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82–184 2015

A CONTINUING INVESTIGATION INTO THE FUNGAL 

MENINGITIS OUTBREAK AND WHETHER IT 

COULD HAVE BEEN PREVENTED 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

APRIL 16, 2013 

Serial No. 113–31 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

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 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

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 

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 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

(III) 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

GREGG HARPER, Mississippi 

PETE OLSON, Texas 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

BRUCE L. BRALEY, Iowa 

BEN RAY LUJAN, New Mexico 

EDWARD J. MARKEY, Massachusetts 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

PETER WELCH, Vermont 

PAUL TONKO, New York 

GENE GREEN, Texas 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 3 

Hon. Diana DeGette, a Representative in Congress from the state of Colorado, 

opening statement ................................................................................................ 5 

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

opening statement ................................................................................................ 7 

Prepared statement .......................................................................................... 8 

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

California, opening statement ............................................................................. 9 

Hon. Edward J. Markey, a Representative in Congress from the Commonwealth of Massachusetts, prepared statement .................................................. 74 

WITNESSES

Margaret A. Hamburg, M.D., Commissioner, U.S. Food and Drug Administration ........................................................................................................................ 11

Prepared statement .......................................................................................... 14 

Answers to submitted questions ...................................................................... 114 

SUBMITTED MATERIAL

Minority memorandum ........................................................................................... 77 

Majority memorandum ............................................................................................ 98 

Letter of April 11, 2013, from the committee to the subcommittee .................... 101 

Document binder 1

1 The document binder is available at http://docs.house.gov/meetings/if/if02/ 

20130416/100668/hhrg-113-if02-20130416.xml. 

(1) 

A CONTINUING INVESTIGATION INTO THE 

FUNGAL MENINGITIS OUTBREAK AND 

WHETHER IT COULD HAVE BEEN PREVENTED 

TUESDAY, APRIL 16, 2013 

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

The subcommittee met, pursuant to call, at 10:02 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Tim Murphy 

(chairman of the subcommittee) presiding. 

Members present: Representatives Murphy, Burgess, Scalise, 

Harper, Olson, Gardner, Griffith, Johnson, Long, Ellmers, Barton, 

Upton (ex officio) DeGette, Braley, Schakowsky, Butterfield, Tonko, 

Green, Dingell, and Waxman (ex officio). 

Staff present: Gary Andres, Staff Director; Mike Bloomquist, 

General Counsel; Sean Bonyun, Communications Director; Matt 

Bravo, Professional Staff Member; Karen Christian, Chief Counsel, 

Oversight; Andy Duberstein, Deputy Press Secretary; Brad Grantz, 

Policy Coordinator, Oversight and Investigations; Debbee Hancock, 

Press Secretary; Sydne Harwick, Legislative Clerk; Brittany Havens, Legislative Clerk; Sean Hayes, Counsel, Oversight and Investigations; Carly McWilliams, Professional Staff Member, Health; 

Andrew Powaleny, Deputy Press Secretary; Krista Rosenthall, 

Counsel to Chairman Emeritus; Charlotte Savercool, Executive Assistant, Legislative Clerk; Alan Slobodin, Deputy Chief Counsel, 

Oversight; John Stone, Counsel, Oversight; Dan Tyrrell, Counsel, 

Oversight; Lyn Walker, Coordinator, Admin/Human Resources; 

Tom Wilbur, Digital Media Advisor; Phil Barnett, Democratic Staff 

Director; Stacia Cardille, Democratic Deputy Chief Counsel; Brian 

Cohen, Democratic Staff Director, Oversight and Investigations, 

Senior Policy Advisor; Eric Flamm, FDA Detailee; Elizabeth Letter, 

Democratic Assistant Press Secretary; Stephen Salsbury, Democratic Special Assistant; and Rachel Sher, Democratic Senior Counsel. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. Good morning. This is a hearing of the House Energy and Commerce Oversight and Investigations Committee entiVerDate Nov 24 2008 12:10 Feb 02, 2015 Jkt 037690 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-31 CHRIS
2 

tled ‘‘A Continuing Investigation into the Fungal Meningitis Outbreak, and Whether it Could Have Been Prevented.’’ 

The subcommittee is here today because 53 people died from a 

pain medication manufactured by the New England Compounding 

Center, NECC. Those patients trusted that the steroid injected into 

their spine or their joints to relieve chronic pain was perfectly safe 

because of the confidence our Nation’s healthcare providers place 

in the Food and Drug Administration. But that drug was contaminated with fungus, a form of mold that attacks bone and nerves. 

More than 700 people who received these lethal injections continue to have symptoms. Today, they are living with the unbearable horror of not knowing whether they will survive. They must 

spend weeks in the hospital, missing work, holidays, and times 

with families. They must take large doses of morphine to ease the 

pain. Each day is lived under the deadly threat of an infection that 

could reach their brains and kill them. 

This outbreak is one of the worst public health disasters in our 

country’s history, and it is a terrible tragedy and an epic failure. 

Sadly, the Food and Drug Administration, which is supposed to 

protect the public, has spent its time passing blame and hiding behind judicial robes rather than taking any responsibility. 

At our hearing last November, Commissioner Hamburg told this 

committee that the FDA faced ‘‘complex’’ issues in taking enforcement action against the New England Compounding Center. 

Here is the truth: this outbreak begins with NECC illegally shipping 17,000 vials of supposedly sterile drugs without patient prescriptions. The FDA insists it could not tell the difference between 

a corner drug store compounder who makes cough syrup for a 

child, and a massive manufacturer illegally shipping into 23 states. 

This committee has discovered the agency had information that 

should have spurred it to act and stop this rogue outfit from continuing to operate as an illegal manufacturer of sterile medication. 

This outbreak is simply not ‘‘complex‘‘ nor was it a surprise. They 

were under the nose of the FDA for a decade. DA field staff and 

FDA headquarters repeatedly received complaints about NECC’s 

numerous transgressions. They even considered additional inspections and enforcement. Ten years of warning signs, alarm bells, 

and flashing red lights were ignored. Complaints from patients, 

nurses, pharmacists, doctors, pain clinics, hospitals, drug companies, drug distributors and even confidential company informants, 

but the only healthcare entity that didn’t seem worried was FDA 

headquarters. Ultimately, the FDA knew NECC was breaking the 

law but chose to do nothing. 

In 2007, the FDA received complaints from patients getting epidural injections of an injectable steroid manufactured by NECC. 

FDA knew long ago that this very NECC product hospitalized patients with meningitis-like symptoms. These complaints led to 

FDA’s first inspection of NECC, and this time, there is no evidence 

that FDA even bothered to inform the state or contact the company 

over this issue. 

In 2011, a representative from the Institute of Safe Medication 

contacted the FDA. This complaint read, ‘‘As a practicing pharmacist, I am shocked that such a product would be allowed to be 

distributed for use in the United States.’’ FDA officials found the 

3 

product to be ‘‘extremely dangerous,’’ and ‘‘they should further 

warn that this bag should not be directly infused to the patient. 

This is unbelievable. I think this is a disaster waiting to happen.’’ 

After FDA headquarters approved, then rejected, sending a 

warning letter to Ameridose in 2009, the current Director of FDA’s 

New England District Office angrily informed other enforcement officials with FDA: ‘‘I have told our Investigations Branch to not 

bother inspecting compounding pharmacies if we aren’t going to act 

on the violations.’’ 

FDA’s primary mission is to protect the public health from unsafe drug products. On numerous occasions, the agency confronted 

a choice in dealing with NECC and Ameridose: take action to protect patients or wait. Repeatedly, the FDA made a conscious decision to do nothing. In particular, under the watch of Dr. Hamburg, 

the FDA put enforcement actions against NECC and Ameridose on 

hold in 2011 and through 2012, because the FDA lawyers wanted 

to wait until finishing a revision of a guidance document. 

During this inspection holiday, 53 people died. 

At the last hearing Congressmen Terry, Scalise, and I asked Dr. 

Hamburg where in the law it said FDA could not act. The FDA did 

not answer our question. We now know that there was nothing in 

the law that prevented the FDA from acting because in the last few 

weeks before this hearing, the FDA has conducted a highly visible 

campaign of inspections. This flurry of well-publicized activity exposes the FDA’s charade. The agency cannot argue it lacked authority to inspect NECC and Ameridose, but now, after the outbreak, has the authority to conduct these inspections. No law has 

changed. The only change is the FDA decided to act. 

During our November hearing, Dr. Lauren Smith of the Massachusetts Department of Public Health recognized that her agency 

could have done things differently. She didn’t hide behind ongoing 

investigations, lawsuits, or limited authority. Instead, she admitted 

that her agency had moved too slowly, and that if they had acted 

quickly in 2012, it could have prevented about a third of the deadly 

drug from being shipped. She took immediate personnel actions as 

a result of these conclusions. 

The hope of this committee is that we will hear admissions from 

the FDA that reflect decisive leadership, an admission of what 

went wrong internally to delay inspections, warnings, and actions. 

What I worry about is we will hear this morning a continued litany 

of excuses, bureaucratic talk, and blame on outside organizations. 

For the sake of the families of those who died, and those who are 

still sick, we will not stop in our effort to get answers and fix this 

problem. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

The Subcommittee is here today because 53 people died from a pain medication 

manufactured by the New England Compounding Center (NECC). Those patients 

trusted that the steroid injected into their spine or their joints to relieve chronic 

pain was perfectly safe because of the confidence our nation’s healthcare providers 

place in the Food and Drug Administration. But that drug was contaminated with 

fungus, a form of mold that attacks bone and nerves. 

More than 700 people received these lethal injections. Today, they are living with 

the unbearable horror of not knowing whether they will survive. They must spend 

4 

weeks in the hospital, missing work, holidays, and time with family. They must take 

large doses of morphine to ease the pain. 

Each day is lived under the deadly threat of an infection that could reach their 

brains and kill them. 

This outbreak is one of the worst public health disasters in our country’s history. 

It is a terrible tragedy and an epic failure. Sadly, the Food and Drug Administration, which is supposed to protect the public, has spent its time passing blame and 

hiding behind judicial robes rather than taking any responsibility. 

At our hearing last November, Commissioner Hamburg told this Committee that 

the FDA faced ‘‘complex’’ issues in taking enforcement action against the New England Compounding Center. 

Here is the truth: this outbreak begins with NECC illegally shipping 17,000 vials 

of supposedly sterile drugs without patient prescriptions. The FDA s insists it could 

not tell the difference between a corner-store compounder who makes cough syrup 

for a child, and a massive manufacturer illegally shipping into 23 states. 

This Committee has discovered the agency had information that should have 

spurred it to act and stop this rogue outfit from continuing to operate as an illegal 

manufacturer of sterile medication. 

This outbreak is not ‘‘complex’’ nor was it a surprise. Neither NECC nor its sister 

company, Ameridose, were operating in the shadows. They were under the nose of 

the FDA for a decade. FDA field staff and FDA headquarters repeatedly received 

complaints about NECC’s numerous transgressions. They even considered additional 

inspections and enforcement actions. Ten years of warning signs, alarm bells, and 

flashing red lights were deliberately ignored. Complaints came from patients, 

nurses, pharmacists, doctors, pain clinics, hospitals, drug companies, drug distributors and even confidential company informants. About the only healthcare entity 

that didn’t seem worried was FDA headquarters. Ultimately, the FDA knew NECC 

was breaking the law but chose to do nothing. 

In 2007, the FDA received complaints from patients getting epidural injections of 

an injectable steroid manufactured by NECC. FDA knew long ago that this very 

NECC product hospitalized patients with meningitis-like symptoms—these complaints led to FDA’s first inspection of NECC. This time, there’s no evidence that 

FDA even bothered to inform the state or contact the company over this issue. 

In 2011, a representative from the Institute of Safe Medication Practices contacted the FDA about an Ameridose medication. 

The complaint read, quote, ‘‘As a practicing pharmacist, I am shocked that such 

a product would be allowed to be distributed for use in the United States.’’ FDA officials found the product to be ‘‘extremely dangerous.’’ A member of FDA’s 

compounding team wrote: ‘‘And they should further warn that this bag should not 

be directly infused to the patient. This is unbelievable! I think this is a disaster 

waiting to happen.’’ 

After FDA headquarters approved—then rejected—sending a Warning Letter to 

Ameridose in 2009, the current Director of FDA’s New England District Office angrily informed other enforcement officials with FDA: ‘‘I’ve told our [Investigations 

Branch] to not bother inspecting compounding pharmacies if we aren’t going to act 

on the violations.’’ 

FDA’s primary mission is to protect the public health from unsafe drug products. 

On numerous occasions, the agency confronted a choice in dealing with NECC and 

Ameridose: take action to protect patients or wait. Repeatedly, the FDA made a conscious decision to do nothing. In particular, under your watch, Dr. Hamburg, the 

FDA put enforcement actions against NECC and Ameridose on hold in 2011 and 

through 2012, because the FDA lawyers wanted to wait until finishing a revision 

of a guidance document. 

During this inspection holiday, 53 people died. 

At the last hearing Congressmen Terry, Scalise, and I asked Dr. Hamburg where 

in the law it said FDA could not act. The FDA did not answer our question. We 

now know that there was nothing in the law that prevented the FDA from acting 

because in the last few weeks before this hearing, the FDA has conducted a highly 

visible campaign of inspections. This flurry of well-publicized activity exposes the 

FDA’s charade. The agency cannot argue it lacked authority to inspect NECC and 

Ameridose, but now, after the outbreak, has the authority to conduct these inspections. 

No law has changed. The only change is the FDA decided to act. 

During our November hearing, Dr. Lauren Smith of the Massachusetts Department of Public Health recognized her agency could have done things differently. She 

did not hide behind ongoing investigations, lawsuits, or limited authority. Instead, 

she admitted that her agency had moved too slowly, and that if they had acted 

quickly in July 2012, it could have prevented about a third of the deadly drug from 

5 

being shipped. She took immediate personnel actions as a result of these conclusions. 

The hope of this committee is that we will hear admissions from the FDA that 

reflect decisive leadership—an admission of what went wrong internally to delay inspections, warnings, and actions. What I fear we will hear this morning is continued 

litany of excuses, bureaucratic talk, and blame on outside organizations. 

For the families of those who died, and those who are still sick, we will not stop 

in our effort to get answers and fix this problem. 

I now recognize my distinguished colleague from Colorado, Ranking Member 

DeGette, for her opening statement. 

Mr. MURPHY. I now recognize my distinguished colleague from 

Colorado, Ranking Member Diana DeGette, who I think also wants 

us to recognize some of the consent here, too. 

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

join you and the rest of the members of this subcommittee in expressing our deepest condolences to those who are affected by the 

tragic events yesterday in Boston, and we are all thinking about 

all the victims. Our colleague, Mr. Markey, has been very interested in this investigation, and understandably, he is not here 

today, but he wanted to participate and he has a statement, and 

he also has an October, 2012 report that you folks have seen called 

‘‘Compounding Pharmacies, Compounding Risk’’, and I ask unanimous consent those both be entered into the record. 

Mr. MURPHY. Without objection, they will be entered into the 

record. 

[The information appears in the document binder.] 

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

Ms. DEGETTE. Thank you very much. 

Mr. Chairman, I want to thank you for having today’s hearing. 

Obviously, this fungal meningitis outbreak is a serious, serious situation, and our committee needs to understand the facts about how 

and why it occurred, and what we can do to prevent it in the future. 

I think that this investigation has the potential to become part 

of the great bipartisan oversight history of this committee. I know 

that good investigations don’t always result in legislative change, 

but in this case, I think we can use this investigation to help us 

identify the legislative changes, if any, that we need to help us 

avoid tragedies like this again in the future. 

As hospitals, clinics, and other medical providers outsource more 

of their compounding, a number of compounding pharmacies have 

sprung up, and frankly, they have been operating underneath the 

regulatory radar screen. A spotty pattern of state regulations and 

enforcement, combined with conflicting federal law, have made that 

even worse. 

So Mr. Chairman, I want to talk about some of the facts we have 

uncovered as we have spent the last 5 months investigating the 

New England Compounding Center, the FDA, and the deadly 

fungal meningitis outbreak caused by contaminated compounded 

drugs. 

First of all, as we all can stipulate, the owners and operators of 

NECC ran a shoddy, fly-by-night operation, and jeopardized the 

6 

lives of thousands of people. Second, for several years prior to the 

outbreak, the FDA received warnings about the company from its 

own inspectors, from State Boards of Pharmacy, and from whistleblowers. The FDA received warnings about, and seriously considered investigating, Ameridose, NECC’s sister company, just a few 

months before NECC began to ship the deadly steroid products. 

One of the states that discovered these deficiencies was my own 

home State of Colorado, and in fact, my State Board of Pharmacy 

issued a Cease and Desist Order to stop the company’s practices. 

Now, I am confident that we can all agree on these two facts 

from both sides of the aisle, but I also hope that we can agree on 

a third fact that will help explain why the FDA Was unable to effectively regulate this company. Then I hope that we can act together to fix the problem. 

Mr. Chairman, in October of 2012, this committee requested 

thousands of pages of documents from the FDA about their interactions with NECC, and their approach to regulating compounded 

drugs. The Democratic staff has reviewed these documents, and 

yesterday released a supplemental memo with key findings. I 

would also ask unanimous consent that this memo be made a part 

of this hearing record. 

This pattern of documents from 2002 through last year demonstrates that under two Administrations and over 10 years, the 

FDA has not been aggressive enough in attempting to regulate 

compounding pharmacies. The question is why? It is a serious and 

legitimate question to ask what the agency should have been doing 

and could have been doing over these many years, and I know from 

your opening statement you intend to do just that. 

I also, though, look forward to hearing what specific solutions 

Commission Hamburg and the FDA believe would help them protect the American people from another outbreak, because these documents show us that for a year, the FDA has been grappling with 

a law that is broken and we need to help fix that law and keep 

the American public safe. We also need to look at how court decisions impacted the FDA’s ability to regulate. 

Mr. Chairman, you say that the FDA is hiding behind judicial 

robes, but in fact, court decisions are the law of the land. And what 

we have here in the wake of the serious meningitis outbreak is a 

patchwork of laws. We have two judicial circuits that are coming 

up with different decisions about the authority of the FDA, which 

is causing some of these compounding pharmacies, not all of them, 

but some of them to resist any regulatory efforts by the FDA. 

As the FDA has been attempting to better regulate this situation 

since these issues came out, there have even been instances of 

compounding pharmacies refusing to provide the FDA access to 

records or facilities, and as we learned during our food safety investigations and some of our other investigations in this committee, if 

you have an allegation of little black particles in some of the vials 

of the pharmaceuticals, the FDA and its cooperating agencies need 

the ability to work fast. And if you have a company that says you 

can’t come in here and makes the FDA go to court, that is not a 

speedy or a desirable resolution. 

And so I am looking forward to hearing from Commissioner 

Hamburg about, number one, what the agency has done to improve 

7 

the situation and to improve enforcement, and number two, what 

the agency thinks that we need to do legislatively to fix this law 

so that this will never happen again. 

Thank you very much, Mr. Chairman. I yield back. 

Mr. MURPHY. Gentlelady yields back. I will now recognize the 

chairman of the full committee, Mr. Upton, for 5 minutes. 

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

Mr. UPTON. Well thank you, Mr. Chairman. I thank you for convening this very important hearing on the deadly outbreak of 

fungal meningitis so that the committee can get answers to the 

question that we could not get last year: what did the FDA know 

about NECC and Ameridose, and what did the FDA do about it? 

When Commissioner Hamburg appeared before us last November, 32 innocent Americans had died. Today, the death toll stands 

at 53 and continues to grow. Hundreds are still sick and suffering. 

An unthinkable, public health disaster continues to get only worse. 

My home State of Michigan has been hit the hardest by fungal 

meningitis. According to the CDC, 15 of the 53 people who died 

after receiving NECC’s contaminated products are from Michigan, 

including three from my district. Two hundred and fifty-nine of the 

730 people who are sick and suffering from infections are from my 

state. 

Just a few weeks ago, our Attorney General Bill Schuette, a 

former colleague, announced that he planned to convene a grand 

jury to investigate possible criminal charges, and I talked with him 

again just minutes ago. 

