— 

Mr. GREEN. Twenty-three States? But did they sell their products 

in the Massachusetts market? 

Ms. SMITH. Yes. 

Mr. GREEN. OK. How many States did it send the contaminated 

injections that led to the outbreak? 

Ms. SMITH. That was the 23. 

Mr. GREEN. OK. 

Ms. SMITH. They may sell into more, but that was the 23. 

91 

Mr. GREEN. NECC was not new to this nationwide shipping. 

Hadn’t they been operating throughout the company—the country 

for about a decade? 

Ms. SMITH. That is correct. 

Mr. GREEN. The Massachusetts Board of Pharmacy had been getting complaints and troubling sings from States around the country 

for that whole period of time. The board received complaints from 

Idaho and New York that NECC was inappropriately soliciting 

business. The board received a report from South Dakota pharmacists that NECC was sending blank forms for dosage size that 

you never use on one person. The board received adverse event reports from NECC products from Florida and New York. And the 

board received complaints from pharmacists in Texas and Iowa on 

how NECC was soliciting and filling prescriptions. The board also 

received reports of cease-and-desist orders for NECC for in Colorado. 

Dr. Smith, red flags came from across the country, and I can go 

over that list of States again. Wasn’t it obvious that NECC was operating on such a large scale that it presented a nationwide problem of a sort that warranted greater involvement by the Federal 

Government? 

Ms. SMITH. Yes. 

Mr. GREEN. Did the board in Massachusetts request any assistance from the FDA? 

Ms. SMITH. I am not aware of any specific requests. However, 

there were—certainly, during this most recent outbreak, we have 

worked together, and—— 

Mr. GREEN. OK. But they have been doing this for 10 years. And 

you all have records of it. Did you share those records with the 

FDA, those complaints? 

Ms. SMITH. I am not aware—I do not recall. I would have to look 

back to check, so I don’t know the—— 

Mr. GREEN. Well, and I think that is our problem. And I have 

been on the committee since ’97. We never included Federal regulation or compounding pharmacists because, frankly, I don’t—that is 

licensing, and that is the State. But when they are in the manufacturing situation, which they are, then that means they should have 

been covered by Federal law. 

And I know it is complicated and it is hard for a doctor to explain 

legal; it is hard for lawyers to explain some of the legal theories 

that the courts do. But that is the decision I think Congress needs 

to make. And I think we have a bipartisan agreement, this subcommittee doesn’t do legislation. But, believe me, the Health Subcommittee can. 

And I don’t know if we can do it by the end of the term. And 

I know our chairman is not here, and even our ranking member. 

But I would hope that we could look at a very quick piece of legislation that we could have a hearing on and to correct this problem. 

Because if you are a compounding manufacturer in Texas and 

selling in interstate commerce, it ought to be Federal law covering 

it. I don’t expect our local pharmacy board in Texas—they go 

around and inspect my pharmacists, whether they be in the large 

pharmacies like Walgreens, in our case, or CVS, I know a Rite Aid 

here, or our neighborhood pharmacists. But they don’t inspect, necVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00095 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
92 

essarily, the compounding manufacturers. And that is where Federal law needs to come. 

And I will be glad to yield to my colleague, and I would hope that 

we would see movement on the bill on a bipartisan basis. Thank 

you. 

Mr. MARKEY. Thank you. 

Let me ask you this, Dr. Hamburg, when you try to inspect compounded drugs, do you get sued by the compounding industry? 

Ms. HAMBURG. We have been sued on numerous occasions, and 

we have been challenged in terms of our authority. 

Mr. MARKEY. When you try to regulate compounded drugs as 

new drugs, do you get sued by the compounding industry? 

Ms. HAMBURG. We do not. The authority there is very clear, the 

expectations on drug manufacturers in terms of what they need to 

do to comply with FDA law. 

Mr. MARKEY. When you request documents from compounding 

firms, do they sue to block you from getting—— 

Ms. HAMBURG. You know, we often have to go to the courts and 

get warrants in order to get the materials that we need. We do not 

have the full authority that we need to review documents. 

Mr. MARKEY. When you are asking a drug company, Merck, 

when you request documents from them, do they go to court? 

Ms. HAMBURG. No, we have much clearer authority over drug 

manufacturers. 

Mr. MARKEY. When you are inspecting Merck, do they question 

your authority to inspect? 

Ms. HAMBURG. No, they do not. 

Mr. MARKEY. And that is why she needs authority. That is why 

the FDA needs authority. Because it is clear that the drug companies accept the law and the FDA’s authority. 

Mr. GREEN. As much as I agree with my colleague from Massachusetts, I yield back my time, but I would hope our committee 

hearing has done what we need to do and can encourage—— 

Mr. STEARNS. Will the gentleman—I think his comments were 

very appropriate and bipartisan, and I appreciate that. 

Do you think in your heart of hearts that the Energy and Commerce Health Subcommittee should provide more regulation and 

authority to the FDA before the end of the year? 

Mr. GREEN. I think we ought to respond to the tragedy that happened, and I think we owe it to the families, but also to probably 

thousands of people who may not have been subject to a death in 

their family but an illness because of the practices of this particular compounding company. It happens to be in Massachusetts, 

but it could have been in any other State. But Massachusetts did 

have warning. There were complaints for 10 years about it. 

And I would hope that we would have better interstate sharing 

between the States and the Federal regulatory agencies, even 

though they may not have had the authority, but somehow, in 10 

years, they could have come to us and maybe we could have given 

it earlier. 

Mr. STEARNS. I thank the gentleman. 

The gentleman from Virginia, Mr. Griffith, is recognized for 5 

minutes. 

93 

Mr. GRIFFITH. Thank you, Mr. Chairman, I appreciate it, and obviously, this is very frustrating. You know, I would like to know 

what kind of due diligence the FDA has the authority to do? Do 

you send out letters to doctors saying, where are you getting your 

compound medicines from, or where are you getting your supplies 

from? And the reason I ask that, and the same thing for hospitals, 

or clinics, or other medical providers, because this was not what we 

think of as compounding. This was manufacturing. In my small 

area, which is, you know, it overlaps the Roanoke Valley, the New 

River Valley, we have compiled a list of approximately 1,415 patients who were advised based on press reports, they were notified 

they could have been exposed to fungal meningitis through the 

tainted steroid injections and other products made by the New 

England Compounding Center, and we have, you know, a hospital 

that didn’t, fortunately, use it, but had it sitting on the shelf. We 

had—that was at the Carilion Giles Community Hospital. We had 

the Insight Imagining in Roanoke and the New River Valley. We 

had other clinics, including Vista Eye Center, LewisGale Medical 

Center in Salem, and Carilion Roanoke Memorial, all of which had 

these products. 

And when you have that many, you know, I don’t represent New 

York City. This is a fairly, compared to other parts of the country, 

a fairly small area, and we have got 1,415 people who have to 

worry about whether or not they are going to get the disease. We 

have more than that who have already contracted it, roughly 50 

confirmed cases in the area. Three of those, so that I am being fair, 

were across the line in West Virginia, but not that far from our 

medical centers. And when you have got that many folks affected, 

we are not dealing with a compounder, which is why it has been 

frustrating all day, I think, for members of this committee, when 

you keep going, our jurisdiction is not clear. Your jurisdiction was 

clear; these folks were manufacturing. 

