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76–015 2012

DRUG SAFETY: AN UPDATE FROM THE FOOD 

AND DRUG ADMINISTRATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED ELEVENTH CONGRESS 

SECOND SESSION 

MARCH 10, 2010 

Serial No. 111–103 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 


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COMMITTEE ON ENERGY AND COMMERCE 

HENRY A. WAXMAN, California, Chairman 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chairman 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

JERRY MCNERNEY, California 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 


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SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

JOHN D. DINGELL, Michigan 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JANE HARMAN, California 

CHARLES A. GONZALEZ, Texas 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

CHRISTOPHER S. MURPHY, Connecticut 

ZACHARY T. SPACE, Ohio 

BETTY SUTTON, Ohio 

BRUCE L. BRALEY, Iowa 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 


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C O N T E N T S 

Page 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 2 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 3 

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

California, opening statement ............................................................................. 4 

Prepared statement .......................................................................................... 6 

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

opening statement ................................................................................................ 10 

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

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 18 

Hon. Steve Buyer, a Representative in Congress from the State of Indiana, 

opening statement ................................................................................................ 19 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

opening statement ................................................................................................ 20 

Hon. Bruce L. Braley, a Representative in Congress from the State of Iowa, 

opening statement ................................................................................................ 21 

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

Tennessee, opening statement ............................................................................ 22 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, opening statement .................................................................................... 23 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 24 

Prepared statement .......................................................................................... 26 

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

of Pennsylvania, opening statement ................................................................... 28 

Hon. Jim Matheson, a Representative in Congress from the State of Utah, 

opening statement ................................................................................................ 29 

WITNESSES

Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug 

Administration ..................................................................................................... 30 

Prepared statement .......................................................................................... 33 

Answers to submitted questions ...................................................................... 66 


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DRUG SAFETY: AN UPDATE FROM THE FOOD 

AND DRUG ADMINISTRATION 

WEDNESDAY, MARCH 10, 2010 

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

The Subcommittee met, pursuant to call, at 2:17 p.m., in room 

2123 of the Rayburn House Office Building, Hon. Frank Pallone, 

Jr. (Chairman of the Subcommittee) presiding. 

Members present: Representatives Pallone, Dingell, Eshoo, 

Green, DeGette, Matheson, Barrow, Christensen, Sarbanes, Murphy of Connecticut, Braley, Waxman (ex officio), Whitfield, Shimkus, Buyer, Pitts, Myrick, Murphy of Pennsylvania, Burgess, 

Blackburn, Gingrey and Barton (ex officio). 

Staff present: Phil Barnett, Staff Director; Bruce Wolpe, Senior 

Advisor; Ruth Katz, Chief Public Health Counsel; Sarah Despres, 

Counsel; Rachel Sher, Counsel; Elana Stair, Policy Advisor; Katie 

Campbell, Professional Staff Member; Stephen Cha, Professional 

Staff Member; Virgil Miller, Professional Staff Member; Allison 

Corr, Special Assistant; Eric Flamm, FDA Detailee; Greg Dotson, 

Chief Counsel, Energy and Environment; Dave Leviss, Chief Oversight Counsel; Karen Lightfoot, Communications Director, Senior 

Policy Advisor; Lindsay Vidal, Special Assistant; Mitchell Smiley, 

Special Assistant; Clay Alspach, Minority Counsel, Health; and 

Ryan Long, Chief Counsel, Health. 

Mr. PALLONE. The meeting of the subcommittee is called to 

order, and today we are having a hearing on ‘‘Drug Safety: An Update from the FDA.’’ 

I think before I give my opening statement, I am going to recognize my colleague, the ranking member of the full committee, the 

gentleman from Texas, Mr. Barton. 

Mr. BARTON. Thank you, Chairman Pallone. I just need to make 

an announcement to the subcommittee. The ranking Republican on 

the subcommittee is Congressman Nathan Deal of Georgia. As we 

all know, he announced several weeks ago his intention to resign 

effective last week. He has since withdrawn the effective date of his 

resignation until after the vote or votes on the House Floor concerning the comprehensive health care bill. But during that time, 

Congressman Deal is not planning on attending Congress or at 

least the subcommittee of which he is the ranking member. Therefore, today I am nominating Congressman Shimkus of Illinois to be 

the temporary ranking member. That is unofficial obviously because there is no such thing as temporary anything, but he will asVerDate Mar 15 2010 08:51 Nov 27, 2012 Jkt 076015 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 E:\HR\OC\A015.XXX A015

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sume the duties of Congressman Deal until such time as Mr. Deal 

does effectively resign. When that happens, I will inform Mr. Waxman that it is my intention to make Mr. Shimkus the ranking 

member of the subcommittee subject to committee approval of such 

designation. So for today’s hearing and any subsequent hearings 

that this subcommittee has, until Mr. Deal actually resigns, Mr. 

Shimkus will assume the duties of the ranking member of this subcommittee. 

Mr. PALLONE. Well, thank you, and let me congratulate Mr. 

Shimkus. He has always been very helpful and tried to work in 

many cases on a bipartisan basis, so I am very happy to welcome 

him as the new or acting ranking member. I was going to ask, 

though, the way you described that, Mr. Barton, it sounded like 

Mr. Deal might still be here for a while, depending on the circumstances. 

Mr. BARTON. It is up to you. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. All right. We will have to see. I shouldn’t say that 

actually. He probably won’t be here for very long based on what I 

believe, but we will see. In any case, congratulations. 

Let me recognize myself for an opening statement. As I mentioned, today the subcommittee is meeting to discuss drug safety. 

It has been at least a year since our last hearing on this issue and 

we are here to get an update and overview from the FDA on current challenges and successes with respect to drug safety. Recently 

there have been a number of drug-related incidents that have 

shaken public confidence in the FDA’s ability to ensure that consumers are using safe and effective drugs. In addition, reports from 

the Institute of Medicine and the Government Accountability Office 

highlight the shortcomings of our current system and provide guidance on how to strengthen the drug safety laws to better protect 

the American public. 

In response to the incidents, Congress passed the FDA Amendment Acts of 2007, or FDAAA, I guess it is pronounced. This bill 

was aimed to provide the FDA with additional authorities, specifically post-approval authorities that would help the agency keep 

drugs safe for consumers to use. For example, the bill provided the 

FDA with the authority to require drug manufacturers to conduct 

post-approval studies that would monitor drugs for safety as they 

are used in the broader population. The bill directed the FDA to 

establish a post-market surveillance system to improve the agency’s ability to detect and act upon drug safety problems and gave 

the FDA the authority to require drug label changes for safety reasons. It also provided the FDA with the authority to impose Risk 

Evaluation Mitigation Strategies, or REMS, for drugs and biologics 

when necessary, and these REMS are designed to manage known 

or potential serious risks with a drug or biologic to ensure that the 

benefits of the product outweigh the risks it poses to the patient. 

Now, the FDA is here today to talk about how effective this law 

is in protecting the American people from unsafe drugs, and I am 

particularly curious to hear about the progress on the implementaVerDate Mar 15 2010 08:51 Nov 27, 2012 Jkt 076015 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 E:\HR\OC\A015.XXX A015

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tion of some of the post-approval authorities and to learn from the 

agency of potential stumbling blocks or challenges that will require 

further Congressional action. 

Outside of the FDAAA realm, however, we already know that we 

need to do more to ensure the safety of our drugs. We all remember 

that horrible incident in early 2008 that again intensified this committee’s focus on drug safety. Baxter Health Care Corporation, one 

of the manufacturers of the blood thinner heparin, which is used 

to prevent blood clots, began noticing an increase in the number of 

adverse effects associated with their product. After further investigation, it was determined that the Baxter heparin contained a 

counterfeit ingredient that mimics an ingredient normally used in 

heparin production but that is highly toxic and dangerous to humans. Baxter had received this ingredient from a manufacturer in 

China, and upon further investigation by the FDA, it was determined that due to a processing error at the agency, this Chinese 

manufacturer had never been inspected by the agency. Tragically, 

81 individuals lost their lives as a result of the contamination. Obviously this should not and cannot happen again and we must do 

everything we can to ensure that it does not happen again. And I 

am curious to hear the FDA’s thoughts and plans for improving import and supply chain safety, especially since the GAO found that 

roughly 80 percent of the active ingredients used in drugs are actually manufactured abroad. 

I and a few of my colleagues on the Energy and Commerce Committee introduced a bill this Congress that aims to provide the 

FDA with additional funding authorities to better regulate the imported materials used in drugs. The bill would also place more responsibility on the manufacturers to ensure that the ingredients 

they are using are safe. As highlighted by the heparin case, we 

know the devastation that can come from an unsafe drug supply 

chain. 

So I am looking forward to hearing from today’s witnesses. 

I now recognize our new ranking member, my friend, Mr. Shimkus. 

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Mr. SHIMKUS. Thank you, Chairman Pallone. Thank you for your 

warm welcome. I want to thank Ranking Member Barton for his 

trust and confidence in me, and I look forward to continuing to 

work hard on behalf of the committee and really the work we need 

to do here. 

The FDA, with all the challenges and the inspection that we do, 

it is still really the gold standard for health and safety in the 

world. A lot of countries don’t have to do all the research and the 

testing because we in essence do it for them, so although we will 

be inquisitive and we will be trying to ask questions, I put that 

first on the table because they world does rely on what we do here. 

And we have spent a great deal of time on the issue of drug safety 

and the Food and Drug Administration Amendments Act, and I 

look forward to Dr. Sharfstein. Welcome, and I look forward to your 

updates. And I want to continue to learn more about the Risk Evaluation Mitigation Strategies, known as REMS, how that is proVerDate Mar 15 2010 08:51 Nov 27, 2012 Jkt 076015 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 E:\HR\OC\A015.XXX A015

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gressing and whether information is being disseminated in a userfriendly manner. I am all about risk-based approach. The bills that 

we passed in a bipartisan, I continuously spoke out on risk-based 

programs. So I am very interested in that. 

Your projections for advisory committee members in the future 

and those projections, I believe it is important to maintain credibility and expert participants. Recent stories indicate the exception 

reductions provisions may be diluting the advisory committee’s 

ability to serve in those functions, and we do want highly qualified 

and the best people to be helpful. 

But in general we know gaps remain when it comes to ensuring 

the safety of drugs in the United States and I remain committed 

to addressing those needs along with Chairman Pallone. One thing 

I know about my colleagues on the other side, they are tenacious 

in moving in that direction and we want to be helpful in that manner. The FDA continues to make progress in utilizing risk-based 

systems like PREDICT and I am curious how this might translate 

in regard to targeting facility inspections. Regardless of the end result, we know that the FDA needs proper funding. We need to 

identify where we can cut out wasteful spending and make sure 

funding to ensure the safety of food and drugs in this country does 

not take a backseat with our appropriators. 

Lastly, echoing remarks I made in the past, I hope we can work 

towards these goals using a prudent formula to get a good bipartisan product. Chairman Waxman, Chairman Emeritus Dingell, 

Chairman Pallone and Chairman Stupak working along with 

Ranking Member Barton, Deal and myself came up with the food 

safety bill that ultimately passed the House really in a huge bipartisan manner, and I think we can do that if we move forward in 

that direction. 

I look forward to continuing our work to get legislation signed 

into law and hope we can use the successes of food safety as our 

motto in any drug safety-related legislation. 

Thank you, Mr. Chairman. I yield back my time. 

Mr. PALLONE. Thank you, Mr. Shimkus. 

Next is our full committee chair, Chairman Waxman. 

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

Mr. WAXMAN. Thank you very much, Chairman Pallone, for holding this hearing today and giving us the opportunity to hear from 

the FDA on the critically important issue of drug safety. 

It has been some time since we focused on drug safety, but we 

did indicate that we wanted to take up this bill after food safety, 

which was the first step, and now we are going to turn to drugs, 

medical devices and cosmetic safety issues. 

We can’t forget the lessons of the 2007 heparin contamination catastrophe which resulted in numerous severe allergic reactions and 

the deaths of at least 80 Americans. In that case, the active ingredient was manufactured in China. Thanks to the excellent work of 

the Subcommittee on Oversight and Investigations in 2008, we 

know that this is not a unique situation: the U.S. drug supply is 

increasingly sourced from abroad. 


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In order to market a drug in the United States, FDA must ensure that the drug meets our appropriately high safety standards. 

So when ingredients or finished drug products are manufactured 

abroad, FDA needs to expand its reach if the agency is to meet its 

responsibilities. 

As heparin illustrated, FDA clearly needs more authorities and 

more resources to do a better job policing the safety of imported 

products. But what heparin also demonstrated is that we cannot 

expect FDA alone to do this job. We need to place a greater onus 

on all manufacturers to oversee the safety of their own products. 

This principle is reflected in the work that Mr. Dingell, Mr. Pallone 

and Mr. Stupak did on their Food and Drug Administration 

Globalization Act. For instance, the bill would require drug manufacturers to implement Quality Risk Management Plans to incorporate risk identification and control into their production processes. We need that. 

This is a principle that should be familiar to all of us. The Food 

Safety Enhancement Act reflects this kind of approach with respect 

to food manufacturers. So I am confident we can get the same kind 

of bipartisan agreement to incorporate this concept into a bill on 

drug safety as well. 

I hope FDA will tell us today about what the agency believes it 

needs to protect us from another heparin disaster. 

I am also eager to hear about FDA’s implementation of the 2007 

FDA Amendments Act. Congress made some major strides toward 

improving the safety of our drug supply in enacting this legislation. 

For the first time, FDA was given the authority to require manufacturers, among other things, to conduct post-market studies, implement Risk Evaluation and Mitigation Strategies, or REMS, and 

make safety-related drug labeling changes. This hearing will be a 

great opportunity to learn about FDA’s challenges and successes 

with the use of these authorities 3 years after the enactment of this 

landmark legislation. 

I want to thank Dr. Sharfstein for being here. He is no stranger 

to me. We worked together in the past in the Oversight and Government Reform Committee and on many of these very same 

issues, and I am quite pleased that you are here and feel a sense 

of confidence that you are responding to us on these issues because 

I know you share our concern about them. 

Thank you very much, Mr. Chairman. 

[The prepared statement of Mr. Waxman follows:] 


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Energy and Commerce Committee 

Subcommittee on Health 

Statement of Chairman Henry A. Waxman 

Hearing on "Drug Safety: An Update from FDA" 

March 10, 2010 

Thank you, Chairman Pallone, for holding this hearing 

today and giving us the opportunity to hear from the FDA 

on the critically important issue of drug safety. 

Although it has been some time since the Committee 

focused on drug safety, that pause does not represent any 

lessening of our collective commitment to this issue. When 

we took up the food safety bill last year, we made it clear 

that the legislation was just a first step. As the Senate 

prepares to take up its version of the food safety legislation 

passed by the House last July, we turn next to drug, 

medical device, and cosmetic safety issues. We start that 

process with today' shearing - knowing already that there 

is much work to be done in the area of drug safety. 
7 


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We cannot forget the lessons of the 2007 heparin 

contamination catastrophe which resulted in numerous 

severe allergic reactions and the deaths of at least 80 

Americans. In that case, the active ingredient was 

manufactured in China. Thanks to the excellent work of 

the Subcommittee on Oversight and Investigations in 2008, 

we know that this is not a unique situation: the U.S. drug 

supply is increasingly sourced from abroad. 

In order to market a drug in the U.S., FDA must 

ensure that the drug meets our appropriately high safety 

standards. So when ingredients or finished drug products 

are manufactured abroad, FDA needs to expand its reach if 

the Agency is to meet its responsibilities. 

2 
8 


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As heparin illustrated, FDA clearly needs more 

authorities and more resources to do a better job policing 

the safety of imported products. But what heparin also 

demonstrated is that we cannot expect FDA alone to do this 

job. We need to place a greater onus on all manufacturers 

to oversee the safety of their own products. This principle 

is reflected in the work that Mr. Dingell, Mr. Pallone, and 

Mr. Stupak did on their Food and Drug Administration 

Globalization Act. For instance, the bill would require 

drug manufacturers to implement "Quality Risk 

Management Plans" to incorporate risk identification and 

control into their production processes. We need that. 

This is a principle that should be familiar to all of us 

the Food Safety Enhancement Act reflects this kind of 

approach with respect to food manufacturers. So I am 

confident we can get the same kind of bipartisan agreement 

to incorporate this concept into a bill on drug safety as well. 

3 
9 


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I hope FDA will tell us today about what the Agency 

believes it needs to protect us from another heparin 

disaster. 

I am also eager to hear about FDA's implementation 

of the 2007 FDA Amendments Act. Congress made some 

major strides toward improving the safety of our drug 

supply in enacting this legislation. For the first time, FDA 

was given the authority to require manufacturers, among 

other things, to conduct post-market studies, implement 

"Risk Evaluation and Mitigation Strategies" or "REMS," 

and make safety-related drug labeling changes. This 

hearing will be a great opportunity to learn about FDA's 

challenges and successes with the use of these authorities 

three years after enactment of this landmark legislation. 

I want to thank Dr. Sharfstein for being here today and 

look forward to his testimony. 

4 
10 

Mr. PALLONE. Thank you, Chairman Waxman. 

Next is our ranking member, Mr. Barton. 

OPENING STATEMENT OF HON. JOE BARTON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BARTON. Thank you, Chairman Pallone. We appreciate this 

hearing today. We appreciate our witness from the FDA coming. 

Before I give my brief statement on the merits of the issue, I do 

want to reiterate the importance I place on this subcommittee and 

the importance I place on Mr. Shimkus assuming the ranking 

membership. On the Republican side, we have a bidding system for 

subcommittees where each member gets to rank one, two, three 

their preference for subcommittees. The most sought-after subcommittee on the Republican side of the full committee is the 

Health Subcommittee, as it should be, given the size of the health 

issue in our debates here in the Congress. Congressman Deal has 

done an outstanding job, first as subcommittee chairman and the 

last two terms as ranking member but he is pursuing the governorship in Georgia, so I thought long and hard about who to replace 

him with, and Mr. Shimkus is somebody who has paid his dues. He 

has an almost 100 percent attendance record as a member of this 

subcommittee. He also serves on two other subcommittees and his 

attendance record there is excellent. He gets into the details of the 

issues, and while any member of the subcommittee on the Republican side I think would make an excellent ranking member, I feel 

Mr. Shimkus will not have a learning curve, so I welcome him to 

his new duties and I hope that he conveys to them the same sense 

of excellence he has in all the other duties he has assumed on the 

committee. 

With regard to today’s hearing, it is good to review what we have 

done with the bill that we passed in the last Congress. We are especially interested on the minority side, as has already been outlined, the REMS issue, the Risk Evaluation Mitigation, how that 

is working. We also would be interested in hearing about the new 

rules that we put into statute regarding conflict of interest and 

how those rules are being used. We hear some concern that it has 

become difficult to get the experts needed on these review panels 

because of the conflict-of-interest rules that we have adopted, so we 

want to hear about that. 

As Chairman Waxman has pointed out, there is hope that we can 

work in a bipartisan fashion on future FDA reform measures. 

Chairman Dingell and I are working on that very issue at the staff 

level, and we are hopeful that our friends on the majority side will 

adopt the model of bipartisanship that they exhibited in the last 

Congress and in this Congress so far with the FDA and not the 

model of partisanship that they adopted on the larger comprehensive health reform bill. I think the proof is in the pudding. When 

we work together in a bipartisan fashion, we certainly have differences but we end up with bills that pass committee with almost 

unanimous support and bills that pass the floor with over 400 

votes. When the other route is chosen, we have bills that barely 

pass committee and barely pass the floor and as of now there 

doesn’t appear to be a compromise between the House and the Senate and the President that can pass anywhere. 


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So we look forward to your testimony, and again, Chairman Pallone and Chairman Waxman, thank you for this hearing. 

[The prepared statement of Mr. Barton follows:] 


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STATEMENT OF THE HONORABLE JOE BARTON 

RANKING MEMBER COMMITTEE ON ENERGY AND 

COMMERCE 

HEALTH SUBCOMMITTEE HEARING: 

"Drug Safety: An Update from the FDA." 

March 10, 2010 

Mr. Chairman, thank you for holding this hearing 

today. Before we get into the substance oftoday's hearing, 

I want to take notice of the starkly different ways in which 

we have handled two important health issues. 