Criminal cases will rightfully examine the company’s liability for 

this tragedy, but it is our job at this committee to also take a hard 

look at the agency under our jurisdiction, the FDA, and ask: did 

its processes work? Did the agency do its job and protect the 

public’s health? And before we get to the matter of additional authorities and new legislation, we have to ensure that the agency is 

going to be ready to implement them properly. It is not enough or 

right just to do something for the sake of doing it. We have to do 

something that is truly effective to prevent this from happening 

again. 

It took months for the FDA to fully cooperate and provide the 

necessary documents, but now we finally have them. Commissioner 

Hamburg, as we look at these, many of us are troubled by what 

we have learned. FDA received complaint after complaint about 

these companies. FDA’s documents paint a picture of two companies who appeared to be acting more like manufacturers than 

compounders. Doctors and other providers made complaints about 

the sterility of their products. FDA district staff pushed to go back 

out and re-inspect these companies or take other enforcement action, but in most cases, it simply didn’t happen. It is this breakdown that concerns me the most. Job one for the FDA is making 

sure the medicines we take are safe, but the mission appears to be 

lost, as delays prevented the FDA from taking decisive action and 

the agency took years to finalize its guidance and regulatory documents. We know now that 53 Americans did not need to die. It 

sickens me that this could have been prevented. 

8 

And as we met this last week, I share your hope that this is a 

constructive hearing. We all want that. We need to get all the facts 

on the table, and I hope you can help us, so we can move forward. 

We owe it to those families, and I know that we can do better and 

work together. 

And I yield now to Mr. Barton. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

I thank Chairman Murphy for convening this important hearing on the deadly 

outbreak of fungal meningitis, so that this committee can get answers to the question we could not at the last hearing: what did FDA know about NECC and 

Ameridose? And what did FDA do about it? 

When Commissioner Hamburg appeared before us last November, 32 innocent 

Americans had perished. Today, the death toll stands at 53 and continues to grow. 

Hundreds are still sick and suffering. An unthinkable, public health disaster keeps 

on getting worse. My home state of Michigan has been hit the hardest by the fungal 

meningitis outbreak. According to the CDC, 15 of the 53 people who died after receiving NECC’s contaminated products are from Michigan, including 3 from my district. Two-hundred fifty-nine of the 730 people who are sick and suffering from infections are from my state. Just a few weeks ago, Michigan Attorney General Bill 

Schuette announced that he planned to convene a grand jury to investigate possible 

criminal charges. 

Criminal cases will rightfully examine the company’s liability for this tragedy. But 

it is our job at this committee to also take a hard look at the agency under our jurisdiction, the FDA, and ask: did its processes work? Did the agency do its job and 

protect the public health? Before we get to the matter of additional authorities and 

new legislation, we have to ensure that the agency is going to be ready to implement them properly. It is not enough or right just to do something for the sake of 

doing something. We have to do something that is truly effective. 

It took months for the FDA to fully cooperate and provide the necessary documents, but now we finally have them. Commissioner Hamburg, I am troubled by 

what I have learned. FDA received complaint after complaint about these companies. FDA’s documents paint a picture of two companies who appeared to be acting 

more like manufacturers than compounders. Doctors and other providers made complaints about the sterility of their products. FDA district staff pushed to go back 

out and re-inspect these companies or take other enforcement action, but in most 

cases, it didn’t happen. It is this breakdown that concerns me the most. ‘‘Job one’’ 

for the FDA is making sure the medicines we take are safe, but this mission seemed 

to be lost, as delays prevented the FDA from taking decisive action and the agency 

took years to finalize its guidance and regulatory documents. We now know that 53 

Americans did not need to die. It sickens me that this could have been prevented. 

Commissioner Hamburg, we met last week. I share your hope that this is a constructive hearing. We need to get all the facts on the table, and I hope you will help 

us, so we can move forward. We owe it to the families who lost loved ones and we 

owe it to those 730 Americans who are still suffering and may never return to leading healthy lives. I yield my remaining time to.... 

Mr. BARTON. Thank you, Mr. Chairman, and I want to echo what 

you just said. 

We have asked several questions at the previous hearing on this. 

The first one was how did this happen, and the second one, could 

this outbreak have been prevented? At the time, we didn’t get answers. Finally after the committee has received the documents, we 

do have at least partial answers to those two questions. 

To the first question, how did it happen, there are two main reasons. Obviously, the company involved acted negligently and didn’t 

follow proper sterilization and sanitation practices, but number 

two, the FDA, the agency responsible for protecting the public 

health and safety, did not act properly, did not do what it should 

have done, and did not act when it could have acted. In fact, it 

9 

failed to take the necessary action against this company to prevent 

future outbreaks, even though they had evidence of serious problems dating back to 2002. 

The answer to the second question, could the outbreak have been 

prevented, I believe the answer to be yes. I believe it could have 

been prevented. Today, we are going to have our FDA commissioner before us to explain the FDA’s failure, and hopefully the 

steps that she is intending and hopefully has taken to prevent any 

future actions. 

And with that, I yield the balance of the time to Dr. Burgess. 

Mr. BURGESS. I thank the gentleman for yielding. 

From a provider’s perspective, I recognize the value of 

compounding pharmacies and compounding pharmacists, and that 

they contribute to the armamentarium of things that we can offer 

to our patients, but there is a vast difference between compounding 

preparation of progesterone to treat a condition, or compounding a 

pediatric elixir for Tamiflu, and being involved with a wholesale 

manufacturer of medicines that are shipped all over the country, 

with no specific prescription thereto attached. I do have to admit, 

reading through this litany that has occurred, honestly, before you 

arrived at the agency, but also since your arrival at the agency, 

and it is troubling. I think the least we can do today is try to uncover those things that were impediments to getting a rapid resolution of this, and honestly, we cannot allow it to happen again. 

And I will yield back. 

Mr. MURPHY. Gentleman yields back. I now recognize the ranking member of the committee, 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, Mr. Chairman. 

I think that the comments of Chairman Upton and Mr. Barton 

and Mr. Burgess are right on point. This has to be a constructive 

investigation. We have to know what happened and how to prevent 

it in the future. 

This meningitis outbreak from compounded drugs has claimed 

the lives of over 50 people, sickened over 700, brought unspeakable 

grief upon hundreds of families, and it is one of our Nation’s worst 

public health disasters in recent memory. So we need to get to the 

bottom of this. 

Our most critical task is to answer this question: how can we 

prevent another NECC tragedy from occurring again? This one has 

happened. It is terrible. 

Last fall, Joyce Lovelace, who lost her husband, courageously testified before this committee and we should heed her words. She 

said ‘‘Don’t just investigate, instead, legislate and regulate. Put 

aside partisan politics, partisan philosophies, industry lobbying, 

and wishes of campaign contributions, and unanimously send to 

the White House a bill that will prevent a recurrence of these 

events. If you will do that, perhaps my family can take some solace 

in the fact that any Lovelace’s public service continues even after 

death.’’ 

10 

Well, I hope we can remember this advice during today’s hearing, 

and stay focused on our most important mission: how can we prevent a recurrence of these events? The committee received in preparation for this hearing over 27,000 documents from the FDA. Mr. 

Chairman, I agree with your comments that the record shows that 

FDA missed important opportunities to address problems at NECC. 

FDA was warned about potential problems at NECC and 

Ameridose, and was simply unable to act or act fast enough. But 

the documents also show more than that. They show why this happened, and if we want to fix this problem, that is exactly what we 

need to understand. 

Mr. Chairman, here is what the documents show. For over a decade, FDA struggled to effectively regulate compounding pharmacies. Basic flaws in the compounding law and a series of conflicting court decisions have created uncertainty and confusion. As 

a result, FDA was unable to develop a coherent policy. Under this 

Administration, beginning in 2009, FDA began to take new steps 

to develop an enforceable national policy for drug compounders, but 

it was never finalized. But this was difficult, because the court 

cases created different rules for different parts of the country, 

which is inherently problematic. FDA had to struggle with how to 

pick up the pieces of a statute in tatters. 

Mr. Chairman, we should ensure that FDA is able to protect all 

of us in a uniform way from unsafe compounded drugs. It is Congress’ job to fix the law when it is inadequate or when courts invalidate it, and that is why we must do more than blame the FDA 

for this tragedy. We must heed the words of Joyce Lovelace, and 

act to give the FDA the clear authority they need to keep the 

American public safe and prevent another drug compounding disaster. 

I am pleased that Dr. Hamburg is here to further answer our 

questions. At the last hearing, a lot of the documents that our committee had requested on a bipartisan basis had not been received, 

and we now have those documents. And what we have is a muddied record of inaction where we would have liked to see action, 

clarity in the law to give you instructions, Dr. Hamburg, but that 

law wasn’t clear and the courts made it even more confusing. 

Our job is not to dwell on the confusion. Our job is to clarify 

what we want FDA to do, what we expect from FDA. We need to 

clarify it not just by criticism in an oversight hearing, but by acting 

together legislatively to spell out what the law must be in order for 

FDA to do everything it can to prevent another tragedy like this 

from occurring again. 

Thank you, Mr. Chairman. 

Ms. DEGETTE. Mr. Chairman, I would like to renew my unanimous request to put the Democratic memo in the record. 

Mr. MURPHY. Without objection, so be it. Thank you. 

[The information appears at the conclusion of the hearing.] 

Mr. MURPHY. I would now like to introduce the Honorable Margaret A. Hamburg. She has been the commissioner of the U.S. Food 

and Drug Administration since May 18, 2009. She is an experienced medical doctor, scientist, and public health executive. Thank 

you for being here. 

11 

I also ask—let me go here. You are aware that the committee is 

holding an investigative hearing, and when doing so, has the practice of taking testimony under oath. Do you have any objections to 

testifying under oath? 

Dr. HAMBURG. No, I do not. 

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

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

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

your testimony today? 

Dr. HAMBURG. I have with me Mr. Taylor, who is my senior 

counselor, and I would like him to be available to answer questions 

to give you the specific information that you might need. 

Mr. MURPHY. Certainly. You have the right to have counsel 

there, too. 

In that case, would you both please rise and raise your—one moment. Yes? 

Ms. DEGETTE. Mr. Chairman, I don’t believe that Dr. Hamburg 

is saying he is her lawyer, I think he is—— 

Dr. HAMBURG. Oh, I am sorry. 

Ms. DEGETTE [continuing]. A lawyer at FDA here to answer 

questions. My suggestion would be to swear them both in. 

Mr. MURPHY. We will swear them both in then, yes. 

All right, if you both rise and raise your right hand, I will swear 

you in. 

[Witnesses sworn.] 

Mr. MURPHY. Let the record show that both have answered affirmatively, so 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. 

TESTIMONY OF THE HONORABLE MARGARET A. HAMBURG, 

M.D., COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION (FDA) 

Dr. HAMBURG. Thank you very much, Mr. Chairman and members of the subcommittee. I am Dr. Margaret Hamburg, the Commissioner of the FDA. I appreciate the opportunity to testify today. 

I am joined, as I said, by Mr. John Taylor, my senior counselor, 

and former head of both our Drug Enforcement Office and of the 

agency’s Field Inspection Force. 

We are at a critical juncture for public health. The deadly outbreak of fungal meningitis associated with a compounded medication last fall was a horrible tragedy. I speak for everyone at the 

FDA when I say that our hearts go out to the victims and their 

loved ones. 

While our investigation of this deadly outbreak has been a top 

priority, my responsibility is also to make sure that this does not 

happen again. 

In looking at the history and our role with compounding pharmacies, it is clear to me that we should have more aggressively applied existing authorities, in spite of an ambiguous statute, a 

changing legal landscape, and continuous challenges by industry to 

our authorities. We are being more aggressive now. We are working with states to inspect pharmacies that we believe may present 

12 

the highest risk, in addition to responding to specific complaints we 

may receive. Over the past few months, we have conducted over 55 

such inspections. 

What we have seen is troubling: serious issues, including quality 

concerns that have led to product recalls, and practices that create 

risk of contamination, and these inspections have underscored our 

need for stronger, clearer authority to adequately protect public 

health. Even in light of the recent tragic events, astonishingly, 

some of the firms are challenging us, delaying our inspectors or denying them full access to records. In two recent instances, we have 

had to secure administrative warrants from the court and have 

U.S. marshals accompany our inspectors so they could complete 

their work. In other cases, we had to threaten the use of warrants 

to achieve cooperation. 

Lack of clarity in our statutory authorities is not the only concern. The healthcare system and this industry have evolved tremendously. A new breed of pharmacy compounding—‘‘outsourcers,’’ 

has outgrown the legal framework. These outsourcers produce high 

volumes of high risk drugs, often for hospitals that rely on them 

to meet critical product needs for their patients. 

The tools we have under current law for regulating these firms 

are simply not the right fit. Applying them in full force could lead 

to significant dislocations in the healthcare system, and likely 

shortages. We need legislation to preserve the benefits of traditional compounding, while at the same time giving us the right 

tools to regulate the highest risk practices and products. For these 

higher risk compounding pharmacies, we need legislation that: requires compliance with federal quality standards; requires federal 

registration so we know who they are, where they are, and what 

drugs they are making; and requires reporting to FDA of serious 

adverse events—so that we can act before potential problems grow 

out of hand. 

For all pharmacy compounding, certain basic protections should 

be in place, including: clear authority to inspect records to determine the scope and nature of a pharmacy’s operations, and to more 

quickly determine the cause of an outbreak; a prohibition on 

compounding of the most complex and highest risk products; and 

clear labeling of compounded drugs to allow prescribers and consumers to make more informed choices. 

We look forward to working with Congress to explore funding 

mechanisms to support this oversight. 

If you look at FDA’s attempts to regulate pharmacy compounding 

over the last 20 years, as detailed in the tens of thousands of pages 

of documents we have provided to the committee, you see that the 

agency has been struggling with how to effectively oversee this industry. You see numerous approaches that were derailed by a constantly changing legal landscape, challenges to our authority, and 

conflicting court decisions. I wish that during my tenure I had 

brought the need for legislation to you sooner. To be frank, given 

the history of this issue and the efforts of this industry, there were 

many at the agency concerned that seeking new authority would 

result in a weakening, rather than a strengthening of the law. But 

I am here now to ask for your help. We have had an urgent call 

13 

to action. We are all on notice, and we owe it to the public and the 

victims to provide better protection in the future. 

I am happy to answer any questions you may have. 

[The prepared statement of Dr. Hamburg follows:] 

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Mr. MURPHY. I thank you for your testimony, Commissioner 

Hamburg, and I appreciate you want to move forward, but we also 

would like to find out if there are things within the FDA that has 

been going on for the last 10 years that need to be addressed first. 

So I am assuming you accept that the buck stops with you with 

regard to how things are going with the FDA, am I correct? 

Dr. HAMBURG. Yes. 

Mr. MURPHY. OK. Now the FDA documents show that the FDA 

put enforcement actions against NECC and Ameridose on hold in 

2011 through 2012, and suspended all inspections of compounders 

because the FDA wanted to issue new guidance first. For example, 

On October 24 of 2011, e-mail from a compliance officer in the 

FDA’s district office to the district compliance branch director 

shows that in light of the FDA process of drafting guidance on 

compounding, the FDA inspectors did not immediately follow up on 

an informant’s allegations about Ameridose. Salespeople were in 

the clean area, filling product, and that Ameridose continued to repack without an FDA license. The e-mail stated that Tamara Ely, 

the compounding team leader from CDER, said ‘‘no compounding 

facility is slated to be inspected in 2012,’’ and a September, 2011, 

e-mail from a compliance officer at CDER to others in the FDA 

headquarters stated ‘‘the plan is to re-inspect Ameridose 6 months 

after issuance of 503A guidance.’’ Likewise, an October, 2011, 

memorandum from the Office of Unapproved Drugs and Labeling 

Compliance stated ‘‘currently we have suspended inspections of 

compounding facilities, but will reinstate proactive inspections 

based on a risk model 3 to 6 months after the finalization of the 

guides to the industry.’’ 

Did you personally approve of the FDA decision to delay or suspend enforcement actions or inspections of compounding facilities, 

or did somebody else? 

Dr. HAMBURG. I was not directly involved in those decisions, but 

they did reflect the concern that we needed to really have a clear 

regulatory regime that was outlined so that we could bring the 

strongest and best possible cases. 

Mr. MURPHY. So were they then implemented under your knowledge? If you were not the decision-maker, were they implemented 

under your knowledge that they were occurring? 

Dr. HAMBURG. I was not aware of those decisions. 

Mr. MURPHY. Were you personally advised at any time about 

suspending enforcement actions against compounders back in 

2011? 

Dr. HAMBURG. It is important to understand that there were ongoing responses with the compounding industry when problems 

were brought to our attention about specific products, but that in 

terms of a proactive inspectional strategy, we did not have the 

framework in place and we were trying to put that in place with 

the development of the CPG. 

Mr. MURPHY. I appreciate that, but we are trying to find out 

when were you informed about the policy to suspend any enforcement actions and inspections of compounders? 

Dr. HAMBURG. I regret that I was not more fully aware, but I—— 

26 

Mr. MURPHY. When did you find out? Do you recall when you finally found out that there were no inspections? Do you recall when 

that was? 

Dr. HAMBURG. I want to make clear that there were inspections 

of compounding facilities in reaction to specific issues that 

were—— 

Mr. MURPHY. Well, with NECC and—— 

Dr. HAMBURG [continuing]. Brought before us with adulterated or 

other problems with products, but that there was not—there was 

this effort going on within the agency to try to develop—— 

Mr. MURPHY. I understand that. I am just trying to help focus 

here, because I read you quotes from e-mails of at least three different people that the inspections of NECC and Ameridose were 

suspended. It is an important decision. Had the FDA taken enforcement actions, conducted its own inspections, or caused the Massachusetts Board of Pharmacy to inspect, we may have been able to 

prevent this huge public health disaster. So when the FDA made 

the decision to suspend compounding enforcement in 2011, did the 

FDA weigh the potential public health consequences of that decision? 

Dr. HAMBURG. It was not a decision to suspend all enforcement 

of compounding pharmacies—— 

Mr. MURPHY. I know, just with—— 

Dr. HAMBURG [continuing]. But I regret that we didn’t do more, 

and I regret that I was not more directly engaged—— 

Mr. MURPHY. I appreciate that. 

Dr. HAMBURG [continuing]. But I am now and—— 

Mr. MURPHY. I know. 

Dr. HAMBURG [continuing]. And I really hope—— 

Mr. MURPHY. I am still trying to find out when did you find out 

that inspections of NECC were suspended? 

Dr. HAMBURG. I do not recall specifically but I was not aware at 

that time. 

Mr. MURPHY. Was it in preparation for the hearing in the fall or 

this hearing that you finally found out that the inspections hadn’t 

been taking place? 

Dr. HAMBURG. I as Commissioner obviously am not aware of all 

of the inspections we are doing. We are responsible for regulating 

products that come from over 300,000 different facilities—— 

Mr. MURPHY. I am just asking about NECC and I am not getting 

an answer, but that is important because something—it appears 

what has happened with NECC, that the information was not 

going to the top where the buck is supposed to stop, and while you 

are telling us that you didn’t have authority to inspect, last week 

a flurry of publicity came out that you went to 31 different places. 

CBS News did an interview with you, and only one of those was 

someone questioned about a court order. So we still are going to 

need to get some answers to that, but I see my time is up so I am 

now going to recognize the Ranking Member, Ms. DeGette. 

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

Commissioner Hamburg, did you ever find out why they inspected—why they suspended these inspections while they are 

writing new guidance? Why couldn’t they walk and chew gum at 

the same time? 

27 

Dr. HAMBURG. There was, I think, real concern given the history 

with this issue, and the repeated challenges to our authorities that 

we needed to really understand, as court decisions were coming 

down, what were going to be the legal—what was the legal framework under which we would be—— 

Ms. DEGETTE. So they were afraid that they might not have the 

authority to do the inspections? Is that what you are saying? 

Dr. HAMBURG. We have the authority to do the inspections—— 

Ms. DEGETTE. So why couldn’t they do both at once? 

Dr. HAMBURG [continuing]. But inspections are just a piece of 

what needs to be done to take enforcement actions, and 

Ms. DEGETTE. Right, so you don’t know why they didn’t do both, 

because you didn’t know at the time? Is that what you are saying? 