Now what due diligence did you take to find this out? Because 

these are all pretty big operations, and if you just sent them a letter saying, hey, who is providing you with various products? You 

know, I think they would have complied, and you would have had 

then the, you know, you didn’t—FDA, not you—but did some work 

back under the Bush administration, but then it appears that the 

ball was dropped and that there was no—it appears there was no 

due diligence going on that you all weren’t saying, hey, who is providing you with this stuff? Because you know what, we have got 

Colorado involved; we have not Tennessee involved, who made complaints in advance. And we have got 1,415 people who either live 

in my district, or Bob Goodlatte’s predominantly, and you know, 

somebody wasn’t paying attention. 

These were not our compounding. This was not your small 

compounding pharmacy. These were, in fact, manufacturers. And I 

recognize they were violating the laws, but it is very frustrating 

when you come in here and say, our authority wasn’t clear. These 

folks were manufacturing. And what are you doing now to find out 

if there is somebody else out there who is manufacturing under the 

claim that they are not, I mean, you know, spending—— 

94 

Ms. HAMBURG. Well, I think your question speaks directly to why 

we do need legislation and new authorities. Compounding pharmacies are not required—— 

Mr. GRIFFITH. All right, hang on, I am not worried about 

compounding. I am telling you that from the evidence I have heard 

today, it appears that these were manufacturers. So what do you 

all do to find out if somebody is manufacturing illegally, because 

that is what I think we have here? And you keep going back to 

compounding, and that is why everybody is getting frustrated with 

you; 1,415 cases, you know, a number of States away is not a 

compounder. That is a manufacturer. 

Ms. HAMBURG. Well, I think we really do need to clarify that in 

legislation in terms of—— 

Mr. GRIFFITH. All right. I already heard that. Let me go on to 

another question because I have limited time like everybody else 

does. 

There was marketing going on, and I am going to switch to you, 

Dr. Smith. There was marketing going on. They apparently were 

aggressively marketing bulk pricing, discounts to the clinics. You 

are aware of that at this point? 

Ms. SMITH. Well, yes, those were some of the claims, or the 

issues that had come up before. 

Mr. GRIFFITH. OK, and I guess if they are aggressively marketing 

to multiple States, did it—are there any memos, I know you 

weren’t there, and I appreciate you coming forward and saying, 

look, mistakes were made. Did anybody think, hey, wait a minute, 

this is not traditional compounding, this is a manufacturer, we 

need to turn this over to the FDA and let them deal with them as 

manufacturers? Because that is what the evidence—notwithstanding the FDA not wanting to accept some responsibility today 

at all, that appears to be what happened here, is that somebody 

was violating the law, and pulling a fraud and claiming they were 

compounders when they were in fact manufacturers. Did that ever 

come up in any of the notes or the memos that you have seen thus 

far? 

Ms. SMITH. It hasn’t come up, or we haven’t found that level of 

conversation. What has been clear and remains clear, is that Massachusetts law requires one prescription per patient. And so the 

issue that has come up as you describe it, is that clearly you can’t 

do that and still do one prescription per patient. 

Mr. GRIFFITH. Right. 

Ms. SMITH. One of the things we have done since this all has 

come to light is to, A, remind all pharmacies in Massachusetts of 

that; remind hospitals that if you are getting product, that it needs 

to be one prescription per patient, for exactly the reasons that we 

have been discussing. 

Mr. GRIFFITH. Well, I appreciate that. 

And Mr. Chairman I know my time is up, and I appreciate this 

hearing being held. Earlier today you said, or somebody said there 

would be more hearings. I certainly hope there are, and I hope that 

we can get some answers on why and what we need to do, not on 

the compounding side but to make sure the FDA has authority, because apparently, they don’t, to just check and see if we have peoVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00098 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
95 

ple out there who are committing fraud on the public by claiming 

to be a compounder when they are in fact manufacturers. 

Mr. STEARNS. I thank the gentleman. 

And I say to all the members we are going to go for a second 

round. I talked to the ranking member, she has agreed. It is not 

necessarily going to be the full 5 minutes, but if you—if the panel 

will be patient with us, there are no votes today, so we do have this 

unique opportunity to have a second round. 

I want to continue with a little bit what Mr. Griffith indicated. 

He sort of indicated going forward today, have you come up with 

procedures and interpretations so that the manufacturers out there 

that are doing the same thing as NECC, that you can stop them? 

And I didn’t—you didn’t seem to give a clear answer. So what assurance do we have in the public mind and legislators that the 

FDA is going to prevent this from happening today because we 

might not get legislation? This is a lame duck session, but the Republicans control the House; the Democrats the Senate. I mean, it 

is going to be very difficult to get legislation through normally, 

even though this is a very serious problem, and I think we are all 

bipartisan on this. Sometimes between the cup and the lip, it takes 

a while. So I think what Mr. Griffith was touching on is, what assurance can you give the public that the other NECCs that are out 

there, that you are going to stop them? 

Ms. HAMBURG. Well, I do want to underscore that I believe that 

we need legislation—— 

Mr. STEARNS. So you cannot stop them unless you have more legislation? 

Ms. HAMBURG [continuing]. To sanction and clarify authority. In 

the interim, we are working very hard, working with our colleagues 

at the State. I mentioned that we are actively engaging with the 

States in order to both provide our best possible information about 

best practices, et cetera. 

Mr. STEARNS. Do you feel confident you could stop another 

NECC; with the jurisdiction and the understanding you have now, 

could you stop another NECC who is manufacturing drugs? Could 

you stop them today? 

Ms. HAMBURG. NECC was not the first, and it will not be the 

last—— 

Mr. STEARNS. OK. All right. 

Ms. HAMBURG [continuing]. Until we work together to clarify and 

strengthen the laws that surround—— 

Mr. STEARNS. Dr. Smith, you indicated in your opening statement that because of what happened, people have been fired and 

suspended. Is that true? 

Ms. SMITH. Correct. 

Mr. STEARNS. And you have also implemented new regulations 

and new oversight interpretation so that you can prevent this from 

happening again, is that correct? 

Ms. SMITH. Yes. 

Mr. STEARNS. OK. Dr. Hamburg, have you fired or suspended 

anybody at the FDA because of this tragedy? Yes or no? 

Ms. HAMBURG. No. 

Mr. STEARNS. OK, have you gone through, introspectively, looked 

at the agency and said, these are the regulations, these are the 

96 

things we need to do to prevent another NECC? Have you done 

that? 

Ms. HAMBURG. We have done that. We have been working very 

hard to identify what are the authorities that we need to be able 

to protect the American people and to help to ensure that they get 

the quality drugs that they deserve. 

Mr. STEARNS. With the NECC incident, is it your position today 

that this could have been prevented by the Massachusetts Department of Public Health? Yes or no? 

Ms. HAMBURG. I believe that we need a stronger regulation 

framework—— 

Mr. STEARNS. No, could they have, in your opinion—— 

Ms. HAMBURG [continuing]. But I believe that different actions 

might have been taken with NECC that could have—— 

Mr. STEARNS. See, the problem is that you are saying—— 

Ms. HAMBURG [continuing]. Prevented it, and I wish that that 

were so, but I think we just have to look at the record, that there 

has been—— 

Mr. STEARNS. Did somebody tell you to filibuster us? Is that why 

you are handling the questions—— 

Ms. HAMBURG. I apologize but, you know—— 

Mr. STEARNS. No, the question is—— 

Ms. HAMBURG [continuing]. This is an important issue, and I 

care about it. 