Almost three years ago, this Committee began the 

process to reauthorize several expiring FDA user-fee 

programs. Republicans were presented with a draft that 

was controversial and lacked any input from us. But there 

was real bipartisan interest in advancing legislation, and we 
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worked hard to bridge our policy differences. We ended up 

writing the Food and Drug Administration Amendments 

Act of 2007. That bill passed by a unanimous vote here 

and then it amassed more than 400 votes on the House 

floor. 

That story started poorly and ended well. 

Interestingly, we are replaying a similar story here in the 

House right now, but without the happy ending. Instead, 

the President and his majority party are going to pass a 

government takeover of health care that they created. 

We've witnessed a year's worth of showboating and 

theatrics, but it seems plain that Democrats have been, and 

still are, deaf to nearly every idea that diverges from the 

ones with a White House stamp of approval. 

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Now we're at a point where a complex budget process 

is going to be used to advance the president's will after the 

House passes the Senate health reform bill. I'd just like to 

point out that, as far as I know, this Committee has not 

marked up any legislation despite a specific requirement for 

us to do so in the budget's reconciliation instructions. I 

know that won't matter to many, but unless we are satisfied 

to function as White House servants, it better matter to us. 

I also recognize that the White House threw reason off 

the train last year, but I want to make an appeal before the 

engine crashes into the public and wrecks health care for a 

lot of innocent people. There's still a moment or two left in 

which the brakes can be applied. I urge the leaders of this 

Committee to ask the President and Speaker Pelosi to stop 

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this raw, partisan bill that the American people have 

rejected again and again. Let us have the kind of normal, 

bipartisan discussions that can lead to consensus reforms. 

More than anyone else in Congress, the members of this 

Committee know how to do it because we have done it so 

often in the past. 

Now, turning to the Food and Drug Administration 

Amendments Act of2007, there was great debate and 

considerable thought given to the new powers granted to 

the FDA. I am interested in hearing from Dr. Sharfstein on 

how the FDA has approached and implemented these new 

authorities. 

Specifically, I am interested in the decision-making 

process undertaken by the FDA to determine whether a 

4 
16 


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drug should have a Risk Evaluation and Mitigation 

Strategy, otherwise known as a REMS. The REMS process 

was a critical component of the drug safety reforms 

implemented in 2007. The FDA has used the REMS 

process to require a number of drug manufacturers to 

provide medication guides with their prescription drugs. 

Medication guides can provide useful information to 

patients. However, we must ensure the information being 

given to consumers is both useful and being read. 

I am also interested in hearing about how the FDA is 

adapting to the new rules restricting conflict of interest 

waivers for advisory committees. In 2007, Members on 

both sides of the aisle cautioned that these new restrictions 

could actually have adverse consequences because the 

agency would find it difficu1t to fill slots on advisory 

5 
17 


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committees with knowledgeable individuals. While it is 

important that these advisory committees be independent, 

they must be filled with actual experts in the field to be 

effective. There have been news reports over the past year 

indicating a difficulty in filling advisory committee 

positions due to the onerous new rules, and I am eager to 

hear from Dr. Sharfstein on this subject. 

I yield back the balance of my time. 

6 
18 

Mr. PALLONE. Thank you, Mr. Barton. 

Next is the chairman emeritus, and I should say that Mr. Dingell, as many of you know, has had a long history of working on 

this legislation or the issue of drug safety and food safety and is 

the prime sponsor of the bill that we have been operating on for 

the last couple of sessions on the topic. Thank you, Mr. Chairman. 

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

Mr. DINGELL. Thank you, Mr. Chairman, for those kind words 

and I wish to commend you for having this hearing. It is a very 

valuable event and it will provide us an opportunity not only to receive and update information on drug safety activities at the Food 

and Drug Administration but also to remind the American people 

of the hazards which exist with regard to unsafe food and drugs 

and the fact that this Congress needs to move forward with legislation to address problems in both of these areas. 

As you know, Mr. Chairman, we have reported from this committee a food safety bill which has passed the House. It came 

unanimously out of this committee and it has passed the House by 

an overwhelming vote. It sits, of course, safely ensconced in the 

United States Senate as these things usually do. We are hopeful 

that this hearing might trigger some interest in the Senate in this 

matter so that they can commence to go forward. 

I want to commend my friend Mr. Barton for his comments with 

regard to food safety and safety of pharmaceuticals. As you know, 

Mr. Chairman, you, Mr. Stupak and I and Ms. Sutton and Ms. 

DeGette sponsor H.R. 759, which is a very significant improvement 

in all the things at Food and Drug including their authorities to 

address drug problems, food problems and also importation problems that deal with the importation at the point of import and to 

see to it that inspections at home and abroad and as well as that 

that good manufacturing practices obtained abroad, and I want to 

observe that Mr. Barton worked very well with us on that and that 

my Republican colleagues and my Democratic colleagues and I will 

work well to get that bill out of here and through the House. 

I am hopeful that we can do something similar on the remnants 

of the legislation which we have passed which was H.R. 759. We 

received technical comments from the Food and Drug Administration and we believe that those are very helpful and will be incorporated. As my colleague Mr. Barton has observed, his staff and 

mine are working to see to it that we can bring together a bill 

which can achieve the support of my colleagues on the committee, 

and I look forward to the enthusiastic support in this subcommittee 

and in the full committee, and of course, I look forward to the help 

of Food and Drug and the Department of HHS as well as the Administration. 

According to a 2004 HHS report, the Nation’s medicine cabinets 

are still stuffed with enormous amounts of pharmaceuticals. Almost half of all people in this country take at least one prescription 

medicine and one in six has three or more medications that they 

take. Americans have come to expect that their prescription drugs 

will improve health and prolong life expectancy. They do not expect 


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their drugs to cause harm or death. The Food and Drug Administration plays a critical role in ensuring the Nation’s drug supply 

meets the safety expectations of American consumers. The role 

FDA plays is so critical that it has earned that agency an American 

Food and Pharmaceutical Products as the gold standard not only 

of regulatory bodies but as regulatory substances. 

Unfortunately, FDA approval of pharmaceuticals as a gold standard is now called into question by an unfortunate series of facts. 

Drug safety incidents have occurred and have created a confidence 

crisis in FDA. During the past 8 years, Food and Drug was led by 

leadership specialized at best in gross incompetence or at worst severe deception, and as a result, American lives have been placed 

in jeopardy under all the products that are marketed under the 

regulation of that agency, and of course, the confidence of the 

American people in that agency has been severely compromised. 

Now under a new Administration, Food and Drug has been taking steps to rebuild, and through Congressional and administrative 

action, the agency has gained additional resources, not sufficient 

but to begin enabling it to move towards doing its job properly 

though many including myself still believe that the resources and 

authorities of Food and Drug are still lacking in the wake of years 

of inattention and starvation. 

In 2007, the Congress made substantial progress in the way of 

drug safety with the passage of FDA Amendments Act of 2007. 

This law strengthened FDA’s post-market safety oversight. No 

longer is it ok for the oversight to end at the mere approval of a 

drug. This is a significant step forward. However, it did not take 

long before we were aware of enormous gaps in FDA’s ability to 

protect consumers from an increasingly global drug supply. In 

2008, in one instance alone, 81 deaths of Americans were linked to 

recalled heparin that contained Chinese tainted API. The safety of 

imported pharmaceuticals and supplies as well as the raw materials from which these are made is a matter of safety and great 

concern that must be addressed in this Congress. Last year the 

Congress unanimously passed the bipartisan bill I mentioned with 

regard to our food safety supply. I believe that we can and should 

and will pass similar legislation during this Congress. 

I look forward to the deputy commissioner’s testimony. I hope he 

is able to give us better testimony than the predecessor of the current head of FDA gave us when he came up to tell us that all was 

well and to leave a patch of skin behind in this committee because 

of the unfortunate character of his testimony and his lack of information. 

Mr. Chairman, I thank you again and I yield the balance of my 

time. 

Mr. PALLONE. Thank you, Chairman Dingell. 

The gentleman from Indiana, Mr. Buyer. 

OPENING STATEMENT OF HON. STEVE BUYER, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF INDIANA 

Mr. BUYER. Thank you very much. 

For the past several years, I have been studying the problem of 

counterfeit drugs entering our Nation through our 12 international 

mail facilities and express carrier facilities. In 2008, Congress 


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Matheson and I introduced the Safeguarding America’s Pharmaceuticals Act to combat the flow of unapproved drugs into our country and to strengthen and safeguard the domestic pharmaceutical 

supply by creating also this system of electronic pedigree. At the 

beginning of last year when we introduced the legislation, we then 

submitted to the FDA and other stakeholders, Customers Border 

Protection and the California Board of Pharmacy to improve the 

Safeguarding America’s Pharmaceuticals Act. I would ask you to 

look over your left shoulder because there are two ladies that were 

a lot of help. They put in a lot of time for the technical assistant. 

Elisa Bernstein, thank you very much. We traveled to many of 

these facilities with you. And Jeannie Ireland, thank you very 

much for the technical assistance you have given to make this legislation even better. Mr. Matheson and I have the commitment of 

Mr. Dingell and we want to make sure that this legislation becomes a reality. 

Last June, Dr. Hamburg testified before this subcommittee and 

stated that the problem of counterfeit drugs is a significant concern 

and gave her commitment to working with me to address the issue, 

so I turn ask for the very same commitment. 

The FDA then followed up in its response to many questions for 

the record and confirmed that the agency supports a single national uniform standard for a drug track and trade system. Additionally, the agency addressed an issue of great importance to me 

when it stated that it supports streamlining the destruction of 

these unapproved FDA drugs that constantly come into the market. 

And let us stop enabling these counterfeiters by this policy of return to sender. It is just awful, and I hope that you can address 

that to us. The worldwide counterfeit drug market is expected to 

grow to $75 billion, so we have to aggressively address this, and 

I look forward to working with Mr. Dingell to do that. 

So I know this is a great concern to you, and I look forward to 

working with you and your comments. I yield back. 

Mr. PALLONE. Thank you, Mr. Buyer. 

Next is the gentlewoman from the Virgin Islands, Mrs. 

Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. I am waiving my 

opening statement. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Gingrey. 

OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA 

Mr. GINGREY. Mr. Chairman, before I start, let me join with my 

ranking member on congratulating Mr. Shimkus as ranking member of this Health Subcommittee. 

Mr. Chairman, first I would like to thank you for calling this 

hearing today. Ensuring that medications are both safe and effective for our Nation’s patients is a goal that I believe we can all support. Whether our inquiries include pre-market and post-market 

testing of products, domestic and foreign facility inspections or 

even the authority and resources of the FDA, this committee and 

its chairman should be commended for their efforts today. 


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However, I want to focus for a moment on some troubling news 

that just came out of Britain. As some of you may have read earlier 

this week, the U.K.’s National Health Service received four independent audits on the overall state of their health care system. All 

four reports found a system that put the politics of the government 

above the health of the patient. One report based on the evidence 

of almost 200 top managers and doctors in the British system 

found that hospitals ignored basic hygiene so they could cram patients into beds to meet waiting time targets, thereby losing sight 

of fundamental hygiene requirements for infection prevention. This 

neglect of the most basic hygienic standards was credited with 

causing the deaths of 265 patients in 2005. All four reports in fact 

hit the same note: the British system placed little emphasis on patient care. Even more shocking, these reports are suppressed by 

the British government and only came to light recently. To quote 

the Times of London, ‘‘These reports diagnose a blind pursuit of political and managerial targets as the root cause of a string of hospital scandals that have cost thousands of lives.’’ 

I see the same blind pursuit of political targets in our current 

health care reform debate. For the past week, I have seen the demonization of the insurance industry. Sure, the industry needs reform. We all agree with that. But insurance reforms alone should 

not be the reason for turning health care over to our government 

lock, stock and barrel, and if the Senate bill passes, what then? 

Who is going to monitor our government when it controls all health 

care decisions? If the British are our example, will politics supersede the needs of patients here like they did in the U.K.? I fear 

that Washington politics have already trumped their needs. Our 

constituents are telling us that they want reform but not this reform. They don’t want a bill bought with political payoffs and backroom deals. Every day they echo these sentiments, yet their elected 

officials ignore them. They voted for a Republican to represent 

Massachusetts in the United States Senate and still Washington 

refuses to listen. If we cannot trust our government to put its citizens first when debating a health care reform bill, how can we expect it to safeguard their citizens’ interests when it controls health 

care? If Britain continues to be our example, I fear for the safety 

of patients if our government controls our health care choices. 

Mr. Chairman, with that I yield back. 

Mr. PALLONE. Thank you. 

Next is the gentleman from Iowa, Mr. Braley. 

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF IOWA 

Mr. BRALEY. Thank you, Mr. Chairman. I am very pleased that 

we are holding this important hearing and I am very pleased with 

the scope of the testimony that Dr. Sharfstein has laid out in his 

written materials. 

I want to begin my brief remarks by echoing the concern raised 

by my colleague from Indiana, Mr. Buyer, because one of the things 

that was very obvious to me when I visited the Custom and Border 

Patrol inspection facilities in Nogales, Arizona, and Mexico, is that 

we have an enormous problem with counterfeit drugs entering 

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trolled, which contributes enormously to the problem you have 

identified with the known points of products for non-counterfeit 

drugs. So we have got two major problems in terms of enforceability of the FDA’s mandate in counterfeit and non-counterfeit 

production facilities overseas. We also have enormous challenges in 

terms of the accountability of the manufacturers of those non-counterfeit and counterfeit drugs in this country, and one of the things 

that I hope you are able to address in your testimony is what the 

FDA is doing to promote greater accountability with those overseas 

manufacturers. 

I also want to compliment you on some of the progress has been 

made since the passage of the FDAAA because I personally benefited from one of the changes you identified in your statement 

where you describe the changes to the prescription information of 

a class of antibiotics to warn about the risk of tendon rupture. I 

have experienced a ruptured Achilles tendon, and when I was prescribed those antibiotics, as a patient I was given informed information to make a choice about whether or not to take that antibiotic in light of my own health history. So I can tell you that if 

consumers are presented with information that allows them to 

make the choices that are best for them based upon their own 

unique health conditions, the FDA is fulfilling the mandate that 

you set forth so succinctly at the beginning of your written remarks. 

But I also want to hear from you in your testimony about the 

Sentinel Initiative that you described, which you have identified as 

a national integrated electronic system for monitoring medical 

product safety. The concern I want you to address is exactly what 

model that Sentinel Initiative is based upon because I am familiar 

with other sentinel event reporting systems that have been adapted 

in this country designed to promote patient safety that have been 

woefully inadequate in reaching the level of reporting that would 

be required to truly bring about changes in patient safety. 

So I look forward to your comments. I appreciate your willingness to come here today. It is a very important subject that affects 

every American, and this is not a partisan issue, it is a bipartisan 

issue that every American should be concerned about, and I yield 

back. 

Mr. PALLONE. Thank you, Mr. Braley. 

The gentlewoman from Tennessee, Mrs. Blackburn. 

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

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

I am so pleased that we are doing an oversight hearing today. 

Oversight is something that we should doing a little bit more of, 

and I think that after we passed the FDA Amendments Act in 2007 

that was supposed to help streamline some of those processes and 

procedures that it is important that we come back and look at what 

is happening with the efficiencies in this area as well as to look at 

the relationship between the FDA and industry, and some of my 

colleagues have mentioned some of the conflict-of-interest questions 

that we will have. 


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I also hope that today we are going to look at whether or not the 

FDA has the appropriate resources as well as the institutional will 

to continue to evolve and review processes that are in place, and 

I know, Dr. Sharfstein, that you are very well aware that with the 

inspections process with NDA and ANDA, we hear from constituents who may have questions or concerns as they have gone 

through that process. So I think that is something we need to jointly look at to see is this review process working and how do we simplify it, how do we look at time, money, the usage as well as public 

safety. So I thank you for your willingness to look at that. 

The other point that I hope we look to is FDA’s internal problems 

and see if those have improved not only with the decision-making 

process but also the oversight and the post-market drug safety 

issues that are out there, the counterfeit, and then let us also touch 

on one of the things we have talked about repeatedly over the last 

few years which is your interagency communications and the different divisions and how they are transferring that information. 

Repeatedly we have seen this as a roadblock or being cited as well 

we didn’t know they were doing. So I hope that you will take a moment to address that. 

I thank you for being here with us. We welcome you. 

Mr. Chairman, I yield back. 

Mr. PALLONE. Thank you, Mrs. Blackburn. 

And next, the gentlewoman from California, Ms. Eshoo. 

OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Ms. ESHOO. Thank you, Mr. Chairman. This is an important 

hearing, and I thank you for having it. 

Before the FDA was created about a century ago, taking drugs 

was a real gamble. There were elixir potions that were sold door 

to door and ‘‘medicines’’ were really taken at one’s own risk. Today, 

as was stated previously and we all know, there are millions of 

Americans that take drugs to prevent, to treat and to cure ailments 

from the common cold to cancer, and the science and technology 

progresses and I see every day the new things that surface in my 

Congressional district and certainly around the country, so do the 

complexity of drugs as well as our ability to regulate them and ensure their safety. So I think that the FDA is the gold standard in 

the world and I think that we all want the FDA to remain the gold 

standard in the world. The recent heparin incident was a stark example of what happens when that standard is not followed and it 

cost 81 American lives. Lapses in drug safety not only harm patients but they cause the public, and I think this is really an important outcome of this, it causes the public to doubt the government’s ability to actually ensure safety. So we have to maintain the 

trust and the support of the American people who rely on safe and 

effective drugs. 

I am very pleased to see Dr. Sharfstein here today. I would like 

to know about how the FDA is implementing two provisions that 

I offered in the Food and Drug Administration Amendments Act to 

renew and improve the Best Pharmaceuticals for Children Act, the 

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sions, as you know, were designed to improve drug safety for children in two ways. First, under the BPCA, the legislation provided 

an incentive for a drug of the innovator company agrees to undertake comprehensive pediatric studies requested by the FDA, and 

second, under PREA, the FDA was granted the authority to require 

studies when there is a demonstrated need and the drug companies 

are required to submit a pediatric assessment. I am telling you 

what you already know. 

So my thanks to Dr. Sharfstein for being here today. I look forward to your testimony. I want to thank everyone that is part of 

helping to keep FDA as the gold standard in the world and to work 

with you and make sure that we provide the resource that you 

need in order to do that and good public policy to back it up. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

Next is the gentleman from Pennsylvania, Mr. Pitts. 

Mr. PITTS. I will waive. 

Mr. PALLONE. Thank you. 

The gentleman from Georgia, Mr. Barrow. 

Mr. BARROW. Thank you. I will waive. 

Mr. PALLONE. The gentleman from Kentucky, Mr. Whitfield. 

Mr. WHITFIELD. Thank you, Chairman Pallone, and I also want 

to congratulate Mr. Shimkus on his new responsibilities of this 

subcommittee, and Dr. Sharfstein, we are delighted you are here 

to bring us up to date on the implementation of this act of 2007. 

People have already touched on a lot of these issues, the safety 

of drugs coming into the country, the approval process, whether or 

not there are adequate resources, and I just want to point out one 

additional aspect of this, which is a little bit different, but this 

committee a couple years ago passed the National Prescription 

Drug Monitoring System which I think is vitally important to 

health care providers. We continue to struggle on getting sufficient 

funds to fully implement this because of an unauthorized program 

started in the Appropriations Committee but we have been working 

with both sides of the aisle to try to address that issue and I certainly look forward to your testimony on the other part of this 

equation. Thank you. 

Mr. PALLONE. Thank you, Mr. Whitfield. 

The gentleman from Connecticut, Mr. Murphy. Well, Mr. Green 

just walked in. Do you want to go first? Mr. Green. 

OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. I would like to put my full statement into the record. 