Why didn’t they both do the inspections and write the new guidelines? 

Dr. HAMBURG. I wish that there had been a more aggressive approach in terms of inspections. 

Ms. DEGETTE. But you don’t know why? 

Dr. HAMBURG. There was an effort to follow up on specific concerns. That doesn’t always require an inspection. But the desire 

was to—the CPG was being worked on in order to really provide 

clear guidance about the standards under which we would be looking at enforcement in these facilities, and I wish it had been completed more quickly and I—— 

Ms. DEGETTE. OK. So you testified now that this is at your level, 

the last number of months since November have been aggressively 

trying to go in and inspect, and that various companies have 

tried—have refused entry and you had to get court orders and so 

on. Very briefly, can you tell me how long it took you—it took the 

FDA from the time that you announced you wanted to go in and 

inspect to get these orders to get the marshals in? Was there a 

delay because of the resistance of the compounding pharmacies? 

Dr. HAMBURG. Yes, there have been a variety of delays in terms 

of—— 

Ms. DEGETTE. But how long were those delays? 

Dr. HAMBURG. Days to weeks. 

Ms. DEGETTE. Days to weeks, OK. Now, are you saying—this is 

a really pretty simple question. Are you saying that the FDA 

should have the authority to regulate all drug compounders? 

Dr. HAMBURG. We believe that we need to focus on those 

compounders that are making the highest risk products, the sterile 

products, in advance or without a prescription and shipping to 

other states. We believe that there are not sufficient standards in 

place in the law and enforceable—— 

Ms. DEGETTE. So it is really a targeted group of compounders 

that are engaged in interstate commerce that the FDA believes 

that need stronger authority, is that correct? 

Dr. HAMBURG. We believe we need to focus on the highest risk 

facilities, and that includes those making sterile products and shipping—— 

Ms. DEGETTE. And what percentage of all the drug compounders 

is that? 

Dr. HAMBURG. Well, we don’t really know because we don’t 

know—— 

28 

Ms. DEGETTE. Because you don’t have the authority—— 

Dr. HAMBURG [continuing]. Those compounders because they are 

not required to register with us, and we don’t have full access to 

their records for assessment. 

Ms. DEGETTE. Right. Now let’s talk about this court case thing, 

because some people on this committee seem to think this is more 

important than others. 

Now in 2001, the Ninth Circuit Court found that part of the 1997 

Food and Drug Administration Modernization Act was unconstitutional, correct? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. And so—and then in 2002, the Supreme Court affirmed that decision about the constitutionality. Is that right? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. And then in 2008, there was a different circuit 

court that reached a different conclusion, finding that the key parts 

of the 1997 drug compounding law could remain in effect. Is that 

correct? 

Dr. HAMBURG. That is correct. 

Ms. DEGETTE. And is that that map that your staff put up over 

there? That looks to me like the map that shows, so in other words, 

in the red, that is one of the court decisions. In the blue, that is 

the other court decision, right? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. And then in the gray, that is the rest of the country that is covered by different courts that have not ruled on this, 

right? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. And so the result of this has been that the—is 

that the industry has pushed back against the FDA’s attempts to 

regulate, right? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. Now, I think you do understand and I think you 

recognize we are not saying here that this absolves the FDA from 

responsibility to try, and you believe the FDA does have the responsibility to try to enforce to make sure that these compounding 

pharmacies are doing the right thing, right? 

Dr. HAMBURG. Absolutely. 

Ms. DEGETTE. But nonetheless, there is not a clarity in the law, 

and that is hampering the FDA to know clearly what it should do 

and to do it in a quick fashion. Is that right? 

Dr. HAMBURG. That is absolutely correct. 

Ms. DEGETTE. OK, thank you very much, Mr. Chairman. 

Mr. MURPHY. I now recognize Mr. Barton for 5 minutes. 

Mr. BARTON. Thank you, Mr. Chairman. 

Madam Commissioner, I was puzzled as I listened to you evade 

the answer to the chairman’s questions about when you learned. 

You never gave him a straight answer, so I am going to ask a question and let’s see if we can get a straight answer. 

Does the sun rise in the east, Madam Commissioner? 

Dr. HAMBURG. You have me so confused, I don’t know. 

Mr. BARTON. Well, I would hope that we could have gotten a 

straight answer from that. 

Dr. HAMBURG. No, yes. 

29 

Mr. BARTON. My seven-year-old would know the answer to that 

in the first grade, so if we have now established that you can give 

us some straight answers, I will give you once more chance to answer the chairman’s question, when did you learn about all this? 

When did you become aware? Just a date, a time. 

Dr. HAMBURG. You know, many of the issues that are involved 

here I did become aware of in the course of the investigation and 

reviewing the many documents that—— 

Mr. BARTON. Why are you afraid to just tell us? 

Dr. HAMBURG. Because I am not—I really don’t remember. 

Compounding pharmacies were an issue that—— 

Mr. BARTON. OK, well that is an answer. 

Dr. HAMBURG [continuing]. I was not, deeply—— 

Mr. BARTON. If you don’t remember, you really don’t remember. 

Dr. HAMBURG. And I regret it. 

Mr. BARTON. So we will assume that you really, really don’t remember. 

So I am going to ask you another question. You have been the 

commissioner, I think for a little over 4 years, since you got confirmed by the Senate, so when you found out about this problem, 

how did you feel then and how do you feel now? 

Dr. HAMBURG. When the meningitis outbreak began, like all of 

you, I was deeply concerned and committed the resources of our 

agency to engaging in the public health investigation and response, 

and I have been deeply involved in the subsequent activities, and 

I do believe we need to be more aggressive, and I intend to be more 

aggressive. 

Mr. BARTON. I am asking for the—all the people of America that 

depend on the FDA, the gold standard of regulatory authority in 

the world. You are the point person. Obviously there are thousands 

of people at the FDA and you can’t be personally responsible for 

each and every one of their actions, but in our form of government, 

you are the person that the President of the United States, confirmed by the Senate, is the leader. Are you upset with what this 

company did? Are you outraged? Are you confused? Are you puzzled? I mean, how do you feel? 

Dr. HAMBURG. I am deeply troubled and I am committed to working with all of you, with industry, and with the states in order to 

ensure that we have the regulatory framework that we need in 

order to be able to best protect the health of the American people 

and ensure the safety of their health. 

Mr. BARTON. All right. 

Dr. HAMBURG. We do not presently have that in place, and I am 

worried that if we don’t work together to address it, there may be 

future problems of this magnitude. 

Mr. BARTON. OK, deeply troubled and worried. OK, that is—I 

find that acceptable. 

Now, at our first hearing there was a lot of ping-pong balling 

back and forth whether it was a state problem, a state regulatory 

problem, or a federal regulatory problem, and I believe you testified 

that you needed more authority, and there was some ambiguity in 

the law, things like this. Since that time, you have shut the company down. I think there is a criminal case against the company. 

So obviously, the FDA had enough authority to do what it has 

30 

done. Do you, today, think that the authority is adequate on the 

books for your agency, or do you continue to believe that you need 

more authority? 

Dr. HAMBURG. My understanding is that it was the state authority that was able to—NECC was licensed by the State of Massachusetts and it was the state authority that enabled—— 

Mr. BARTON. But my question is knowing what you know now, 

do you still want this committee to give the FDA additional authority, or are you satisfied that your agency, the FDA, has sufficient 

authority to do its job? 

Dr. HAMBURG. We definitely need additional authorities. At the 

present time, compounding pharmacies under existing law, despite 

the ambiguities and the split court decision, compounding pharmacies are not required to register with us, so we don’t know who 

they are and what they are making. They are not required—these 

large compounding pharmacies that are making sterile products 

are not required in law to—— 

Mr. BARTON. OK, so you think you need additional—— 

Dr. HAMBURG [continuing]. Apply uniform standards—— 

Mr. BARTON. My time is expired and I have one more question 

that I want to ask. Do you feel that this company is typical of the 

average compounding pharmacy? 

Dr. HAMBURG. You know, I cannot—there is an ongoing criminal 

investigation, as you know. I can’t comment on the specifics, but 

there are good players and bad players out there, compounding 

drugs. Compounding plays a critical role in our healthcare system, 

but we need to make sure that there are the standards in place 

and that FDA has the authorities to enforce those standards that 

will assure the quality and safety of these products, particularly 

these highest risk sterile products. 

Mr. BARTON. I thank the commissioner and thank the chairman. 

Mr. MURPHY. Thank you. Mr. Waxman is now recognized for 5 

minutes. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

Dr. Hamburg, if a manufacturer wants to produce a drug, they 

have to go to FDA and get approval and show the drug is safe and 

effective, and you keep track of those manufacturers, or even inspect some of their facilities, isn’t that right? 

Dr. HAMBURG. That is correct. 

Mr. WAXMAN. So a compounding pharmacy can put together 

drugs, but they don’t have to come to the FDA to ask approval or 

even register with you to let you know that they are doing that, 

isn’t that correct? 

Dr. HAMBURG. That is the case. 

Mr. WAXMAN. They go to their states and have to let the states 

know, or does that depend on state law? 

Dr. HAMBURG. State laws are very variable, as well as the resources for enforcement. 

Mr. WAXMAN. Well, some people have said that because recently 

you have gone out and done inspections, between February and 

April of this year, of 30 compounding pharmacies that make sterile 

injectable drugs, and that there are inspections on occasion, that 

you have all the authority you need. Dr. Hamburg and Mr. Taylor, 

can you say that you have the authority to be able to comprehenVerDate Nov 24 2008 12:10 Feb 02, 2015 Jkt 037690 PO 00000 Frm 00036 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-31 CHRIS
31 

sively oversee and inspect this industry that can act without your 

approval and maybe even in occasions you don’t even know who 

they are? 

Dr. HAMBURG. No, we, as you note, don’t have the authority to 

even know who is out there and what they are making. We don’t 

have those uniform national standards for safe practices, good 

manufacturing practices to inspect against and hold them to. They 

do not have to report adverse events that they might hear about 

to us so we can respond rapidly. This is not a system that is adequate to protect in the light of this changing healthcare system and 

its needs, and this evolving industry. 

Mr. WAXMAN. The inspections that you have done are based on 

what information? 

Dr. HAMBURG. We determined who to inspect based on either 

past awareness of concerns, public information about concerns, concerns states had brought to our attention, but we were inspecting 

companies that made sterile products because we view them as the 

highest risk, and we have certainly found considerable concerns 

about ongoing sterility practices, and we have also found that even 

in light of recent events, that companies are questioning our authorities to do full inspections, and the appropriateness of the inspections. 

Mr. WAXMAN. When FDA wanted to look at this NECC, the company that made the drug that has done so much harm, in December of 2006—before you were there—FDA sent them a warning letter highlighting a series of violations of federal law, and this company responded in part that it didn’t need FDA approval before dispensing compounded medications, and further, did not operate in 

a manner that would subject us to FDA regulation. In other words, 

they were resisting FDA doing its job. They were emboldened. 

Didn’t that make your job even tougher? 

Dr. HAMBURG. Well, it certainly has made it tougher. It has 

made it much less effective and efficient, and I think it speaks to 

the reason why I am here now, really asking for the chance to work 

with you to put in place the systems of legal and regulatory requirements that will enable better cooperation—— 

Mr. WAXMAN. I appreciate that. 

Dr. HAMBURG [continuing]. And coordinating. 

Mr. WAXMAN. Now if you find that pharmacy compounder and 

they are doing high risk work and you have some suspicions that 

there are problems and you want to do an inspection, can you get 

their records? 

Dr. HAMBURG. We cannot always get their records. 

Mr. WAXMAN. Well, you don’t have the authority to get record inspections, isn’t that right? The reason I say that is that at the Senate hearing in November, the compounding industry witness said 

FDA doesn’t need new records inspection authority because it can 

access pharmacy records by getting a warrant. 

Mr. Taylor, what does it mean, you have to go get a warrant if 

you want to see their records? 

Mr. TAYLOR. Yes, so it is—once a refusal has occurred, what you 

actually have to do is put together essentially an affidavit that you 

would take to court explaining why you are seeking this warrant. 

Then an FDA employee would testify to the truth of the warrant, 

32 

and you actually have to bring it to a federal court judge. So it 

is—— 

Mr. WAXMAN. Well let me just stop you and say if we want you 

to do your job, we have got to give you the tools. We would rather 

make the law clear, and one ought to be you can do inspections and 

you can get these records and not have to go through the whole rigmarole where they want to fight you and have to go and get a warrant. Some cooperate, but some, especially those we are most suspicious of, can force you to go to court and get a warrant. Isn’t that 

right? 

Mr. TAYLOR. That is correct. 

Mr. WAXMAN. Well, I hope we take that into consideration, Mr. 

Chairman, in addressing this question of the law that needs to be 

adopted by the Congress. 

Mr. MURPHY. Thank you. Gentleman yields back, and I now recognize Dr. Burgess for 5 minutes. 

Mr. BURGESS. I thank the chairman for the recognition. Dr. 

Hamburg, as always, welcome back to our humble committee room 

here in the Energy and Commerce Committee. 

You know, I just have to say, reading through the information 

that was provided by your office that the staff has assembled, I 

mean, your staff must be some of the most frustrated people in the 

world, because it seems like they were always coming right up to 

the point where someone could pull the plug on NECC, on the New 

England Compounding Center, and then for whatever reason, they 

backed off. I don’t know whether they were thrown off the scent or 

dissuaded by your lawyers, but you are a doctor. You run a public 

health agency. Lawyer stuff is for lawyers. We are supposed to take 

care of people. We are supposed to prevent this stuff from happening, and the system was blinking red for 10 years. So I appreciate that there is a newfound enthusiasm and vigilance after the 

end of September of 2012. Everything seems to be a pre- and postmeningitis mindset at the FDA and I am grateful for the work that 

the agency is doing now, but I just fail to understand why you 

could not do that same work prior to the death of 50 people. It 

just—it almost defies gravity. 

In your own written testimony, you—on the third page, beginning of the top of the page, you actually reference ‘‘Since the NECC 

outbreak’’, and then you go into magnesium sulfate preparation 

that was contaminated, apparently with no injuries. Then you talk 

about eye infections associated with repackaged Avastin. But that 

is not really new information, because the FDA had received warnings and complaints relating to the sterility of NECC’s Avastin 

products for a long time, 2007. The FDA was repeatedly put on notice that NECC may again be experiencing problems relating to the 

sterility and/or safety of its products. An adverse drug reaction report which was supplied by you to our committee, so obviously it 

was received by the FDA, talked about just one of those eye infections that occurred after repackaged, repurposed Avastin—apparently the company took a bulk amount of compound that was duly 

licensed for treatment of colon cancer, broke it up into smaller 

amounts, and dispensed it to ophthalmologists for use in treating 

macular degeneration. The problem is, and as has been referenced 

by your folks, every time you pierce that vial, the risk for contamiVerDate Nov 24 2008 12:10 Feb 02, 2015 Jkt 037690 PO 00000 Frm 00038 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-31 CHRIS
33 

nation occurs. So you make up multiple preparations that can now 

be used for intraocular injection, but the last syringes that are prepared that day may have extra stuff in them. You cannot have a 

preservative to prevent the growth of bacteria or fungus in an 

Avastin preparation for ophthalmic use, because it is going into the 

eye and you can’t have a preservative injected into the eye. 

So I guess what troubles me is you are talking about it here, the 

serious eye infections with repackaged Avastin, but that wasn’t exactly news to you, was it? 

Dr. HAMBURG. I think what you are speaking to underscores the 

fact that we really do now need to recognize that the existing legal 

authorities and enforcement strategy is not adequate to address 

the problems that we have. We need to be able to—— 

Mr. BURGESS. I am sorry, I do need to interrupt—— 

Dr. HAMBURG [continuing]. Repackaging to sanitary standards. 

Mr. BURGESS [continuing]. In the interest of time, because you 

now are in those companies. I mean, in your own testimony you 

talk about compounding pharmacies producing what should be 

sterile products shipping across state lines, and in advance of or 

without a prescription—I am not a lawyer. I don’t really understand what makes a manufacturer a manufacturer, but I feel like 

that old Supreme Court justice. I don’t know the definition of manufacturer, but I know one when I see it, and that is a manufacturer, and you have absolute authority to regulate manufacture of 

pharmaceuticals, do you not? 

Dr. HAMBURG. Yes, we do. 

Mr. BURGESS. Yes is the answer. Thank you for the direct answer 

to that question. And you are doing it now in the post-NECC environment and we are grateful for that enforcement activity. I just 

got to believe your folks at the various divisions within the agency, 

I mean, they had to be pulling their hair. In fact, we have the testimony of one of—the fellow that is now the head of the whole New 

England district office, Mutahar Shamsi, I mean, he said why do 

we even inspect if we are not going to follow through on these 

things? They are doing all the work. They are getting right up to 

the point where, again, someone should pull the plug on the bad 

guys and they tell the cop to stand down. Don’t do it. Your agency 

must be internally in turmoil because of this. 

Dr. HAMBURG. We would very much like to have some of the 

same kinds of authorities that we have with conventional manufacturers with these highest risk compounders. 

Mr. BURGESS. Wait a minute. 

Dr. HAMBURG. We do not presently have them, and that is why 

we are seeking legislation. 

Mr. BURGESS. You have the authority to regulate manufacturing. 

I mean, that is—no one is disputing that. That is not in question. 

You have that authority. In fact, if you don’t believe you have that 

authority, maybe somebody else ought to run the agency, but you 

have that authority. 

Dr. HAMBURG. Of course we do, but what I am saying to you is 

we do not have the same authorities to regulate compounding pharmacies. 

Mr. BURGESS. If they are manufacturing—if they are engaging in 

manufacturing, I submit that you do. 

34 

Thank you, Mr. Chairman. Maybe we can have time for a second 

round. 

Mr. MURPHY. Thank you. Chair recognizes the gentleman from 

Michigan, Mr. Dingell. 

Mr. DINGELL. Thank you, Mr. Chairman. 

I am quite outraged. Here I sit. We are picking nits and straining at nats instead of addressing what this committee should be 

doing. We should be figuring out what are the problems, and then 

to proceed to address them. We have had 733 cases, 53 deaths, 15 

deaths in Michigan, the highest number of cases, and the deaths, 

and we are dealing here with an agency that doesn’t have the authority to do the things that it needs to do. 

Section 503 exempts compounded drugs from three critical requirements at FDA. First of all, they don’t have to comply with 

good manufacturing practices. If you look at what happened up in 

New England, you will find they weren’t even within rock-throwing 

distance of good manufacturing practices. And so they have no authority to address these things as new drugs. They really have 

questionable, if any, authority to address these people as manufacturers, and there is no requirement that these things have directions for proper use. In addition to this, these people who have vigorously opposed any kind of control have not only got themselves 

statutory exemption, but they don’t even have to report adverse 

consequences of the use of their pharmaceuticals. 

And here we sit, picking nits about what did Food and Drug 

know, and when did they know it? This committee should be saying 

what authority do you need, and then saying by golly, we are going 

to get it for you. 

Now, let me ask you a few questions, Administrator. You said 

that you don’t have sufficient authority to regulate these people. Is 

that right? 

Dr. HAMBURG. Correct. 

Mr. DINGELL. Yes. Now, since the fungal meningitis outbreak, 

FDA has inspected compounding pharmacies that are known to 

have produced sterile drugs in the past. Is this correct? 

Dr. HAMBURG. That is correct. 

Mr. DINGELL. Can you explain briefly what the Food and Drug 

Administration found during these inspections? 

Dr. HAMBURG. We have found serious lapses in sterility—procedures, insufficient ventilation—— 

Mr. DINGELL. I want you to submit that for the record, if you 

please. 

Now, was Food and Drug granted full access to all of the identified compounding pharmacies for inspection? Yes or no? 

Dr. HAMBURG. No. 

Mr. DINGELL. Would you submit to us what it was that they did 

to deny you that access? 

Now, was Food and Drug granted full access to records by all of 

the identified compounding pharmacies during inspection? 

Dr. HAMBURG. No. 

Mr. DINGELL. Did you encounter resistance from any of the identifying compounding pharmacies when Food and Drug arrived for 

inspection? 

Dr. HAMBURG. Questioning of our authority, yes. 