Mr. STEARNS. You are saying you did not have the authority to 

stop this, is what you keep saying today; you don’t have the authority to do it. Do you think that Dr. Smith’s agency should have 

stopped it? Just yes or no. If you don’t know, just say you don’t 

know. 

Ms. HAMBURG. Well, I think that clearly, Massachusetts was 

working very hard. 

Mr. STEARNS. So you think they could have stopped it, and you 

didn’t have to stop it. 

Ms. HAMBURG. They were unsuccessful, and it is, you know, was 

tragic. We worked hard with them to limit the—— 

Mr. STEARNS. OK. OK. I understand. 

Ms. HAMBURG [continuing]. Outbreak, and we want to work with 

you. 

Mr. STEARNS. I have two more questions for you here. Is it your 

position today that the NECC was not a manufacturing pharmacy 

and that you had no jurisdiction over its business activities? Is that 

your position today? 

Ms. HAMBURG. NECC is—— 

Mr. STEARNS. Yes or no. 

Ms. HAMBURG [continuing]. Registered as a compounding pharmacy. 

Mr. STEARNS. No, I am talking about NECC. Did they, in your 

opinion, in your opinion, this is the crux of the hearing now, it is 

your position today that the NECC was not a manufacturing pharmacy, and you had no jurisdiction over its business activity? Is that 

your position today? Yes or no? 

Ms. HAMBURG. No, that is a subject of an ongoing investigation. 

Mr. STEARNS. No, but you have been telling us all day today—— 

Ms. HAMBURG. I cannot characterize. 

97 

Mr. STEARNS [continuing]. That you had no jurisdiction, it is 

murky? 

Ms. HAMBURG. I cannot characterize that while there is a criminal investigation that is underway. 

Mr. STEARNS. Let me get more pointed. Is it your position today 

that the FDA could not have prevented this tragedy because you 

did not have jurisdiction, is that what you are telling me today? 

Ms. HAMBURG. I, you know—— 

Mr. STEARNS. Yes or no? 

Ms. HAMBURG. I am sorry, we can speculate—— 

Mr. STEARNS. You are in charge of the FDA. You are the chief 

honcho. You are the great poobah of the FDA, and I am asking you, 

basically, could you have prevented this tragedy, and you are saying you can’t because you didn’t have jurisdiction. 

Ms. HAMBURG. It is very hard to know if any one action that we 

might have taken could have stopped this terrible tragedy. I wish 

that I could identify what that would be. What I can’t—— 

Mr. STEARNS. FDA did nothing wrong, in your opinion? 

Ms. HAMBURG. No, what I am—I am not saying that. 

Mr. STEARNS. In 2002, when they inspected and found all of the 

problems, and 2006, when they wrote the letter and said, we are 

going to shut you down; I mean, all of that is just too murky for 

you, and you don’t think the FDA has any responsibility? 

Ms. HAMBURG. No, this is—this is not a forum, unfortunately, 

that enables us to speak to the—— 

Mr. STEARNS. Well, you can speak it pretty well. We have given 

you lots of time. 

Ms. HAMBURG. I think that, you know, what we really want to 

do together is make sure that this kind of event—— 

Mr. STEARNS. Oh, that is axiomatic. We all understand that, but 

the question is, we are trying to say that—we are trying to understand how this could be prevented, and you are saying you don’t 

know how it could have been prevented by the FDA. 

Ms. HAMBURG. I think that—— 

Mr. STEARNS. You are not even—you haven’t fired anybody. You 

haven’t suspended anybody. It is not even clear that you have actually initiated anything, so I think we are leaving with the impression that thank goodness that Dr. Smith stepped up to the plate 

and did something, and we are just a little unsure what you are 

going to do. In fact, according to the staff, we are waiting, as Mr. 

Dingell said, we are waiting for all of this information from your 

agency, and we didn’t even get assurance when you were asked by 

the chairman and by Mr. Dingell that we are going to get all this 

information. I am telling you, there is so much out there that your 

agency has not given us, in all deference to you, Madam. I mean, 

you have only been there a short time, I appreciate that. We need 

your assurance that you will provide it. 

Ms. HAMBURG. We will provide the information that you have requested. 

Mr. STEARNS. OK, my time is expired. 

Mr. STEARNS. Go ahead, Ms. DeGette. 

Ms. DEGETTE. I am pulling myself together. I am going to ask 

some questions. 

98 

Dr. Hamburg, I think you can agree with me that, between 2002 

and 2006, the FDA made some attempts to investigate this, and 

they were pretty inconclusive, correct, yes or no? Yes or no? 

Ms. HAMBURG. I apologize—— 

Ms. DEGETTE. OK, you are not going to answer that. Let’s just 

keep going on. OK, now, in April of 2002, the FDA began an inspection of the New England Compounding Center, correct? Yes or 

no? 

Ms. HAMBURG. Yes. 

Ms. DEGETTE. And that inspection continued throughout the fall 

and winter of 2002 and 2003, correct? 

Ms. HAMBURG. Correct. 

Ms. DEGETTE. Now, eventually, now, you weren’t there. This was 

not your—it was not your job to defend what they did. But in 2002, 

the FDA investigators concluded, after a lot of investigation, that 

they—that there were jurisdictional issues, is that correct, yes or 

no? 

Ms. HAMBURG. That is correct. 

Ms. DEGETTE. They then turned this investigation—there still 

was some FDA involvement, but for the most part, they turned this 

investigation over to Massachusetts, yes or no? 

Ms. HAMBURG. Yes. 

Ms. DEGETTE. And so what happened at that point was then the 

FDA did have some involvement, but it was primarily Massachusetts, is that right? Yes or no? 

Ms. HAMBURG. That is correct. 

Ms. DEGETTE. Now, in the meantime, you know, I will say we 

are just trying to get answers here because we do need to figure 

out how to prevent this. And if we can’t prevent this kind of a 

thing, then shame on us, because this is a company that had black 

specks floating in the vials. It had cleanliness that wouldn’t even 

be accepted anywhere in the world. And we are all sitting here 

wringing our hands. So we have to figure out how to give you the 

jurisdiction to do what you need to do, and we have to figure out 

how to give Dr. Smith and all of the other State regulators, like 

Colorado, the ability to work with you to do that. OK? 

Ms. HAMBURG. Agreed. 

Ms. DEGETTE. And these inconclusive answers are not helping 

us. Now, the act, Section 503 of the act has all of these requirements regarding the compounders, correct? 

Ms. HAMBURG. Correct. 

Ms. DEGETTE. And what it says is, a compounded drug is exempt 

from a variety of requirements of the Federal Food, Drug and Cosmetic Act relating to drugs to get FDA pre-approval if the drug is 

compounded for an individual patient based on the unsolicited receipt of a valid prescription, correct? 

Ms. HAMBURG. Correct. 

Ms. DEGETTE. And it says, the drug is compounded by a licensed 

compounding pharmacy, correct? 