Following our chairman emeritus and the earlier statements, 

first I want to thank you for holding the hearing and today with 

new FDA folks on the current status of our drug safety system, and 

a lot of our frustrated that the Senate hasn’t moved on the bill but 

I had the opportunity like a lot of members on several hearings led 

by Chairman Pallone and Chairman Stupak, the FDA and drug 

safety over the past 2 years. All these hearings clearly show the 

FDA is woefully underfunded and neglected by Congress for far too 

many years and that has left the FDA without the resources, funding or technology it needs to protect the American public from 


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counterfeit or tainted drugs entering our country. This committee 

worked over a year on FDA drug safety legislation passed out of 

the committee. The legislation is aimed at improving our drug safety system by giving FDA increased resources for overseeing facility 

inspections by the FDA, an up-to-date registry of all foreign drug 

manufacturing facilities, country-of-origin labeling, verification of 

drug purity and safety. It gives the FDA the ability to issue fines 

and mandatory recalls, and also the FDA’s foreign drug inspection 

program needs to be changed and some hurdles to overcome. The 

FDA currently does not have the authority to conduct these inspections overseas and must be invited to a plant to conduct inspections. That is almost like me driving down the Houston freeway inviting an officer to watch me while I speed. That just doesn’t work 

in the real world. 

And Mr. Chairman, that is why I would hope with the new FDA 

that they will not only take their job seriously, and I know they 

do, but also we need to provide the resources for them, and I appreciate the opportunity to give the opening statement and again, I 

would like to have my full statement placed in the record. 

[The prepared statement of Mr. Green follows:] 


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Statement of Congressman Gene Green 

Committee on Energy and Commerce 

Subcommittee on Health 

Drug Safety: An Update from Food and Drug Administration 

March 10,2010 

Mr. Chainnan, I want to thank you for holding this hearing today with 

the new FDA folks on the current status of our drug safety system. 

I had the opportunity to participate in several hearings led by Chairman 

Pallone and Chainnan Stupak the FDA and drug safety over the past two 

years. 

All of these hearings clearly show that the FDA has been woefully 

underfunded and neglected by Congress for far too many years. 

This has left the FDA without the resources, funding, or technology it 

needs to protect the American public from counterfeit or tainted drugs 

entering this country. 

This Committee worked for over a year on drug FDA drug safety 

legislation and passed it out of the Committee. 

This legislation aimed to improve our drug safety system by giving the 

FDA increased resources for overseas facility inspections by the FDA, 

an up to date registry of all foreign drug manufacturing facilities, 

country of origin labeling, verification of drug purity and safety, and 

gives the FDA the ability to issue fines and mandatory recalls. 

Also, the FDA foreign drug inspection program needs to be changed and 

has some hurdles to overcome. 

The FDA currently does not have the authority to conduct inspections at 

will overseas and must be invited to a plant in order to conduct 

inspections and the FDA often warns plant officials before they are 

inspected. 
27 


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Additionally, the FDA does not rely on end product testing with drugs as 

they do with food products, which can detect contamination in a final 

product. Also, the FDA does not have one system to track and monitor 

foreign drug inspections. 

The FDA needs resources induding more employees, an IT system, and 

appropriate funding. In short, the foreign drug inspection program needs 

a complete overhaul in order to ensure product safety, which I know is 

something we all want. 

We passed the Food Safety Enhancement Act out of the House and I am 

hopeful we will begin work on drug safety and the FDA soon. 

Additionally, I've been a strong supporter and original cosponsor of 

legislation, Safeguarding America's Pharmaceuticals Act, which was 

proposed in the 11 oth Congress by Reps. Buyer, Matheson, and Rogers. 

This proposed legislation makes changes to help protect our nation's 

pharmaceutical supply as well. 

The proposed Safeguarding America's Pharmaceuticals Act also gives 

us one national pedigree system to allow for consistency and efficiency 

when pharmaceuticals are moving about the country. 

The bill also creates a track and trace system, that will establish a drug 

identification and tracking system through which drug manufacturers, 

repackagers, wholesale distributors, and dispensers may authenticate the 

wholesale distribution history of any prescription drug that has the 

standardized numerical identifier. 

Again, I want to thank the Chairman for holding this hearing today and I 

want to thank the witnesses for appearing before the committee today. I 

yield back my time. 
28 

Mr. PALLONE. Without objection, so ordered. 

The gentleman from Texas, Mr. Burgess. 

Dr. BURGESS. Thank you, Mr. Chairman. I will waive opening 

statement and reserve time for questions. Welcome, Dr. Sharfstein, 

to our committee. 

Mr. PALLONE. Thank you. 

The gentleman from Connecticut, Mr. Murphy. 

Mr. MURPHY OF CONNECTICUT. Thank you, Mr. Chairman, and 

welcome, Dr. Sharfstein. 

In your testimony, you recite some of the examples of safety 

lapses that we have seen and you summarize by saying, ‘‘These episodes and others are not random mistakes, they are driven by a 

common feature, which is economic incentive.’’ And I guess it underscores what we have seen as a facet of our health care system 

for a very long time. Too often, profit is being put ahead of quality 

and safety, and everything we do, whether it is changing the way 

that the FDA works or whether it is the discussion surrounding 

health care reform, has to be around reversing that phenomenon. 

We have to be putting safety and quality first, profit and cash second whether it is running the FDA, whether it is how we reimburse providers or whether it is how we regulate insurers. I don’t 

begrudge drug companies from making a buck. We have got a lot 

of very good ones in Connecticut. But we should never, ever be sacrificing safety for profit. We should never, ever be sacrificing quality for profit. That I think is the guiding principle behind health 

care reform and that of course I know is the principle that you 

bring to your leadership at the FDA, and I appreciate your testimony today. 

Mr. PALLONE. Thank you. The other Mr. Murphy from Pennsylvania. 

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

Mr. MURPHY OF PENNSYLVANIA. Thank you, Mr. Chairman. 

I would first like to mention, unfortunately I am not going to be 

able to remain here, Chairman and Dr. Sharfstein, although I 

would love to hear your testimony. You know what it is like, we 

have other things pending. 

But I would like to bring something to your attention in this, and 

if it not something you are able to respond to today, please, I hope 

you can get back to me. I wanted to tell you about a couple of my 

constituents, Russell and Robely Rosewitz in Mount Lebanon. They 

have lived a terrible tragedy. Their daughter, Hannah, was vaccinated for DPT, as you know, diphtheria, pertussis and tetanus, 

and 2 hours after she received her shot, she began experiencing seizures. She was once a healthy infant and now she needs 100 percent round-the-clock care. Unfortunately, adverse reactions to complicated vaccines do occur and years upon years of scientific evidence have shown the public health benefits of vaccination are 

greater than the isolated, unfortunate adverse action. And to encourage families to vaccine their children and ensure vaccine makers continue produce lifesaving medicine, Congress passed the National Childhood Vaccine Injury Act in 1986. This law compensates 


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victims of vaccination adverse effects and allows the Secretary of 

Health and Human Services to automatically award damages when 

a victim has experienced adverse reactions. But the DPT vaccine 

in this case was removed from the table of vaccines known to cause 

adverse events just 1 month prior to when Hannah’s family applied 

for compensation. After a 10-year legal battle to prove that the vaccine caused Hannah’s seizures, the case is now before the Supreme 

Court. Hannah’s parents believe there were safer alternatives to 

the DPT vaccine administered to their daughter. The question before the Supreme Court is whether or not companies are immune 

to civil suits if they participate in vaccine victims’ compensation 

fund. 

Now, I am not here to argue the merits of the case. The Supreme 

Court will decide whether or not that was the Congressional intent. 

But this case raises an important issue about vaccine safety. For 

example, if they are imported and the FDA is not capable of inspecting the manufacturing process, then where does the responsibility and liability for assuring safety lie? By the way, that particular DPT vaccine was later removed from the market after 50 

years of sales. 

So I hope at some point you can get back to us and let us know 

about some of these important issues. I know you are deeply concerned as are we, and quite frankly, I believe that contrary to what 

some others may say, that manufacturers also want to ensure the 

safety of their products because they do not want to see anybody 

harmed from these as well. so if you could please get back to us 

and let us know how we keep up-to-date on the latest scientific evidence here and how you are ensuring vaccine makers are using the 

latest and safest innovation in vaccine design. 

Thank you so much for being here. Again, I apologize. I wish I 

could stay because I am deeply interested in hearing your testimony, but I look forward to hearing from you. 

And with that, I yield back, Mr. Chairman. 

Mr. PALLONE. Thank you, Mr. Murphy. 

The gentleman from Utah, Mr. Matheson. 

OPENING STATEMENT OF HON. JIM MATHESON, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF UTAH 

Mr. MATHESON. Thank you, Mr. Chairman. I do appreciate this 

hearing and look forward to the testimony. 

In the coming weeks, I will be introducing a bipartisan bill with 

my colleague, Representative Buyer, to develop a system for the 

protection of our Nation’s pharmaceutical supplies for domestic and 

international counterfeiting threats. Within the past 2 years, Representative Buyer and I have engaged stakeholders all along the 

supply chain to develop a workable and commonsense approach. As 

an integral part of the stakeholder process, I also appreciate the recent helpful comments from the Food and Drug Administration and 

their suggestions of how to improve upon our approach and achieve 

our shared ultimate goal. 

Specifically, core elements of the bill that we plan in introducing 

are the creation of a system by which we will be able to track drugs 

from the time they leave the manufacturing facility to the time 

they reach patients in the pharmacy, hospital, nursing home or 


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doctor’s office. Counterfeiting of drugs is a public health concern. 

By implementing these steps now, we can go a long way towards 

safeguarding the medicine people need to get well and stay 

healthy. 

Another feature will be one uniform national pedigree system. By 

having one federal standard, I believe we can ensure our Nation’s 

drug market is efficient, it can ensure products flow safely and 

freely throughout the country. This is a guiding principle that 

seems to unite a majority of the members of the supply chain. 

Third, our bill will raise the standards for drug wholesalers while 

maintaining States’ rights to regulate drug wholesalers. I believe 

this is a necessary step to ridding the market of bad actors and ensuring that anyone handling America’s pharmaceuticals must be 

held to high standards. 

Counterfeit drugs are the latest and potentially the most dangerous front in the long-running battle against intellectual-property 

crimes. In 2007, pharmaceuticals made up about 6 percent of total 

seizures. Last year they accounted for 10 percent to become the 

third largest category with an estimated market value of $28 million. Counterfeiters are alarmingly good at their jobs. They can create pills and drug packages that are so close to real products that 

they are indistinguishable to consumers. By strengthening current 

laws and regulations, building upon the successful model signed 

into law in California, and by creating a uniform national standard, our legislation further secures the health care supply chain. 

This enhances our country’s and the Food and Drug Administration’s high standard for patient safety. 

I look forward to the witness testimony. I will yield back my 

time. 

Mr. PALLONE. Thank you. 

The gentlewoman from Colorado, Ms. DeGette. 

Ms. DEGETTE. I will submit my statement for the record. 

[The prepared statement of Ms. DeGette was unavailable at the 

time of printing.] 

Mr. PALLONE. Without objection, so ordered. 

I think that that concludes our opening statements by members 

of the subcommittee, so we will now turn to our one witness, which 

we are so pleased that Joshua M. Sharfstein is here today. He is 

the principal deputy commissioner from the Food and Drug Administration, and thanks for being here, or coming back to us, so if you 

would give us your statement, we would appreciate it. 

STATEMENT OF JOSHUA M. SHARFSTEIN, M.D., PRINCIPAL 

DEPUTY COMMISSIONER, FOOD AND DRUG ADMINISTRATION 

Dr. SHARFSTEIN. I thank you very much. It is good to be back 

here. Good afternoon, Mr. Chairman and members of the subcommittee. I am Dr. Joshua Sharfstein, the principal deputy commissioner at the Food and Drug Administration. Thank you for the 

opportunity to discuss the safety of the U.S. drug supply. 

Protecting Americans from unsafe or contaminated drugs is not 

just an important responsibility of FDA, it is our core charge. Drug 

safety was the primary reason for the passage of our guiding statute. In 1937, more than 100 people, including many children, died 

from ingesting Elixir Sulfanilamide, which contained the deadly 


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poison diethylene glycol. Congress then passed, and President 

Franklin D. Roosevelt signed, the Food, Drug, and Cosmetic Act to 

prevent future catastrophes. And yet as you know, many years 

later, the threat of unsafe drugs remains. 

I would like to thank the subcommittee for its leadership on this 

issue twice. First, thank you. There have been numerous hearings 

in this chamber have helped the public understand the challenge 

of regulating a global marketplace. And second, members of this 

subcommittee, along with the chairman of the full committee and 

the chairman emeritus, were the key architects of the Food and 

Drug Administration Amendments Act of 2007, which gave the 

agency significant new authorities and resources to address the 

safety of drugs. In this testimony, I will cover both of these important issues: import safety and the implementation of the drug safety authorities in what we call FDAAA. 

Globalization has created new risks and challenges for the safety 

of the drug supply. Where Americans once used drugs that were 

mostly manufactured domestically, now up to 40 percent of the 

drugs we take are imported, and up to 80 percent of the active 

pharmaceutical ingredients in these drugs are from foreign sources. 

This makes oversight significantly more difficult and leads to 

weaknesses through which counterfeit, adulterated and misbranded products can infiltrate the legitimate supply chain. That 

was the case with the contamination of heparin in 2007 and 2008 

and most recently with the counterfeit Tamiflu discovered during 

the H1N1 outbreak. 

When the modern FDA was created in 1938, imports were a tiny 

part of the products used in our country. Now that an estimated 

20 million shipments of FDA-regulated imports come into this 

country ever year, FDA must adopt a new approach, one that addresses product safety by preventing problems at every point in the 

global supply chain from the raw ingredient through production 

and distribution all the way to U.S. consumers. 

In the food arena, this approach to prevention is embodied in legislation passed by this subcommittee and the full House of Representatives, which is now awaiting action in the Senate. In the 

area of drugs and other medical products, we are taking a number 

of steps to begin making this shift as best we can with our current 

authorities. But there is much more to be done. 

As Secretary of Health and Human Services Kathleen Sebelius 

noted when she appeared before this committee, FDA needs additional tools to move our oversight capabilities into the 21st century. 

FDA needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain and 

have reasonable and reliable options for enforcement. 

I will now turn to the drug safety authorities in FDAAA, a milestone legislative achievement that has helped the agency protect 

the public health in many ways. FDAAA provided important new 

authorities to enhance our ability to monitor approved drugs after 

they are marketed and to take definitive action when needed. With 

our new authority, FDA has required drug sponsors to conduct 

around 200 post-marketing studies or trials. The agency has required safety-related labeling changes in individual or classes of 

drugs 32 times and has developed and put into place 10 evaluation 


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and mitigation strategies with elements to support safe use into 

the REMS, all with the goal of better identifying and managing the 

risk of drugs on the U.S. market. 

To give you one example, FDA has established a program to support the safe use of a product, a medication in patients with a very 

severe bleeding disorder in which the blood does not clot because 

of low platelets. This medication, however, has serious side effects 

which include blood cancers, bone marrow fibrosis, a risk of blood 

clots, and even worse platelet counts when the therapy is stopped. 

However, it is an important treatment option for patients who have 

failed to respond to other therapies. By requiring elements to ensure safe use, the benefits of the drug can outweigh the risks and 

we can provide patients access to this critical product without 

being concerned that it would be used in other patients and could 

cause them more harm than good. 

I also want to know that FDAAA also reauthorized and amended 

the Best Pharmaceuticals for Children Act, which continues to provide valuable safety and dosing information for the use of drugs in 

children. As a pediatrician, I echo the comments of Congresswoman 

Eshoo, who worked so hard on this issue. This legislation represents a fundamental shift in prescribing for the pediatric population, even since the passage of the FDAAA legislation, 109 labeling changes related to the use of medications in children. It has 

been a tremendous step forward for pediatrics. We are very happy 

to discuss the lessons we have learned over the last 2 years in implementing FDAAA and work together to fine-tune the program. 

Over the last 7 decades, so much has changed in pharmaceutical 

science and drug regulation, yet in 2007, when scores of patients 

died from contamination of medications in Bangladesh, and in 2006 

when children died in Panama, the culprit was familiar. It was 

diethylene glycol, the very same poison that had led to the passage 

of the Food, Drug and Cosmetic Act in 1938. 

FDA’s work is far from done. The scientists, doctors, nurses, inspectors and other public health professionals, some of whom are 

here with me today, who make up FDA thank you for your support 

for our mission. 

I appreciate the opportunity to testify today and am happy to address any questions you may have. 

[The prepared statement of Dr. Sharfstein follows:] 


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~,n>'l~l. 

( ~ DEPARTMENT OF HEALTH AND HUMAN SERVICES 

".~}i.-

STATEMENT OF 

JOSHUA M. SHARFSTEIN, M.D. 

PRINCIPAL DEPUTY COMMISSIONER 

FOOD AND DRUG ADMINISTRATION 

Food and Drug Administration 

Silver Spring MO 20993 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON HEALTH 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

MARCH 10, 2010 

FOR RELEASE ONLY UPON DELIVERY 
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INTRODUCTION 

Mr. Chairman and Members of the Subcommittee, I am Dr. Joshua M. Sharf stein, Principal 

Deputy Commissioner at the Food and Drug Administration (FDA or the Agency) in the 

Department of Health and Human Services (HHS). Thank you for the opportunity to discuss the 

safety of the American drug supply. 

Protecting Americans from unsafe or contaminated drugs is not just an important responsibility 

of FDA-it is our core charge. Drug safety was the primary reason for the passage of our 

guiding statute. In 1937, more than 100 people, including many children, died from ingesting 

Elixir Sulfanilamide, which contained the deadly poison diethylene glycol. Congress then 

passed, and President Franklin D. Roosevelt signed, the Federal Food, Drug, and Cosmetic Act 

(FD&C Act) to prevent future catastrophes. 

And yet, as you know, the threat remains. 

I would like to thank the Subcommittee for its leadership on this issue. Numerous hearings in 

this chamber have helped the public understand the challenge of regulating a global marketplace. 

Members of this Subcommittee, along with the Chairman of the full Committee and the 

Chairman Emeritus, were key architects of the Food and Drug Administration Amendments Act 

of2007 (FDAAA), which gave the Agency significant new authorities and resources to address 

postmarket safety. 

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In this testimony, I will address two important issues: import safety and the implementation of 

the drug safety authorities in FDAAA. 

IMPORTS 

As the Subcommittee's work has documented, globalization has created new risks and 

challenges for the safety of the drug supply. 

Where Americans once used drugs that were mostly manufactured domestically, now up to 40 

percent of the drugs we take are imported, and up to 80 percent of the active phannaceutical 

ingredients in the drugs we use are from foreign sources. In addition to the grovvth in the sheer 

volume of imports and foreign facilities, there has been an increase in the variety and complexity 

of imported products, and a large expansion in the number of countries involved in producing 

these products-including many with less sophisticated regulatory systems than our own. 

Simultaneously, the supply chain from raw material to consumer has become more and more 

complex, involving a web ofrepackagers and redistributors in a variety oflocations. This makes 

oversight significantly more difficult and leaves weaknesses through which counterfeit, 

adulterated, and misbranded products might infiltrate the legitimate supply chain. 

A few examples: 

• In 2007 and 2008, contaminated heparin (a blood-thinning drug) came from China and 

was linked to deaths and a number of serious allergic-type reactions here at home. 

• Counterfeit Tamiflu (oseltamivir phosphate) was discovered during the novel HINI 

outbreak. 
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• In 2007, Xenical (orlistat) capsules ordered over the Internet were found to be composed 

only of talc and starch. 

• In January 2010, counterfeit Alii (orlistat) was discovered, which did not contain the 

active ingredient but instead contained varying amounts of the stimulant sibutramine, 

which can lead to serious toxicity ifused by people with certain cardiac diseases. 

These episodes and others were not random mistakes. They share a common feature-an 

economic incentive. In the case of heparin, it appears that a contaminant was introduced to 

increase the profit ofthe raw material suppliers. In the case of counterfeit drugs, criminals can 

make millions by pretending their dangerous or inetTective products are safe and effective. These 

are despicable acts that seek profit by putting lives at risk. 

These are global problems. Contamination and counterfeit drugs represent a much greater threat 

in the developing world, where the systems of laws and regulatory oversight do not afford much 

protection. And these problems can pose a risk to us at home, when, for example, patients do not 

get fully treated for infection abroad because of ineffective drugs ... and as a result, drug 

resistance intensifies. 

When the modern FDA was created in 1938, imports were a tiny part ofthc products used in our 

country. Our focus was on stopping harmful products at the border through inspections of 

imported goods. This approach is adequate to the challenge when the volume is small. But it 

fails when an estimated 20 million shipments of FDA-regulated imports come into the country 

each year. 