35 

Mr. DINGELL. All right. Now, would you please submit for the 

record what actually happened to you in these cases where they refused you access to the records? 

Now, Madam Administrator, even in light of the fungal meningitis outbreak, with 53 deaths and over 700 confirmed cases, some 

of these compounding pharmacies refused to grant you access to 

their facility or records for inspection. Yes or no? 

Dr. HAMBURG. Yes. 

Mr. DINGELL. Do you need inspection authority to effectively regulate compounding pharmacies? Yes or no? 

Dr. HAMBURG. Yes, absolutely. 

Mr. DINGELL. Do you believe that the states are able or have carried out their responsibilities fully on these matters? 

Dr. HAMBURG. It is very variable, but no, not in their entirety. 

Mr. DINGELL. OK. Do you believe that FDA has clear authority 

to access all records when inspecting a compounding pharmacy? 

Yes or no? 

Dr. HAMBURG. I am sorry. Could you repeat that? 

Mr. DINGELL. Do you believe that FDA has clear authority to access all records when inspecting a compounding pharmacy? Yes or 

no? 

Dr. HAMBURG. No. 

Mr. DINGELL. Has FDA faced litigation regarding its ability to inspect records in pharmacies? 

Dr. HAMBURG. Yes, we have. 

Mr. DINGELL. Do you need this authority to effectively regulate 

compounding pharmacies? 

Dr. HAMBURG. Yes. 

Mr. DINGELL. Would these authorities help FDA to enter a 

compounding pharmacy without delay to conduct proactive inspections? 

Dr. HAMBURG. Yes. 

Mr. DINGELL. Would these authorities assist FDA in preventing 

future outbreaks? 

Dr. HAMBURG. Yes. 

Mr. DINGELL. Thank you, Commissioner. 

Now, I want to make some observations here. This committee 

has an important responsibility. Our responsibility is to find out if 

the laws are being properly enforced and if there is additional law 

that is needed to make the situation better. We are having people 

who have been killed. We can anticipate if we don’t do something 

more, there are going to be more. The Democratic members on this 

committee have sent to the leadership of this committee a request 

to bring in the trade association of these people to discuss what it 

is they are doing, and why and when and how. They have refused 

to assist and cooperate with Food and Drug. They have gone further and they have instructed their members as how to obfuscate, 

delay, and to refuse to comply. 

We have a nasty situation on our hands. Let’s get down to addressing the problem that is before us. Let’s haul the right people 

in. Let’s get the right kind of legislation drafted. Let’s get the proper testimony, and let’s move forward. 

Thank you, Mr. Chairman. 

Mr. MURPHY. Thank the gentleman. 

36 

By the way, Chairman Dingell has asked for a number of documents for the record, and at the last hearing in November, a number of members also asked for documents. We haven’t received 

those yet, so I would like to expect those documents by the 19th 

of April, to have answers to those questions. 

Dr. HAMBURG. By the 19th of April? 

Mr. MURPHY. The questions for the record from the last hearing. 

the questions for the record from the last hearing, which was in 

November. 

The chair now recognizes for 5 minutes the gentleman from Louisiana, Mr. Scalise, for 5 minutes. 

Mr. SCALISE. Thank you, Mr. Chairman. I appreciate you having 

this hearing and following up on something that we have been 

delving into for a few months now. 

I know I had asked, as others did, back at that last hearing— 

and I will reiterate, I would like to get whatever law it is that you 

all are hiding behind that says you do not have the legal authority 

to investigate these pharmacies like Ameridose and NECC. I don’t 

know why haven’t gotten it in the months since our hearing, but 

can you get us whatever it is that legally you are hiding behind 

that you say prevented you from doing the proper investigation, 

things that you are saying you need to change the law now. Well, 

if you need to change the law now, then clearly you are hiding behind some section of law that you think doesn’t allow you to do it 

today. Can you get us that information? 

Dr. HAMBURG. I can certainly get you relevant law. I would just 

like to underscore that it is not just the FDA that is concerned 

about the ambiguity in the law. This has been a serious issue for 

a long time, going back to when it was first enacted, the statute— 

503A of the Food, Drug and Cosmetic Act, when David Kessler sat 

before a committee and said that he was concerned that the law 

was going to create loopholes that would enable compounding pharmacies to be able to—— 

Mr. SCALISE. But did you just say earlier in your testimony that 

you have gone and investigated over 50 of these pharmacies since 

the outbreak? 

Dr. HAMBURG. Because we have been able to go in and investigate—— 

Mr. SCALISE. Well if you have been able to investigate—— 

Dr. HAMBURG [continuing]. Does not mean that we have the full 

authority that—— 

Mr. SCALISE. So you are investigating without legal authority 

now? Is that what you think you are doing? 

Dr. HAMBURG. No, we have the authority to go in, as Congressman Dingell just indicated. We don’t have the full authorities we 

need in order to do the full inspections, and we don’t know who 

they are. 

Mr. SCALISE. Well let me just ask you this. We are running low 

on time, I apologize, but if we can first put up, there is a chart that 

documents complaints that have been filed for months and months 

prior to the deaths that you all were receiving. FDA was getting 

complaints about this facility—not in general, but about this facility. Now, I don’t know what you all were doing about it back then, 

but if you were claiming you didn’t have the legal authority to do 

37 

it and yet you are getting these complaints, did you at least pick 

up the phone and call the State of Massachusetts and ask them to 

use their legal authority to investigate? 

Ms. DEGETTE. Mr. Chairman, I have to ask, does the witness 

have a list of those complaints, because I certainly can’t read it 

from here. 

Mr. SCALISE. Do you know about those complaints? I will ask the 

commissioner. Those complaints, we got them because we got them 

from the FDA. Do you know that they are out there? 

Dr. HAMBURG. I am aware that there were complaints, and—— 

Mr. SCALISE. So did you all pick up the phone and call the State 

of Massachusetts? 

Dr. HAMBURG. To the best of my understanding, we have made 

an effort to follow up in the general—— 

Mr. SCALISE. During the time prior to the 53 deaths, you are getting flooded with complaints from people saying this place is unsafe. It is highly questionable what they are doing. Did you, at 

some point—when you said in your own decision making process 

that you didn’t think you had the legal authority to go in and check 

them out, did you at least pick up the phone and say—— 

Dr. HAMBURG. No. I want to be clear. 

Mr. SCALISE. You are here to protect public health. Call Massachusetts. 

Dr. HAMBURG. I did not say we don’t have authority. We have 

authority that is not adequate to fully regulate—— 

Mr. SCALISE. Then why didn’t you pick up the phone and call 

somebody who did? If in your opinion you were concerned about 

your question on authority, why didn’t you call Massachusetts, or 

did you call Massachusetts prior to the deaths occurring? 

Dr. HAMBURG. We—— 

Mr. SCALISE. That is a yes or no question. 

Dr. HAMBURG. We have worked with Massachusetts and we 

worked with others—— 

Mr. SCALISE. But did you call the State of Massachusetts and forward the complaints and say look, there is a real serious question 

about this company in your state. We are not sure if we can go in. 

You all ought to go in because you have the legal authority. Did 

you make that call? Did you pass that information on? 

Dr. HAMBURG. I have said that—— 

Mr. SCALISE. Yes or no. 

Dr. HAMBURG [continuing]. I do not believe—— 

Mr. SCALISE. We are running out of time here. 

Dr. HAMBURG [continuing]. That our response to the 

compounding industry and specific issues that you are raising—— 

Mr. SCALISE. So did you forward any of these complaints? 

Dr. HAMBURG [continuing]. Was adequately—— 

Mr. SCALISE. And this is a yes or no question. Did you forward 

any of these complaints to the State of Massachusetts prior to the 

deaths? Any of them? 

Dr. HAMBURG. In many instances we are working—— 

Mr. SCALISE. Yes or no? 

Dr. HAMBURG [continuing]. With the states to do inspections. 

Mr. SCALISE. Did you forward the complaints? Yes or no? 

38 

Dr. HAMBURG. I can’t speak to—I don’t know what complaints 

you are referring to, but—— 

Mr. SCALISE. You don’t know? 

Dr. HAMBURG [continuing]. In many instances yes, we were—— 

Mr. SCALISE. Yes, you did? 

Dr. HAMBURG. I don’t know what complaints you are referring to. 

Mr. SCALISE. Did you send the complaints? Yes or no? And I am 

only trying to pressure—I mean, you were happy to answer Mr. 

Dingell’s questions yes or no. I have got 40 seconds left. Did you 

forward any of these complaints that you got to the State of Massachusetts? Yes or no? 

Dr. HAMBURG. We discussed complaints—— 

Mr. SCALISE. Yes or no? 

Dr. HAMBURG [continuing]. With the states. We did inspections 

with the states—— 

Mr. SCALISE. Can you answer this in a yes or no fashion? Are 

you evading? 

Dr. HAMBURG. I can’t speak—— 

Mr. SCALISE. Let me ask you this. I went to your Web site. I 

went to your Web site. This is right now, live. Your Web site Commissioner’s Page says that it is your mission to find ‘‘novel ways 

to prevent illness and promote public health, and be transparent 

in explaining our decision-making, says Dr. Hamburg.’’ That is you. 

You are not—number one, you did not find novel ways to protect 

public health, and you are not right now being transparent in explaining your decision-making process. So you are failing in your 

mission. 

So I will at least ask you this. Maybe you can answer—— 

Dr. HAMBURG. I am not—— 

Mr. SCALISE. Has anybody at FDA been held accountable for the 

53 deaths that occurred? Anybody? 

Dr. HAMBURG. We are working hard, both in responding—— 

Mr. SCALISE. Has anyone been held accountable? Yes or no? Or 

do you not know? 

Dr. HAMBURG. You know, my statement to you is that we could 

have been more vigorous, but that—— 

Mr. SCALISE. Has anyone been held accountable? 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. SCALISE. Have you held anyone accountable? The buck stops 

with you. You said that today in your testimony. Have you—— 

Mr. MURPHY. Gentleman’s—— 

Mr. SCALISE [continuing]. Held anyone accountable for 53 

deaths? 

Dr. HAMBURG. This is a problem that is one that needs to be addressed by—— 

Mr. SCALISE. I will take that as a no. 

Dr. HAMBURG [continuing]. The FDA, states—— 

Mr. SCALISE. I will take that as a no and I will yield back the 

balance of my time. 

Mr. MURPHY. Gentleman’s time is expired. Now recognize the 

gentlelady from Illinois, Ms. Schakowsky, for 5 minutes. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman, and thank you, 

Mr. Tonko, for allowing me to go out of turn. 

39 

Commissioner Hamburg, by the time the Obama Administration 

entered office in January of 2009, FDA guidance and law regarding 

compounding pharmacies had been governed by confusion and uncertainty for nearly 7 years. In May, 2009, top FDA officials met 

with the acting commissioner, your predecessor, to resolve the issue 

of unregulated compounding pharmacies. I want to ask you about 

a document that the FDA produced—gave to the committee. You 

can find it at Tab 45. It is a written summary of a meeting that 

occurred on May 12, 2009. This summary of the meeting noted that 

‘‘Unregulated compounding raises significant public health concerns. FDA has seen numerous examples of serious patient injury 

and death caused by improper compounding.’’ At this meeting, the 

recommended path forward was to seek legislation amending Section 503A to enhance FDA’s oversight of compounded drug, much, 

I guess, like you are saying now to do that. 

But this document also lists a disadvantage of that legislative approach, and the summary stated ‘‘The legislative process will be 

time and resource intensive, and the compounding community will 

actively oppose the changes that we seek. They have a very effective grass roots organization that will make it difficult for us to 

achieve our legislative ends. We cannot know if the result of our 

efforts will be better law than Section 503A in its current form.’’ 

So Dr. Hamburg, this was not a meeting that you attended, and 

I am not going to ask you about it specifically, but I would like to 

ask you a question about the influence of the compounding industry generally, and its leading trade group, the International Academy of Compounding Pharmacies, or IACP. Can you describe the 

general views of the compounding industry with regard to the FDA 

authority that you are talking about requesting today? 

Dr. HAMBURG. Well, I think it is clear that the organization and 

the industry more broadly has, over many years, questioned our 

authorities to fully regulate the compounding pharmacies. They 

have challenged us in court, as has been documented, and in addition to questioning FDA authorities, as was demonstrated in the 

document that was put together by Congressman Waxman and others, they also were making concerted efforts to weaken regulatory 

authorities at the state level and I think that this was even while 

recognizing that this could lead to some serious concerns, and certainly it has made our ability to regulate this industry much more 

challenging. It has required much more complexity in terms of the 

actions we can take and the resources required to take those actions, and it has certainly also thwarted earlier efforts at legislation. In 2007, Senators Kennedy, Burr, and Roberts proposed some 

legislation that would have strengthened the FDA role and clarified 

some of these issues, and industry was up on the Hill lobbying intensively, and that legislation was never introduced. And I don’t 

believe there was anything on the House side either. 

Ms. SCHAKOWSKY. So would you say that the IACP has made it 

more difficult for FDA to effectively regulate drug compounders? 

Dr. HAMBURG. I would. 

Ms. SCHAKOWSKY. And would you agree that the compounders 

have traditionally been adamantly opposed to any expansion of 

FDA authority over drug compounders? 

40 

Dr. HAMBURG. Absolutely, and I think the industry is questioning the inspections that we are doing now. 

Ms. SCHAKOWSKY. So Dr. Hamburg, earlier this week the subcommittee released a letter asking that a representative of 

compounding pharmacies be invited here today, but the Majority 

rejected our request. I would like to ask that the letter and underlying documents, all of which show that the compounding industry 

has fought relentlessly to avoid FDA oversight, be added to the 

hearing record. 

Mr. MURPHY. Without objection. 

[The information appears at the conclusion of the hearing.] 

Ms. SCHAKOWSKY. Thank you. 

I think this proceeding would have benefitted from hearing their 

testimony. Our drug supply needs to have FDA oversight and drug 

compounders shouldn’t get to create—to evade regulation by the 

agency. We as a committee need to join together and finally give 

the FDA, give you the authority that you need, that the agency 

needs to effectively oversee drug compounders. 

And I yield back. 

Mr. MURPHY. The gentlelady yields back. I now recognize Mr. 

Olson for 5 minutes. 

Mr. OLSON. I thank the chair, and welcome, Dr. Hamburg. 

As you know, ma’am, one of my duties as an elected representative of the people of Texas 22 is to provide oversight and investigate the Executive Branch to ensure that they comply with the 

Constitution and the laws. Put simply, my job is to find the truth. 

The truth is that 55 Americans died because their spinal injection 

was contaminated, and at least 700 Americans were made seriously 

ill by that drug. These families deserve to know the truth, and I 

intend to get that for them. 

During your testimony in November, you made a number of 

statements about how the compounding industry has evolved in recent years. You also highlighted that the Massachusetts State 

Pharmacy Board was in the best position to oversee NECC. But 

that decision was made in 2003, is that correct? 

Dr. HAMBURG. As I think you probably know, compounding pharmacies historically have been regulated by states, and it is the 

states that license pharmacies. 

Mr. OLSON. Yes, ma’am. These are complaints—please refer to 

Tabs 2 and 3 in your binder there. I will give you some time to do 

that. These complaints about the NECC from pharmacists in Wisconsin and Iowa that the Massachusetts Pharmacy Board forwarded to FDA in April and May of 2004. 

In an e-mail to Massachusetts Board related to the second complaint in Tab 3, the lead attorney for the board asked, could you 

clarify what we may not have known about your operation previously that this e-mail tells us, as in what the FDA might not 

know in a prior assessment that the NECC was not a ‘‘manufacturer.’’ 

Commissioner Hamburg, a different picture of the NECC began 

to emerge soon after the FDA decided the state should take the 

lead, isn’t that right? Much different picture, ma’am, much different. 

41 

Dr. HAMBURG. As I think was discussed at the last hearing, it 

was agreed during this early period that, in fact, the State of Massachusetts had the lead in responding because it was a licensed 

pharmacy in Massachusetts. However, I think it is important to 

underscore that the line between compounder and manufacturer is 

not a bright one, and that that is part of what we are seeking is 

to get more explicitness in law with respect to what is a manufacturer and what is a compounder. 

Mr. OLSON. Yes, ma’am, but these documents show that by 2004, 

soon after the FDA’s decision that the state would take the lead in 

overseeing NECC, FDA had already begun to receive information 

showing that the company was shipping products across the country without patient-specific prescriptions. Based on documents provided, pharmacists and hospitals continued to forward NECC’s solicitation to you, to the FDA. 

Let me give you one example. It is Tab 4 there in your binder. 

In January of 2006, the FDA received a complaint about NECC soliciting a multiple use sterile injectable product. Are you familiar 

with this complaint, ma’am? Yes or no? 

Dr. HAMBURG. Yes. 

Mr. OLSON. Yes. This complaint stated that NECC does, and this 

is a quote, ‘‘not need or desire to have the patient’s name.’’ This 

would suggest that the company is no longer acting like a 

compounder, right? It is not filling patient-specific prescriptions. 

Recently, a 60 Minutes report in which you were interviewed, an 

NECC anonymous informant claimed the company was forging patient prescriptions. Are you familiar with that charge, ma’am? Yes 

or no? 

Dr. HAMBURG. You know, with respect to some of these specific 

documents, et cetera, because of the ongoing criminal investigation—I discussed this with the chairman before—I cannot characterize this situation for you. We all want that criminal investigation to go forward, and I do not want to—— 

Mr. OLSON. Ma’am, with all due respect—— 

Dr. HAMBURG [continuing]. Do or say something that would compromise that. 

Mr. OLSON [continuing]. You are not the subject of an open investigation. This committee has not sought any documents from the 

FDA or U.S. Attorney’s Office that are being used in an open criminal case. By definition, we are not asking any questions about the 

open case or evidence that is part of that case. This Congress does 

not necessarily have your respect for ‘‘open criminal case’’ and that 

excuse. Thirty years ago in the Reagan Administration, this committee and other committees in the House held EPA Administrator 

Anne Gorsuch in contempt for not producing documents, even 

though Administrator Gorsuch was advised by Department of Justice and the White House that she could not produce to Congress 

these documents because of executive privilege. Please give us 

these documents. 

Again, I don’t think open case applies. It hasn’t historically. It 

shouldn’t apply here. 

Dr. HAMBURG. You clearly have a huge number of documents, 

but I cannot speak to the specifics of some of these documents because of the ongoing criminal investigation. I don’t know the speVerDate Nov 24 2008 12:10 Feb 02, 2015 Jkt 037690 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-31 CHRIS
42 

cifics of what is—I am not part of the ongoing criminal investigation in terms of the collection of information and its analysis, but 

I have been told that I need to be careful not to compromise that 

investigation. 

Mr. OLSON. That is—— 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. OLSON [continuing]. A subject of investigation and we have 

not sought any documents from FDA or—— 

Ms. DEGETTE. Mr. Chairman? 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. OLSON. I yield back. 

Ms. DEGETTE. I would respectfully ask that members—I would 

ask unanimous consent to ask Commissioner Hamburg, were you 

advised by counsel not to answer questions about the ongoing 

criminal investigation at NECC? 

Dr. HAMBURG. I was. 

Ms. DEGETTE. So Mr. Chairman, I would ask members not to ask 

those—if she has been advised by counsel not to do that, I don’t 

want to hurt a criminal investigation of a company that has killed 

55 people and sickened hundreds more, and I am going to assume 

no one else does. 

Mr. MURPHY. I am assuming you would be able to show us a letter from the Attorney General or someone’s office saying you cannot speak to certain subjects here so we know exactly where you 

can and cannot. Can you show us some documentation? 

Dr. HAMBURG. Well, I don’t have such a letter but I was advised 

that I should be very careful about not compromising the criminal 

investigation, and I think we all share that concern. None of us 

want to imperil the important criminal investigation that is ongoing. 

Mr. MURPHY. I appreciate that. We will make sure we ask questions relevant to what you did and didn’t do, and what the FDA 

is responsible for in this. Thank you. 

Chair now recognizes the gentleman from New York, Mr. Tonko, 

for 5 minutes. 

Mr. TONKO. Thank you very much, chair. 

First, thank you for appearing before the committee, Dr. Hamburg, and thank you for your service as commissioner at FDA. 