Ms. HAMBURG. Correct. 

Ms. DEGETTE. So what has happened over all of these years is 

these drug compounders have started these great big manufacturing facilities, and then they have the illusion that they are keepVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00102 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
99 

ing these scripts for the individual patients, but they are really not 

doing that. Is that correct? 

Ms. HAMBURG. That is correct. 

Ms. DEGETTE. And that is part of the problem, right? 

Ms. HAMBURG. That is. 

Ms. DEGETTE. OK, now, just hold off. So the other thing that has 

happened then, Section 503(a) says, and this goes to what Mr. Griffith was saying, is Section 503(a) says that the FDA can take jurisdiction if these compounding pharmacies are exporting more than 

5 percent of their drugs to other States, correct? It says that, right? 

Ms. HAMBURG. 503(a), yes. 

Ms. DEGETTE. So what Mr. Griffith is saying then, is why doesn’t 

the FDA just enforce that? But here is the problem, Mr. Griffith, 

and this is what Commissioner Hamburg is trying to say. Is the 

Ninth Circuit has thrown out all of Section 503, and it says, it 

doesn’t even apply. And the Fifth Circuit has said Section 503(a) 

only applies to advertising, and that is what that map is about. 

And so what Dr. Hamburg is trying to say is, you know, we can 

point fingers and we can be upset, and everything, and we should 

be, about what happened 10 years ago, and why this operation 

wasn’t shut down, but what we really need to think about is what 

are we going to do going forward to make sure that the jurisdiction 

is clarified? 

And I would bet you if we could all sit down and talk about it, 

we could agree on the same principles. We don’t want the FDA 

having jurisdiction over the doctor and the little mom-and-pop 

pharmacy who is trying to make the ointment for the kid. But if 

it really is a big manufacturing operation, even though it is a 

compounding pharmacy, we need to, if the law isn’t clarified now, 

if there is litigation, if there is a separation of court decisions in 

the cases, we need to fix that. And that is our job as Congress. 

So I guess I would say, Dr. Hamburg, you know, I understand 

what you are saying, but within the—within the purview of the law 

as it is written now, the FDA needs to do everything it can to make 

sure it prevents this kind of activity. And furthermore, we have a 

job, we have a job to all of these victims as Congress to not try to 

move the lounge chairs around on the Titanic. 

We have a job to clarify the law if there is not clarity in the law, 

and we can easily do it. So thank you, Mr. Chairman, and I yield 

back. 

Mr. STEARNS. I think we have a little time here. We could—you 

and I could have a colloquy here, and Mr. Griffith, you can participate in this colloquy. You are an attorney, Ms. DeGette, and I appreciate what you are saying, but I think the interpretation of 

what you did on the Supreme Court is not wholly explained, as you 

said. I am asking staff, did the Supreme Court throw out the entire 

was it 503(a). I don’t think they threw it out. They threw out only 

that portion that dealt with marketing. And so for you to say they 

threw out the whole thing so that the commissioner and the FDA 

had no interpretation—— 

Ms. DEGETTE. No, no that is not what I said, Mr. Chairman. 

Mr. STEARNS. Well, that is what you sort of implied, and the 

legal problem is that the Supreme Court only did a very small portion of that and left intact the idea that the company that is manuVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00103 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
100 

facturing still can be determined if they are a small pharmaceutical 

or they are a manufacturer, so I would submit—— 

Ms. DEGETTE. Mr. Chairman, if you would like to have a colloquy, I will tell you what I said. 

Mr. STEARNS. I think you appreciate what I said. 

Ms. DEGETTE. What I said was that the Fifth Circuit threw out 

the 503(a) provision only on advertising, and left the rest of it intact. 

Mr. STEARNS. Right. 

Ms. DEGETTE. The Ninth Circuit threw out all of 503, and then 

the Supreme Court took cert on the Fifth Circuit—Ninth Circuit 

case, but they only talked about the advertising. So now it is really 

a big mess. 

Mr. STEARNS. And I agree, because of the Fifth, and Ninth Circuit, and the Supreme Court. But I don’t think, and this is what 

you are implying, that it creates such a position that the FDA had 

their hands tied, and they couldn’t determine what is a manufacturing and what is a small pharmaceutical. I think you still 

have—— 

Ms. DEGETTE. Again, you are misinterpreting what I said. 

Mr. STEARNS. OK. 

Ms. DEGETTE. What I said is that there is a lack of clarity in the 

law and what that means is that evil-doers like this compounding 

pharmacy, don’t feel like they have to listen to the FDA. They don’t 

feel like they have to produce the documents when they are requested, and they sue whenever there is anything that happens. 

And that is the problem, is it ties the FDA’s hands when they are 

trying to take enforcement actions against these folks even if they 

want to. 

Mr. STEARNS. OK, you are welcome to step in here, but I think 

I would—— 

Mr. WAXMAN. Point of order, Mr. Chairman. Whose time is it 

now? 

Mr. STEARNS. Right now, it is hers. I gave her the time, and she 

yielded back, and I asked her if I could have a colloquy with her, 

which she agreed to, and you are welcome to join in. I think this 

is a legal interpretation, which I think you are welcome to join in. 

Mr. WAXMAN. Mr. Chairman, I wouldn’t want to interrupt your 

discussion, but we do have members on both sides of the aisle waiting for their opportunity to get to the round of questions. 

Mr. STEARNS. Oh, sure, well, you weren’t here at the time, and 

I would be glad to recognize you. 

Mr. WAXMAN. It goes to your side next. 

Mr. STEARNS. Oh, that is right. You are right. I am going to take 

15 seconds and just say the purview of the chairman is I think 

what Ms. DeGette is talking about between the Fifth and the 

Ninth Circuit Court, and the Supreme Court—— 

Ms. DEGETTE. Don’t interpret what I am saying. 

Mr. STEARNS. I know, but I am the chairman, and what I think 

is that there was still left the integrity of the law so that the FDA 

could determine who is manufacturing and who they have jurisdiction over. 

Mr. WAXMAN. Regular order, Mr. Chairman. 

101 

Mr. STEARNS. With that, I will recognize the gentlelady from 

Tennessee. 

Mrs. BLACKBURN. Thank you, Mr. Chairman, and I have just a 

couple of questions. 

You all have stayed with us, and I do appreciate this. 

A point of clarification, Dr. Hamburg. You mentioned earlier 

there are 7,500 advanced compounding pharmacists and 3,000 sterile. 

Ms. HAMBURG. That is information that was given to us by the 

International Association of Compounding Pharmacies. 

Mrs. BLACKBURN. OK, well, that is what I want to know if that 

was—— 

Ms. HAMBURG. We don’t know the numbers because they are not 

required to actually report to us, so we don’t know numbers from 

our own assessments. 

Mrs. BLACKBURN. OK, but you can source that for us? Would you 

provide that sourcing so that we have that? 

Ms. HAMBURG. OK, certainly. 

Mrs. BLACKBURN. OK, thank you, I appreciate that. Let me, I 

want to go back to this issue that you all had because you had the 

Colorado complaint against NECC in May of 2011, is that correct? 

Ms. HAMBURG. That is correct. 

Mrs. BLACKBURN. OK. And that complaint came into you well in 

advance to any of these contaminated lots being shipped, is that 

also correct? 