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To fulfill our public health mission in a global age, FDA must adopt a new approach--one that 

addresses product safety by preventing problems at every point along the global supply chain, 

from the raw ingredient through production and distribution, all the way to U.S. consumers. 

We are moving from an approach based on reacting to problems to one that proactively prevents 

such problems from ever occurring. 

In the food arena, this approach to prevention is embodied in legislation passed by this 

Committee and the full House of Representatives, and which is now awaiting action in the 

Senate. This bill would for the first time allow FDA to establish basic preventive controls 

throughout the food production process and give the Agency strong enforcement authorities and 

resources to meet these obligations. 

In the arena of drugs and other medical products we are taking a number of steps to begin 

making this shift within our current authorities. 

First, we are seeking better controls at the point of production, wherever that may be. 

We now have permanent FDA offices in Beijing, Shanghai, and Guangzhou, China, in New 

Delhi and Mumbai, India, in San Jose, Costa Rica, Mexico City, Santiago, Chile, and soon, 

Amman, Jordan. These offices enable us to have a regional presence around the world, a home 

base from which to undertake a range of important activities, including building regulatory 

capacity. 

We now have more than 30 agreements with foreign counterparts to share inspection reports and 

other nonpublic information that can help us make better decisions about the safety of foreign 

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products. So if a shipment of contaminated drugs shows up in a port in Italy, we will hear about 

it swiftly and be on the lookout for products from the same shipper. 

Second, we are working with industry to help them strengthen the safety of their supply chains. 

In this day and age, companies should be able to effectively demonstrate that safety, quality, and 

compliance with international and U.S. standards are built into every component of every 

product and every step of the production process. 

Some companies already do a terrific job at this, tracking where and how their products and their 

components are made and the path.taken to reach our shores. In fact, I have met with some 

companies that react with incredible swiftness to questions about the integrity of their supply 

chain. Obviously they have a vital interest in ensuring confidence in the safety and quality of 

their products and their brand. These best practices need to become standard practice throughout 

industry. 

There is much more to be done. As Secretary of Health and Human Services Kathleen Sebelius 

noted when she appeared before this Committee on February 4,2010, FDA needs additional 

tools to move our oversight capabilities into the 21 st century. FDA needs to access regulatory 

information quickly, hold all parties responsible for the quality of products in the supply chain, 

and have reasonable and reliable options for enforcement. 

DRUG SAFETY AUTHORITIES IN FDAAA 

I will now turn to the drug safety authorities in FDAAA, a milestone legislative achievement that 

has helped the Agency protect the public health in many different ways. 

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Because no amount of premarket study can provide the full information about what the benefits 

and risks of a new drug will be when it is used by the general population, FDAAA provided 

important new authorities to enhance our ability to monitor approved drugs after they are 

marketed and to take definitive action when needed. 

Under FDAAA, FDA can require drug sponsors to conduct postmarketing studies and clinical 

trials, make certain safety-related labeling changes, and develop and put into place risk 

evaluation and mitigation strategies (REMS)-all with the goal of better identifYing and 

managing the risks of drugs on the U.S. market. 

Here are some details. 

Between the passage of FDAAA and March 8, 2010, FDA has required that sponsors conduct 

around 200 postmarketing studies or trials. FDA is tracking the conduct of these studies and will 

take enforcement action if studies are not conducted in a timely manner without good cause. 

With respect to label changes, as of February 28,2009, FDA had used its new authorities to 

require safety label changes in individual or classes of drugs 32 times since March 25,2008. For 

example, FDA required safety label changes (0 add the risk of a life-threatening neurological 

disorder to the prescribing information for certain antidepressants, and changes to the prescribing 

information of a class of antibiotics to warn about the risk of tendon rupture. 

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With respect to risk management, if FDA determines that a REMS is necessary to ensure that the 

benefits of a drug outweigh the risks of the drug, FDA can require manufacturers to have a 

REMS in place when a drug comes on the market, or implement one later if FDA becomes aware 

of new safety data. The authority to require REMS provides FDA a very useful set of tools that 

can be used to reduce the risks of marketed products, while allowing patients to benefit from 

lifesaving and other beneficial treatments that could not be safely marketed without a risk 

management program. 

In the design ofREMS with elements to ensure safe use (the most comprehensive REMS 

programs), FDA is mindful of the provisions in FDAAA stating that the elements to ensure safe 

use must be, among other things, commensurate with the specific serious risk listed in the FDAapproved labeling of the drug, not be unduly burdensome on patient access to the drug, and be 

designed to be compatible with established distribution, procurement, and dispensing systems for 

drugs. 

Most of the REMS with elements to ensure safe use include educating prescribers about the risks 

and appropriate use of the drug as a condition of certification or enrollment in the REMS 

program. Other programs require enrollment by pharmacists and sometimes patients as well. 

Some programs require the prescriber to monitor the patient immediately following drug 

administration and for a period of time afterwards. Each of these programs is designed to 

provide critical information to clinicians without unduly restricting access to the drugs. 

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We have learned that designing and implementing the most comprehensive REMS requires a 

careful balancing of the need to adequately manage risks and also to maintain patient access to 

important medications. Since using this authority is a work in progress, FDA is committed to 

addressing the concerns we have heard from prescribers, pharmacists, distributors, and payers 

about their roles in implementing REMs and from patient groups about the effects ofREMS on 

access to needed products, and are planning to hold a public meeting to hear from these and other 

stakeholders. 

Additional implementation challenges include ensuring consistency in the handling of safety 

problems with all products, including over-the-counter (OTC) products and generic drugs; the 

lack of clarity in certain provisions of the law with respect to REMS; and burdens imposed on 

application holders and FDA that do not contribute significantly to drug safety. We would be 

very happy to discuss the lessons we have learned over the last two years with Congress and 

work together to fine tune the program so that it can be even more effective in improving public 

health. 

Sentinel Initiative 

FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data 

sources and to establish a postmarket risk identification and analysis system to link and analyze 

health care data from multiple sources. On May 22, 2008, FDA launched the Sentinel Initiative 

with the ultimate goal of creating and implementing the Sentinel System-a national, integrated, 

electronic system for monitoring medical product safety. The Sentinel System, once up and 

running, will enable FDA to actively gather information about the postmarket safety and 

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performance of its regulated products-a significant step forward from our current, primarily 

passive safety surveillance systems. The law sets a goal of access to data from 25 million 

patients by July 1,2010, and 100 million patients by July 1,2012. 

FDA has gathered public input on issues related to the creation and development of Sentinel, 

held numerous meetings and a public workshop, and established a working group consisting of 

representatives of numerous federal agencies to share information and discuss issues related to 

ongoing efforts that are complementary to Sentinel. FDA has awarded key contracts for a pilot 

project to gather information that will be essential to fully implementing the Sentinel System. 

Track and Trace 

FDAAA also required the development of standards for the identification, validation, 

authentication, and tracking and tracing of prescription drugs as a step towards further securing 

our nation's drug supply. Very shortly, FDA will issue a guidance establishing a standard for 

unique identification for prescription drug packages, which ultimately will help in identifying the 

whereabouts and authenticity of drug packages and distinguish them from counterfeits. 

SAFE USE INITIATIVE 

Before I close, I would like to briefly mention a new drug safety initiative at FDA called the Safe 

Use Initiative. Every approved drug has both benefits and risks. Underlying FDAAA is the 

principle that Congress wants to see the benefits maximized for patients and the risks minimized. 

We all want patients to get better on medication and avoid unncccssary injuries, even death, as a 

result of preventable medication errors or misusc. 

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In November 2009, we annonnced the lannch of FDA's Safe Use Initiative. Through this 

initiative, FDA will identify, using a transparent and collaborative process, specific candidate 

cases (e.g., drugs, drug classes, and/or therapeutic situations) that are associated with significant 

anlOunts of preventable harm. FDA will then work with hospitals, doctors, nurses, patient groups 

and others to recognize and mitigate these risks. In a voluntary complement to the REMS 

program, we will use our understanding of drug risk as a tool to gather partners together and 

develop and implement strategies for progress. 

CONCLUSION 

Over the last seven decades, so much has changed in pharmaceutical science and drug regulation. 

Yet in 2007, when scores of patients died of contamination in Bangladesh, and in 2006 when 

children died in Panama, the culprit was familiar. It was diethylene glycol, or DEG-the very 

same poison that had led to the passage of the FD&C Act in 1938. 

FDA's work is far from done. The scientists, doctors, nurses, inspectors, and other public health 

professionals who make up FDA thank you for your support and confidence in our mission. 

Thank you very much for the 0ppOltunity to testify today. I welcome your ideas and your 

questions. 

11 
44 

Mr. PALLONE. Thank you, Dr. Sharfstein. I appreciate your testimony. It is good. We are just going to have questions, as you know, 

alternating between the Ds and the Rs, and I will start out. 

I mentioned in my opening statement that this committee 

worked very hard to pass the Food and Drug Administration 

Amendments Act of 2007. We call it FDAAA. And as part of 

FDAAA, Congress gave FDA the authority to require manufacturers to implement the so-called REMS, or Risk Evaluation Mitigation Strategies. They can require REMS when the agency believes 

it is necessary to ensure that a drug’s benefits outweigh its risks. 

So I wanted to ask you initially, could you provide the committee 

with an update on how FDA has made use of this authority, how 

many REMS have been required and approved, and what has been 

the public health impact of REMS? 

Dr. SHARFSTEIN. Sure. There are about 80 or 90 REMS that have 

been approved since the passage of the legislation. The vast majority of those are called medication guide only REMS where the 

REMS just consist of the fact that we have a medication guide for 

patients about the drug. 

There are about 10 REMS for 10 drugs that have what we call 

elements to assure safety. This is sort of the next level of control, 

and that can include restrictions on which pharmacies can provide 

the medication, whether the doctor needs special training and 

whether there needs to be a patient registry, and these have been 

used for medications for seizures, for the low platelets that we were 

talking about before, for medications for schizophrenia, and they 

really make it possible for FDA to approve the treatment because 

without this ability to put some restrictions and some safeguards 

in place, we would be very worried that these medications could do 

more harm than good. I think that this is very clearly a work in 

progress. 

There are certain things that in the implementation of this provision we have learned about. One of the issues is the differential 

treatment between generic medications and brand-name medications when it comes to communication plans. We can require that 

companies that make brand-name drugs do communication plans 

for health care professionals but when it comes to generic drugs, 

the FDA would have to pay for and run the communication plan. 

So there are a few specific issues, and I am happy to talk about 

them more if you want, where we think that we could be more effective with REMS. One of the others is that we have the authority 

to require a REM but we don’t necessarily have the authority to 

require a specific type of REM, so that leads to negotiations that 

can go on for a while between the company and FDA, and recently 

we did a REMS for certain medications that can stimulate the bone 

marrow that took, you know, over a year to develop. 

So I think that there are definitely areas where this could be improved but in general our view is that this is a tremendously important authority and we are really making a lot of progress with 

it. 

Mr. PALLONE. Well, I want to use an example of a drug that 

came to my attention, and I heard you say you have the authority 

to require REMS but not a particular type, and I would like you 

to comment on that. But let me throw this example out and then 


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I don’t know if this relates to what you said about the type, and 

I would like you to answer that too so maybe give me a response 

to that, what you mean by type that you don’t have the authority 

but also this example. I am using as an example that there are 

three types of fast-acting Fentanyls, I guess is the way, or rapidonset opioids, on the market right now, and I think it is an example where REMS would be critically important because these are 

extremely powerful pain relievers or opioids intended to treat 

breakthrough pain in adult opioid-tolerant cancer patients but a 

dose in a non-tolerant patient could be deadly. So it is my understanding that one of these products has a REMS with very different elements from the REMS that is required of the other two. 

For example, the REMS dictates that only especially trained, tested 

and registered health care professionals can actually prescribe the 

product and distribution and dispensing must be done through a 

specially trained and registered distributor and/or pharmacist. So 

explain why there would be differences between the elements of 

REMS for these three fast-acting Fentanyls, and does that relate 

back to what you said before about how you can only require the 

REMS but not different types? 

Dr. SHARFSTEIN. It does relate back to that, and I don’t think all 

of them have what we would call formal REMS. Some of them are 

sort of in the intermediate stage because they had a risk management program in place when the Act was passed. But I think for 

the purpose of your question, it definitely relates to what I was 

saying. The way the law works is, it says that we need to take 

steps to assure safe use, and the company comes to FDA with a 

proposal on how to accomplish that, and there may be more than 

one path to get to that goal. One company might say, you know, 

the path that we want to take is to really work through a series 

of just a couple pharmacies or a central pharmacy. Another might 

want to put particular restrictions on which physicians so that we 

have the responsibility of making sure that they work. We are not 

going to approve something that we don’t think is going to hit the 

mark. But they won’t necessarily all look exactly the same. 

In the case of the Fentanyl products, there is one that is for a 

film that does restrict the pharmacies, and there is another that 

is more of a lollipop that you put in the mouth and that one has 

an older risk management plan that we haven’t announced the 

form REMS for. 

Mr. PALLONE. Well, then, does this difference in authority make 

sense to you or would you like to have the power to dictate the 

type? 

Dr. SHARFSTEIN. Well, I think it is very important for us to work 

with companies to come up with something that works and, you 

know, there is no question there is a lot we learn from the inner 

chains of companies and what we can hear from others, but I think 

that it is—when you find that it is taking a long time to come to 

agreement and when there may be a level of consistency that we 

would like to see if one approach really makes sense, I think that 

we would be very open to discussing ways that we could be able 

to more effectively move to closure on REMS in a way that makes 

sense for public health. 


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Mr. PALLONE. Well, my time has run out, but I have to say, this 

is kind of disconcerting to me, the fact that you don’t have the ability to dictate the type and therefore we end up with these big differences, but I guess we will have to take it up at another time because I want to move to my ranking member, Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I am going to follow up 

on this line of questions also on the REMS. 

So I think the last question was, the time it takes in negotiations. We see that across the board in the federal government, and 

we always say that there should be a stop clock, a backstop that 

eventually there is a time when you have to make a decision. You 

let the folks negotiate but eventually you have got to get the closure. Would a backstop provision be helpful? 

Dr. SHARFSTEIN. You know, some of the REMS that we are putting into place are coming at the time of approval, and there is a 

lot of incentive for the company to get its drug approved, and with 

REMS, the standard is, we wouldn’t approve the drug without it. 

So—— 

Mr. SHIMKUS. So they have an incentive to get an agreement? 

Dr. SHARFSTEIN. Those are happening, but it is when the drug 

is already marketed—— 

Mr. SHIMKUS. Well, let me go to the generic/brand name. You did 

allude in your opening testimony that there is a difference between 

your ability to effect, I thought I heard, negotiations between a generic and a brand name. Can you clarify that a little better? 

Dr. SHARFSTEIN. Sure. That relates to this provision about communication plans, so one of the things that we can do is require 

a company to make certain communications to health care professionals. 

Mr. SHIMKUS. Why can’t that be placed on the generic producer 

of the drug? 

Dr. SHARFSTEIN. Someone is going to tap me on the shoulder if 

I get this wrong, but I think that the law doesn’t allow us to do 

that for generics. 

Mr. SHIMKUS. So the issue would be a responsibility for us to address if we are going to move forward to help assist that. OK. 

Thanks. 

The other question I wanted to talk about was also alluded to in 

my opening statement, and in the FDA Week Inside Washington 

on January 22nd, on the second page it says, ‘‘As FDA struggles 

with whether to relax conflict-of-interest policies that have made it 

difficult to fill slots in the pharmaceutical advisor panels,’’ so you 

all, the FDA, is saying we have problems filling these slots. We 

have a tendency, the unforeseen consequences of legislation, and I 

think what we are seeing to some extent is these advisory panels 

because of which we can’t fill. We pulled up from the Web site gastrointestinal drug advisory committee where there is five openings 

that you all identified. Our office has personal experience with 

someone who had a catastrophic death because of this. What do 

you tell us and is there anything we need to do ease legislatively? 

I mean, the response was to make sure there was no conflict of interest and people weren’t benefiting from their advisory role while 

benefiting financially but we have got to be careful that we don’t 

go overboard and that we lose all this expertise. You alluded to 


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some of that in your opening statement. What can you tell us and 

what advice can you give us? 

Dr. SHARFSTEIN. Sure. Well, this is an issue which clearly requires a balance and it is a balance that Congress faced in writing 

the law, it is a balance that the agency faces. On one hand, we 

clearly would prefer advisors who don’t have conflicts of interest 

and it is really important for us to look for qualified advisors who 

don’t have a conflict of interest. On the other hand, the agency 

needs to get the best advice in order to make the best decisions, 

and there are certain situations where the people who have the 

best advice and unique expertise are going to have conflicts of interest. We have got to somehow, you know, balance those two 

things, and I think the bill did a very good job and gives the agency 

some leeway to figure out how to do that, and within the scope of 

what the legislation has done, it gives us the ability to figure out 

the right spot, and I will be more specific. The legislation sets a 

cap on the number of waivers that we can have for advisory committees, and that cap goes down over time. I think it is somewhere 

in the ballpark of 13 percent. But we are right now well under 

that. I think we are granting waivers, like 4 to 5 percent of the 

people who are on the advisory committees are getting waivers. So 

without changing the law, we have the ability if we think that it 

is important to get certain members to grant more waivers. If—— 

Mr. SHIMKUS. Well, let me ask a question because my time is 

running. On this from the FDA Web site, you have quite a few vacancies listed there. Now, I don’t know what to relate that to you 

because I didn’t pull up the previous month or I didn’t look at last 

year’s. Is this excessive vacancies? I mean, we have got anywhere 

from 21 in one of the areas. Well, in fact, pharmaceutical science, 

there are 21 vacancies. Advisory committee reproductive health 

drugs, there are eight vacancies. There are nine in drug safety and 

risk management. That looks like there is a lot of vacancies, and 

if that is, then maybe we need to—— 

Dr. SHARFSTEIN. Right. Well, I don’t like vacancies on the advisory committees. We definitely want to fill them. I actually asked 

the advisory committee dean whether they felt that there were 

more now, and they said that they have always had vacancies. 

They couldn’t say that there are more now. Having said that, I 

think it is important for us to strike the right balance, and it is 

not a question for the statute because the statute gives us more 

room. If we feel the right decision is to grant people more waivers, 

we have got plenty of room under the statutory cap. It is really up 

to what the people at FDA want to do. I think the way Dr. Hamburg and I are looking at this is, there are situations where it is 

important for us to get the best advice from someone who requires 

a waiver. We need to take into account the type of conflict they 

may have, the type of decision that is being asked for and make 

a decision, but we understand that that will be necessary. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

Thank you, Doctor. 

Mr. PALLONE. Thank you. 

Chairman Dingell. 

Mr. DINGELL. Thank you. 


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Dr. Sharfstein, I want you to understand these are friendly questions. I want yes or no answers. You are familiar with the heparin 

crisis which caused 81 American deaths. Does FDA currently have 

the adequate resources, personnel authorities to prevent another 

heparin crisis? 

Dr. SHARFSTEIN. No. 

Mr. DINGELL. Do you have the ability to control the safety of imported pharmaceuticals? 

Dr. SHARFSTEIN. Not to the extent we would like. 

Mr. DINGELL. Do you have the authority and resources to address the safety of components now being imported into this country? 

Dr. SHARFSTEIN. No, not to the extent we would like. 

Mr. DINGELL. Do you have the authorities and resources to see 

to it that good manufacturing practices are properly observed overseas? 

Dr. SHARFSTEIN. No, not to the extent we would like. 

Mr. DINGELL. Would you please submit to the committee the 

number of people that you have at the different ports to assure the 

safety and the inspection of pharmaceuticals coming into this country, and also would you give us the number of people that you need 

to see to it that this is done? Please submit that for the record. 

Dr. SHARFSTEIN. Sure. 

Mr. DINGELL. Do you have adequate authority to keep out unsafe 

drug shipments at the border? 

Dr. SHARFSTEIN. No. 

Mr. DINGELL. Do you have authority to require manufacturers to 

assure the safety of their supply chain? 

Dr. SHARFSTEIN. No. 