It has been well-documented that the FDA has been stepping up 

its inspections of compounding pharmacies in the wake of tragedies, and while that is a first good step, can you tell us which additional efforts you need? What follow-up intervention would and 

should be available as the next tools in the kit to do your job and 

do it effectively? 

Dr. HAMBURG. Well thank you for that question. We do feel that 

we want to be more aggressive, and to do that, there are some critical gaps in our authorities. 

First of all, we need these companies that are making the highest risk products, the sterile products, in advance of or without a 

prescription and shipping them interstate, they need to be held to 

a national uniform standard for safety practice in good manufacturing that they will adhere to, that we can inspect against, and 

that we can take enforcement actions against that will hold. They 

need to be required to register with us so that we can even know 

43 

who is out there and what they are making. And we certainly want 

them also to report adverse events to us if they hear about them 

in relation to a product so that we can get in quickly and try to 

mitigate that problem as fast as possible. 

Mr. TONKO. Thank you. The partnership, the interrelationship 

with the state authorities, are there requirements for them to inform the FDA as to findings? Does the ball rest in your court to 

approach them? Are they required—is there a registry of sorts that 

requires them to update you routinely as that structure—is it 

standardized? 

Dr. HAMBURG. A very important question. As you know, states 

historically have regulated compounding pharmacies, as they do 

the practice of pharmacy in general, and states have very different 

laws with different requirements. But as far as I know, there are 

not any specific requirements on reporting to the FDA. We often 

work in concert with states and that is important, and we sometimes piggy-back on their authorities when we are going into facilities and, for example, trying to get access to records which we 

might be denied. Going forward, we feel very strongly that we need 

to strengthen the working relationships with the state and systematize some of the mechanisms for communication, because that will 

make a difference. 

In these recent inspections that we have just done, we did do 

them in almost all the cases in coordination with the states. 

Mr. TONKO. It seems to me that there was a lot of talk as to 

what intervention there was or what interaction there might have 

been between FDA and the states. It seems to me there is an added 

safety net offered if there is a structured, standardized requirement 

of states to inform good and bad news being shared with you about 

their oversight and to give an authority that they now have. I 

think that would improve the system. 

And also, you asked about the explicitness of some of the details 

that guide your day-to-day operations in these matters. Are there 

other things you would bring to this committee’s attention that 

would be useful and provide for, perhaps, more public safety here 

and consumer protection? 

Dr. HAMBURG. Well, I think what is just abundantly clear and 

is demonstrated in the documents that we have given to you is that 

we have been compromised in our ability to provide the full and aggressive enforcement that I think is necessary to protect the health 

of the American people, that we have an ambiguous statute. We 

have a statute that is complicated by differing court opinions that 

reflect the ambiguity that even federal courts can’t agree about 

what the law is and how it should be applied. And that just is not 

a system that serves anyone, and that is overlaid on the fact that 

all of the states have different laws and practices. So we do not 

have the kind of strong regulatory system that really can assure 

safety and get patients the products that they need. 

In addition, the statute doesn’t fit the current healthcare environment, patient needs, hospital needs. It is simply the wrong fit 

and we have an opportunity—I think we have an obligation now 

to work with all of you to try to make sure that we have the kind 

of regulatory program in place, the kinds of laws that we can really 

build on and enforce against. 

44 

Mr. TONKO. I appreciate that effort, and I would hope that we 

gather this information and go forward and do the work that is essential to respond to—in the aftermath of these tragedies to the 

needs of the general public. 

So thank you again for your information here today. 

Dr. HAMBURG. Thank you. 

Mr. MURPHY. Right now recognize the—— 

Mr. TONKO. I yield back. 

Mr. MURPHY. Gentleman yields back. We now recognize for 5 

minutes the gentleman from Virginia, Mr. Griffith, for 5 minutes. 

Mr. GRIFFITH. Dr. Hamburg, while the circuits may disagree on 

some aspects of the law, isn’t it correct that in order to be a 

compounding pharmacy, you are supposed to be making something 

for a specific patient with a specific prescription? Isn’t that true? 

Dr. HAMBURG. Well in fact—— 

Mr. GRIFFITH. Yes or no? 

Dr. HAMBURG [continuing]. Many states allow anticipatory 

compounding and—— 

Mr. GRIFFITH. I am talking about the code that—the Federal 

Code, and isn’t it true that for federal purposes, it is supposed to 

be a specific prescription and a specific patient? Yes? 

Dr. HAMBURG. That is. 

Mr. GRIFFITH. All right. Now let’s move on to the sister of—the 

sister company of NECC, Ameridose, because they also had problems and you all received—FDA received information about those 

problems at Ameridose in 2009, 2010, 2011 from internal company 

sources, isn’t that correct? Yes or no? 

Dr. HAMBURG. That is correct. 

Mr. GRIFFITH. And the concerns that were raised related to the 

safety of the products and practices at Ameridose, but also the company’s management, isn’t that also correct? 

Dr. HAMBURG. Yes. 

Mr. GRIFFITH. And isn’t it correct that you all were alerted by 

the folks in Ohio that there was actually a question that they 

didn’t have these prescriptions for individual patients, but in fact, 

were manufacturers and Ohio was asking you all to look into this 

in trying to decide whether they were going to issue a Cease and 

Desist letter? Isn’t that also correct? 

Dr. HAMBURG. Again, I apologize but we are getting into the area 

of an ongoing investigation and—— 

Mr. GRIFFITH. I am asking you if it is a fact whether you gave 

information to this committee, and I want it out there in the public 

so everybody in the United States knows, you all received information—I am not asking you whether it was true or not, but you received information from the State of Ohio that they felt like what 

they were looking at with Ameridose was a manufacturer and not 

a prescriber. Isn’t that correct? Excuse me, not a compounder, because they didn’t have specific prescriptions. You received that information, yes or no? 

Dr. HAMBURG. You know, I actually cannot speak to that specific 

document. 

Mr. GRIFFITH. So you were unaware that this information had 

come to the attention of the FDA that Ohio was very concerned 

about this? 

45 

All right, I am going to move on. Are you aware that there were 

notes that were involved in these complaints and concerns about 

whether or not there was going to be an investigation, and that one 

of those notes—and I would point you to Tab 26, go to the second 

part where it starts listing out things, and it says—I believe I have 

got this right here. On page 4, note 4, specifically part of the inspection was to read ‘‘Are written prescriptions/physician orders for 

identified individual patients received before dispensing compounded injectable products each time they are dispensed?’’ That is 

part of one of your own memos, is it not? 

And Mr. Taylor, if you want to jump in here, it might be your 

memo, but it is an FDA memo. Yes or no? 

Dr. HAMBURG. The issue about prescriptions is one that has been 

an area of ambiguity in terms of whether 503A applies or not, et 

cetera, and it has been part of this changing landscape in terms 

of—— 

Mr. GRIFFITH. There was an inspection request and as a part of 

that inspection request, attached to that was background information and what you ought to do, and one of those was to look into 

that information. But you all never did that with Ameridose, did 

you? Before the NECC problem, their sister company was discovered through the deaths of American citizens and 1,415 people in 

my region of the State of Virginia and a little bit over into West 

Virginia were impacted by these drug companies or these manufacturers posing as compounders. You never asked for that information—the FDA never did that, did they? 

Dr. HAMBURG. As I said, there is an ongoing investigation by the 

FDA with respect to Ameridose, and we are—— 

Mr. GRIFFITH. All right. You never held an inspection, yes? 

Dr. HAMBURG. We have inspected Ameridose on a number of occasions, but I cannot speak to the specifics. 

Mr. GRIFFITH. All right. And there were numerous requests to inspect both Ameridose and NECC, and as these inspection requests 

came in, you all sometimes—you answered earlier that to get a 

warrant might take you days or weeks, but isn’t it true that on several occasions when NECC wrote you back and said we don’t think 

you have authority, you took 2 years before you even sent them a 

letter back? Isn’t that not also true? 

Dr. HAMBURG. As I said, I wish that we had been more 

prompt—— 

Mr. GRIFFITH. And I appreciate that, and I do appreciate the answers today much better. My time is running out, ma’am, so I am 

going to move on. I do appreciate it. I understand that you are now 

going to be more aggressive, but in order to fix this, we have to figure out where the problems are. And when you have 2-year delays 

when somebody just sends you a letter and says hey, we don’t 

think you have authority, that is not acceptable. I believe that we 

have got to figure out what the problems were, not just at NECC, 

but across the board. I believe there are a lot of companies out 

there posing, perhaps, as compounders who are really manufacturers and I think if you insisted on the requirement that there be a 

prescription for a specific patient or that the compounding made for 

a specific patient like it was for my son on one occasion, then we 

46 

wouldn’t have had this problem in the first place and I think you 

all failed the American people. 

Mr. MURPHY. Gentleman yields back. Now recognize the gentleman from Texas, Mr. Green, for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman. Again, thank you, Dr. 

Hamburg, for coming back. I remember the hearing that we had 

earlier, and I have to admit, having been on the committee for a 

long time, I didn’t think the FDA was something we could be proud 

of then because of what my colleagues on the other side have 

talked about. 

Since the fungal meningitis outbreak was traced back to the socalled compounding pharmacy in Massachusetts, all we have seen 

is finger pointing from the FDA, the industry, Republicans, Democrats, even states have played this role, and it is time for the finger 

pointing to end and we begin to legislate. 

I have always supported community-based compounding pharmacies, because historically that is how pharmacies started. But I 

was shocked at what was going on in Massachusetts was considered the same type of facility as my neighborhood compounder who 

is filling the prescription from a physician, or even a larger pharmacy that supplies hospitals or large practices, or even a heavy client load. And to know the FDA is requesting additional authority 

from Congress to regulate certain compounding pharmacies. 

I also know that that was your testimony previously, but in the 

meantime, you have been able to open up investigations. So you 

can see why from our side of this, it looks like maybe FDA did have 

some authority and just didn’t use it. But I also know that in a 

legal situation, you probably need some background or some support based on changing the law. But I don’t want you not doing 

what you are doing right now, and I know you have opened some 

investigations. So somewhere along the way, one of your attorneys 

said we can do this now. And I guess they didn’t tell you that 2 

years ago or whenever. Is that correct? 

Dr. HAMBURG. I want to be clear that I never said we didn’t have 

authorities. I said our authorities were limited and we are determined to be as aggressive as possible using our current authorities. 

But they are not adequate to provide the American people with the 

safety protections that they need, and our current round of inspections are, I think, underscoring that fact that we cannot have an 

inspectional system in a regulatory regime where the very players 

that are at the center of the questions don’t even have to register 

with us, don’t even have to let us know what—— 

Mr. GREEN. And I agree, but what the FDA is requesting the authority, is it over all compounders, including the ones who are regulated by the states, particularly like a local compounding pharmacist who just does prescriptions? Does the FDA want to get into 

that, or do you want to look at the manufacturing that only goes 

across state lines? 

Dr. HAMBURG. Traditional compounding, the corner pharmacy 

type you are describing, I think has a very important role in our 

healthcare system, and we all recognize that. We are concerned 

about this evolving new hybrid of compounding pharmacy that is 

making sterile, high risk products in advance of or without a prescription and selling across state lines. We do believe we need new 

47 

authorities in order to adequately regulate them. Again, they provide an important service to our healthcare system. Hospitals depend on the products that they make, and if done right, they can 

make these products safe. 

Mr. GREEN. That is one of my concerns, and I am going to run 

out of time, and you know our time limits. 

As we write legislation, we should keep in mind that your intent 

is to try to keep the compounding pharmacies that are locally in 

the domain of state regulators, but for example, in Texas we have 

a great medical center in Houston, and I am assuming they have 

a contract with some type of compounding company that—whether 

it is across state lines or not, that they may work with, but that 

compounding company is using prescriptions from this medical center or this hospital system or this practice of doctors. You don’t intend to go as far as for someone that has a prescription from either 

a group of doctors to a compounding pharmacist? 

Dr. HAMBURG. We appreciate the tradition and the importance of 

traditional compounding. We do think that there are some requirements that should apply to all compounders, big or small, traditional, non-traditional. For example, there are certain products 

that probably should not be compounded by pharmacies, no matter 

what. They should be made by manufacturers within the new drug 

approval process to assure safety and efficacy, products that are 

complex and involve hard-to-deliver kinds of mechanisms, et cetera. 

We also believe that FDA-approved commercially available drugs 

should not be—— 

Mr. GREEN. OK. I hate to cut you off, but I want to ask—get a 

chance to ask you a question. These additional inspections that you 

are doing now, or the additional authority, does FDA have the capacity to expand on that, considering the funding flow that you already have? Are you going to be able to find the money to do that, 

even if Congress continues with sequestration, which it looks like 

we are, but also with the current appropriations process? 

Dr. HAMBURG. It is an enormous concern in terms of the expansion of responsibilities. Already, we are responsible for overseeing 

some 5,600 conventional manufacturers. It is estimated there are 

about 28,000 compounding pharmacies overall, probably 7,500 or so 

specialty pharmacies, and about 3,000 that are doing sterile 

compounding. 

Mr. GREEN. Mr. Chairman, I am out of time and I understand. 

I have one more question I would like to submit, if we could submit 

a question particularly dealing with the Texas—an entity in Texas 

with—but I would like to submit that too if I have permission to 

do that. 

Mr. MURPHY. Yes, and we probably are going to be doing a second round, too. If you are still here, you can ask that directly. 

Mr. GREEN. OK. If we do a second round, I will be back. 

Dr. HAMBURG. OK. 

Mr. MURPHY. Now recognize the gentleman from Ohio, Mr. Johnson, for 5 minutes. 

Mr. JOHNSON. Thank you, Mr. Chairman. 

Ms. Hamburg, you said in a response to our colleague, Mr. 

Tonko, a little while ago that you want compounding pharmacies 

to report adverse events so we can mitigate them as fast as posVerDate Nov 24 2008 12:10 Feb 02, 2015 Jkt 037690 PO 00000 Frm 00053 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-31 CHRIS
48 

sible. Would you please explain briefly, what is an adverse event 

report? 

Dr. HAMBURG. An adverse event report is when someone submits 

to the FDA a concern about a product. It doesn’t mean that actually there is a legitimate or ultimately verified concern, but it is 

that there seems to have been some negative reaction associated 

with a product. 

Mr. JOHNSON. OK. Well the FDA made a decision in 2011 to suspend inspections of compounding pharmacies until the agency could 

issue guidance on compounding and manufacturing, right? That is 

what you have testified to thus far? 

Dr. HAMBURG. Yes. 

Mr. JOHNSON. That is a yes, correct? 

Dr. HAMBURG. Yes. You know, it is a bit more complicated than 

that—— 

Mr. JOHNSON. No, it was a very simple question. The FDA made 

a decision in 2011 to suspend inspections of compounding pharmacies until the agency could issue guidance on compounding and 

manufacturing. 

Dr. HAMBURG. We were doing for-cause inspections when we 

learned about a problem—— 

Mr. JOHNSON. Well, I want to talk about certain adverse event 

reports that came into the agency about Ameridose after this decision to suspend inspections were made. The agency produced these 

reports to us, but didn’t produce any documents showing how the 

agency responded to them, so let me run through them. 

They are located—the complaints are located in your binder 

starting at Tab 40. We know that the FDA didn’t conduct any inspections of Ameridose from 2011 until the outbreak. Is that accurate? Is that correct? 

Dr. HAMBURG. After 2011, I do not believe we did any inspections. 

Mr. JOHNSON. OK. I want to determine what the FDA did with 

these reports, including sharing the information with the state or 

investigating them. On November 17, 2011, FDA received an adverse event report associated with three pregnant women in labor 

having to have c-sections, since the epidural injections of an 

Ameridose-made Fentanyl product were not working. Did the FDA 

take any action on that adverse event report? 

Dr. HAMBURG. My understanding is that we were in there inspecting. We did—— 

Mr. JOHNSON. No, I am not asking if you were in there inspecting. I asked did the FDA take any action on that adverse event report? You testified earlier that you want to mitigate them as fast 

as possible, so these have a sense of urgency to them in your own 

opinion. Did the FDA take any action on that report that came in 

on November 17? 

Dr. HAMBURG. I can’t speak to every complaint—— 

Mr. JOHNSON. Would you get that back to the record? 

Dr. HAMBURG. I will get back to you on that. 

Mr. JOHNSON. OK. On January 24, 2012, FDA received an adverse event report associated with Ameridose-made Fentanyl injections. This time, the complaint related to confusing labeling resulting in two near-misses where nurses had stated that they almost 

49 

gave their patients 100 milligrams instead of 50 milligrams. What 

action did the FDA take in that case? 

Dr. HAMBURG. I would like to get back to you on that. 

Mr. JOHNSON. OK, submit that one for the record as well, please. 

Can I have your commitment on that to submit that one to the 

record? 

Dr. HAMBURG. Yes. 

Mr. JOHNSON. OK. The next day, on January 25, 2012, FDA received an adverse event report involving an Ameridose-made Heparin-IV bags that a hospital administered to patients, only for the 

hospital staff to determine after several tests that the bags contained no Heparin. What did the FDA respond to that adverse 

event report? 

Dr. HAMBURG. Again, it would be very helpful to me, because of 

the ongoing FDA investigation—— 

Mr. JOHNSON. They are in your tab, ma’am. 

Dr. HAMBURG. I am uncertain what would be harmful for me to 

say—— 

Mr. JOHNSON. No, what did the FDA do in response to that adverse event report, if anything? 

Dr. HAMBURG. You know—— 

Mr. JOHNSON. Get that back for the record, also. 

Dr. HAMBURG [continuing]. Adverse event report—— 

Mr. JOHNSON. Looks like we are striking out here. My time is 

limited, ma’am, because I have several others here. On March 12, 

2012, the FDA received another adverse event report involving potency issues with Ameridose-made Fentanyl products, at Tab 43. 

Any response by the FDA? 

Dr. HAMBURG. I would like to get back to you—— 

Mr. JOHNSON. OK, I would appreciate that. 

Dr. HAMBURG [continuing]. Because I can’t respond to—— 

Mr. JOHNSON. Less than 2 weeks later, on March 23, 2012, the 

FDA received yet another report involving another hospital close 

call associated with confusing Ameridose labeling. That is at Tab 

44. I am out of time, so I will ask you to get me responses back— 

the committee responses back on all of those, please. 

Mr. MURPHY. Gentleman yields back. Chair now recognizes Mr. 

Long of Missouri for 5 minutes. 

Mr. LONG. Thank you, Mr. Chairman, and thank you, Dr. Hamburg, for being here today. I know this hasn’t been real easy, and 

Mr. Taylor, for your assistance. 

The President stepped to the microphone yesterday and said that 

at a time like this with the Boston attack yesterday, that we are 

not Democrats and we are not Republicans, we are Americans. And 

I think when a situation like this NECC situation with the FDA 

comes up, well, that is how we need to approach things, as Americans, and trying to get to the bottom of this and see what you can 

do to be helpful to us and what we can to do be helpful to you. 

Back in—do you remember the first time—when was the first time 

you were apprised of the fact that warning signals or warning flags 

had been raised about the activities of the New England 

Compounding Center? 

Dr. HAMBURG. You know, as I think I said before, as Commissioner, I am not aware of every enforcement action that is being 

50 

taken, every complaint that comes in, and so, unfortunately I was 

not aware of many of the facts that are now before us until—— 

Mr. LONG. Well, I am just asking the first time that you—— 

Dr. HAMBURG [continuing]. This tragedy occurred. 

Mr. LONG. The first time you were apprised of this, I mean, was 

it on a newscast, or how were you made aware of the serious problem? 

Dr. HAMBURG. You know, I became aware of NECC when the 

first reports of the meningitis outbreak began to emerge, and you 

know—— 

Mr. LONG. Which was approximately—— 

Dr. HAMBURG. Which was in the fall of 2012, and we began to 

work very quickly with our colleagues at the state level, and with 

the CDC to try to understand the nature of the contamination and 

what could be done to address it, and to make sure that appropriate actions were taken. 

Mr. LONG. Prior to that time, had you all ever inspected the facilities of NECC? Had the FDA ever been in there and done any 

inspections? 

Dr. HAMBURG. Yes, there had been inspections. 