Ms. HAMBURG. Well, as I understand it, it was a request for information from us about whether they were registered as a manufacturer, a drug manufacturer, and they—NECC is listed as a 

compounder. 

Mrs. BLACKBURN. Well, I think Colorado notified the same FDA 

compliance officers who had inspected NECC in the past, is that 

correct? 

Ms. HAMBURG. I believe. 

Mrs. BLACKBURN. And that these inspectors were aware of 

NECC’s past violations, isn’t that correct? 

Ms. HAMBURG. I believe that the email from Colorado was shared 

within the FDA because of the history with NECC. 

Mrs. BLACKBURN. OK, and then, in that email, did they not say 

that NECC was again shipping volumes of drugs without a prescription? 

Ms. HAMBURG. What they indicated to us was that they were 

concerned that NECC was operating in violation of Colorado State 

Board of Pharmacy licensure and registration laws, and they included attachments—— 

Mrs. BLACKBURN. OK. Doctor. 

Ms. HAMBURG [continuing]. About the volume of product that 

was being shipped. 

Mrs. BLACKBURN. But it was clear that it was a repeat violation, 

isn’t that correct? 

Ms. HAMBURG. What was clear was there were not specific safety 

and quality concerns, but they were noting that there were not 

valid prescriptions for the materials that were being sent to Colorado. 

102 

Mrs. BLACKBURN. OK, let me ask you this. Did the FDA do anything at all with that complaint? 

Ms. HAMBURG. Well, we suggested that they follow up with the 

Massachusetts Board of Pharmacy because—— 

Mrs. BLACKBURN. You suggested? You suggested; you didn’t require. Did you even pick up the telephone and call the Massachusetts Board of Pharmacy and say, ‘‘We think we have a repeat offender’’? 

Ms. HAMBURG. I understand, you know, what you are getting at 

there, but it—— 

Mrs. BLACKBURN. Yes or no. Did you pick up the phone and call? 

Did anybody pick up the phone and call? 

Ms. HAMBURG. Email was being used, but it was communicated 

through the Colorado Board of Pharmacy. 

Mrs. BLACKBURN. Would you like to supply all of those emails to 

us for the record? 

Ms. HAMBURG. I believe you have them. 

Mrs. BLACKBURN. OK, we have got all of those in total. When did 

you personally become aware of the situation? I mean, at what 

point in the process did you individually, not your staff, but you? 

When did you hear of it. 

Ms. HAMBURG. When the first cluster of meningitis cases and the 

possible link to NECC was identified. It was in late September. 

Mrs. BLACKBURN. OK, Dr. Smith, let me come to you with my 

last minute. Did the FDA ever contact you? 

Ms. SMITH. Are you—just so I can understand, do you mean in 

the past or around this current outbreak? 

Mrs. BLACKBURN. No, let’s go back to the Colorado complaint. 

Did they ever contact you? Did you ever—did you ever get a phone 

call or an email from anybody that said, we think we have a repeat 

offender out here? 

Ms. SMITH. Well, I can’t speak to the phone calls, but review of 

the emails does not suggest that we got any information then. 

Mrs. BLACKBURN. So they knew they had a repeat offender, but 

they did not call you. 

With the boards of pharmacy, like with Colorado, back to you, is 

there any direct contact there? You know, so many of our State 

boards, who do a great job of regulating areas, contact and work 

with other State boards who have like supervision in their States. 

Ms. SMITH. Well, we did receive information from Colorado about 

the action, but it wasn’t until July of 2012, and we weren’t, or I 

wasn’t aware of that until we discovered that in the process of producing the documents for this committee. 

Mrs. BLACKBURN. OK, and let me ask you this: Personnel actions 

in response to this, the NECC, have you taken any actions there? 

Ms. SMITH. Yes, the executive director at the time has been let 

go from the department, and the board counsel has been put on administrative leave as was the division director for that area. 

Mrs. BLACKBURN. And are you reviewing your processes and best 

practices? 

Ms. SMITH. Regarding personnel actions? 

Mrs. BLACKBURN. Yes. 

103 

Ms. SMITH. Yes, as we reviewed the information, again, that we 

presented for this committee, we have identified lapses in judgment, which have resulted in these personnel actions. 

Mrs. BLACKBURN. Thank you. I yield back. 

Mr. STEARNS. The gentleman from California, Mr. Waxman, is 

recognized for 5 minutes. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

I find this hearing amazing. 

Mr. STEARNS. Amazing. 

Mr. WAXMAN. Because what we need to do is to work together 

to solve a problem and make sure it will never happen again. Instead what I hear from my Republican colleagues is they want to 

prosecute the director of the Food and Drug Administration. Did 

she know this? What action did she take? 

It sounds like Massachusetts has a lot to be apologetic about. 

Isn’t that a fair statement, Dr. Smith. 

Ms. SMITH. Yes, you are right. 

Mr. WAXMAN. And the question is, did FDA fail to do things they 

should have done? Well, it sounds like you could have done more. 

The FDA as an institution could have done more. The first time 

they wrote a letter was in 2006, saying that this thing seemed to 

be—this company seemed to be out of control. And then they didn’t 

do anything after that. 

Now, I have a feeling, Dr. Hamburg, you are being picked on because you are part of the Obama administration, and Republicans 

have been picking on Obama for 4 years, and usually their mantra 

goes, job-destroying regulation, let industry police itself, we don’t 

want government involvement. 

Now, they are saying, we want more government involvement, 

and I think they are right. We want appropriate government involvement to stop these things from happening. 

So you would think that our obligation would be to figure out, 

do you have the authority? I respect the chairman greatly, but I 

have never understood him to be a great legal scholar. It seems to 

me there is some ambiguity. If there is an ambiguity it is our job 

to clear it up. You think there is an ambiguity because the law that 

we drafted in 1997 said one thing and the court came in and said 

something else. You don’t know whether you can act, whether you 

can’t act. If we want to make sure you act in the future, other than 

just beat you up for not acting, we ought to make sure that you 

have all of the authority appropriate to act. The courts have 

thrown out part of that 1997 law. The courts are themselves divided on whether Section 503(a) continues to have any legal force. 

In the Western States, 503(a) is not effective; while in Texas, Louisiana, and Mississippi, it is. And as the map is put together by the 

compounding industry itself shows, there is a very large gray area 

in-between. 

So why are we looking for anybody to blame other than the company and making sure that the regulators have all of the power 

that they need. That involves, my colleagues, regulatory power to 

act. It also involves, I tell you regulators, to do your action, to take 

action to stop these bad actors from doing what they want. 

And I wasn’t in the room, but I understand the chairman of the 

Oversight Committee said, they are not going to do any legislation. 

104 

Well, I would rather we do it now before he leaves. Because he is 

so involved and steeped in this whole question, he should want to 

work with us to solve this problem. It doesn’t sound like that difficult a problem. We need to say the FDA has the authority to do 

this, to do this, to do that. 