Mr. DINGELL. Do you have the authority to see to it that good 

manufacturing practices are observed in this country in both food 

and drugs and abroad, yes or no? 

Dr. SHARFSTEIN. Not to the extent we would like, no. 

Mr. DINGELL. Does FDA have the authority to require mandatory 

drug recalls? 

Dr. SHARFSTEIN. No. 

Mr. DINGELL. Now, do you have authorities, or rather do you 

have cooperative management agreements or letters of cooperation 

between Food and Drug, the Department of Homeland Security and 

other agencies that have personnel at the points of entry? 

Dr. SHARFSTEIN. We do work closely with other agencies at the 

point of entry. 

Mr. DINGELL. Do you have the—— 

Mr. PALLONE. Mr. Dingell, excuse me. Can you speak more into 

the mic because I can barely hear you. 

Dr. SHARFSTEIN. I am sorry about that. 

Mr. PALLONE. That is all right. 

Mr. DINGELL. Do you have adequate authority to require mandatory drug recall? 

Dr. SHARFSTEIN. No. 

Mr. DINGELL. Do you need that authority? 

Dr. SHARFSTEIN. We would like that authority, yes. 

Mr. DINGELL. Would you like it, or do you need it? 

Dr. SHARFSTEIN. I would say we need it. 


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Mr. DINGELL. You have also the legislation down there in H.R. 

759 which gives you additional authorities that was introduced by 

Mr. Pallone, Mr. Stupak, Ms. Sutton, Ms. DeGette and I. That 

would give you significant authorities to address your current lack 

of capability. Is that right? 

Dr. SHARFSTEIN. That legislation has some very important elements, yes. 

Mr. DINGELL. It would also give you the resources which you 

need of a financial character by enabling you to collect fees from 

both manufacturers of food and from pharmaceuticals. Is that 

right? 

Dr. SHARFSTEIN. It does have that provision, yes. 

Mr. DINGELL. And you can do that both at home and abroad. Is 

that right? 

Dr. SHARFSTEIN. I believe so, yes. 

Mr. DINGELL. And are those resources and those fees included in 

your budget submissions to the Congress that the Administration 

has submitted? 

Dr. SHARFSTEIN. I don’t believe so. 

Mr. DINGELL. You don’t? I understood they were. 

Dr. SHARFSTEIN. I am sorry. For food, it is, yes. 

Mr. DINGELL. For food? 

Dr. SHARFSTEIN. Yes, for food. 

Mr. DINGELL. How about pharmaceuticals? 

Dr. SHARFSTEIN. I don’t believe so, no. 

Mr. DINGELL. But that is built into your budget with regard to 

food? 

Dr. SHARFSTEIN. Correct. 

Mr. DINGELL. Now, it is a curious situation that I have observed 

that you were in the awkward place at Food and Drug of having 

somebody being able to bring unsafe foods into the United States 

and you can’t catch them at the point of entry. But you also have 

the problem if you do catch them, you don’t have authority to seize, 

impound or to destroy. Is that right? 

Dr. SHARFSTEIN. Yes. 

Mr. DINGELL. So you send them back out. That is right? 

Dr. SHARFSTEIN. I believe so. Often that is what happens. 

Mr. DINGELL. And they then bring them back in. Is that right? 

Through another port of entry. 

Dr. SHARFSTEIN. I think they can try, yes. 

Mr. DINGELL. Do you have that same problem with regard to 

pharmaceuticals? 

Dr. SHARFSTEIN. Yes. 

Mr. DINGELL. So that problem exists in both places. Now, you 

have problems with unsafe commodities being brought in, foods 

and pharmaceuticals, and you also have some that are overaged, 

improperly stored, contaminated, filthy, improperly packaged, 

counterfeit, and you also have some that are full of inert substances. You mentioned talcum powder and things like that coming 

in. Do you have authority to deal with those? 

Dr. SHARFSTEIN. We have some authorities but not enough. 

Mr. DINGELL. Do you have enough? 

Dr. SHARFSTEIN. We don’t have enough. 

Mr. DINGELL. As proven by heparin. 


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Dr. SHARFSTEIN. Yes. 

Mr. DINGELL. And of course, you have coming into this country 

from China on a fairly regular basis, from Mexico and other places, 

unsafe foods and pharmaceuticals and I can recall mushrooms, I 

can recall berries, I can recall tomatoes and jalapeno peppers. I can 

recall the heparin scare and a large number of others. This an ongoing and continuing problem, is it not? 

Dr. SHARFSTEIN. Absolutely. 

Mr. DINGELL. And you lack the Congressional support in both 

authority and money to do the job that you need to do to protect 

the American people. Isn’t that right? 

Dr. SHARFSTEIN. Well, we very much want to do more. 

Mr. DINGELL. I don’t want you to be afraid to say that we haven’t 

given you the authority you need—— 

Dr. SHARFSTEIN. We want more authority. 

Mr. DINGELL [continuing]. If it is the truth because we are going 

to try and get it for you. 

Mr. Chairman, I thank you for your courtesy. 

Mr. PALLONE. Thank you, Mr. Dingell. 

The gentleman from Pennsylvania, Mr. Pitts. 

Mr. PITTS. Thank you, Mr. Chairman. Going back to this concern 

for counterfeit drugs, there is a growing global threat from counterfeit medicines. For example, in 2008, counterfeit medicine article 

seizures rose 118 percent in the European Union, and 8.9 million 

counterfeit medicine articles were seized by E.U. customs officials. 

Over just a 2-month period in 2008, the European Commission 

seized 34 million counterfeit pills including antibiotics, cancer, cholesterol and antimalaria medicines. Does this staggering increase 

in counterfeiting in places like the E.U. present concerns to the 

United States, and can you quantify it for us? 

Dr. SHARFSTEIN. It definitely does present concerns, and I think, 

you know, the problems with counterfeit products, first of all, they 

can be dangerous in and of themselves, but second of all, they can 

fail to treat the condition that the patient has and the patient can 

get much sicker if they are taking medicines that are ineffective or 

subpotent. So it presents a serious problem and I think the problems that we see globally are very much a potential threat to the 

United States. 

In terms of quantifying, I can’t unfortunately quantify how many 

counterfeits are in the United States. We do that reports that we 

have been investigating have gone up over the last 2 years so that 

our investigators at FDA are hearing about this problem more, but 

we do think that in general we do not have a huge problem with 

counterfeit in part because we have a closed—a generally closed 

system. When pharmacies order medications, they can get them 

through licensed wholesalers, they can get them from licensed 

manufacturers, but we know that there are ways for other products 

to enter the legitimate supply chain and that makes us concerned. 

You may remember in 2003 there were several million, I think, 

pills of Lipitor that were counterfeit that got into pharmacies, and 

there are other problems too. Recently we had a situation where 

a truck full of insulin was stolen and then the insulin started 

showing up later, and we didn’t know whether the insulin had been 

adequately refrigerated and it had sort of reentered the supply 


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chain in a way that could potentially have been quite dangerous to 

patients. So there is no question that the problems seen around the 

world are of concern to us and we think that we do need additional 

work here to really secure the supply chain in the United States 

against this potential threat. 

Mr. PITTS. When the U.S. authorities interdict counterfeit drugs 

here in the United States, what occurs? What is done with those 

drugs? 

Dr. SHARFSTEIN. When we actually find the drugs and we know 

that they are counterfeit? I am not sure, but I think they are destroyed. If we identify products that are, you know, in the supply 

chain that are counterfeit, I can double check, but I think they get 

destroyed. 

Mr. PITTS. Where are the major gaps, in your opinion, as far as 

interdiction of counterfeit drugs here in the United States? 

Dr. SHARFSTEIN. The major gap is that we don’t require a pedigree for the product to go all the way from the manufacturer to the 

final sale. If people are ordering from the right places, they can get 

medicines that are safe and not counterfeit. There are opportunities for counterfeit products to potentially get in without a clear requirement where we are holding each person in the chain responsible for making sure that they only have legitimate products. So 

the kind of provisions that we would like to see are that each person in the supply chain as it goes from the manufacturer to the 

wholesaler, they are responsible. If they let something in that is 

not legitimate, then there is a real penalty for that and every single person in the supply chain, every single company is responsible 

for making sure those products are legitimate, and that would require a new authority. 

Mr. PITTS. Do you have a regular system or procedure for testing 

drugs that are coming in the United States that you pursue? 

Dr. SHARFSTEIN. We do do some tests. We do some targeted sampling based on where we think the risk is but it is really only a 

small part of the solution, the testing. There is no way we could 

test our way out of the problem just because of the sheer volume 

of imports. 

Mr. PITTS. What is the greatest need that you have as an agency 

as far as addressing this problem? 

Dr. SHARFSTEIN. I think the greatest need is the ability to enforce the supply chain requirements across the supply chain. You 

know, we have been working on and are about to come out with 

a process for unique numbers for each kind of bottle of pills but we 

don’t have the authority to say you are responsible for making sure 

that every person when they get the medication that it is legitimate medication. That is what we would like. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. SHIMKUS. Would the gentleman yield for one second? 

Mr. PITTS. I will yield. 

Mr. SHIMKUS. But that discussion was all about the legal distribution chain. You haven’t even addressed the illegal Web sites 

and the illegal mail order sites that if some senior goes on a Web 

site, clicks on 90-day supply of Lipitor and it gets mailed to them, 

there is no way. We don’t know. Is that correct? I mean, that was 


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a good discussion about legal process, of all the good actors. I think 

the concern that most of us have is the bad actors. 

Dr. SHARFSTEIN. We have brought some cases recently against 

bad actors and legitimate chain and the ability of products to infiltrate the legitimate supply chain is something that we need to be 

very vigilant about, but you are right. You are raising a separate 

issue that is very important and I think this gets a little bit to the 

issue that Congressman Buyer and Congressman Matheson were 

raising about destruction authority and other things, and that is 

also an issue that we care about. 

Mr. SHIMKUS. Yes, and I only bring it up because there is really—I agree with your statements but I think for both of us it is 

that other issue that has us more concerned than anything. 

I appreciate the gentleman yielding. 

Mr. PITTS. Thank you, Mr. Chairman. I yield back. 

Mr. PALLONE. Thank you. 

The gentlewoman from the Virgin Islands, Mrs. Christensen. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and thank you for 

holding this hearing, and welcome back, Dr. Sharfstein. 

First of all, I can attest to the fact to the answer to Chairman 

Dingell’s question about collaboration with other agencies because 

Customs and Border Protection acts on behalf of FDA at the Puerto 

Rico transit station—and your staff knows where I am going, I can 

see them nodding—to confiscate medication going to and from the 

Virgin Islands, but I am not sure if you are aware of this problem 

but I have to bring it up, and your staff is aware of it. We are outside of the U.S. customs zone. We are fully part of the United 

States. We are outside of the U.S. customs zone. All of our pharmacists are U.S. trained, and while they are locally licensed, they 

have their U.S. DEA license and are governed like the Virgin Islands are in general by all the U.S. laws and they are governed by 

all FDA rules and regulations. They order their medication including my hospital pharmacies, which are also overseen by JCAHO 

and CMS. They order their medication from distributors in the 

States. These are either U.S.-made medication or something that 

FDA has approved for importation into the United States. They 

cannot send it back to their distributor. They are prohibited because we are outside of the customs zone from sending it back to 

their distributor if they are oversupplied, if they are damaged, if 

they are expired. It is an extreme burden on my pharmacies. My 

hospital pharmacies were cited by one of the certifying agencies for 

having too many expired drugs in the pharmacy. 

If we could craft some narrow language, and we have tried, that 

would just allow our pharmacies to send their medication back to 

the place that they brought it from, would you be willing to take 

a look at that? 

Dr. SHARFSTEIN. Absolutely, and I do recall your raising this 

issue before and I know that there are people at FDA who have 

been actually in touch with entities in the Virgin Islands to work 

on this. 

Mrs. CHRISTENSEN. Yes, we have had some conference calls. 

Dr. SHARFSTEIN. So I am extremely sympathetic to the situation 

that they were in and I think we would like to find a solution. 


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Mrs. CHRISTENSEN. I appreciate that. And the other question is 

about importation. Well, I don’t consider ours importation or reimportation of drugs because they are U.S.-made drugs, U.S. pharmacies, it is U.S. jurisdiction. But Congress and FDA acknowledge 

that there have been numerous safety issues related to drug importation, and I voted against it when I had the opportunity. One of 

the issues I am concerned about from a safety perspective is the 

importation of products subject to the REMS requirements that 

have been discussed in other ways here today. Does the FDA support this posture that they can be reimported subject to the REMS 

requirements, and how does FDA view the reimportation safety 

concerns as they relate to the REMS process? And would FDA ever 

under any circumstances consider an exemption of certain drugs 

under reimportation policy if it would lead to the obfuscation of the 

REMS requirements? Is that clear? 

Dr. SHARFSTEIN. I think I understand. You know, the Administration supports finding a safe and effective way for patients to obtain medications from other countries but it is a challenge because 

there are a lot of safety concerns, and certainly one of the safety 

concerns that would have to be overcome is trying to figure out 

what to do with the products that have a narrow therapeutic window. Another way of saying that, where you are worried that they 

could actually do more harm than good where you have a REMS 

in place or other medicines where it depends on how they are used, 

and that very much would be an issue for us, I think, and we 

would not want people to get medications without the kind of controls that are needed to ensure their safe use. 

Mrs. CHRISTENSEN. Is there something that we need to do to, or 

is there something the improvements that need to be made or becoming more assured of the safety and use of the REMS process? 

Is there something that we need to do? Is there something that 

FDA can do administratively? 

Dr. SHARFSTEIN. I don’t think there is an issue before Congress 

on this point right now, but if there is, we can be in touch. But I 

think the premise of your question that there are certain drugs we 

have to be very careful about, that does underlie FDAAA and that 

is something that FDA feels very strongly about. 

Mrs. CHRISTENSEN. Thank you. 

Thank you, Mr. Chairman. 

Mr. PALLONE. Mr. Burgess. 

Dr. BURGESS. Thank you, Mr. Chairman, and again, Dr. 

Sharfstein, thank you for being with us and staying with us late 

this afternoon. 

On the issue of resources, we have heard I don’t know how many 

times in this committee and the Subcommittee on Oversight and 

Investigations about inadequate resourcing of the agency and that 

the resources haven’t kept pace with the increase in demands 

placed on the FDA, the fact that now you are having to really function as almost a global agency with budgets that 10 years ago 

seemed adequate but now you seem significantly underfunded. It 

always happens. In fact, I was on this committee for several years 

before I realized that the funding actually comes from the USDA 

appropriations bill, not through HHS. That funding structure someVerDate Mar 15 2010 08:51 Nov 27, 2012 Jkt 076015 PO 00000 Frm 00059 Fmt 6633 Sfmt 6633 E:\HR\OC\A015.XXX A015

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thing that you all have to deal with but should we consider some 

way modernizing how Congress funds the FDA? 

Dr. SHARFSTEIN. You know, I think over the last few years FDA 

has gotten a tremendous amount of new resources and the subcommittees, both of which I testified at last year, were extremely 

supportive of the agency, and the agency really has been using 

those resources to develop a real foundation for the future on these 

issues. I think that it is not just resources that are an issue when 

it comes to an issue like safe drugs and imported safe drugs. We 

need to be able to secure the supply chain, hold people in the supply chain accountable, set good standards—— 

Dr. BURGESS. I don’t mean to interrupt you, but I will run out 

of time here. 

Mr. Chairman, if you will just make note that the witness testified that they have all the money they need and Congress does not 

need to supply any more. 

But it begs the next question, and I know it is a drug safety 

hearing, but you must get a tremendous volume of new drug applications. Is that correct? 

Dr. SHARFSTEIN. I think that there is a tremendous amount of 

work when it comes to the new drug applications and additional indications for existing drugs, so there are a lot of different types of 

applications that the agency has to handle, yes. 

Dr. BURGESS. Do you have any idea as to the magnitude of the 

backlog? 

Dr. SHARFSTEIN. Well, there is not really a backlog when it 

comes to the new drug applications. We are on a clock and we do 

our best to hit the goals of reviewed timetables. When it comes to 

generic drugs, there is a backlog. It is a different type of review 

process, a different type of application, and there are several thousand applications that are kind of in the queue to be approved. 

Dr. BURGESS. Well, for example, we got funding for the National 

Institute of Health in the stimulus bill, a significant amount of 

money, and the idea was, of course, to generate new research and 

new discoveries. Do you have what you need to keep pace with the 

rapidity of those new discoveries and new developments? 

Dr. SHARFSTEIN. That is an excellent question, and slightly different than just reviewing the applications. I think that FDA, and 

Dr. Hamburg has been very engaged on this issue. We feel that the 

agency needs to do a lot more to be able to review the products of 

the 21st century, and that involves updating and upgrading our 

scientific standards for review and it involves a lot of needed investments, not just by the government but by academia and others, 

in what we call regulatory science, which is the science of how you 

know whether something is safe and effective. For example, we 

want to be able to identify a safety problem very quickly in the lab 

and not have a company spend all this time and money in development and then find the safety problem; let us identify that quickly. 

If there is a way on the effectiveness side to find a marker that 

a drug will be effective without having to require a tremendous and 

long amount of time before we show that it works, that is just an 

enormous benefit to the drug development process, and that is separate from the review of any one application but that area of regulatory science and those kinds of investments are extremely imporVerDate Mar 15 2010 08:51 Nov 27, 2012 Jkt 076015 PO 00000 Frm 00060 Fmt 6633 Sfmt 6633 E:\HR\OC\A015.XXX A015

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tant. The President’s budget for the first time has an initiative on 

that but over the course of the future this is where we think that 

there needs to be a lot more done. 

Dr. BURGESS. Well, just as a case in point, a real-world example, 

yesterday the Alzheimer’s association was on the Hill visiting every 

office asking for a significant plus-up in funding for Alzheimer’s research, a noble goal, a worthwhile goal. This comes on top of the 

reauthorization we did at NIH back in 2006, level funding of $30 

billion a year to increase 5 percent a year. I don’t know that we 

have ever met those goals. But then the $10 billion in addition to 

the authorized amount that we gave in the stimulus bill, now we 

are asking at least in the Alzheimer’s legislation that Mr. Markey 

has, another $2 billion to put forward to the research for new Alzheimer’s drugs. Can you guys keep up with that if you have that 

kind of push in the pipeline for new products coming down? 

Dr. SHARFSTEIN. I will tell you the analogy that Dr. Hamburg 

uses when she talks about is of a rower with one very muscular 

arm and one kind of scrawny arm, and if we are pouring a lot into 

basic medical research but we don’t have the science to decide 

whether the products are safe and effective, then you don’t get a 

system that moves forward. It kind of goes in circles. You don’t see 

the treatment—— 

Dr. BURGESS. And are you aligning yourself to that, to making 

a more muscular—— 

Dr. SHARFSTEIN. Yes. And in fact, a few weeks ago, Secretary of 

Health Kathleen Sebelius went out to NIH with Dr. Collins and Dr. 

Hamburg and we announced a whole set of collaborations with 

NIH to bridge the gap so that it is not that money goes to NIH and 

then here is FDA on the other side but that we are going to have 

in addition to a public meeting and open docket for suggestions on 

how we can work together, we can have a council that is going to 

meet and oversee a whole new range of collaborations, and for the 

first time both agencies are putting in money to fund this kind of 

research in academia around regulatory science. 

Dr. BURGESS. But at the present time, to the extent that those 

new discoveries are arriving on your doorstep, there is no backlog? 

Those applications are receiving timely review and—— 

Dr. SHARFSTEIN. It is not a question of the timeliness of the review, it is the tools we have. We would like to upgrade the tools 

we have for the new types of products. 

Dr. BURGESS. Are all those applications online? Is that all in an 

electronic database? 

Dr. SHARFSTEIN. We are moving towards full electronic submission but the problem is—— 

Dr. BURGESS. So the applications are paper applications? 

Dr. SHARFSTEIN. In some cases, but I think we are moving pretty 

quickly to electronic, but I think the issue is—— 

Dr. BURGESS. But, you know, here, and I will just give you a 

real-world example. If this were a class-action lawsuit, for example, 

a big law firm, any of the big law firms downtown or in downtown 

Dallas would hire the people to digitize that data and then have 

it done within a couple of months’ time in order to make their case 

either pro or con in the legal action. This is something that is done 


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all the time but outside organizations. The FDA should be the leader on this. 