Mr. LONG. What type of inspection? I mean, what were they inspecting for? I mean, is this something where you would monitor 

for such things as mold, or do you do microscopic tests, or what 

kind of inspections would you conduct? 

Dr. HAMBURG. Well, I think we were not doing routine inspections because NECC was being regulated by the State of Massachusetts as a licensed pharmacy. But over the course of history, we 

were in there for various reasons in response to specific complaints 

of product contamination or adulteration or misbranding. 

Mr. LONG. Did you know they were bad actors then? I mean, 

would you have considered them a bad actor from your prior experience? 

Dr. HAMBURG. This is the area that I cannot address because of 

the ongoing criminal investigation. 

Mr. LONG. But you have no letter or anything from Justice or 

anyone telling you not to speak here openly today about—to answer a question, I guess? 

Dr. HAMBURG. You know, I think none of us would want to compromise the importance of that criminal investigation and 

what—— 

Mr. LONG. We don’t want to compromise the American public, either, and—— 

Dr. HAMBURG. No, and that—— 

Mr. LONG. We have had 53 deaths and we have 700 and some 

that are ill now with it, might lead to their demise. There is another—I think Morgan Griffith said there are 1,400 and some just 

in his district alone, so—but back on April—in fact, it has been 2 

years and 1 day ago, Colorado issued a Cease and Desist order to 

the New England Compounding Company, or whatever the last ‘‘C’’ 

is on there, for shipping drugs to states without requiring individual prescriptions for each drug. Back then, 2 years ago, prior to 

2012 and this outbreak, what—isn’t there somewhere you all called 

off the dogs for a year? What point was that? 

51 

Dr. HAMBURG. Well, I think you are referring to a Cease and Desist order that had happened—— 

Mr. LONG. From Colorado. 

Dr. HAMBURG [continuing]. Based on Colorado State pharmacy 

law. 

Mr. LONG. Right, but that didn’t raise any red flags to you all 

that—— 

Dr. HAMBURG. You know, as we have discussed, states have very 

different laws with respect to what they will allow in their states, 

and what also they will license pharmacists and pharmacies to do, 

and we did do that as a matter of state law fundamentally. 

Mr. LONG. You said earlier in your testimony that we needed legislation, and legislation takes a little while in this town. And while 

we are waiting for this legislation, what are you doing in the interim to prevent this from happening again, or continuing to happen? There may be other compounding facilities out there as we 

speak with mold in their facility, along with other things. What are 

you doing now? 

Dr. HAMBURG. Well, I am deeply concerned that we could have 

another tragedy, and that is why I really am hoping we will be able 

to work with you on new legislation. But in the meantime, we are 

going to apply our current authorities as adequately as we can, recognizing that they are limited, that they don’t allow us to know everyone who is out there and what they are making. They don’t 

allow us to have a clear uniform set of standards that are enforceable in law for these highest risk compounders to adhere to, and 

that we are being challenged every day about our authorities in 

terms of the industry believing that we are overstepping, that we 

don’t have authorities, and we know we need changes in the law 

in order to really be able to proactively provide the kind of regulatory framework that will prevent problems from happening in the 

first place, rather than responding—— 

Mr. LONG. Short of having new legislation, are you satisfied that 

your agency is doing everything possible—— 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. LONG [continuing]. Now to protect the American public in 

the interim? Because like I said, it takes forever and a day to get 

new legislation done in this town. 

Mr. MURPHY. Gentleman’s time—— 

Dr. HAMBURG. Yes. 

Mr. LONG. Particularly when one side of the aisle refers to the 

other side of the aisle, and then that side of the aisle refers to their 

friends on the other side of the aisle. Like I said, I want to go back 

to my opening statement that I think we need to all work as Americans for a solution here and forget this malarkey about each side 

of the aisle. I think this is one time that we need to pull together, 

because there has been a lot of people that—families that have 

been crushed by this and—— 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. LONG [continuing]. We need to prevent this in the future. I 

yield back what time I don’t have. 

Mr. MURPHY. Thank you. Gentleman’s time has expired. Now 

recognize the gentlewoman from North Carolina, Ms. Ellmers, for 

5 minutes. 

52 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you, Dr. 

Hamburg, for coming today. I do have many questions, but most 

importantly, I would like to say that I am incredibly confused by 

your testimony, and because I am confused, I would like to try to 

break this down into very simple terms. I would like for you to answer as if you were answering to one of the 53 families who are 

now without their loved one as a result of these actions that have 

taken place. 

You continuously contradict yourself on what the FDA knew, 

what the FDA did not know, what the FDA passed on to the state, 

what the FDA did not pass on to the state, and then when you find 

yourself in a corner, you say that you cannot respond because of 

the ongoing criminal investigations. So let’s try to get to the bottom 

of it in very simple terms, because there again, one minute you 

were going in for inspections, and then the next minute you were 

not going in for inspections. One minute you understand that there 

were complaints filed, and the next moment you did not know that 

there were complaints filed. I don’t understand how we can get to 

the bottom of this situation. Furthermore, I would like to say that 

I don’t understand how more legislation, regulation, and authority 

is going to help this situation, when the FDA did not apply what 

they already had. That is very confusing to me because the authority that was there, the authority that you had to share information 

with a state obviously did not take place. Were there complaints 

that the FDA received shared with the state? Yes or no? 

Dr. HAMBURG. In some cases, but what you asked me to speak 

to the families—— 

Mrs. ELLMERS. There are a number of incidents of complaints 

there starting in 2002 all the way to 2012. Which of those complaints were shared with the state? Now mind you, I understand 

in your testimony you said here that you worked very quickly with 

your colleagues at the state level. How did you work with the state 

level when this went on for 10 years? 

Dr. HAMBURG. You know, I think the critical point that I want 

to make to you and would make to the families and their victims 

is that I wish that the FDA had been more aggressive—— 

Mrs. ELLMERS. That is the third time you have used the term ‘‘I 

wish.’’ I bet that those families wish you had acted as well. 

Now let me go on to my questioning, because again, I am so confused as to what authority you have, what authority you don’t 

have, how you have worked with the states, because they are the 

licensure of these pharmacies and compounding pharmacies/manufacturers. You know, we keep getting into this gray area and that 

seems to be your reasoning for inaction. 

I have some documentation in front of me, some from the previous hearing that took place, of which I was not here. I am a new 

member to the Energy and Commerce Committee. Basically you 

said at the last hearing in your written statement, you pointed to 

the fact that the state had inspected NECC in 2011 and found that 

the facility to be ‘‘satisfactory.’’ Commissioner Hamburg, when did 

FDA first become aware of the inspection by Massachusetts Board 

of Pharmacy that had taken place? Did you know about this? 

Dr. HAMBURG. I was not aware of it personally until preparing 

for the hearing, but—— 

53 

Mrs. ELLMERS. So it was—— 

Dr. HAMBURG [continuing]. Let me say that it is not surprising 

that you are confused, because even federal judges have been confused about—— 

Mrs. ELLMERS. We are not going to talk about federal judges 

today. We are going to talk about the FDA. We are going to talk 

about your role and your responsibility. Was it in preparation— 

that inspection, was it in preparation for the November hearing? 

Dr. HAMBURG. Was it preparation, yes. 

Mrs. ELLMERS. OK. Did you know that the state’s inspection you 

cited was announced and conducted solely in connection with the 

renovation of NECC, and that inspection had taken place not as a 

follow-up to previous violations, or the complaints, but because 

they were actually under renovation? 

Dr. HAMBURG. My understanding that—this is really a question 

for the state—that as part of their licensure as a compounding 

pharmacy in Massachusetts, they needed to have the state come in 

to do an inspection when they were—— 

Mrs. ELLMERS. And they said that they were satisfactory? 

Dr. HAMBURG [continuing]. And that was where they were—and 

I think that was the facility where subsequently these products 

were being made. 

Mrs. ELLMERS. And it was called satisfactory? 

Dr. HAMBURG. It was a state inspection, but that is my understanding. 

Mrs. ELLMERS. OK. All right, I am looking forward to the second 

round of questioning. Thank you. 

Mr. MURPHY. Thank you. Now recognize Mr. Harper for 5 minutes. 

Mr. HARPER. Thank you, Mr. Chairman. 

As you are likely aware, CMS recently modified its billing methodology for compounding pharmacies providing drugs used in implanted pain pumps. This change jeopardizes access to necessary 

pain medications for some of Medicare’s most vulnerable beneficiaries. Even more, this change prohibiting compounding pharmacies from billing Medicare directly eliminates an important accreditation requirement designed to protect patient safety. Pharmacies billing Medicare directly for these drugs must comply with 

Medicare, supplier standards, and federal regulations such as U.S. 

Pharmacopeia 797. These standards provide an additional layer of 

quality promotion and patient safety for compounding pharmacies 

and dispensing sterile products for use in implanted pain pumps. 

On the other hand, pharmacies which sell their compounded 

products to physicians, clinics, or hospitals are not required to be 

accredited, since they do not bill Medicare directly. In light of the 

recent tragedy relating to a pharmacy which appears to have been 

acting outside of its licensure, I believe it is critical that CMS and 

FDA encourage models of care that promote patient safety. 

Saying this, do you find it concerning that CMS in the wake of 

a tragic outbreak is encouraging pharmacies to sell drugs directly 

to physicians, as opposed to billing Medicare directly and complying with quality accreditation standards? 

Dr. HAMBURG. You know, I am really not an expert on the CMS 

policy in this regard, and so I think—I mean, many aspects of your 

54 

question are probably best directed toward CMS, but with respect 

to the FDA role, I would like to be able to look at the question you 

have asked and get back to you. 

Mr. HARPER. Would you be willing to look into that situation and 

if you are indeed concerned about that, would you be willing to express your concern to CMS about that? 

Dr. HAMBURG. Yes. 

Mr. HARPER. OK. In September, 2008, the head of the FDA New 

England office, Mr. Shamsi, e-mailed a senior FDA compliance officer, Ms. Autor, and asked to do a new inspection of NECC due to 

concerns about sterile injectables. Now, sterile injectables are difficult drugs to make, am I correct? 

Dr. HAMBURG. That is correct. 

Mr. HARPER. Some have questioned whether compounding pharmacies should even make these drugs, am I correct? 

Dr. HAMBURG. Some have, yes. 

Mr. HARPER. At the time the request for a new inspection was 

made, the 2006 warning letter was still pending because FDA 

hadn’t replied to NECC’s response to the warning letter. I would 

ask if you would refer in your notebook to Tab 19, if you could look 

at that? Tab 19. In this e-mail from October 1, 2008, Mr. Shamsi, 

the current head of the FDA district office, e-mailed Ms. Autor, a 

senior compliance officer, and asked whether ‘‘our lack of response 

would hinder any further action against NECC?’’ Mr. Shamsi believed the FDA lawyer in the chief counsel’s office would be reluctant to approve an injunction if they had replied to NECC’s response to the warning letter. It seems like FDA’s staff were considering—it seems like if they were—the FDA staff were considering 

serious enforcement actions like enjoining the company, but a 

breakdown in process was preventing the agency from taking decisive action. Is that a correct statement? 

Dr. HAMBURG. As I said before, we should have been more 

prompt, but it is the case that during that period, there was a series of court decisions that were altering the landscape with respect 

to the application of relevant legislation with respect to FDA authorities, and that was, unfortunately, slowing our response. 

I hope that we will not be in that situation again going forward, 

that is why I am here really saying that we do need strengthening 

and clarification of our regulatory authorities. We do need new 

laws that will enable us to be able to provide the clear, consistent, 

and uniform regulatory oversight and action with these 

compounding pharmacies that are making, as you point out, the 

higher risk sterile products. 

Mr. HARPER. So in that situation, no matter the risk, FDA was 

not willing to do anything? 

Dr. HAMBURG. You know, again I am a little bit uncertain about 

how much detail to speak to because of the ongoing criminal investigation. 

Mr. HARPER. OK. The ongoing criminal investigation, which you 

have nothing in writing advising you of constraints for that, correct? You have said that there is nothing in writing. Do you have 

anybody here from the U.S. Attorney’s Office that is here with you 

today to advise you on which questions to answer or not answer? 

Dr. HAMBURG. No, I don’t. 

55 

Mr. HARPER. Has there been any communication from the U.S. 

Department of Justice to this committee advising you what you 

should or shouldn’t respond to? 

Dr. HAMBURG. There has not been formal communication to this 

committee, no. 

Mr. HARPER. I yield back. 

Mr. MURPHY. Thank you. The gentleman’s time is expired. 

We will go through a quick second round of questions here, so 

let me begin here. 

Commissioner Hamburg, obviously one of our key concerns here 

is that the FDA’s process failed. For a year, inspections were suspended. I am not sure we still have a clear answer yet of when you 

became aware of that. And we also recognize this has gone on for 

10 years. There is nothing political about this. This took place 

under different commissioners, different Administrations. 

What I believe a number of us are concerned about is that while 

you were here asking for some new laws and new authority, I, for 

one, am not yet convinced that the FDA has taken steps to clean 

up its own house here. Inspectors wanted to go back and re-inspect. 

They were frustrated because of decisions by the Chief Counsel’s 

Office to delay it. 

Now, it would seem to me that a common sense next step would 

be for you to call together a post mortem after you became aware 

of all these problems. Get the people together responsible, and say 

who knew what and when and who made this decision and why. 

So I want to ask, have you gone back and had such meetings with 

your agencies, and have you done this post mortem and asked your 

staff to review the process that took place? 

Dr. HAMBURG. We have looked very carefully back at some of the 

steps that were taken, decisions made, and as I said, I am troubled 

that we did delay because of internal discussions and conflict, and 

the changing legal landscape, and not being certain exactly what 

law we would be applying in different parts of the country, et 

cetera, so we have taken that deeper dive. We also have reorganized within FDA to try to strengthen our efforts in this area, and 

as you noted, have embarked on a much more aggressive effort to 

use our current and existing authorities. 

Mr. MURPHY. I understand that, and you told us you embarked 

on a more aggressive effort. We have seen you doing more inspections now. You have acknowledged that, and you have made some 

recommendations to us about changes you want into law. What I 

am asking is have you had an internal formal investigation where 

you have addressed the issues that have taken place? For example, 

has anyone at the FDA at your request talked to the head of the 

Center for Drugs about the NECC or Ameridose cases in terms of 

what happened? 

Dr. HAMBURG. We have internally had many ongoing discussions 

about not just the specifics of this case, but also the broader efforts 

with the compounding industry, and I think we all agree that the 

FDA could have done a stronger job, and that we are committed 

to doing so going forward, but to do the best job for the American 

people, we do feel that our regulations, the ambiguity of the statute, the—— 

56 

Mr. MURPHY. I understand that, but I am trying to find out 

about the post mortem—— 

Dr. HAMBURG [continuing]. Different state laws, all compromise 

that. 

Mr. MURPHY. I am trying to find out what the policy change 

within that—we will address the ambiguities and other things 

later, but did you talk to the head of the New England District Office since you became aware of the problems with NECC? 

Dr. HAMBURG. I have talked—well, the head of the district office 

that you are probably referring to retired around that time, but we 

have had discussions and clearly we want to learn as much as we 

can about the inadequacies of past responses to the compounding 

pharmacy issues—— 

Mr. MURPHY. Well let me ask you this—— 

Dr. HAMBURG [continuing]. So we can do a better job going forward. 

Mr. MURPHY. Listen, we are trying to help you. We really are. 

If you have done a post mortem, if you have done this analysis that 

for 10 years handcuffed the agency from moving forward because 

of internal decisions, there were multiple times that the FDA knew 

about problems taking place in states, but it appears that they 

didn’t call Massachusetts or the states to say we got this complaint. 

You are the agency in charge. And I go back to when you say that 

you want them to report adverse events so you can mitigate as fast 

as possible. One of the ways to mitigate is to inform the states. You 

don’t have to take other action, other than to pass that on. I am 

not sure yet I hear that there has been a change of policy. Has 

there been a change of policy with regard to notifying states of information you have received in complaints? 

Dr. HAMBURG. We are actively engaged in that. Now, one thing 

we did was, in fact, to bring in all the 50 states soon after this 

event to start to talk about how to strengthen communication—— 

Mr. MURPHY. So there is no specific policy at this point to say 

when we get a complaint, that is to be passed on to the state of 

jurisdiction. Until such time we can clarify that you have authority, 

you know the states have authority. Do you have a policy in place 

that those complaints would be passed on to the states right away? 

Dr. HAMBURG. There has been a reorganization and we have 

identified a new set of players to work on this, and we will be—— 

Mr. MURPHY. Who is that—— 

Dr. HAMBURG [continuing]. Beginning stronger follow-up with the 

states and we will be—— 

Mr. MURPHY. Is that an automatic process now? 

Dr. HAMBURG. Pardon me? 

Mr. MURPHY. Is it going to go through—because see, part of the 

problem here is it goes through—what we have heard from you is 

it goes through lots of chains of lawyers and discussions, and there 

is one year that no inspections were taking place, everything was 

on hold. There was a long period of time before a complaint was 

responded to, and what you are telling me is there is going to be 

more discussions. That does not satisfy this committee or the 

American public to know that you are going to have more discussions. They want to know about action. Do you have some automatic policies that you have authorized now when you receive comVerDate Nov 24 2008 12:10 Feb 02, 2015 Jkt 037690 PO 00000 Frm 00062 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-31 CHRIS
57 

plaints from the states who have jurisdiction, you have said, that 

they automatically get that information? 

Dr. HAMBURG. We have set up a structure to ensure that those 

kinds of communications occur. We also do try to respond and investigate—— 

Mr. MURPHY. Is it automatic? 

Dr. HAMBURG [continuing]. Complaints that we get and adverse 

event reports that we get. 

Mr. MURPHY. Would you give us any documents that describe 

that policy now, because I am not satisfied with saying you are 

going to try, you are going to review, you are going to discuss. I 

think this is what hamstrung the FDA up the last 10 years, and 

why in the words of one family who lost a loved one, they said they 

don’t trust the FDA. If there is one federal agency among them all 

that we ought to have an inherent and implicit trust in, it should 

be the FDA, and I don’t think that is there right now, so I would 

like you to share with us those policy documents so we could know 

that. 

Thank you—and in a timely manner. 

Ms. DeGette for 5 minutes. 

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

The real issue here, Commissioner Hamburg, is what authority 

does the FDA have that they didn’t exercise for whatever reason 

in the last 10 years, and what new authority does Congress want 

to give them? I never met a member of Congress on either side of 

the aisle who said, I think the agency should just go out and do 

whatever they want. We are always concerned that the agency acts 

within the authority that we give it. But if you already have the 

authority, we want you to exercise that. If you need a clarification, 

we want you to do that. I think that is pretty clear, correct? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. OK. So I want to talk to you specifically about the 

authority that you have, because Mr. Burgess, in his questioning, 

he accurately said that the FDA has authority over drug manufacturers, correct? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. But under that authority, that is not the authority 

that the FDA has over compounding pharmacies, is that correct? 

Dr. HAMBURG. That is correct. 

Ms. DEGETTE. And that is because the courts and others have 

determined that compounding drugs is not the same as manufacturing drugs, is that right? 

Dr. HAMBURG. There are certain explicit exemptions for 

compounding pharmacies from the authorities we have over conventional drug—— 

Ms. DEGETTE. Right, and that is in Section 503A of the 1997 

Food and Drug Modernization Act, right? 

Dr. HAMBURG. That is right. 

Ms. DEGETTE. So in 1997 when Congress enacted that law, we 

specifically set forth—we thought we specifically set forth what authority the FDA had over compounding pharmacies, correct? 

Dr. HAMBURG. Correct. 

58 

Ms. DEGETTE. And what has happened since 1997, number one, 

the nature of the industry has changed. It is not just a mom and 

pop pharmacy down on the corner, right? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. And the other thing that has happened is that 

around the country, some of the compounding pharmacies have 

been aggressively challenging the FDA’s authority even under Section 503A, right? 

Dr. HAMBURG. That is very true. 

Ms. DEGETTE. And that is what we talked about before with the 

confusing court cases, right? So now what happens is—and I want 

to say, I share everybody else’s deep concern that the agency really 

fumbled around for about 10 years. OK, so now you come in and 

you say this is appalling. These people shouldn’t be at risk, this 

poster over here with the black stuff floating, that is unacceptable. 