Commissioner Hamburg, can I ask you for a commitment to 

make your staff available to us this week if we started a process 

to—— 

Ms. HAMBURG. Absolutely, tomorrow. We are so eager to work 

with you because we feel there are significant gaps in our authorities that limit and undermine our ability to do all that we want to 

do to protect the health and safety of the American people. You 

know, I think that the fact that we have a situation like that map 

reveals, suggests that we don’t have a comprehensive, integrated 

legal framework for action, and we think that we can work with 

you to identify critical areas from registration, so we know who is 

out there, and what they are doing, to developing Federal standards that should be adhered to to ensure safe and high-quality 

products, to the ability to do full inspections. 

Mr. WAXMAN. I don’t want to get you off the hook completely. I 

think you need the law to be clarified, but if I were sitting in your 

shoes—that is a mixed metaphor—if I were sitting in your seat and 

I was the head of the FDA and I heard that Colorado was concerned about this situation, and you heard other reports, I would 

have assumed I had jurisdiction. I would have assumed the jurisdiction. I would have acted on it. 

And I have to say to the State, you know, people want to make 

partisan comments, and I think what some of what is going on is 

a little partisan. When FDA first sent the letter, the chairman said 

when you sent a letter, was the FDA under the Bush administration? When the State of Massachusetts had a weak consent agreement, it was under Governor Romney’s administration. You are 

now here under Governor Deval Patrick and here under President 

Obama. Let’s put partisanship aside. Let’s make sure you have the 

authority and the resources to do the job. We want you to do the 

job because we ought to be mindful of the comments that Mrs. 

Lovelace made and all of the other people who are waiting to see 

if they are going to die from this contaminated drug. 

We don’t want excuses. We don’t want to leave this law ambiguous because you are sued if you act. And if you act, assuming you 

have authority when you don’t, you are usually called before committees to say, how could you act as if you have authority when 

Congress didn’t give it to you? 

I think we ought to put our partisanship aside. The election is 

over. Figure out a clear law for the Federal Government to be able 

to act because, because with all due respect, this is not a State 

issue if a drug is being shipped around in the country. It is an 

interstate issue. 

Thank you, Mr. Chairman. 

Mr. STEARNS. Sure, and I will be the first to recognize— to recommend you as you as chairman of the FDA. 

Ms. DEGETTE. Can we finish this hearing, please? 

Ms. HAMBURG. Might not want that job. 

Mr. STEARNS. All right, Dr. Burgess is recognized. 

105 

Mr. BURGESS. Thank you, Mr. Chairman. 

And something that is very important, I don’t want it to get lost 

in the translation. Representative Blackburn asked about emails 

between the FDA regional office, and the Massachusetts Board of 

Pharmacy. 

And Mr. Chairman, may I suggest that those emails are a critical 

part of our investigation and that we must receive those, even if 

it is necessary to exercise subpoena authority. We need access to 

that critical part of the—— 

Mr. STEARNS. If the gentleman will yield for one second. We have 

tried. We have got no emails from the FDA. The crux of this hearing is to get to the bottom of what happened. We can’t get to the 

bottom if we don’t have the information. So you are exactly right. 

The FDA has got to cooperate and give us the emails, because we 

have gotten zero. 

Mr. BURGESS. Well, and of course, the FDA has a lot of material, 

and the access to the opinion of your experts would be important 

to us in this investigation. So the intransigence that Chairman 

Upton referenced in his opening statement is something that really 

must be overcome. Now, I am of the opinion that you had all of the 

authority that you needed, and yes, it was a previous commissioner, and it was a previous administration. So, once again, I 

would also ask that if there is a memo from a general counsel at 

FDA to the then commissioner about, you don’t have the authority 

to do what you said you were going to do in this enforcement letter, 

I think the committee really should see that as well. And again, I 

think we should exercise every power that we have in order to get 

that. And the reason it is important is if new legislation is indeed 

passed and passed hurriedly, as has been recommended, before the 

end of the year, and yet you are not going to act on that authority, 

then we are going to be right back here in the same soup with the 

same problem at some point in the future, and it may be a different 

commissioner from the FDA and they will say, well, there was an 

ambiguity. Look, there is no ambiguity. You have got a criminal investigation going on against NECC, is that not correct? 

Ms. HAMBURG. There is a criminal investigation, yes. 

Mr. BURGESS. So where is the ambiguity? If you have a criminal 

investigation, if you had all of the guys in FDA jackets seizing computers out of the compounder, where is the ambiguity? 

Ms. HAMBURG. First, let me say, we are working to get you the 

emails that you want. We have been trying to develop documents 

and get them to you as swiftly as we can in light of everything that 

is going on. You know, I know it is not the answer that you want 

to hear, but I do think that there is clearly ambiguity and a lack 

of—— 

Mr. BURGESS. A criminal investigation, guys in FDA jackets 

seized the computers, did it on TV so everybody can see. That 

doesn’t look ambiguous—— 

Ms. HAMBURG. No, but—the need for legislation. You know, I 

want to do everything to work with you and get you the information that you need, but I think we also do need to look forward and 

look at where are the gaps in authority. 

I cannot speak to what was going on in the FDA during that period because, as has been noted, I wasn’t there. 

106 

As I understand it, there were very intense discussions and conflicts about what were our authorities, what—there was ongoing 

litigation; what basis would we use for different regulatory actions 

that might be taken. 

Mr. BURGESS. So help us here. If we are going to craft legislation 

rapidly before the end of the year, as has been suggested several 

times on the other side of the dais, how do we keep from making 

the same mistake again? Look, do you have the authority to conduct an investigation as to whether or not you have jurisdiction to 

conduct an investigation because that is what I have been hearing 

all day? 

Ms. HAMBURG. We have authorities that have been consistently 

contested, have resulted in split court decisions, in a patchwork of 

regulatory legal oversight, and you know, that is part of what I 

think we can and should address together. 

Mr. BURGESS. Yes. Look, people are dead. Doctors have administered medication that they thought was safe, and their patients 

have suffered. They have got to live with those consequences. The 

case we heard about today where the doctors in the intensive care 

unit at Vanderbilt Hospital didn’t have a clue as to what was really 

the culprit in that gentlemen’s illness. There is a lot of stuff here 

that, if there is a problem with the existing statute, it needs to be 

corrected. Then you owe us the ability to look at those internal documents and see what the discussion—— 

Ms. HAMBURG. And we will get that to you. 

Mr. BURGESS. Well, it has been said time again, we have to do 

this before the end of the year, give us the stuff. Mr. Chairman, 

I am going to ask that we subpoena the stuff that we need, and 

do that forthwith. I mean, yes, I know it is holiday season and nobody wants to be working on this stuff, but we have got to do it. 

And if we rapidly produce legislation so that we can just say we 

have done something before the end of the year so we can all feel 

good about ourselves, again, we are going to be back here in the 

same mess, 2 years, 3 years, 4 years fill in the blank. If all you 

need for the cloak of invisibility is to say you have a compounding 

pharmacist, I mean, what is to stop Pfizer tomorrow from saying, 

oh, I am a compounding pharmacist. All of this stuff goes out the 

door and you can’t stop me. You can’t touch me because the Fifth 

Circuit or the Ninth Circuit or someone said, you can’t touch me. 

That is nonsense. No one believes that that is the way it should 

be, and surely, you don’t either. 

Ms. HAMBURG. I do not. And that is why I really do feel this is 

an extraordinary opportunity for us to fix some of those problems 

that have really been present for now at least 15 years and have 

tragically resulted in incidents involving deaths, loss of vision, 

other injuries and harm from drugs that the patients thought 

would help them, not harm them. So I think we can strengthen—— 

Mr. BURGESS. Look, you owe us the information you have. 