Dr. SHARFSTEIN. There is no question that we need to have electronic data submissions, and we want to do it in a way that the 

data comes in so that it can be analyzed very efficiently. The challenge is, it is not so much the review of the application that comes 

in, it is that we don’t get the applications, products don’t make it 

all the way to the point where they have enough evidence to get 

to FDA’s doorstep. That is the kind of gulf we are trying to cross 

by working with the NIH, that they do the research, they go, oh, 

maybe this product works. Then how do you get it from there to 

the point where you can do clinical trials? I mean, how do you— 

what is the right kind of clinical trial to do, what is the right tool 

to know, how do you get the companies in, ready to invest. 

Dr. BURGESS. And after companies have made that investment 

and they come to you for the approval, that is the part of the chain 

that I am worried about, that you have the tools you need to be 

able to get these things to the people who so desperately need 

them. 

Dr. SHARFSTEIN. I agree with that completely, and we also want 

more drugs to come to our doorstep than are coming now, more applications. We would like to see that happen because there are a 

lot of people who have diseases that need medicine. 

Dr. BURGESS. I don’t know what time frame would be the correct 

unit, but how many new drug applications per month or quarter 

or fiscal year? 

Dr. SHARFSTEIN. I think it is a ballpark of about 25 new, completely new drugs getting approved by the FDA roughly every year. 

Dr. BURGESS. How many applications, though, how many new 

drug applications that seek approval will you get a year? So 25 

make it through the—— 

Dr. SHARFSTEIN. This is Dr. Woodcock from FDA. About 30 to 35. 

You know, that is my point about we would like to see more. But 

to do that, we have to help the discoveries bridge the way to the 

point of FDA application. 

Dr. BURGESS. Interestingly, Dr. Zerhouni at NIH 8 years ago told 

me that they were working on, I think it was no fewer than 88 

drugs to deal with obesity. With that kind of pressure in the research pipeline, you guys are going to have to be really precise and 

efficient to be able to handle that kind of research coming in your 

direction. 

Dr. SHARFSTEIN. I think that is true. What we want to do is help 

NIH as it is investing in those 88 or however many it is products, 

pursue that investment so it is pushing the products closer to an 

FDA application rather than, you know, being all these different 

steps to get there. And so that is one of the things we are going 

to work with them on. If NIH is going to pay for a trial, what is 

the right way to design that so that we get really good usable data 

for an application. So it is not so much once the application comes 

in, we need better tools to review them, but it is how you get more 

applications of promising therapies. That is what Dr. Hamburg is 

extremely committed to and why we are doing this big product 

with NIH. 


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Mr. PALLONE. Dr. Burgess, we are actually going to have a second round, so I just want you to know. 

Mr. Braley. 

Mr. BRALEY. Thank you. 

Dr. Sharfstein, I want to start with a word that we hear still 

today frequently called mail order drugs, and in this Internet age, 

isn’t that somewhat of an oxymoron? There is a very specific reason 

I am asking you this question. We heard our colleague Dr. Gingrey 

spend his time that he had in his opening instead of talking about 

drug safety blasting the health care legislation we are considering 

right now. But when you have 47 million Americans without access 

to health insurance and a lot of people losing their jobs with employer-based health care coverage and you have got people who are 

in prescription drugs who suddenly have no means because they 

can’t afford to pay their COBRA payments without a job who go online like many of us and surf for some answer to their medication 

needs. There are endless Web sites out there of predatory companies looking to see what may or may not be an actual pharmaceutical to somebody desperate for treatment. Would you agree 

with that? 

Dr. SHARFSTEIN. I think it is a recipe for tragedy. 

Mr. BRALEY. And we all know that the problem is, your agency 

has limited resources you are dealing with. Research applications, 

you are dealing with enforcement issues overseas, you are dealing 

with enforcement and compliance in domestic manufacturers. So I 

guess my question is, if we do nothing to improve access and affordability for prescription drugs, aren’t we just inviting chaos as 

consumers look to these disreputable online companies, and I am 

not lumping all online companies into that category but there are 

plenty of them out there. Aren’t desperate people going to resort to 

desperate measures to try to solve their health care needs? 

Dr. SHARFSTEIN. I think there is no question that health care reform that gets more Americans access to prescription drug coverage 

is extraordinarily important for avoiding the kinds of problems we 

are talking about. 

Mr. BRALEY. Thank you. One of the things that I wanted to talk 

to you about was your remarks about the Sentinel Initiative because I am interested in learning more about that, what it was 

based upon, what model it was based upon and how it is going to 

achieve the objective of a national integrated electronic system for 

monitoring medical product safety. And Dr. Christensen mentioned 

JCAHO, which is looked to by many people as a forerunner in setting up a Sentinel Event Reporting System with root cause analysis and an integrated approach to trying to get to the bottom of 

patient safety issues. In its first 10 years of existence, the Sentinel 

Event Reporting System averaged annually 300 reports, which is 

an abysmal statistic given the high number of medical errors that 

occur in this country every year. So tell me how this Sentinel Initiative that FDA is pursuing is going to achieve the objective and 

the access data goals that you have identified and truly reach a 

comprehensive reporting system that is going to get to the heart 

of patient and drug safety? 

Dr. SHARFSTEIN. Sure. I appreciate the question. What we are 

doing and the sentinel system at JCAHO are very, very different. 


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They have the same word but they are very, very different. They 

are, I think what you are describing is sort of a reporting system 

where people actually have to report. That is not what the FDA’s 

sentinel system is based on. The concept is that there are data resources out there, generally large, integrated health systems, 

where you have data for millions of Americans who are taking 

medications and that we can use that information in a way that 

is completely protective of their confidentiality. In fact, the data we 

are looking at doesn’t come to the federal government, it is done 

by the systems themselves. They look into their system to answer 

key questions about drug safety and over time we put into place 

a system to look in advance. In other words, if we have a concern 

that a particular product might cause a problem, we can program 

it so that if we see that when patients are getting it, it automatically lets us know. That is the long-term goal. So—— 

Mr. BRALEY. Let me just interrupt you briefly to add another 

component to this, because my time is running out. There has been 

a big push not only in the American Recovery and Reinvestment 

Act that we passed earlier in 2009 but also in this health care bill 

that we have been talking about to move aggressively toward electronic medical records, which we all know is one way to try to deal 

with drug interactions and to dramatically reduce the number of 

drug errors. So is that another reason why getting it right on EMR 

is so important in addressing some of the goals of this Sentinel Initiative? 

Dr. SHARFSTEIN. Absolutely. If we have more patients with effective medical records and we are working with the Office of the National Coordinator to make sure the standards on those records are 

good for this kind of work, then we will be able to tap into more 

Americans’ experiences with medications to identify whether there 

are legitimate safety issues that we have to respond to. So where 

we are now if that we are working with certain health care systems 

that have data and we are setting up basic standards so that they 

will be able to respond to inquiries. It is a system where we don’t 

need anyone to volunteer anything. Once we have a question, they 

go out and they just program their data set and they tell us whether they are seeing that, and it is a network so it is not just one 

big database. It is, you know, we are going to go up to New England and there is a data set there, there is a data set in California, 

and we are going to be able to look in a much quicker way than 

we can do to see if there are safety signals emerging. And there 

has been a lot of work done at FDA. We are constantly reviewing 

how this is going to make sure we are keeping it on track. It is 

a very ambitious project but there has been a tremendous amount 

of leadership at the agency on it and we are very appreciative of 

the support we have gotten. 

Mr. BRALEY. Thank you. I will yield back, and I would just encourage you to keep us informed on the progress you are making 

in the rollout of that system. 

Dr. SHARFSTEIN. Sure. 

Mr. PALLONE. Thank you. 

The gentleman from Kentucky, Mr. Whitfield. 

Mr. WHITFIELD. Thank you very much. 


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I have a relatively simple question. As you continue to work and 

develop the REMS program, and I had mentioned in my opening 

statement about NASPER, the national prescription drug monitoring system. I was curious, have you yourself worked or your 

agency worked very much with the DEA or SAMHSA in implementing this national prescription drug monitoring system? 

Dr. SHARFSTEIN. It is an excellent question, and that system is 

primarily dedicated to the schedule drugs, and we have been having some public meetings about how to ensure the safe use of certain schedule drugs that have very important medical uses. They 

are long-acting opiate medicines. You know, our reach in the REMS 

program goes really to the manufacturers and what they can do, 

but we are very aware that there are other key players and we 

have been in discussions with DEA and others to try to figure out 

what the right balance is. We clearly know that patients benefit 

from pain relief and it is extremely important. On the other hand, 

we don’t like to see the fact that patients can die of unnecessary 

overdoses or there can be diversion. So it is a combination, and we 

have some tools to put on the table to help with this balance and 

we are very aware that the other agencies do and the prescription 

drug monitoring program is very much part of the discussion. 

Mr. WHITFIELD. Well, I appreciate that, and of course, REMS is 

designed to minimize risk for patients and certainly that is the 

same goal of NASPER as well to give the health care providers 

more information. So I hope that you all will keep that in your 

minds as we move forward on trying to obtain adequate funding to 

fully implement NASPER. 

Dr. SHARFSTEIN. Thank you. That is an excellent point. 

Mr. PALLONE. Dr. Sharfstein, you describe in your testimony the 

importance of moving from a reactive approach to drug safety problems to one that prevents such problems from occurring in the first 

place. Obviously prevention is what we are all about in every aspect of health care. As you know, the committee worked very closely with the FDA to develop and pass the Food Safety Enhancement 

Act this past summer. We are now waiting and waiting for the 

Senate to pass its version, which we hope will be very similar to 

our bill. I understand they did pass a bill out of committee. In my 

view, one of the most critical components of the food safety legislation was giving the food industry more responsibility to ensure the 

safety of their foods and giving FDA more authority to ensure the 

preventive safety controls are in place, and you mentioned this provision in your testimony and stated that FDA is taking steps to 

begin making this kind of shift within your current authorities. 

And what I am trying to understand is whether your current authorities are adequate to accomplish this. 

The Food and Drug Administration Globalization Act of 2009, 

that is the bill that was developed by Mr. Dingell, myself, Mr. Stupak and others, and that contains a similar provision to that in the 

food safety bill. Specifically, section 204 of that bill would require 

drug companies to develop and implement a quality risk management plan to incorporate risk identification and control into the 

production processes. The plan would, for example, require the 

company to assess the competence of potential suppliers of raw materials or ingredients. It would also require the company to conduct 


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periodic onsite audits and carefully monitor the safety of drug ingredients, and this plan would be available for FDA review during 

inspections. So what I am trying to find out is whether you think 

this approach is workable and necessary for drugs as we did for 

foods, and would it help FDA’s efforts to shift to a more preventative-based drug safety system if the agency had that kind of enforceable authority? 

Dr. SHARFSTEIN. Thank you. It is a great question, and it is in 

fact true that the same principle that underlies the food safety bill 

and a lot of the authorities that is needed in the medical product 

arena also. We do think that new authorities are going to be necessary for FDA to have confidence in the preventive-oriented approach. Right now, FDA inspectors are at the border under a legal 

standard that we can hold something if there is an appearance of 

adulteration, but we can’t require, we don’t have access, because 

we can’t require people to have current registration for, you know, 

just those facilities that they are making. We can’t require them 

to present information about their products meeting key safety 

standards like having a preventive plan in place. And so we are not 

operating under a paradigm that is really focused on prevention, 

and we would like to make that shift and there are definitely elements in the bill that would accomplish that. 

Mr. PALLONE. I appreciate that. When we did this Globalization 

Act, we had the four areas you mentioned, medical devices, there 

is also cosmetics, and of course ultimately we would like to develop 

legislation or pass legislation for all four, but we separated out the 

food safety because we were making more progress and we felt that 

that was the most likely that we could move. But now we want to 

move to certainly deal with the drugs and ultimately with the others as well. So I just ask that you—you know, I know that you provided a lot of help to us as we developed the food safety legislation. 

We would like to have the same cooperation and help as we move 

towards drug safety and the others. 

Dr. SHARFSTEIN. Well, we really appreciate the subcommittee’s 

leadership in this area. 

Mr. PALLONE. Thank you. 

Mr. Shimkus. 

Mr. SHIMKUS. Thank you, Mr. Chairman. 

This is a good line of questions and debate and instruction, so 

I am glad we are going down this route. I want to go back. We 

were involved with the legislation that is pending over on the Senate side now and so it is a template for where we want to move 

but we need to get some clarification. Does the FDA have tools at 

its disposal to have a company take its drug off the market? Do you 

have the tools right now? 

Dr. SHARFSTEIN. There are mechanisms for FDA to have drugs— 

you mean if a drug is unsafe? 

Mr. SHIMKUS. Right. 

Dr. SHARFSTEIN. Yes, there is a process for that. 

Mr. SHIMKUS. So we do have the tools? 

Dr. SHARFSTEIN. If there a safety problem with the medicine so 

it is no longer safe and effective, yes, there is a process for that. 


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Mr. SHIMKUS. And so in the past years you have asked drug companies to take drugs that are identified as being bad off the market, have you not? 

Dr. SHARFSTEIN. Yes. 

Mr. SHIMKUS. Has any company ever refused to do so? 

Dr. SHARFSTEIN. I have to go back, but not that I know of. 

Mr. SHIMKUS. There has been—— 

Dr. SHARFSTEIN. I shouldn’t say not that I know of. I think we 

would have to get back to you because there may be some examples 

of that. But I think that you have to distinguish between—there 

are two things. One is the products and the other is the manufacturing, whether there are manufacturing issues that could come up 

as well. 

Mr. SHIMKUS. A follow-on question, because we really want to 

drill down because we know you have got the ability to do—we just 

don’t want you to say boom, here is all this new stuff if there are 

things that are doing successfully now. We don’t want to create 

multiple additional new levels of bureaucracy, we want to build on 

what is working now. And so that is why we want to be very specific with our questions. 

Dr. SHARFSTEIN. Sure. The one thing I would say is that it is important that, you know, there may a process to accomplish something but if that process is so burdensome and time consuming, it 

may not be fully protective of public health. So as we get back on 

these things to provide technical assistance, it may be that, yes, 

there is a process but we would like a better process, a simpler 

process that can be more effective. 

Mr. SHIMKUS. In your response to Chairman Dingell, you stated 

that you needed additional authority to require manufacturers to 

implement quality risk management plans. And the follow-up question is, do you actually need this authority or is that something you 

can do now? Could you just incorporate this into your good manufacturing practice regulations? 

Dr. SHARFSTEIN. We feel like we would need the authority. 

Mr. SHIMKUS. I think we need to talk more. 

Dr. SHARFSTEIN. I am always happy to talk more, but I think 

that we—— 

Mr. SHIMKUS. That is the whole thing. When we move legislation, we are going to get more specific. You can help educate us and 

we are going to be getting you all the resources you need. 

Dr. SHARFSTEIN. They are very different, and it is similar to the 

food safety language, because even though there are food GMPs 

that we get authority that the food safety to set preventive standards. 

Mr. SHIMKUS. But having been in the room on that, we struck 

a good balance, that we didn’t go overboard and that we brought 

industry at the table so that we didn’t duplicate things. 

Dr. SHARFSTEIN. I agree. 

Mr. SHIMKUS. And that is where we want to be very, very—because we want to be helpful. We don’t want to be harmful. We don’t 

want to create such—and we talked about this gap. You talked 

about really this gap from NIH to FDA, and you know what ties 

the companies over to continue to develop these new drugs, and 

that is the certainty that if they are successful, they have a patent 


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and they have a return on that investment. And of course, we are 

always attacking that patent. We do want to attack—I have always 

been in the position that when they game the system and extend 

that, but I have always supported these folks who are taking the 

risk all these years, that gap, the only thing that keeps them going 

is that assurance that there is going to be a return on that investment based upon at least some period of time where they have exclusive rights to sell that drug. Isn’t that correct? 

Dr. SHARFSTEIN. I think it is very important that companies have 

some protection. 

Mr. SHIMKUS. And I am going to end on this as far as my line. 

I do appreciate this. As we move forward, I have great respect for 

the chairman of this committee. There are times that we have 

agreed and we worked well together and there are times when we 

fought and we still are friends. And so I look forward to both times 

as we move forward. 

But I also want to be careful, and I am also on the high-tech 

committee here and I understand the benefits of digital records, 

and we are always going to fall into this concern on privacy and 

the collection of data, and it is a tough balance. So when we hear 

words about collecting data, information on personal records that 

help us do something, I think that is going to be easier said than 

done. 

Dr. SHARFSTEIN. Right. And just to be clear, what I was talking 

about, the sentinel system, there is no personal data at all that 

comes to FDA. It is done by the health systems themselves, the 

studies. 

Mr. SHIMKUS. I am just telling you, most data breaches are people stealing data and—— 

Dr. SHARFSTEIN. It is a very serious issue—— 

Mr. SHIMKUS [continuing]. Selling it with flash drives and stuff, 

so thank you, Mr. Chairman. 

Mr. PALLONE. Thank you. 

The gentleman from Texas, Mr. Burgess. 

Dr. BURGESS. Thank you, Mr. Chairman. This is a good hearing 

and a good discussion. I hope we actually have an opportunity to 

have a similar discussion regarding medical devices at some point 

in the future because they deserve no less of our scrutiny. 

Dr. Sharfstein, I wasn’t in the room when Mr. Dingell was asking questions, but some of them have been sort of reintroduced now 

by Mr. Shimkus. On the border authority—we all remember the 

story of the tomatoes a couple years ago and the unfortunate discovery at 5:00 on a Friday afternoon that it was Mexican peppers 

that were causing salmonella outbreaks that had riveted the news 

shows for the whole summer, but the FDA lacked the authority to 

actually stop the importation at that point. Have you identified the 

authority that you need there to keep this occurrence from happening in the future? Are there things you need from us to be able 

to have that authority if you have identified the authority and you 

lack it? 

Dr. SHARFSTEIN. With respect to food particularly? 

Dr. BURGESS. Particularly with respect to food, but we are going 

to get into some of the pharmaceuticals in a minute. 


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Dr. SHARFSTEIN. There is no question we need more authority because we want to shift to prevention. We need to be able to see—— 

Dr. BURGESS. So can you identify for us specifically what that authority is that you need? 

Dr. SHARFSTEIN. Well, I think that that is where we worked with 

the committee on the legislation that is hopefully going to pass, is 

going to address that gap. There are sections that relate to what 

is required to import food. 

Dr. BURGESS. And is the language in the bill that Mr. Dingell 

said was languishing safely in the Senate, is that language 

enough? Is it going to provide you enough of the authority of what 

you need to have? 

Dr. SHARFSTEIN. Yes, we support that legislation because it is 

going to be an enormous step forward for how we can assure the 

safety of imported food and domestic food. 

Dr. BURGESS. So any changes that occur over the other body then 

would need to be scrutinized pretty carefully to make certain that 

they didn’t strip away the authority that you have identified that 

you will need? 

Dr. SHARFSTEIN. Well, there is no question. All these provisions 

are extremely important, and it is very important that, you know, 

we look at all of them as they get modified in the legislative process. 

Dr. BURGESS. Another story that really just riveted the headlines 

2 years ago was the Chinese heparin story. What has happened? 

We had a hearing I think in April or May of 2008. It hasn’t really 

been in the news stories. What is happening in that investigation 

now? Is there anything new that has come up from your looking 

into the manufacturer of the isolation of heparin overseas? Are we 

still importing the active pharmaceutical ingredient from overseas? 

Where are we with that? 

Dr. SHARFSTEIN. There is certainly a huge level of import from 

China for heparin. What has really happened since that time is 

after the source of the problem was identified, there was a new 

standard written for heparin that has been adopted by companies 

and regulators around the world. It has been incorporated into the 

USP, which is sort of the standard-setting body, so that now—previously it wouldn’t have caught the problem, oversulfated 

chondroitin sulfate. 

Dr. BURGESS. Right. It was a clever contaminant to hide behind. 

Dr. SHARFSTEIN. Right. Much cheaper than heparin, but evaded 

the tests, went below the radar. FDA played a critical role in identifying how you can find that contaminant, demonstrated that 

when you add that contaminant to heparin you get the problem in 

animals, and then set up a standard that has been incorporated 

around the world and we haven’t seen those kinds of reports that 

we were getting since that time. 