It is unacceptable. You agree with that, right? 

Dr. HAMBURG. I absolutely agree with that. 

Ms. DEGETTE. So now you are trying to take the authority we 

gave you under 503A and to inspect at-risk pharmacies, people that 

you think might have a trouble, right? 

Dr. HAMBURG. Correct. 

Ms. DEGETTE. And what you are saying to us is that these pharmacies are pushing back and they are saying that Congress did not 

give you the authority to conduct these investigations, is that 

right? 

Dr. HAMBURG. Yes, and it is broader than that in terms of we 

don’t have the authorities to have a regulatory regime that makes 

sense. 

Ms. DEGETTE. OK. What is it specifically that you need, Commissioner Hamburg? 

Dr. HAMBURG. We need these compounder of high risk products 

to register with us. We need—— 

Ms. DEGETTE. And how do you know what the high risk products 

are? 

Dr. HAMBURG. Well, in order—we also need the authority—the 

high-risk products we define as—the highest risk, I think, are the 

sterile products. We all agree on that. 

Ms. DEGETTE. OK. 

Dr. HAMBURG. We need inspectional authority and full access to 

records in order to determine if a compounding pharmacy, in fact, 

is making products of concern, and how they are distributing, et 

cetera. Clearly, there should be a uniform set of standards for safety practices and quality manufacturing. 

Ms. DEGETTE. OK. Do you know that you don’t have those 

inspectional abilities now? 

Dr. HAMBURG. Pharmacies are exempt in terms of full inspection 

requirements and access to records under section 704. 

Ms. DEGETTE. OK, so the answer is yes, you know you don’t have 

that authority, right? And what other authority do you need? 

Dr. HAMBURG. We need—I mean, I sound a little bit like a broken record, but we need the authority for high risk manufacturers 

to register with—— 

Ms. DEGETTE. And then once they register, what will that do? 

59 

Dr. HAMBURG. Then we will know who they are and what they 

are making, how they are distributing, if they are selling to wholesalers, then they are behaving like a manufacturer, so—— 

Ms. DEGETTE. And then do you—once they register then, do you 

think if you get a complaint about them you have the authority to 

investigate them, or is that the second thing you were just talking 

about? 

Dr. HAMBURG. We need the inspectional authority. We need the 

ability to have these clear standards that they will adhere to for 

safety and that we can inspect against and enforce against, and the 

adverse event reporting is very critical as well. 

Ms. DEGETTE. And do you think that if we do some of this very 

targeted legislative language, that will help with what the chairman was talking to you about, about the tensions between the regulators and the lawyers and the agency, which is really of a concern to all of us? 

Dr. HAMBURG. I think it absolutely will. You know, I think we 

allowed ourselves to be far too cautious because of fears of litigation that might actually further undermine our ability to apply authorities and take enforcement actions, and that should not happen. Public health should not be impeded by those kinds of legal 

regulatory ambiguities. 

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

Mr. MURPHY. Thank you. Now recognize again Mr. Griffith for 5 

minutes. 

Mr. GRIFFITH. And in fact, you have authority over manufacturers, isn’t that true? Yes or no? 

Dr. HAMBURG. Yes. 

Mr. GRIFFITH. And with complaints from the State of Ohio indicating that they were—the manufacturing process going on—back 

to Ameridose, which is the sister of NECC, and the Cease and Desist from Colorado, Mr. Taylor, wouldn’t have been that difficult to 

probably get—if they refused to let you in, wouldn’t it have been 

that hard to get a warrant under your manufacturing authority, 

isn’t that true, for both NECC and Ameridose?. 

Mr. TAYLOR. I am not sure that—I mean, it takes more evidence 

than that, but let me just—to your point, communication with the 

states is one of the things that we recognize needs to be improved. 

Mr. GRIFFITH. OK, but the bottom line is, you and I both know 

as practicing attorneys that it doesn’t really take a very high 

standard to get a warrant to go and get information, particularly 

when the risk to the public is as great as it is when you are doing 

things with sterile injections. Isn’t it true that it is a fairly low bar 

to get a warrant under these types of circumstances? Yes or no? 

Mr. TAYLOR. No. It requires—— 

Mr. GRIFFITH. I respectfully disagree. I got to move on. 

Mr. TAYLOR. All right. 

Mr. GRIFFITH. I only get 5 minutes, so I would love to have that 

discussion with you sometime, but not today. 

Mr. TAYLOR. That is fair. 

Mr. GRIFFITH. I am concerned that you all were receiving—Dr. 

Hamburg, you all were receiving a lot of things—if you look at Tab 

31 in the binder that is there on your table, and then you flip over 

to page 3, a summary would be that in July and August of 2008, 

60 

FDA came to Ameridose for inspection. The company performed— 

this is an informant’s statement that was sent to you all that is in 

documents you provided us. In July and August of 2008, FDA came 

to Ameridose for an inspection. The company performed illegal and 

unethical actions. They directed the testing facilities to change reports based on the drug resorts. They forged documents. Now that 

was—the person was referring to July and August of 2008. This 

was received by you all, according to the information you sent us, 

in August of 2009. And after that complaint came in, FDA New 

England District Office Mr.—I don’t want to—he may be a doctor 

but I can’t tell here—Shamsi, after reviewing the complaint, sent 

an e-mail saying ‘‘we are waiting for assignment from the Center 

for Drugs to go out and we will follow up on this. Ameridose has 

been on our radar for quite some time.’’ 

Commissioner, nothing was done at that time to further investigate Ameridose, isn’t that correct? 

Dr. HAMBURG. You know, there was follow-up to many of the concerns that were raised. 

Mr. GRIFFITH. OK. Can you provide that to us, because in the information we already have, there doesn’t appear to be any follow 

up on that. Can you provide that to us, because apparently it was 

neglected—somebody neglected to give that to us before this hearing. 

Dr. HAMBURG. I want to be clear—— 

Mr. GRIFFITH. Yes, ma’am. 

Dr. HAMBURG [continuing]. That I do not feel that we responded 

adequately but that—— 

Mr. GRIFFITH. I am asking you to respond adequately to this 

committee and the documents that we have in the binder here 

don’t show that you responded at all after that complaint came in 

in 2009, even though your New England District Office was asking 

for clearance to respond. ‘‘We are waiting for an assignment from 

the Center for Drugs to go out and we will follow up on this. 

Ameridose has been on our radar for quite some time.’’ And you 

didn’t follow through, unless you have got documents we don’t have 

that you failed to give to us. 

Dr. HAMBURG. What I am saying is that we get a lot of complaints and—— 

Mr. GRIFFITH. So more authority really wouldn’t do you any 

good? 

Dr. HAMBURG. I can’t speak to the specifics there, but there is 

just no doubt that, I don’t think that we responded with the vigor 

that we should have. I do think that we were—— 

Mr. GRIFFITH. So now you are saying that you didn’t follow up 

on that? 

Dr. HAMBURG. No, I am saying that I can’t speak to the specifics 

of—— 

Mr. GRIFFITH. All right. 

Dr. HAMBURG [continuing]. All of the 30,000 pages of documents. 

Mr. GRIFFITH. All right. You also received information, and that 

would be Tab 32, an internal source at Ameridose raised in July 

and August of 2010, and the source was identified as a pharmacist 

in the notes that you have given to us, and according to a memorandum of conversation between the pharmacist and a compliance 

61 

officer, the pharmacist said that ‘‘Ameridose personnel from their 

sales force were assisting in labeling’’—and this is sales force—‘‘assisting in labeling operations in the clean room, and that one of the 

three clean rooms had a result for positive mold growth.’’ Now, the 

sales force is not supposed to be involved in that, according to other 

documents. That is correct, isn’t it? They are not supposed to be 

cleaning up and labeling things, they are supposed to be selling. 

Dr. HAMBURG. Right. 

Mr. GRIFFITH. And yet, there is a note here that there was a 

positive result for mold growth. That individual was told that the 

FDA takes this seriously. There is an e-mail in that Tab 32, that 

‘‘this is taken seriously. Mold growth can affect sterility of drugs.’’ 

Now remember, this is the sister to NECC. It is usually taken seriously by the FDA, but the FDA didn’t follow up, so it wasn’t taken 

seriously in this case, was it, ma’am? 

Dr. HAMBURG. I cannot speak to the specifics of that instance, 

but those kinds of concerns are concerns that would worry me then, 

and certainly worry me now. There are, unfortunately, too many 

ongoing problems with compounding pharmacies, and I really do 

feel strongly that if we are going to be—— 

Mr. GRIFFITH. But Ameridose was—— 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. GRIFFITH [continuing]. Also a manufacturer, was it not? 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. GRIFFITH. I apologize, Mr. Chairman. I yield back. 

Mr. MURPHY. Gentleman from Michigan, Mr. Dingell, is recognized for 5 minutes. 

Mr. DINGELL. Thank you, Mr. Chairman. 

Dr. Hamburg, we have here before us a most interesting circumstance. You have got a recalcitrant industry, trade association 

that is circularizing folks as to how they can frustrate Food and 

Drug, and its examination of their businesses and their protection 

of consumers. They are instructed as to limitations on Food and 

Drug’s authorities. They are also—we also find that they are diligently at work to get the powers of Food and Drug curtailed. And 

to see to it that legislation as was done here specifically exempts 

them from three critical provisions: premarket approval of new 

drugs, requirement that drugs be made in compliance with good 

manufacturing practices standards, and the requirement that the 

drug bear adequate directions for use, i.e., your labeling requirements. 

Have those situations caused you difficulty at Food and Drug as 

you go about your business trying to regulate these good-hearted 

folk? 

Dr. HAMBURG. We do not have the same kinds of problems with 

conventional manufacturers—— 

Mr. DINGELL. I understand that, but—— 

Dr. HAMBURG [continuing]. As we have with compounding pharmacies. 

Mr. DINGELL. But you have huge problems with the 

compounders, do you not? 

Dr. HAMBURG. We do. 

62 

Mr. DINGELL. Unsafe clean rooms, pharmaceuticals that are compounded with all kinds of things, including filth and other things 

in them, dust spots and things of that sort, am I right? 

Dr. HAMBURG. That is correct. 

Mr. DINGELL. OK. So you don’t have authority to require them 

to register so you know who is in the business, right? 

Dr. HAMBURG. Correct. 

Mr. DINGELL. States have a somewhat varied record on these 

matters. Michigan has five people who are looking into this, is that 

right? And Michigan’s folk cannot go across the borders of the 

State of Michigan to look see what those good-hearted folks in Massachusetts are doing to kill off Michigan’s citizens by unsafe pharmaceuticals, is that right? 

Dr. HAMBURG. You know, I am not familiar with the specifics of 

state laws, but it creates a real—we have heard from the states 

that they don’t feel that they can provide adequate regulatory oversight of what is happening in pharmacies in other states—— 

Mr. DINGELL. Now, you have no authority to get in books and 

records and to inspect compounders, is that right? 

Dr. HAMBURG. We are limited in our access to records. 

Mr. DINGELL. All right. And you have no authority to inspect a 

business according to what they circularize their memberships from 

the trade association, is that right? 

Dr. HAMBURG. That is right. 

Mr. DINGELL. Now, you had no authority to require information 

on adverse events, right? 

Dr. HAMBURG. Correct. 

Mr. DINGELL. So on that wonderful event that occurred up in 

Massachusetts where they shipped all this bad stuff around to 

Michigan and other places, they had no requirement and no responsibility to circularize—rather, to inform you of the events that 

occurred, is that right? 

Dr. HAMBURG. That is right. 

Mr. DINGELL. And you had no authority to extract it from them, 

is that right? 

Dr. HAMBURG. No authority to inspect—to fully inspect? 

Mr. DINGELL. You had no authority to compel them to present 

that information, is that right? 

Dr. HAMBURG. That is correct. 

Mr. DINGELL. OK. And you have no requirements for good—you 

have no ability to impose good manufacturing practices on them? 

Dr. HAMBURG. Pharmacies that are exempt under existing legislation, we don’t have that authority. 

Mr. DINGELL. And good manufacturing practices are absolutely 

critical to seeing to it that the pharmaceuticals are safe, is that not 

so? 

Dr. HAMBURG. Good manufacturing practices are essential. 

Mr. DINGELL. All right. And you—do you have the resources, the 

monies that you need to properly police the behavior of these organizations? 

Dr. HAMBURG. We do not have the resources that would be necessary to put in place the kind of strong regulatory oversight we 

need. 

63 

Mr. DINGELL. At what point does it cease to be compounding and 

become manufacturing? 

Dr. HAMBURG. Well—— 

Mr. DINGELL. There are good-hearted folks up in Massachusetts 

who were churning out stuff by the thousands, and you couldn’t 

find out who they were, you couldn’t find out what they were doing, 

you couldn’t impose good manufacturing practices on them, but at 

what point could you have—could they have been charged with 

being manufacturers? They are shipping all over the country. 

Dr. HAMBURG. Yes, it is an issue where people think it is black 

and white. Either you are a compounding pharmacy or a manufacturer, but that has been at the root of many of these problems in 

terms of the conflicting court decisions, and it is not written in the 

statute. 

Mr. DINGELL. Do you have—— 

Dr. HAMBURG. The statute is ambiguous. 

Mr. DINGELL. Do you have the personnel to inspect these people? 

Dr. HAMBURG. We don’t have the personnel to inspect all the—— 

Mr. DINGELL. OK. Now Doctor, do you have the authority to ban 

bad actors? 

Dr. HAMBURG. Not directly. 

Mr. DINGELL. These—— 

Dr. HAMBURG. The compounding pharmacies are licensed by the 

states. 

Mr. DINGELL. You have got these people in Massachusetts that 

are creating thousands of prescriptions that are being distributed 

all over the country, clearly to me, that are bad actors. You have 

virtually no authority of them. What can you do about them? 

Dr. HAMBURG. Well, I think that if we want a system that is 

really preventive and protects against problems and ensures safety, 

we do need new legislation. I think that—— 

Mr. DINGELL. What authority—— 

Mr. MURPHY. Gentleman’s time is expired. 

Mr. DINGELL. What authority do you have to supervise to see to 

it that stuff moving across the state lines that is supposed to be 

supervised by the states, which can’t do it, is, in fact, not something that is going to create safety problems for people? Now would 

you just submit the answer to that for the record? 

Dr. HAMBURG. OK. 

Mr. DINGELL. Mr. Chairman, you have graciously given me a 

minute more than I am entitled to. 

Mr. MURPHY. I thank the gentleman. Now I recognize the gentleman from Texas, Mr. Olson, for 5 minutes. 

Mr. OLSON. I thank the chair and I yield to him as much time 

as he may consume. 

Mr. MURPHY. Thank you. I appreciate that. 

Ms. Hamburg, you have said repeatedly in one version or another 

you feel you don’t have the authority to have strong oversight. My 

concern remains that where you do have authority, you haven’t had 

that kind of oversight that you can exercise, except for the recent 

flurry of well-publicized inspections. 

Let me run through some specifics here to again illustrate my 

concerns of the agency for 10 years, and hopefully your comments 

64 

of what you have done to rectify that, within the authority you 

have now. 

The FDA inspected NECC in 2004, primarily in response to complaints related to the company soliciting a product being used in 

cataract surgery. You may recall that, if you reviewed that. The 

violations letter the FDA observed during that inspection were finally addressed over 2 years later in a warning letter issued in December of 2006. That warning letter noted the concerns about 

NECC and mentioned the fact that NECC was reportedly informing patient’s physician’s offices that patient-specific prescriptions 

were not required. Do you recall that from history? OK. It wasn’t 

under your administration, but I just wanted to make sure you 

knew that. 

NECC responded immediately in January 2007, noting that it 

had been over 2 years since the FDA had been at their facility and 

rejecting a number of FDA’s charges. Is that correct? 

Dr. HAMBURG. Yes. 

Mr. MURPHY. Now, at Tab 16 in your binder, if you look at it 

there, Steven Silverman, who was then the director of the Division 

of New Drugs and Labeling Compliance at FDA’s Center for Drugs 

thought that ‘‘NECC’s response was unacceptable.’’ Do you agree 

that staff appeared frustrated with the fact that it took chief counsel’s office 2 years to issue the warning letter? 

Dr. HAMBURG. Yes. 

Mr. MURPHY. And this frustration appears to have been shared 

by Deborah Autor, the head of the compliance at FDA’s Center for 

Drugs at the time. In an e-mail to Mr. Silverman, which is located 

at Tab 17, Ms. Autor stated that they have ‘‘completely lost sight 

of the point that the warning letters are intended to quickly get 

word to violators that they need to come into compliance. Instead, 

the lawyers are concerned about perfecting documents that quickly 

become irrelevant.’’ Now, do you agree with this observation that 

concerns about perfecting documents have resulted in delay when 

issuing warning letters? 

Dr. HAMBURG. I am concerned when there are those kinds of 

delays. 

Mr. MURPHY. The key is does that mindset still exist today? 

Dr. HAMBURG. I think that the mindset is very different. I think 

we are determined to use the authorities that we have to the greatest degree that we possibly can, even in the face of challenges to 

our authority, and in the face of potential inability to actually be 

successful in some of our enforcement actions. We are doing inspections now. We are finding things that are of serious concern. We 

intend to pursue those concerns, and already there have been recalls and other actions taken. But we intend to use the authority 

we have to the greatest degree possible. But I am deeply concerned 

that we don’t have the authorities we need to have the kind of system in place that will provide better protection and that will reduce 

the kinds of problems that we are seeing that could put people at 

risk in the future. 

Mr. MURPHY. Did the FDA have the authority to suspend inspections in 2011 and 2012 for NECC? 

Dr. HAMBURG. I think what happened there was what happened 

in other instances as well where unfortunately because of a lack of 

65 

clarity about what should the regulatory and enforcement framework be that we slowed down. We weren’t as aggressive as we 

could have been, and I regret that. 

Mr. MURPHY. What other instances—— 

Dr. HAMBURG. But I don’t think that we have a system now in 

terms of the authorities that are available to us that is sufficient 

for these highest risk manufacturers making the sterile products. 

Mr. MURPHY. So have you identified who made this decision that 

the inspections wouldn’t take place against NECC in 2011, 2012 in 

your post mortem? Have you determined who that was? 

Dr. HAMBURG. There was an ongoing debate that was reflecting 

the fact that decisions—a series of legal decisions had come down. 

There was an issue about whether to go to the Supreme Court to 

try to resolve the circuit court split, and then we were sort of left 

with the map and trying to determine what was the best way to 

develop the enforcement—— 

Mr. MURPHY. So given that, have you gone back in to see if there 

are any stalls or other problems like that with other companies 

under—who are compounding pharmacies? I know you just did a 

bunch of inspections. Have you gone back to see if those conditions 

exist for any other pharmacies? 

Dr. HAMBURG. I am sorry, in terms of—— 

Mr. MURPHY. Well, did any other—— 

Dr. HAMBURG. During that period, we were not aggressively pursuing compounding pharmacies in a proactive way. We were responding when complaints came to us. We were, in fact, engaged 

in some litigation around compounding pharmacies, and sadly, one 

that we thought was one that would be very successful and we lost, 

all of that was contributing to the sense that the uncertainty and 

ambiguity in the law and the patchwork of applications of this law 

was making it harder for us to do our job. 

Mr. MURPHY. I appreciate that, and I know that the concern still 

from the American public is these discussions are taking place, 

lawyers, et cetera, but still, it wasn’t addressing your primary mission as taking care of some of the public’s health first. But we will 

continue to talk about that. 

Mr. Waxman is recognized for 5 minutes. 

Mr. WAXMAN. I thank you, Mr. Chairman. I haven’t been here 

throughout the whole hearing, but I find it hard to understand why 

anyone would argue with you that you had enough authority under 

the law, when it is clear that two different circuit courts have said 

different things about a law, and limited the amount of actions you 

can take. For example, under existing law, under the underlying 

law itself, you can’t have sample collections, you can’t—just go 

through some of the things you cannot do. 

Dr. HAMBURG. Under 503A? 

Mr. WAXMAN. Yes. 

Dr. HAMBURG. Well, there is, of course, the broader issue—— 

Mr. WAXMAN. Let me—look. This is not where I wanted to go 

with my questions, but there are so many things you cannot do, including some things my staff pointed out to me, and I wrote it 

down and I can’t read my writing. But—— 

Dr. HAMBURG. Well, I am happy to discuss—— 

66 

Mr. WAXMAN [continuing]. It is hard for any reasonable person 

to not conclude you need a stronger, clearer law to give you authority. 