Ms. HAMBURG. And we will get that to you. 

Mr. BURGESS. You have emails. You have experts under your 

control. If this is something that has been discussed internally, and 

there has been a conflict internally, let us be privy of that information so that when we try to craft the legislative fix, it is not an imperfect product. And you have got all of the authority you need 

107 

today to shut this place down, lock them up, and send them away 

for however long that anyone would care to think, for whatever 

reason, it didn’t happen in 2002, 2004, 2006, 2008. 

Mr. STEARNS. The gentleman’s time has expired. 

Mr. BURGESS. I yield back. 

Mr. STEARNS. Mr. Dingell, before I recognize Mr. Dingell, Dr. 

Hamburg, we have gotten thousands and thousands of emails from 

Dr. Smith’s agency, so the fact that you have got none—she has 

less resources than you do, yet they complied and have given us all 

of the information. So I just really urge you and your staff to comply. 

Ms. HAMBURG. We will get that to you. 

Mr. STEARNS. All right, Mr. Dingell is recognized for 5 minutes. 

Mr. DINGELL. Mr. Chairman, thank you. 

Dr. Smith, and commissioner, it is possible for the two of you to 

execute Memorandums of Understanding defining your respective 

jurisdiction, is it not? 

Ms. HAMBURG. Yes. 

Mr. DINGELL. Is there any reason why you could not or would not 

begin to devote your attention to achieving such a Memorandum of 

Understanding so that you could define where the authorities of 

Food and Drug lie, and the authorities of the agency in the State 

of Massachusetts lie? Are you willing to undertake that, ladies? 

Ms. SMITH. Well, I certainly think that there are multiple opportunities for us to do better in terms of communication and that sort 

of thing as a beginning. 

Mr. DINGELL. We are going to try, I think you can sense from the 

committee and its questions to proceed towards a legislative solution, and it may very well be that we have to do so, and I think 

we are determined to do so. 

What I am hoping is that while we are doing that, that you will 

commence doing what you have the capacity to doing, i.e. A Memorandum of Understanding, where the two of you define your respective responsibilities so that we can get ahead of this curve. And if 

we cannot complete our business by year end because of the Senate 

or other things, that we are able, therefore, because of your labors, 

to commence the process of moving along on a parallel track. Are 

you willing to do that? 

Ms. HAMBURG. We are certainly willing to do that, and we are 

pulling together all of the 50 States in order to really begin—— 

Mr. DINGELL. Well, I don’t want to put out difficulty for you, but 

I want to look at how to resolve the problem. 

Ms. HAMBURG. But I just have to underscore that it still won’t 

address what the courts say, different regulatory requirements. 

Mr. DINGELL. Doctor, the clock runs, and it is most uncharitable. 

I will look for you to give me an answer on what you can do to 

get a Memorandum of Understanding done between your two agencies and/or other agencies. 

Now, it is possible to define a compounder as a person who 

makes certain amounts and to define a manufacturer as a person 

who makes certain amounts of pharmaceuticals, is it not? Yes or 

no? 

Ms. HAMBURG. You could decide to put that in legislation. Currently, that does not exist in the legislation. 

108 

Mr. DINGELL. You are telling me you don’t have the authority to 

do that? You do or don’t have that authority? 

Ms. HAMBURG. Volume in and of itself is not dispositive. It could 

be put into legislation as a statutory factor in our determination. 

Mr. DINGELL. It appears that the New England Compounding 

Center and other like-hearted rascals have engaged in the practice 

of figuring themselves a fine loophole in which, through lobbying 

and other efforts, they have been able to assure that they are able 

to engage in practices that impose substantial dangers on the 

American people. 

Now, having said that, I would like to have you tell me one more 

thing here, if you please, Doctor. 

You have one of the required treatments for this particular fungicidal meningitis that takes place is to have availability of a substance called oral voriconazole, which is a therapy used in treating 

spinal meningitis. There is a great concern on the part of a hospital 

in my district St. Joseph Mercy in Ann Arbor, and they are troubled that there is going to be a shortage of this particular pharmaceutical available to them to provide the necessary treatments for 

their patients who have been hurt by this particular—the particular injectable that we are talking about today. 

What is there that we can do to assure that there is an adequate, 

current, and future supply chain for oral voriconazole? 

Ms. HAMBURG. Well, voriconazole has been used in the treatment 

intravenously, and from the very beginning, we have been looking 

at the possibility of shortages. When last I discussed that with—— 

Mr. DINGELL. What are we going to do about that? 

Ms. HAMBURG [continuing]. They did not feel it was in shortage. 

I have not heard anything further. I will get back to you if there 

are concerns, but I do not believe that it is at risk for shortage at 

the present time. 

Mr. DINGELL. This is a matter of urgent concern, and I would 

suspect that my people at St. Joe’s are concerned that you all have 

hospitals and practitioners elsewhere in the country who all have 

the same concern. So I would appreciate if you can look—— 

Ms. HAMBURG. Yes, we will be examining that. 

Mr. DINGELL [continuing]. Into that. 

Mr. Chairman, I thank you for your courtesy. 

Mr. STEARNS. The gentleman from Virginia is recognized for 5 

minutes, Mr. Griffith. 

Mr. GRIFFITH. Mr. Chairman, this is probably a first for me in 

the time that I have served on this committee, but I agree with Mr. 

Waxman when he said that he would have made the assumption, 

particularly in those areas that are gray, that you had the authority. And so I just point that out to you. 

Now, maybe it is because I was a criminal defense attorney in 

my prior life, you know, the threats that somebody might sue me 

just aren’t something that would stop me from trying to do my job. 

And if I thought I was right, I would have gone forward. And that 

is why we want to see the emails, and we want to see the memorandums. You have heard all of these questions, and I thought Ms. 

DeGette did a nice summation. And I wish you would have been 

as clear in your answers as she was in trying to interpret your position. 

109 

But having been a criminal defense attorney and having heard 

you all day say that, you know, you didn’t have authority or your 

authority was vague, or you needed clarification of authority, I 

have to ask the question, what is your legal basis for the FDA 

going in and doing a criminal investigation in this case? 

Ms. HAMBURG. Well, of course, that is being done with the Department of Justice, but the Food, Drug, and Cosmetics Act, obviously, is the basis for so much of our regulatory actions, but the 

problem here is that a component of 503(a) has been questioned in 

the courts, and it applies in some areas and it doesn’t apply in 

other areas. And we have, around compounding pharmacies, we 

have guidance that we have put out that would be applying in 

some areas, but that doesn’t have the force of law. So, you know, 

it is a challenging arena for regulatory—— 

Mr. GRIFFITH. Well, here is the problem, and I fear that in your 

comments today, you may have made the argument for the defense 

that they are going to escape criminal sanctions because you have 

said the law is ambiguous and that you don’t have the authority 

to go forward. And I think that is a mistake because, look, you 

know, I think, as I said before, they are a manufacturer, particularly when we have 1,415 patients in my area alone. I think they 

are a manufacturer. And just because they call themselves a 

compounder doesn’t make it so. I could call myself the Duke of Earl 

and claim diplomatic immunity. That does not make it so. In a 

trier of fact, if you all had been aggressive on this, I believe a trier 

of fact would have found they were weren’t a compounder a long 

time ago, which is why, as you move forward, you didn’t answer 

the question earlier, so I am assuming that you don’t routinely contact medical professionals and ask them where they are getting 

their drugs from so that you couldn’t identify. I think that is what 

you should have been doing, but hindsight is 20/20, as we all know. 