Dr. BURGESS. Well, now, heparin wouldn’t truly be regarded as 

a biologic but there has been some question in this committee 

about how your agency would administer the follow-on biologic approval process. So in light of everything, do you feel like you have 

an adequate ability to safely and properly monitor and implement 

the approval process for follow-on biologics or what are referred to 

as follow-on biologics? 


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Dr. SHARFSTEIN. From the perspective of the supply chain, I 

think for all, you know, medications and biologics, we would like 

to see strengthening of the supply chain including the things that 

are there now but—— 

Dr. BURGESS. Right. The supply chain in this instance just 

showed the weakness, though, of the process used to identify contaminants. In approving follow-up biologics, I mean, it underscores 

how important the safety aspect is. Do you feel that with what you 

have available to monitor and screen the follow-on biologics in that 

process? We have had that debate somewhat in this committee. We 

have never had you guys in to ask you about that. We have had 

the Federal Trade Commission in, which I never understood. So 

now that I have got you here, what about the discussion on followon biologics? 

Dr. SHARFSTEIN. I think that the follow-on biologics sort of supply chain issues are the same as for the regular. In some cases, 

they are the same companies making them. So—— 

Dr. BURGESS. No, outside the supply chain, just the overall safety 

of follow-on biologics. 

Dr. SHARFSTEIN. That is something that is very important to 

base on individual products and the best science available, and 

FDA believes that with adequate resources and the right—— 

Dr. BURGESS. You said you had all the money you needed, remember, the previous question. 

Dr. SHARFSTEIN. I don’t—we could check the transcript on that 

one. I think that what we would like is the flexibility to have 

standards that are based on the best available science for particular products, and with that in place, we would explain how we 

are setting up those standards and be able to do it in a way that 

could get products on the market that could be enormously important to the public. 

Dr. BURGESS. So where are we in that process now? We had some 

language in the bill that we passed, and goodness knows what is 

going to happen to that bill, but are you all waiting for Congress 

to do something? 

Dr. SHARFSTEIN. I think we are certainly waiting to see what 

happens with health care reform because there is some language 

in there, but I think that we would also look to the authority we 

have to decide whether it would make sense for us to move forward 

without new language, but that is not something we have reached 

final decision on. 

Dr. BURGESS. Is there a product out there right now that is 

awaiting your ability to be able to offer those approvals or direct 

further study? 

Dr. SHARFSTEIN. There is certainly a lot of interest in the industry but I don’t know if I could point to a particular product. 

Mr. PALLONE. OK. 

Dr. BURGESS. Thank you, Mr. Chairman. 

Mr. PALLONE. You are welcome. 

Let me thank Dr. Sharfstein. Thanks a lot. This was very helpful, and we appreciate it, and obviously we would like to move forward on the drug safety issue as we did on food safety. You actually said that you are going to follow up with certain written responses in some cases, so I would appreciate those as soon as posVerDate Mar 15 2010 08:51 Nov 27, 2012 Jkt 076015 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 E:\HR\OC\A015.XXX A015

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sible, and members can submit additional questions for the record 

as well. I am going to try to get those submitted to the clerk within 

the next 10 days, so I would ask members if they want to submit 

written questions, to give them to us within the next 10 days, and 

then after that we would ask you to get back to us as quickly as 

possible. 

Dr. SHARFSTEIN. OK. Great. 

Mr. PALLONE. Thank you again, and without objection, the hearing of the subcommittee is adjourned. 

[Whereupon, at 4:22 p.m., the Subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 


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pmangrum on DSK3VPTVN1PROD with HEARINGInsert offset folio 74 here 76015A.024

DEPARTMENT OF HEALTH & HUMA.N SERVICES 

-------_ .. __ ._--------------

The Honorable Henry A. Waxman 

Chairman 

Committee on Energy and Commerce 

House of Representatives 

Washington, D.C. 20515-6115 

Dear Me. Chairman: 

APR 3 0 2010 

Food and Drug Administration 

Rockville MD 20857 

Thank you for providing the opportunity for the Food and Drug Administration (FDA or 

the Agency) to testify at the March 10, 2010, heating entitled "Drug Safety: An Update 

from the Food and Drug Administration," before the Subcommittee on Health, Committee 

on Energy and Commerce. This lettet provides responses for the record to questions poscd 

hyce11ain Members oftlle Subconmlittee at the March 10,2010, hearing, as well as in your 

letter dated March 25, 2010. 

As you requested, we have addressed our responses to each Member. We have restated 

eacb question below in bold type, followed by FDA's responses. 

Representative Tim Murphv 

1. Could you please get back to us and let us know how we could keep up to date on 

the latest scientific evidence (pertaining to vaccines) here? 

Scientiilcally accurate infonnalion pe11mning to vaccines is available on the FDA Web 

site. This includes Web pages devoted to vaccines and rclated research, as well as 

annual reports and other relevant infornlation from FDA's Center for Biologics 

Evaluation and Research (CBER). FDA's vaccincs Web page can be found at; 

http://www!da.gov/Bio!ogicsBloodVaccines/Vaccineslde!auit.hlm. Furthennore, 

external Web sites, such as those for the Institnte of Medicine, Centers for Disease 

Control and Prevention, National Institutes of Health, and Johns Hopkins Bloomberg 

School of Public Health (Institnte for Vaccine Safety), include infonuation on vaccine 

usc, safety, and reviews, which may provide additional information. 

2. How are you ensuring that vaccine makers are using the latest and safest 

innovations in vaccine design '? 

FDA has scientific and regulatory expertise, as well as our own laboratories, to 

adequately assess the safety, purity and potency of vaccines for use in the United 

States, and strives to keep this expertise up to date. Throughout the clinical 

development of a vaccine, we assess the available data and provide scientific advice to 

vaccine manufacturers. We also conduct research related to the development) 

manufacture, and testing of vaccines and related products. This work supports the 
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Page 2 - The Honorable Henry A. Waxman 

regulatory process and assists in establishing methods and standards to ensure the 

continued safety, purity, and potency of vaccines regulated by FDA. These include 

products prepared by genetic engineering, synthetic procedures, and other innovations 

in vaccine design. We have made the advancement of regulatory science at FDA a top 

priority. President Obama included $25 million in his Fiscal Year 2011 budget request 

specifically for that purpose. 

We provide our scientific expertise in guidance documents for industry, such as the 

recently finalized !,ruidance doeumcnt pertaining to the development of safe and 

effective cell-based viral vaccines. (See "Characterization and Qualification o/Cell 

Substrates and Other Biolob>ical Materials Used in the Production 0/ Viral Vaccinesf(Jr 

blfectious Disease Indications," Guidance for Industry [February 2010]). In addition, 

we convene scientific workshops on emerging scientific and regulatory issues, where 

we share our knowledge of the latest science and seek input from other scientific 

leaders. We utilize an advisory committee comprised of a panel of outside independent 

teclmical experts from various scientific disciplines, whom we convene in a public 

forum to assist us in analyzing detailed scientific data and understanding its public 

health significance. 

Some licensed vaccines (such as seasonal influenza vaccines made in eggs) are 

produced using technologies that have been in use for a long period oftime. Tn general, 

such products have a lengthy and established track record of safety and effectiveness, 

which is an important consideration for preventative vaccines that are given to healthy 

individuals. FDA may consider the record of safe use associated with such "older" 

technologies, when the Agency evaluates the Tisks and benefits of products made using 

the latest innovations in vaccine design. 

Representative John Shimkus 

1. In the past years you have asked' drug companies to take drugs that are identified 

as being bad off the market. Have you not? Have they ever or has any company 

ever refused to do so? 

In cases where FDA reaches a conclusion that a dmg's benefits no longer outweigh its 

risks and should no longer be marketed, FDA will ask the manufacturer to voluntarily 

withdraw the dmg from the market. FDA has requested the voluntary withdrawal of 

about 50 drugs since 1976. The only instance in which the dmg withdrawal was 

involuntary was the case ofphenformin hydrochloride in 1979. The involuntary 

withdrawal procedure requires notice to the holder of the drug application and an 

opportunity for a hearing (section 505(e) ofthe Federal Food, Drug, and Cosmetic Act 

(FD&C Act or the Act)). 

In cases where a drug is either defective or potentially hamlful, for example, due to 

problems with packaging, manufacturing, or contamination with foreign matter, FDA 

may request that a manufacturer voluntarily recall the product. (FDA does not have 

the authority to require that an adulterated, misbranded, or unapproved drug be 

recalled, although this authority exists for some FDA-regulated products, such as 
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Page 3 - The Honorable Henry A. Waxman 

medical devices and infant fon11ula). A voluntary recall is when the manufacturer 

recognizes the problem and initiates action. While most manufacturers will undertake 

a voluntary recall promptly, in some cases, manufacturers will refuse to recall a 

product. In those instances, FDA issues a request for a recall, which is still not 

mandatory. A request for a recall is issued when FDA recognizes a problem but the 

company has not promptly initiated a voluntary recall. Since 2006, FDA has issued 

three requests for recalls. When a drug manufacturer does not comply with FDA's 

request for a recall, FDA uses press and other communication tools to notify the public 

of the potential risks. These actions were taken for the three situations noted above. 

After FDA issued press releases following issuance of the FDA Requested Recall 

action to the manufacturers, two oUhe manufacturers subsequently complied with 

FDA's recall requests. The third manufacturer refused to comply and, as a result, FDA 

seized the product that was on hand at the firm. A seizure action requires FDA to 

obtain a court order. 

FDA believes that mandatory recall authority for drugs, modeled after section 111 

ofH.R. 2749, the Food Safety Enhancement Act, would enhance the Agency's ability 

to promptly address hannful drugs in the marketplace. 

Representative Anna Eshoo 

1. The Food and Drug Administration Amendments Act of 2007 included a provision 

to give the FDA anthority to require that television drug advertisements be 

reviewed by the FDA before airing. 

o How often bas the FDA utilized its authority? 

• What constitutes an "acceptable" drug advertisement? 

• Does the FDA provide guidelines for drug companies crafting television 

advertisements? 

.. To your knowledge, have drug companies edited theiI· advertisements base 011 

the FDA's comments? 

• How often do you reject advertisements based on objectionable content? 

To date, FDA has applied its pre-review authority to three drugs. FDA is currently 

working to apply this provision to numerous other categories of drugs, and plans to 

issue guidance publicizing the categories oftclcvision ads that should be submitted for 

pre-review latcr this year. 

An acceptable drug advertisement is one that complies with the FD&C Act and FDA's 

prescription drug advertising regulations, which require ads to be accurate, nonmisleading, and fair and balanced in their presentation of risk and benefit infonnation 

about the dnlg. 

Drug companies must take the requirements in FDA's regulations into account \vhen 

crafting television advertisements. We have published several guidance documents 

relating to prescription drug advertising that provide guidelines for drug companies as 

they develop their ads. In addition, the regulations allow companies to voluntarily 
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Page 4 - Tbe Honorable Henry A. Waxman 

submit draft versions of ads to the Agency before the ads are publicly run. The 

Agency reviews these draft ads and provides companies with advisory comments, 

which infOlm them of any problems with the ads. This pre-review allows companies 

to correct problems before ads are aired or published. FDA is tracking the number of 

pre-reviews of drug adveltisements through FDA-Track, available at: 

http://1'';ww fda.gov/A boutF DA/What WeDo/track/ucm20623 7. h1m. 

Companies frequently edit their advertisements based on comments FDA provides 

through this voluntary advisory process. If FDA detennines that a publicly 

disseminated ad is false or misleading, we can send the company all enforcement letter 

requesting that the company immediately cease the violative adveltising. Companies 

also edit ads based on the objections FDA raises in these enforcement letters. 

We comment on all the TV ads reviewed under the advisOlY process. This is not a 

pre-approval process, so we do not "reject" ads, but we do notifY companies of 

regulatory problems with the ads and request revisions. We can also take enforcement 

action against misleading ads being publicly run. We sent 41 enforcement letters last 

year on false or misleading prescription drug promotion. 

2. The Food and Drug Administration Amendments Act of 2007 included the 

reauthorization of and improvements to the Best Pharmaceuticals for Children 

Act (BPCA) and the Pediatric Research Equity Act (PREA). Can you comment 

011 bow these programs aloe ,~orkil1g? 

FDA has implemented several major changes conceming review of pediatric drug 

products as a result of the Food and Drug Administration Amendments Act of 2007 

(FDAAA). Under FDAAA, FDA was provided increased authority to require 

pediatric studies and improve pediatric labeling. These programs are working well 

and have resulted in an increase in useful infonnation for pediatric drug products. 

Some of the key cbanges include the following: 

FDA~A. provides greater transparency and broadens the pediatric safety 

review process by requiring the Agency to apply the same processes for 

products studied under PREA and BPCA. There are three key areas in 

which this occurs: 

(1) Pediatric studies under PREA are now subject to the same postlabeling, pediatric-focused safety reviews that have been used for BPCA, 

including review by FDA's Pediatric Advisory Committee. This Challge 

has resulted in a more comprehensive review of pediatric adverse events, in 

that it includes biological products. 

(2) There is now a statutory requirement for inclusion of negative or 

inconclusive pediatric trial data in labcling. This clinical trial data, even if 

negative or inconclusive, is significant because many approved drug 

products arc used "off label" in the pediatric population by medical 
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Pagc 5 -, The Honorable Henry A. Waxman 

practitioners, as there is a lack of approved products for many pediatric 

indications. 

(3) There is a rcquired posting of the mcdical, statistical, and clinical 

phamlacology reviews of pediatric studies conducted to meet the PREA 

and BPCA requirements: regardless of whether the application is ultimately 

approved. Posting the reviews, instead of just summaries of the reviews, 

provides a better understanding of the clinical trial results and more 

substance as to the analysis ofthe data. It can also provide useful 

infonnation to researchers and others involved in designing future pediatric 

studies. Given the limited number of pediatric trials that are conducted, 

this information can be particularly useful. 

Following are some additional statistics (since enactment ofFDAAA): 

Pediatric Advisory Committee (PAC) Review of Safety for Pediatric Products: 

36 products have gone to the PAC pursuant to FDAAA as of March 22,2010. 

o 17 pursuant to BPCA 

o 19 pursuant to PREA (including 7 biological products) 

FDAAA Full Reviews Posted: 

Total Number of Products Studied under BPCA = 37 

Total Numbcr of Products Studied under PREA = 47 

FDAAA LabclingChanges Summary as of March 24, 2010 (Both BPCA ang 

PREA) (N= II..±). 

New or Enhanced Safety Infonnation - 23 

Safety & Efficacy not Established in Pediatrics - 23 

Expanded Age to Include Ages Previously not Included 87 

Specific Dosing Change! Adjustment - 4 

o FDAAA BPCA Labeling Changes Summary (N"" 52) 

Expanded Age to Include Ages Previously not Included - 29 

New or Enhanced Safety Information - 12 

Safety & Efficacy 110t Established in Pediatrics - 21 

Specific Dosing Change! Adjustment - 1 

o FDAAA PREA Labeling Changes Summary (N= 62) 

Expanded Age to Tnclude Ages Previously not Included - 58 

New or Enhanced Safety Infonnatiol1 - [1 

Safety & Efficacy 110t Established in Pediatrics - 2 

Specific Dosing Changeiadjustment- 3 

3. The legislation also created the cross-division pediatric research consortium, or 

PeRC. PeRC provides consultation and review of pediatric plans, assessments, 

and studies across the agency. Can you comment on the progress of this 

consortium'? 
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Page 6 - The Honorable Henry A. Waxman 

FDAAA required the creation of an intemal FDA committee to carry Ollt certain 

functions with respect to PREA and BPCA. FDA established this intemal committee, 

called the Pediatric Review Committee (PeRC or the Committee), in October 2007. 

FDAAA required that, within 30 days after the enactment ofFDAAA, this committee 

provide consultation to FDA Review Divisions on pediatric plans, assessments, 

deferrals, and waivers under PREA. This same committee \vas also directed to review 

all Written Requests issued under BPCA on or after the enactment ofFDAAA. 

PeRC plays an important role in providing an integrated and more consistent approach 

across FDA, from a scientific, Jegal, and ethical perspective, for pediatric dl11g product 

developmcnt, regardless of whether the product is studied under PREA or under 

BPCA. Previously, only products studied undcr BPCA were reviewed by the 

predecessor internal committee called the Pediatric Implementation Team (PDIT). 

PeRC is an internal cross-Agency committee with members with critical expertise in 

not just pediatric matters but also in biopharmaco]ogy, statistics, chemistry, legal 

issues, pediatric ethics, and other scientific and medical specialties. Additionally, the 

PeRC includes individuals with appropriate expertise pertaining to particular products 

under revicw by the Committee. In addition, PeRC includes representatives (in 

addition to the pediatric ethicist) from the Offiee of Pediatric Therapeutics, who assist 

in collecting data, coordin3tingthe safety reviews with upcoming labeling actions, and 

integrating infonnation from the Pediatric Cluster, with the European Medicines 

Agency, in an effort to ensure optimal pediatric trial design and to prevent mmecessary 

duplication of pediatric trials. 

FDAAA also required PeRC to conduct a retrospective review of infonnation and 

actions taken in response to thc Pediatric Research Equity Act 0[2003. This report is 

publicly available at: 

htlp:llwwwfda.govldownloadsIDrugsIDevelopmentApprovalProcesslDevelopmcntRes 

ourceslUCM197636pdJ 

PeRC has held 140 meetings as of Mareh 24, 2010. As of that date, with respect to 

PREA, PeRC had reviewed 145 deferrals, 143 pediatric plans, 117 pediatric 

assessments (the data submitted to fulfill the PREA requirements to provide data on 

the dosing, safety, and effectiveness in all relevant pediatric populations), and 334 

waivers. With respect to BPCA, PeRC had reviewed 46 \vritten requests. 

Representative Mike Rogers 

1. In FDAAA, I drafted language to require FDA to look into new technologies used 

for the identification, validation, tracking and tmcing, aud authentication of 

prescription drugs in Ordel" to secnre the supply chain and protect patients from 

counterfeit products. What is the status of this report? What are the promising 

technologies FDA is exploring? 
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Page 7 - The Honorable Henry A. Waxman 

Section 913 ofFDAAA requires that FDA ("the SecretalY") "prioritize and develop 

standards for the identification, validation, authentication, and tracking and tracing of 

prescription drugs," which shall address promising technologies for achieving these 

goals. FDA is cUlTently, and has been, exploring various existing, new, and emerging 

technologies that can be used for identification, validation, tracking and tracing, and 

authentication of prescription drugs. In order to find out morc information to assist in 

that effort, in March 2008, FDA published a notice in the Federal Register, seeking 

comments on the following questions: 

1. What are the radio-frequency identification (RFIO) technologies, encrypting 

technologies, and nanotechnologies that are relevant? What are other relevant 

technologies? 

2. Please provide infolTllatlon related to: 

" Strengths for identification, validation, track and trace, or authentication 

.. Limitations for identification, validation, track and trace, or 

authentication 

" Costs of implel1)entation and use 

.. Benefits to the public health 

D Feasibility for widespread usc 

.. Utility for e-pedlgree 

3. Is the technology interoperable with other technologies? If so, describe. 

4. What standards arc necessary for supply chain usc of the specific technology? 

What is the status of development of such standards? 

FDA has reviewed and analyzed comments received in response to infonnation 

requests about promising technologies and is using it to fi.rrther infolTll the standards 

development required under section 505D of the FO&C Act (section 913, FDAAA), 

and implementation issues related to these standards. The types of technologies 

include, but are not limited to: RFID, encryption, holograms, bar codes, taggants, inks, 

and various types of nanotechnology. 

The statutory requirement did not include a fonnal report to Congress related to the 

technologies for identification, validation, tracking and tracing, and authentication of 

prescription drugs; however, we welcome the opportunity to keep you updated on our 

efforts in this area. 