People want to go over the history, and so I want to ask you 

about the history of the Obama Administration. I mean, this started much before, but in 2009, the Obama Administration entered office. For 7 years, the Bush Administration had been stymied by a 

series of conflicting court decisions and inherently weak laws. So 

leaders at FDA met in the spring of 2009, and according to the 

notes of the meeting, the participants acknowledged the risks of 

compounding and sent forth a new path for a national policy. Ultimately, they decided to implement Section 503A nationwide, except 

in the Ninth Circuit. And there they would implement a compliance policy guidance based on Section 503A. Most of these decisions were made before you were confirmed, isn’t that correct? 

Dr. HAMBURG. That is correct. 

Mr. WAXMAN. But can you elaborate on why, in your understanding, the agency made those decisions? 

Dr. HAMBURG. Well, I think that we were faced with a situation 

where we felt we did need to do more, and there was a lot of eagerness as reflected in the documents to do more, and we needed to 

determine the legal framework that we would be applying. We 

needed to—— 

Mr. WAXMAN. You were looking for the most legally defensible 

way to develop a coherent and rational policy. 

Dr. HAMBURG. Well, that is absolutely right, and I—— 

Mr. WAXMAN. And so as you looked at different alternatives, you 

said well, we can’t do this and we can’t do that. Is that right? 

Dr. HAMBURG. That is absolutely right. 

Mr. WAXMAN. Can you help us understand what FDA’s concerns 

were about going forward with inspections and potential enforcement actions before releasing a new compliance policy guidance 

that would give a coherent national policy to address conflicting 

court cases? You were asked earlier why the agency couldn’t walk 

and chew gum at the same time; that is, conduct the inspections 

while developing the CPG. I assume the agency had compelling 

concerns about the problems it would encounter if it had conducted 

those inspections. Can you describe them for us? I would like to address this question Mr. Taylor, because he is the enforcement expert. 

Mr. TAYLOR. I am sorry, I was—— 

Mr. WAXMAN. OK, put your mike on, first of all. And what I want 

to know is why couldn’t the agency go forward with the inspections 

at the same time you are doing a CPG? 

Mr. TAYLOR. Well, the—and I wasn’t there, but the people were 

worried that if they moved ahead with actions with the circuit 

courts split and without clear guidance, that it would lead to losses 

in court, some losses that would possibly undercut the authority 

that the agency had further. So there was a fear that it could actually make this unsettled legal landscape even worse, and it appears 

from the documents that that accounts for some of the conservative—which we regret, which is why we are being more aggressive 

now. 

67 

Mr. WAXMAN. Right, why you are here and why you have to answer questions. I know one thing, if you had acted, you know what 

would have happened? The compounding industry would have clear 

ordered their—they would have alerted all their members. They 

would have aggressively pursued back in the public and on the 

Hill, to push back on you. Maybe you would have gone to court, 

maybe they would have sued you to go to court to challenge what 

you were doing. FDA probably would have faced pressure from 

members of this body to pull back. In hindsight, it is easy to blame 

the FDA, but in the real world, prior to that outbreak, it would 

have been very hard to do this. 

One internal document said the agency intended to release the 

guidance by December, 2011. The subsequent internal document 

indicated the agency was trying to get the document cleared by 

September, 2012. October came and went. Dozens of people died in 

the meningitis outbreak, and still FDA showed no guidance. So my 

question is what happened here? Why did it take the agency this 

long to get the guidance out? Had you gotten the guidance out, do 

you think you could have prevented the meningitis outbreak? Can 

you describe what the guidance would have accomplished, and can 

you describe what the guidance would not have been able to do, 

and would have the guidance eliminated the need for new legislative authority that you now seek? 

Dr. HAMBURG. It took too long to get the guidance out, but it is 

important to understand what the guidance actually represents. It 

is just that. It is guidance to industry about how we would be approaching regulation in this area. But the guidance is only as 

strong as the underlying statute. It cannot substitute for a strong, 

clear law. You cannot fill gaps in the law with guidance, and so it 

was an imperfect second to what we really need and what we are 

hoping to work with all of you to do, which is to get the kind of 

strong, clear law that is necessary to put in place a program that 

is comprehensive in terms of the kinds of authorities we don’t have 

now, that focuses on the highest risk producers of the sterile products, and that will enable us to really work with industry in a preventive way, rather than being forced into a situation where we are 

more reactive than we should be. 

Mr. WAXMAN. Yes, I thank you. 

Let’s work on that law, Mr. Chairman. 

Mr. MURPHY. Thank you, Mr. Chairman. 

Mr. Johnson, 5 minutes. 

Mr. JOHNSON. Thank you, Mr. Chairman. 

Commissioner Hamburg, despite your assertions at the last hearing that FDA really doesn’t know how many compounding operations were out there because they didn’t have access or didn’t 

have to register with the agency, FDA has recently embarked on 

a sweeping risk-based inspection campaign, targeting approximately 50 facilities, primarily of large scale compounding operations. Is that right? 

Dr. HAMBURG. That is correct, but it is not because they 

have—— 

Mr. JOHNSON. OK, good. Commissioner Hamburg, then in your 

opinion, how many of these companies have been operating in the 

shadows? 

68 

Dr. HAMBURG. We targeted these inspections—about 31 of those 

inspections were surveillance. Others—the rest of them—were for 

cause when problems were brought to our attention, but we targeted them based on information that had come to us about concerns that they were making sterile products; but that is not an 

adequate approach when it comes to really being able to have a 

regulatory system that enables us on a routine basis to go in and 

do inspections, and as I said, to work in a way with the companies 

so that problems can be prevented. 

Mr. JOHNSON. So how did you determine which facilities to inspect? 

Dr. HAMBURG. It was a risk-based determination, using information from different sources—— 

Mr. JOHNSON. So it is safe to say that—— 

Dr. HAMBURG [continuing]. From what states were telling us—— 

Mr. JOHNSON [continuing]. Many of these companies had long 

been on the agency’s radar, correct? 

Dr. HAMBURG. Some of them had been. Some of it was based on 

what states had told us. Some was public information from the 

media. 

Mr. JOHNSON. Public information from the media? 

Dr. HAMBURG. But we would like—— 

Mr. JOHNSON. Had you received event reports—I think that is 

what we call it—earlier? Had you received reports from—— 

Dr. HAMBURG. I don’t believe we had for all of the facilities that 

we inspected. I would have to go back and ask—— 

Mr. JOHNSON. Well what I am trying to figure out is you didn’t 

choose to inspect NECC and you didn’t choose to inspect 

Ameridose, but you chose to inspect all of these others, and you 

don’t even know whether or not there were event reports associated 

with them, so what I would like—if you would take this for the 

record, to provide this committee with all the complaints that the 

FDA has received associated with their products and practices, because I think the committee could be enlightened by what your 

standard or what your water level is to determine who you are 

going to inspect and who you are not. I would like to see that, and 

I think many of my colleagues here on the committee would too. 

That would be edifying to us, because there is a real—because I am 

sort of alarmed by what you just said that many of them did not 

have event reports. 

Dr. HAMBURG. It is not required for these facilities to provide 

us—— 

Mr. JOHNSON. I didn’t say it was—— 

Dr. HAMBURG [continuing]. Provide us with—— 

Mr. JOHNSON. I didn’t say it was required. That is a judgment 

call, apparently, on who you inspect and who you don’t, and you 

made the decision not to inspect NECC or Ameridose, but you 

chose then since the outbreak to inspect these other 50. I want to 

see what the criteria is. What causes you enough alarm to want to 

go inspect, and if event reports, let’s say public health is in danger 

and that lives are in danger, if that is not enough, I would like to 

be able to understand that. 

69 

Dr. HAMBURG. Well, I—what I am saying to you is that we need 

to have a system that actually requires these compounding pharmacies to register with us so that we will know—— 

Mr. JOHNSON. We are not talking about—— 

Dr. HAMBURG [continuing]. Who they are—— 

Mr. JOHNSON [continuing]. The ones that didn’t register. We are 

talking about the 50 that you chose to inspect. What was the criteria—— 

Dr. HAMBURG. We chose to do that in lieu of having information 

that we think should be part of a strong and meaningful regulatory 

scheme going forward—— 

Mr. JOHNSON. But what was the criteria used, and how does that 

balance against the criteria of the multiple event reports that you 

received on Ameridose? So I—can you take that for the record 

and—— 

Dr. HAMBURG. We can certainly take that for the record and, I 

think this goes to the heart of some of our concerns about what we 

need to do to have the kind of safety net in terms of—— 

Mr. JOHNSON. The heart of my concern is the judgment. The 

heart of my concern is the judgment used by the FDA to decide 

who to inspect and who not to inspect, and based upon your testimony here now, I have even further questions about that because 

you just said that many of the new 50 that you are inspecting did 

not have event reports associated with them. So I am really confused how, with as much advanced notice and concern that you had 

about Ameridose, that something didn’t trigger with your organization and you said the buck stops with you, how that did not trigger 

something at the FDA that that company needed to be inspected? 

So to be clear, I need you to provide the committee, if you would, 

please, all of the complaints that the FDA had that led you to— 

with their products and practices that led to the selection of those 

50 that you chose to inspect. 

And with that, I yield back, Mr. Chairman. 

Mr. MURPHY. Gentleman yields back. Now recognize the 

gentlelady from North Carolina, Ms. Ellmers, for 5 minutes. 

Mrs. ELLMERS. Thank you, Mr. Chairman. 

II would like to follow my colleague from Ohio. Of the 50 that 

were inspected, were they all registered with you, with the FDA? 

Dr. HAMBURG. No, they were not. That is what I am saying is 

we need—— 

Mrs. ELLMERS. OK, you just went in and inspected and chose to 

inspect those. So I don’t understand how, then, you keep reflecting 

back on the fact that you did not have the authority to inspect the 

numerous complaints that we have received here about Ameridose 

and NECC. How then—— 

Dr. HAMBURG. I didn’t say we didn’t have the authority, and I 

said I regretted that we didn’t, in some of the instances, go back 

in more quickly. 

Mrs. ELLMERS. But you didn’t have the authority—and there 

again, I am just jotting down notes here. So you felt you didn’t 

have the ability or authority to intervene with Ameridose? OK. 

Let’s get back to the common sense of this. There have been numerous complaints which over a 10-year period had been submitted. They were submitted to you, the FDA, things that were 

70 

taking place in these facilities. Somehow, there should be that communication with the state. Of the complaints that were submitted, 

which ones were reported to the state, and when? 

Dr. HAMBURG. I indicated that we would try to go back and look 

at that, but I—— 

Mrs. ELLMERS. OK. Were any submitted to the state? Were any 

complaints then passed on to the state? 

Dr. HAMBURG. In certain instances, we actually went in with the 

state to do inspections. 

Mrs. ELLMERS. In certain instances you did go—OK. I do want 

that for the record. I would like for you to submit the complaints 

that were passed on to the state and the number of inspections 

that took place with the state into these facilities, especially the 

Ameridose and the NECC. 

Now having said that, is there a law in place now that prevents 

you from sharing information? 

Dr. HAMBURG. No. 

Mrs. ELLMERS. Legislation, law, regulation, guideline that prevents you from sharing information—— 

Dr. HAMBURG. With the states? 

Mrs. ELLMERS [continuing]. With the states? 

Dr. HAMBURG. No, and I think that that is an area where we are 

trying to do a much stronger job. 

Mrs. ELLMERS. So there wasn’t anything preventing you, but you 

want to do a better job. How do you do a better job if there wasn’t 

anything preventing you? 

Dr. HAMBURG. I am just saying that as I look back over some of 

the—— 

Mrs. ELLMERS. This was an area of failure. 

Dr. HAMBURG [continuing]. Issues, that I think that we could 

definitely benefit, all of us, by working more closely, having more 

systematized mechanisms—— 

Mrs. ELLMERS. Because you have noted over and over again the 

state has the authority, the licensure ability, the regulation for the 

state, and yet, there seems to be this barrier there for sharing information that had been given to you, privy to you. 

Now, let’s back up to some of the complaints here. I just want 

to point out a couple, and this had to do with Ameridose. In one 

of the instances here, it says the ‘‘FDA received another call from 

Ameridose, informant alleging that not only was the Ameridose 

sales team assisting in labeling in the clean room, but that one of 

the three clean rooms had a positive result of mold growth.’’ Let 

me further that. That was August, 2010. Another from August, 

2010, ‘‘Informant called again a few days later, stating that the 

mold was found in the hood in which operations took place.’’ Dr. 

Hamburg, what is mold? 

Dr. HAMBURG. Mold is an organism that can cause diseases—— 

Mrs. ELLMERS. And what kind of disease? What is mold specifically? 

Dr. HAMBURG. Well, my microbiology days are long behind me, 

but it is a micro-organism—— 

Mrs. ELLMERS. It is a fungus. 

Dr. HAMBURG. Well, OK. 

71 

Mrs. ELLMERS. It is a fungus. So you will acknowledge that it is 

a fungus? August, 2011, an Ameridose informant notifies FDA 

‘‘when packaging was dropped on the floor, employees are told to 

pick it up and ship.’’ He further stated that ‘‘the bubble wrap is 

stored directly on the floor and that this room is dirty and never 

cleaned.’’ I can go on and on. There is also an incident after the 

event, after 53 Americans died as a result of the failures of these 

facilities, that there were dead birds found in that facility. Dr. 

Hamburg, what kinds of diseases can result as of human contact 

with bird feces or droppings? 

Dr. HAMBURG. Clearly, there are serious medical conditions—— 

Mrs. ELLMERS. Fungal diseases. 

Dr. HAMBURG [continuing]. And clearly, the kinds of environmental exposures you are describing are not acceptable to sterile 

practice. 

Mrs. ELLMERS. Absolutely not, completely and totally. And that 

is where I get back to the common sense factor here. When these 

things have been reported to you, how could it possibly be that they 

were not relayed on to the states? 

And with that, I use up the remainder of my time. Thank you, 

Mr. Chairman. 

Mr. MURPHY. Thank you. Now recognize Dr. Burgess of Texas for 

5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman, and Director Hamburg, 

thank you for being with us through this long session. 

When Ms. Ellmers was just talking about picking up of the product that had fallen on the floor and then was retrieved and still 

shipped out, it made me remember in this very subcommittee, 

probably 4 years ago, Mr. Parnell of the Peanut Corporation of 

America undertook the same sort of practice in his peanut factory, 

and the consequence was a significant salmonella outbreak that 

sickened and I think killed some patients. Mr. Parnell is now in 

jail. So I mean, this is—he had been indicted. All right, I stand corrected. He should go to jail. But I mean, those are peanuts to make 

peanut butter. This is a sterile injectable to go into the subdural 

space or the epidural space of a patient. And so it is equally, if not 

much more, serious what Ms. Ellmers was just bringing up. 

I do want to say for the record, early on in this process and in 

September of 2012, I want to acknowledge the help that the CDC 

provided our office when it was just almost impossible to get any 

phone calls returned or any information. The doctors at the CDC 

actually walked me through what they thought was going on, and 

I have to say, they did an excellent job of rounding up patients and 

getting people in for testing. I had—it had been a long time since 

I had been in microbiology, too. I don’t think I even encountered— 

while I was in microbiology, but they did a very good tutorial for 

me on just what that organism was, how dangerous it was, even 

though it was one that wasn’t normally thought of as a pathogen. 

I know we have been through a lot of this stuff over and over 

and over again, and this stuff with Ameridose just—we keep coming back to it and I recognize a lot of it happened before you became administrator, and so I will stipulate that. But in July of 

2011, you were the administrator, and in an exchange of e-mails 

that is in your binder there, Tab 37, there was a lot of discussion 

72 

about, once again, there are problems that have come up at 

Ameridose. I think it is Paige Taylor, a lawyer who sort of re-documented all of the problems that were there, and she sent that in 

an e-mail to the FDA’s chief litigator. And the FDA’s chief litigator, 

when she asked should we not re-inspect, I mean, I think he said 

well, it is CDER’s call, but if the problems are serious safety issues, 

why would we only issue a warning letter? Why not seize? So that 

is a valid question. I mean, at this point, in July of 2011, the evidence is finding that there is a problem. Ameridose has come 

across the screen so many times. Your own chief litigator said why 

are we doing another warning letter? Why don’t we just go in there 

and shut them down? So why not? 

Dr. HAMBURG. Well I think that there was, again, internal discussion about how we should proceed, and I wish that we had been 

more aggressive, but I am saying we are going to be more aggressive now. And you mentioned the Peanut Corporation of America 

example. That is an example where actually in working with Congress, we were able to get the additional legislation, the Food Safety Modernization Act, that gave us new tools to work with companies to prevent problems and to really address some of those kinds 

of concerns, and I think that is not—— 

Mr. BURGESS. Well, let’s not wax too eloquent, because we still 

have salmonella outbreaks and we all recognize that, but we all 

recognize that there were problems that needed to be addressed. 

Your chief litigator went on to say my concern is that if we just 

issue a warning letter under one legal theory, and either do nothing until we issue the guidance, which apparently will take forever, 

or as noted below, would put another nail in our consistent policy 

coffin. I mean, those words were kind of prophetic, weren’t they? 

I will accept the fact that you acknowledge that the agency was 

far too cautious and that you are accepting some responsibility for 

that—being that risk averse. But I just got to tell you, I disagree 

with Mr. Waxman on the issue of the circuit court split. I mean, 

yes, there is a reason to protect their traditional compounding 

pharmacists. I used them when I was in medical practice. They fill 

a niche that needs to be filled, but the FDA has known for years 

that New England Compounding Corporation and Ameridose were 

not the mom and pop compounding. They were not traditional 

compounders in any conceivable definition. And I guess the concern 

as we wrap up this hearing, it does seem that at the agency the 

priority was on perfecting the policy or perfecting the policy guidelines, and not on protecting the patient. And if we learned nothing 

else from this today, it is that the mission of the Food and Drug 

Administration should be, first and foremost, on patient safety. The 

policy will always work itself out if we keep that number one objective in mind. 

Mr. Chairman, you have been very generous with the time. I 

don’t know if the commissioner wishes to respond, but I will be 

happy to yield back my time. 

Mr. MURPHY. I thank the gentleman and on his behalf, Commissioner, do you want to answer that question? 

Dr. HAMBURG. I just wanted to underscore what Dr. Burgess 

said, that I agree that patients and public health have to be our 

first priority, and I want to assure you that we are going to be as 

73 

aggressive as we can be with our current authorities, and that if 

you give us additional authorities that we feel we need to do the 

best job possible for the American people, we will use them. 

Mr. BURGESS. I just have to say, it is going to take—that takes 

a lot of time, and you know that. You know what the political environment is here in Congress. Why not just use the authority that 

you have? Don’t ask us for another tool when you have existing 

tools. My old daddy used to say, it is a poor worker who blames 

his tools. Don’t blame your tools. Do your work. 

Dr. HAMBURG. I think we need new tools. 

Mr. MURPHY. Well, to that, I want to thank you for coming today 

and sitting through two rounds of questions, and for the members’ 

devotions to this hearing today. 

The committee rules provide that members have 10 days to submit additional questions for the record to witnesses. Let me say 

something very important about that. It was brought to our attention earlier today, Mr. Dingell and other members had asked questions last November. This is an opportunity to prove that the culture delay within the FDA has changed, because even with this 

committee, it has not. So I ask you to get the answers to the committee questions from last November to us by the 19th of April, 

and the members, since they have 10 days to submit questions to 

you, that you get back to us within 30 days of that date. It is important, because otherwise it leaves us thinking that delays continue. 

I also ask unanimous consent to put the following documents into 

the record: the document binder at the witness table, subject to appropriate redactions by staff; opening statements of members; and 

the reports issued by Majority and Minority staff for this hearing, 

including the report from Mr. Markey, the Minority staff report of 

April 15, and the Majority staff report of April 16. 

[The information appears at the conclusion of the hearing.] 

Mr. MURPHY. Again, I thank all members for coming here, and 

with that, this hearing is adjourned. 

[Whereupon, at 1:00 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

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