But I think you ought to be looking at doing something like that 

in the future so that you can protect the American public. I think, 

like Mr. Waxman said, you should have assumed you had the authority when you had a bad actor. And I think as you go forward, 

you have to look at that. And Dr. Smith, I would hope that you all 

would look—I believe they may have undermined their criminal 

case today. So since they said it was a State’s responsibility, perhaps there is a State law that you could look into and ask your attorney generals to look and see if there is any criminal prosecution 

that could be brought under State law, because if FDA doesn’t have 

the authority to deal with them from a regulatory standpoint, I am 

not sure they have the authority to go in and seize the computers 

and do what they are doing. 

That being said, I would now yield my time to the gentlewoman, 

Congresswoman Blackburn. 

Mrs. BLACKBURN. Thank you. I appreciate that, and Dr. Hamburg, I want to go back to this issue with the emails that pertain 

to NECC. The first violation came up in 2002, and please understand that it was unclear in your answer to me about the emails. 

You seemed to indicate you thought we had your emails. We do 

not. So let me be very clear: We want to see this entire file going 

back to 2002. We want all of those emails, and we want the conVerDate Aug 31 2005 12:21 Jun 19, 2014 Jkt 037690 PO 00000 Frm 00113 Fmt 6633 Sfmt 6633 F:\112-18~2\112-18~1 WAYNE
110 

versation that took place via email with the Massachusetts Board 

of Pharmacy. 

I have 81 Tennesseeans and 13 deaths. We are very concerned 

about this. We are concerned about everyone that has been adversely impacted. Our sympathies and thoughts are with them, and 

we are incredibly concerned about the ineffectiveness of the bureaucracy, and it doesn’t matter which administration. It is the 

lack of attention by this agency to a situation that has gotten out 

of hand. 

So just to be certain that you understand what we are asking, 

all of the emails, we are not in possession of this. We are—and we 

have asked for this. So we do ask that you comply quickly, so that 

we can see the full extent to your participation and the manner in 

which you all communicated with, responded both on an intraagency, and then also with the Massachusetts Board of Pharmacy. 

And with that, I will yield back the balance of my time. 

Mr. STEARNS. The gentlelady’s time—gives up her time, and the 

gentleman from Massachusetts is recognized for 5 minutes. 

Mr. MARKEY. Thank you, Mr. Chairman, very much. 

Dr. Hamburg, isn’t it true that the legal definition of drug manufacturer in Section 510 of the Food, Drug, and Cosmetics Act exempts pharmacies? 

Ms. HAMBURG. You know, I am not a lawyer, but my understanding is yes. 

Mr. MARKEY. Yes. So that creates a problem right up front from 

a legal perspective. 

Ms. HAMBURG. Yes. 

Mr. MARKEY. That clear statement that exempts pharmacies 

from FDA jurisdiction, and when it comes to drug manufacturers, 

that in the actual definition itself, it kind of talks about what 

would be equivalent of Merck, Bayer, or Pfizer as a manufacturer, 

and then it explicitly says pharmacies aren’t covered, you know, in 

that definition. So that is just loaded with potential for lawsuits, 

you know, for questions that can be raised about your authority, 

and do you need that clarified so that you absolutely have the ability to regulate compounding pharmacies in a way that protects the 

public health and safety? 

Ms. HAMBURG. I think that 510 exempts from registration, not 

any kind of jurisdiction, but I think the problem is that—I am not 

saying we have no authority. I am saying that our authority over 

drug manufacturers is very different, and it requires a set of clear 

actions on the part of the manufacturers and the part of FDA. 

In this area, it is simply much more murky, and it is contested 

in the courts, and we have a split court decision. We have different 

legal frameworks that govern different States, yet we have an industry that operates across State boundaries. 

We don’t have the kind of authorities that we need, and we don’t 

have the kind of clarity of the legislation that we need as well, you 

know. I am deeply troubled by what has happened in this case and 

with NECC, and if there were actions that could have been taken 

at an earlier time to prevent it, I would wish that that were so. 

But you know, what I am speaking to now is, we have this opportunity. It is a clarion call to action, I think. And if we don’t want 

to see that kind of event repeated, and it is not an event that has 

111 

occurred in isolation, you know. There have been events in so many 

Members’ districts in the past over a period of many years, that I 

think we have an obligation to work together to create new legislation that defines this in a way that is clear and understood and 

that gives FDA new authorities. 

Mr. Griffith mentioned, you know, why aren’t we writing to 

compounders, or why aren’t you writing to patients telling them 

that they might be getting drugs from compounders? Well, we don’t 

even know the universe of compounders and what they are making. 

So we clearly need additional authorities in order to achieve some 

of this goals that we have been talking about. 

Mr. MARKEY. And, Doctor, that is why I listed the individual 

component parts of my legislation, just so it could be clear that you 

would welcome that authority. And then we could ensure that you 

can be the true cop on the beat. 

But I do believe that it is troublesome that in the legal definition 

of ‘‘drug manufacturer,’’ the legal definition in the FDA statute, it 

actually exempts pharmacies in that definition. 

So the whole area is just rife with ambiguity. And in that atmosphere of ambiguity, we have wound up with a mess on our hands. 

And we just have to make sure that that never happens again. 

Mr. Chairman, I thank you so much. 

Mr. STEARNS. Thank you. 

And I would say to the panel, we have completed our questions 

here. And, as the chairman, I have usually the ability to say the 

last few words. And in defense of Mr. Markey, who had made the 

case, in his words, as murky, I go back to what Mr. Waxman said, 

that if he was chairman of the FDA, he would not have been cautious; he would have been siding on safety and gone through and 

exercised, regardless of what the situation. I agree with him, and 

that is why I think he probably should consider being the commission chairman. 

And, also, I would say to you, if Pfizer or Merck or any large 

pharmaceutical company suddenly call themselves a compounding 

company, you are implying that you wouldn’t have jurisdiction over 

them, when we know that is not true. In fact, you know, when you 

look historically, you see lots of criminals that are being indicted; 

they make the case that, ‘‘I was doing work for the FBI under 

cover.’’ And, lo and behold, that was just a front so that they could 

defend themselves when, actually, they were committing fraud and 

criminal activity. 

And, lastly, I would just conclude, Mr. Griffith and Dr. Burgess 

both mentioned the FDA appears to have the legal authority to 

walk in and take computers with their jackets, we have seen on television. And, certainly, if you had the ability to go in and prosecute 

and take the computers from NECC, then surely you had the jurisdiction to shut them down, because you had the jurisdiction to go 

in and take their equipment. 

And, certainly, I think many of us in this committee are disappointed that you are not providing the emails and information 

we need so we can get to the bottom of this. And that was the intention of this whole hearing, is to see what really happened. 

112 

So, with that, the subcommittee is adjourned. 

[Whereupon, at 2:00 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

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