FDA's ability to ensure product safety and address safety concerns would be greatly 

enhanced if Congress were to grant explicit authority to require a system that would 

allow for tracking, tracing, and authenticating drugs, devices, and tissues throughout 

the supply chain. Effective traek-and-trace systems can make it more difficult for 

persons to introduce counterfeit or intentionally adulterated medical products into the 

U.S. market, make it easier to identify persons responsible for making a product 

unsafe, and facilitate the recall of unsafe products by more quickly identifying where a 

product is located in the marketplace. 
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Page 8, The Honorable Henry A. Waxman 

2. I was interested to see that FDA recently issued Draft Guidance related to 

combating counterfeit drugs and the use of physical-chemical identifiers (PCIDs) 

or taggants. When do you expect the final gUidance to be issued? Is this guidance 

meant to cover all forms of on-dose technology, including those that are not 

chemical identifiers and add nothing to the product? 1 am concerned that as 

drafted, the guidance could be perceived as an endorsement of tag gants over 

other Oil-dose technologies. Can you assure us that all on-dose technologies wiII 

be addressed in the Final Guidance? 

FDA is working to finalize this guidance. We are cunently in the process of 

reviewing the comments received on the draft guidance to determine what changes 

may be needed. The final document will incorporate our eunent thinking on how best 

to address the risks in the'use oftaggants. New technologies are constantly being 

developed and the final guidance will be written to take into account the necessary 

flexibility in applying new technologies. 

3. I am aware that FDA is.' developing a Risk Evaluation and Mitigation Strategy 

(REMS) for certain opioid analgesics. To date, opioid programs have focused on 

patient and prescriber education. While these elements will play an important 

role in the opioid-specitlc REMS, controlling the criminal elements, illicit 

diversion, and intentional misuse and abuse of opioid products will require a 

more specialized mitigation 'approach to track and trace products at the dosage 

level. What does FDA envision for the opioid-specific REMS and how this 

strategy will differ fro III current efforts to control abuse and misuse of these 

products? 

Section 505-1 ofthe FD&C Act, as amended by FDAAA, describes the specific 

elements that maybe included in a REMS. The elements are: a Medication Guide (or 

patient package insert); a Couimunication Plan; and Elements to Assure Safe Use. All 

REMS must include a timetable for assessment of the REMS. 

In addition, section 505-1 (1:) lists the types of Elements to Assure Safe Use that a 

REMS may contain. The REMS may require that: 

.. Health care professionals who prescribe the dl1lg have paliicular training or 

experience or are certified 

.. Pharmacies, practitioners, or health care settings that dispense the dl1lg are 

specially certified 

" The drug may be dispensed to patients only in certain health care settings, such 

as hospital s 

" The drug may be dispensed to patients with evidence or other documentation 

of safe-use conditions, such as laboratory test results 

• Each patient using the drug be subject to certain monitoring or 

.. Each patient using the dmg be enrolled in a registry 
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Page 9 - The Honorable Henry A. Waxman 

FDA believes that establishing a REMS for opioids in accordance ""ith our authority 

under FDAAA will reduce misuse, abuse, and accidental overdose, while still ensuring 

that patients with legitimate need for pain medications v.ill continue to have 

appropriate access to them. 

FDA may not be able to use the REMS to control the criminal elements and curb illicit 

diversion and intcntionalmisuse and abuse of opioid products. However, other FDA 

efforts may more directly address these issues. Pursuant to section 505D of the Act, 

FDA is developing standards for identification, validation, tracking and traeing, and 

authentication of prescription drugs. In March 201 0, FDA published a guidance 

entitled "Standards for Securing the Drug Supply Chain Standardized Numerical 

Identification for Prescription Drug Packages 

(http://WH.wfda.govIRegulatorylnformationIGuidal1ceslucm125505.htm).This 

guidance describes the standard for unique identification of prescription drug 

packages. FDA views this standard as an initial step to in the development of other 

standards and systems for further securing the drug supply chain. Many aspects of 

implemcntation of package level identification will take shape in the future as 

additional standards are developed. Although this track-and-trace system will not be 

implemented for several years, it could be used in the future as a means of reducing 

the criminal elements, diversion, and abusc associated with opioid products. Dosage 

level tracking and tracing is not being explored at the current time. In the meantime, 

FDA will continue to use its investigative and enforcement resources and work with 

DEA to curb criminal activity associated with opioid products. 

We cannot describe the REMS', at this point because FDA has not yet decided on the 

specific elements of the REMS. Once we have developed a proposed REMS, we will 

publish the proposal for comment, and plan to hold an advisory committee meeting to 

obtain expert advice and public input, before directing the sponsors to submit a REMS. 

Programs such as these ~re extremely complex to develop, and FDA is actively 

working to ensure that the REMS is robust, effective, and will facilitate safe use of the 

drugs. 

4. Technology can provide a significant resource to FDA and law enforcement in 

addressing diversion. From an enforcement perspective, one of tlle most 

fundamental variables in a successful investigation is the product source 

information. Unfortunately, in the case of illegally diverted opioids, the 

information is minimal given that the medication is typically repackaged and the 

drug itself carries no information as to the intended site of distribution or origin. 

This lack of on-dose source information presents a challenge for government 

agencies seeking to mitigate diversion. Are you exploring the use of Ilew track 

and trace technologies on the dosage form to control diversion and intentional 

misuse and abuse? 

FDA agrees that existing and emerging technologies can be useful in mitigating 

diversion, among other supply chain security threats. We are educating ourselves 

about various types of technologies, including on-dose tec1mologies, as a means to 
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Page 10 - The Honorable Henry A. Waxman 

further secure the dmg supply chain. Currently, however, we are focusing our efforts 

on tracking and tracing of prescription drug packages and pallets, as described in 

section 505D of the Act. FDA welcomes the oPPoltunity to work with Congress to 

obtain explicit authority to require a system that would allow for tracking, tracing, and 

authenticating dmgs, devices, and tissues throughout the supply chain. 

Representative Phil Gingrcy 

1. In the FDAAA legislation, I supported language to require FDA to look into new 

technologies used for the identification, validation, tracking and tracing, and 

authentication of prescription drugs in order to secure the supply chain and 

protect patients from counterfeit products. What is the status of this report? 

What are the promising technologies FDA is exploring? 

Section 9] 3 of FDAAA requires that FDA "prioritize and develop standards for the 

identification, validation, authentication, and tracking and tracing of prescription 

drugs," which shall address promising technologies for achieving these goals. FDA is 

currently, and has been, exploring various existing, new, and emerging technologies 

that can be used for identification, validation, tracking and tracing, and authentication 

of prescription dmgs. In order to find out more information to assist in that effort, in 

March 2008, FDA published a notice in the Federal Register, seeking comments on 

the following questions: 

1. What are the RFID technologies, encrypting technologies, and nanotechnologies 

that are relevant? "YVhat arc other relevant technologies? 

2. Please provide infonnation related to: 

D Strengths for identification, validation, track and trace, or autllentication 

" Limitations for identification, validation, track and trace, or 

authentication 

.. Costs of implementation and use 

.. Benefits to the public health 

.. Feasibility for widespread use 

o Utility for e-pedigree 

3. Is the technology interopcrablc with othcr teclmologies? If so, describe. 

4. What standards are necessary for supply chain use of the specific technology? 

What is the status of development of such standards? 

FDA has reviewed and analyzed comments received in responsc to information 

requests about promising technologies and is using it to further infoml the standards 

development required under 505D of the Act (section 913, FDAAA) and 

implementation issues related to these standards. The types oftechl1ologies include, 

but arc not limited to: RFID, encryption, holograms, bar codes, taggants, inks, and 

various types ofnanotechnoJogy. 
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Page 11 - The Honorable Henry A. Waxman 

The statutory requirement did not include a formal report to Congress related to the 

technologies for identification, validation, tracking and tracing, and authentication of 

prescription drugs; however, we welcome the 0ppOltunity to keep you updated on our 

efforts in this area. 

FDA's ability to ensure product safety and address safety concerns would be greatly 

enhanced if Congress were to grant explicit authority to require a system that would 

allow for tracking, tracing, and authenticating drugs, devices, and tissues throughout 

the supply chain. Effective track-and-trace systems can make it more difficult for 

people to introduce counterfeit or intentionally adulterated medical products into the 

U.S. market, make it easier to identify people responsibJe for making a product unsafe, 

and facilitate the recal! of unsafe products by more quickly identifying where a 

product is located in the marketplace. 

2. I was interested to see that FDA recently issued Draft Guidance related to 

combating counterfeit drugs and the use of physical-chemical identifiers (PCIDs) 

or taggants. When do you expect the final guidance to be issued? Is this 

guidance meant to cover aUfol'ms of on-dose technology, including those that are 

NOT chemical identifiers and add nothing to the product? I am concerned that 

as drafted, the guidance could be perceived as an endorsement of tag gants over 

other on-dose technologies, can you assure us that ALL OIl-dose technologies will 

be appropriately addressed in the Final Guidance? 

FDA is working to finalize this guidance. We are currently in the process of 

revicwing the comments received on the draft guidance to detem1ine what changes 

may be needed, The final document will incorporate our current thinking on how best 

to address the risks in the use of tag gants, New technologies are constantly being 

developed, and the final guidance will be written to take into account the necessary 

flexibility in applying new technologies. 

3. Will tbe FDA be bolding a public hearing on tbe guidance and, if so, will the 

administration ensure that all interested parties are invited to participate? 

FDA solicited public eomment 'through publication of a notice of availability of the 

draft guidance in the Federal Register on July 14,2009. Anyone can comment on any 

guidance at any time, but to ensure that FDA considers the comments before it begins 

work on the final version, they are encouraged to submit their comments within the 

deadline given jn the Federal Register notice. As noted above, we are in the proeess 

of reviewing the comments received from interested parties, and at this time we do not 

anticipate seheduling a public hearing. 

Representative Michael Burgess 

During tbe debate on follow-on biologics in Congress, the focus bas been on those 

products approved under the authority of the Public Health Service Act and proteins. 

There are, however, a subset of products approved under the authority of the Food 

Drug and Cosmetic Act (human growth hormone, insulin and low molecular weight 
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Page 12 - The Honorable Henry A. Waxman 

heparin) which are biologically derived for which the traditional process for 

approving generics should not apply. In an effort to deal with these types of 

molecules, pending legislation intends to create a pathway for follow-on biologics that 

includes a transition rule for some of these molecules. This is a recognition that these 

products are too complicated for a simplt) abbreviated new drug application (ANDA) 

route for generic approval. There remain, however, significant issues with regards to 

transitioning these products to a PHS approval pathway. Chairman Frank Pallone, 

on April 3, 2008 sent a series of 46 Questions to 36 different groups including FDA. 

One questiou addressed the transition directly. 

The question read, "Should a newly created FOBs pathway include all biologics 

approved under the FFDCA and PHSA? FDA responded, "We believe that any 

proposal to transfer certain products now regulated under section 505 orthe FD&C 

Act to section 351 of the PHSA should not be nndertaken without very carefnl 

consideration of tbe legal and policy implications of such a change on the regulation of 

these products. For example, insulin products are proteins that have been regulated 

under the FD&C Act for more than 60 years. There could be significant regulatory 

implications if this product class were now to be approved or licensed and regulated 

under the PHSA. The Agency has not completed its consideration of this issue and 

would want to fully consider,the'p~tential implications of any specific proposal." 

While citing insulins, the implication for other products falling into this scenario is the 

same. 

We are interested in the foll~'vi~g: 

1. Has tile FDA completed its review oftlle scientific, legal and policy implications 

of this cllange? 

2. If so, wllat was tile conclusion? 

3. If not, what are the issues they are still considering and do tlley feel they have 

the appropriate authority to move these products to the new regime sooner? 

4. Does the FDA feel it needs the fulIlO year transition ill order to prepare for the 

change? 

Your questions concern the scientific, legal, and policy implications of transfelring 

certain products cun'ently regulated under section 505 of the FD&C Act to section 351 

of the Public Health Service Act (PHS Act). 

Under the recently enacted Patient Protection and Affordable Care Act (Publie Law 

111-148), FDA has been given the authority and responsibility to regulate biosimilar 

biological produets, a newly defined class of medical products, Currently, FDA is 

carefully evaluating the newly enacted biosimilar provisions eontained in the health 

care legislation to detennine how best to implement these new provisions, Because 

we have not completed our review of the new Jaw, including the provisions related to 
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Page 13 - The Honorable Henry A. Waxman 

transferring certain products currently regulated under section 505 of the FD&C Act to 

section 351 of the PHS Act, we cannot answer your specific questions concerning 

these provisions at this time. 

FDA established a cross-center \vorking group that has been charged with the 

responsibility for establishing policies and procedures to implement the new 

provisions in a manner that best serves the public health. This working group is being 

led by Dr. Janet \Voodcock, Director of the Center for Drug Evaluation and Research 

CCDER), and Dr. Karen Midthun, Acting Director of CBER. 

Representative John Dingell 

1. Would you please submit to the committee the number of people that you have at 

the different ports to ensure the safety and inspection of pharmaceuticals coming 

into this country? 

It is important to note that not all import control work occurs on the docks or at the 

border crossings. FDA staffs ports of entry in a variety of ways, depending upon 

geography and type and logistics of workload. Much of FDA's work in screening 

and examining import shipments occurs at locations other than ports of entry. 

Entry data for all commercial shipments of FDA-regulated products are transmitted 

electronically by U.S. Customs and Border Protection (CBP) to FDA. Entry data 

for admissibility are routed to FDA offices based on the port of entry identified in 

the submission. Although some admissibility reviews are conducted at the ports, 

FDA employees conduct the majority of admissibility reviews of FDA-regulated 

products electronically at disn-ict or other field offices across the counn-y. 

Entry reviewers in the field offices examine shipment infol1nation electronically that 

are flagged for review based upon criteria placed in FDA's computer system, the 

Operational and Administrative System for Import Support (OASIS). Entry 

reviewers will schedule an examination and/or sampling of those products that 

appear to pose the highest risk or based on existing assignments. They allow the 

remaining products to proceed without physical examination. 

The physical location where field examinations and/or sampling occur varies. Truck 

freight is often examined at a highway border port; however, many of these and the 

vast majority of ocean containers are examined and/or sampled at destination. 111is is 

permitted under section 801 (b) of the FD&C Aet, which states that articles may move 

to destination under a Customs bond to final destination, under condition that product 

is held and not distributed. 

With regard to inspectional staffing of ports, below is some general information: 

• Some ports are staffed onsite. For example, the New York District has 

investigators stationed daily at the Peace Bridge and the Lewiston Bridge in the 

port of Buffalo-Niagara Falls. 
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o Some ports are visited on a daily basis as needed, but the FDA inspcctional 

staff is based at a central facility, which covers multiple ports within a 

metropolitan area. For example, San Francisco District covers entries through 

the ports of San Francisco, San Francisco Airport, Oakland, Richmond, 

Alameda, Crockett, and Martinez, among others, from the District Office in 

Alameda, Most oftlle import inspectional work is performed at consignee 

warehouscs scattered throughout the Bay Area, 

o Somc rcmotc ports have little FDA-regulated import traffle. These ports are 

rarely visited. Nonetheless, FDA reviews the entlies for these POliS as 

described above, and provides inspectional coverage onsite or at consignce 

locations, as needed, Examples of such ports would include Hilo, Kahului, and 

Nawiliwili-Port Allen in Hawaii, and Eastport, Bath, Bar Harbor, and 

Rockland in Maine. 

Most ports are given inspectional coverage as required from the nearest FDA office 

during nonnal business hours, Monday through Friday. As mentioned above, many 

examinations and sample collections are performed not at the ports themselves, but 

at shipment destinations to which the goods travel under bond, There are a few 

major tntck pOliS where FDA has inspectional staff during the evenings and 

weekends, such as the A1l').bassador Bridge in Detroit, Michigan and the Peace 

Bridge in Buffalo, New York, 

Representative Joseph Pitts.,. 

1. When the U.S. authorities interdict counterfeit drugs here in the United States, 

what occurs? What is done with those drugs? 

United States authorities encounter and interdict counterfeit drugs in different ways, 

including when they are offered for import into the United States or when discovered 

domestically. FDA relies on various enforccment tools to execute both regulatory and 

criminal responses when counterfeit drugs are encountered, In fact, these responses 

are not mutually exclusive, and there may well be circumstances under which both a 

regulatory and criminal response is appropriate. 

FDA's import operations personnel may encounter counterfeit drugs at International 

Mail Facilities (IMFs) in addition to any U,S, part of entry during routine FDA 

screening/sampling operations of commercial entries. These encounters will most 

likely occur for products still in import status. FDA import operations personnel at 

L'v1Fs review parcel contents for suspected counterfeit products by visually comparing 

the products in the parcel against known standards for U.S.-available products and 

packaging. [f inspection of the shipment indicates a possible counterfeit, tile 

information is provided to FDA's Office of Criminal Investigations (OCJ) for potential 

follow up, as discussed further below. If OCl opens a criminal investigation, the 

counterfeit product may be seized as evidence, Otherwise, the products will be 

detained and ultimately refused admission into the United States by FDA's import 

operations staff. The expoliation or destruction of the shipment is catTied out under 

the direction of CBP, 
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FDA may also request sample collection for analysis of the product offered for import, 

and/or its packaging, by fDA's Forensic Chemistry Center (FCC). The determination 

to collect samples is made on a case-by-case basis, depending on the level of evidence 

supporting the suspicion of counterfeiting. Some type oflaboratory analysis may be 

required to confirm that foreign shipments of ilillgs discovered by U.S. authorities at a 

port of entry arc in fact eountelfeit. FCC is FDA's lead laboratory for the analysis of 

counterfeit pharmaceutical products, including counterfeit active pharmaceutical 

ingredients (APls), pharmaceutical dosage forms, and packaging. The FCC laboratory 

is accredited by the American Society of Crime Laboratory Directors/Laboratory 

Accreditation Board (ASCLD/LAB) and is staffed with experts on the analysis of 

counterfeit pharmaceutical products. 

With regard to imported products, although FDA and CBP have authority to seize 

violative products, CBP eUlTently does not have authority to destroy such products 

without first clearing resource-consuming procedural hurdles. FDA supports allowing 

CBP to destroy products in violation of FDA regulations that are valued at $2,000 or 

less that pose a reasonable probability of causing a significant adverse health effect, 

with an opportunity for a hearing to he held after destruction. Such destmction would 

prevent repeated attempts to import products that have already been refused 

ailinission. FDA supports providing a post-destmction hearing in those cases, and a 

pre-destmction hearing in the case of articles valued at more than S2,000 or that do not 

present a reasonable probability of causing significant health effects. 

FDA counterfeit drug investigations may also originate from other sources, such as 

OCl's pro-active law enforcenient activities, FDA inspections, private/trade industry 

information, the general public, regulatory partners, news media, and domestic/foreign 

law enforcement agencies. OCl will evaluate infom1ation received conceming 

counterfeit dmgs for possible criminal investigation and, if appropriate, will make 

arrangements to obtain the counterfeit dmgs for use in the investigation. In some 

instances, these investigations are conducted jointly with other law enforcement 

agencies, such as U.S. Immigration and Customs Enforcement (ICE) and the Federal 

Bureau ofInvestigations (FBI). Once a case is initiated, ocr Special Agents assigned 

to field offices throughout the United States conduct thorough and well-planned 

investigations, many times utilizing such investigative teclmiques as undercover 

investigations and surveillance operations. Counterfeit drugs are then used as evidence 

to support successful prosecutions through federal or state court systems, as 

appropriate. ocr maintains control of counterfeit drugs collected during an 

investigation and throughout the judicial proceedings. At the conclusion of trial, the 

evidence will remain in OCI's possession until the court authorizes its destruction. 

The FD&C Act authorizes FDA to seize counterfeit dmgs, as well as their containers 

and labeling (See 21 United States Code (U.S.C.) 334(a)(2». This authority has not 

been used in recent years, as most counterfeit cases are investigated (and product is 

seized as evidence) by OCL However, once evidence is established to prove that a 

product is counterfeit, FDA, working with the U.S. Department of Justice, can file a 
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complaint seeking forfeiture of the articles in U.S. District Court. If approved, the 

seizure is executed by the U.S. Marshals Service and court-ordered destruction, except 

in very unusual circumstances, would take place in the same judicial district in which 

the goods were originally located. 

Thank you again for your interest in drug safety. If you have further questions, please let 

us know. 

Enclosures 

Sincerely, 

0J.-~~~ 

Jeanne Ireland 

Assistant Commissioner 

for Legislation 

o