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IMPORT SAFETY: STATUS OF FDA’S SCREENING 

EFFORTS AT THE BORDER 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

APRIL 13, 2011 

Serial No. 112–38 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

CLIFF STEARNS, Florida 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

Vice Chairman 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

CHARLES F. BASS, New Hampshire 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

EDWARD J. MARKEY, Massachusetts 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

(II)

(III) 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

CLIFF STEARNS, Florida 

Chairman 

LEE TERRY, Nebraska 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

SUE WILKINS MYRICK, North Carolina 

BRIAN P. BILBRAY, California 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

JANICE D. SCHAKOWSKY, Illinois 

MIKE ROSS, Arkansas 

ANTHONY D. WEINER, New York 

EDWARD J. MARKEY, Massachusetts 

GENE GREEN, Texas 

DONNA M. CHRISTENSEN, Virgin Islands 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

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

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

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

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

opening statement ................................................................................................ 4 

Prepared statement .......................................................................................... 13 

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

California, opening statement ............................................................................. 16 

Prepared statement .......................................................................................... 17 

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

Prepared statement .......................................................................................... 19 

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

prepared statement .............................................................................................. 60 

WITNESSES

Margaret A. Hamburg, M.D., Commissioner, Food and Drug Administration; 

accompanied by David Elder, Acting Deputy Assistant Commissioner for 

Regulatory Affairs for Field Operations ............................................................. 20 

Prepared statement .......................................................................................... 23 

Answers to submitted questions ...................................................................... 74 

SUBMITTED MATERIAL

Testimony from Allan Coukell, Director, Medical Safety Portfolio, Pew Health 

Group, The Pew Charitable Trusts, submitted by Ms. DeGette ...................... 5 

Article entitled, ‘‘The Difficult Fight Against Counterfeit Drugs--Dr. Sanjay 

Gupta investigates fake medications on his first assignment for ‘60 minutes,’’’ submitted by Mr. Dingell ......................................................................... 61 

Discussion Draft of Drug Safety Legislation, Section-by-Section Summary, 

submitted by Mr. Dingell .................................................................................... 67 

Letter of April 15, 2011, from Mr. Dingell to Commissioner Hamburg, submitted by Mr. Dingell .......................................................................................... 73 

(1) 

IMPORT SAFETY: STATUS OF FDA’S 

SCREENING EFFORTS AT THE BORDER 

WEDNESDAY, APRIL 13, 2011 

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

The Subcommittee met, pursuant to call, at 10:34 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Cliff Stearns 

(chairman of the subcommittee) presiding. 

Members present: Representatives Stearns, Murphy, Burgess, 

Blackburn, Myrick, Bilbray, Gingrey, Scalise, Barton, DeGette, 

Schakowsky, Christensen, Dingell, and Waxman (ex officio). 

Staff present: Allison Busbee, Legislative Clerk; Todd Harrison, 

Chief Counsel, Oversight/Investigations; Ruth Saunders, Detailee, 

ICE; Alan Slobodin, Deputy Chief Counsel, Oversight; Sam 

Spector, Counsel, Oversight; John Stone, Associate Counsel; Ali 

Neubauer, Democratic Investigator; Brian Cohen, Democratic Investigations Staff Director and Senior Policy Advisor; Stacia 

Cardille, Democratic Counsel; Rachel Sher, Democratic Counsel; 

Eric Flamm, Democratic FDA Detailee; and Karen Lightfoot, 

Democratic Senior Policy Advisor and Communications Director. 

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

Mr. STEARNS. Good morning everybody, and welcome to the Subcommittee on Oversight and Investigations hearing on Import Safety and the Status of FDA’s Screening Efforts at the Border. 

My colleagues, today the Subcommittee on Oversight and Investigations will examine the status of the Food and Drug Administration’s efforts to ensure that Americans have access to the safest 

and highest quality imported food, drugs and medical products. 

This subcommittee has a bipartisan tradition of periodically meeting with and demanding accountability from the federal officials 

tasked with screening imported food and medicines that the American people increasingly rely on for their health and quality of life. 

As Commissioner Hamburg herself noted in February 2010, FDAregulated products are currently imported from more than 150 

countries, with more than 130,000 importers of record, and more 

than 300,000 foreign facilities. 

This hearing marks Commissioner Hamburg’s first appearance 

before our subcommittee since her confirmation. Since assuming 

her current position, the commissioner has touted a vision for FDA 

to serve as ‘‘a truly global public health agency.’’ In her own words, 

2 

‘‘The FDA faces a daunting set of tasks. Globalization has multiplied the scale of our responsibility and the challenges that we all 

face.’’ I applaud the commissioner’s expressed support for a number 

of important FDA initiatives. 

Our concern this morning, however, is less with what has been 

promised, and more about what has been achieved in the interest 

of the public health. For example, in a February 2010 speech, the 

commissioner unveiled a new program developed over the previous 

decade enabling FDA, for the first time, to comprehensively and intelligently screen all food, drugs and medical products that are entering the United States. This system, known as PREDICT, which 

is short for Predictive Risk-Based Evaluation for Dynamic Import 

Compliance Targeting, is a cutting-edge, risk-based tool that could 

help reduce our vulnerability to poor-quality imported food, and 

counterfeit or otherwise prohibited pharmaceuticals. 

However, despite promises to begin deploying it nationwide by 

late 2009 and have it fully up and running by the spring of 2010, 

PREDICT has only been deployed in three districts over the last 

14 months. At this rate, it would take FDA over 5 years to deploy 

PREDICT in the remaining 16 FDA districts. FDA has informed 

committee staff that the technical glitches holding up PREDICT’s 

nationwide deployment have been resolved, and that FDA anticipates deploying the system to Florida and Puerto Rico by the end 

of this month. 

If the technical issues have been resolved, why does FDA continue to deploy PREDICT in such a piecemeal manner? I don’t see 

any reason not to push more aggressively for its immediate deployment nationwide. I also expect to have the commissioner back here 

before the committee at a future time to comment on the progress 

of PREDICT’s deployment. 

Serious vulnerabilities in our import screening systems do remain. For example, millions of parcels arrive by international mail 

and express couriers’ facilities every year. PREDICT is not deployed at any of these facilities presently, nor am I aware of any 

plans for PREDICT to be used in these settings. FDA must treat 

each and every one of these parcels just as it does imported cargo 

shipments, as potential carriers of dangerous, tainted foods and 

adulterated or counterfeit drugs. FDA cannot claim to be doing all 

it can to protect the American people from these threats so long as 

a major entry point for goods into the country remains largely 

unmonitored. 

FDA also should not overlook the threats posed by rogue Internet 

pharmacies that falsely market their products as Canadian in origin. A recent 60 Minutes CBS report on counterfeit drug imports 

featured a senior FDA official admitting that his agency lacked the 

authority to destroy dangerous shipments and was forced to simply 

return them to the sender. This report highlighted a serious and 

frustrating problem with our current screening process. 

We need to better protect the health and safety of all Americans. 

In March 2007, FDA learned that melamine-contaminated vegetable proteins imported from China and found in certain pet foods 

were sickening and killing cats and dogs. Also, the commissioner 

noted on 60 Minutes that over 80 Americans died in 2008 as a result of contaminated heparin, a blood thinner, which had also been 

3 

imported from China. The commissioner suggested earlier this year 

that ‘‘regrettably, another public health crisis like heparin or melamine seems inevitable’’ unless certain changes are made in our 

import screening process. We cannot and must not accept this inevitability. 

PREDICT is the most promising tool we have to enhance our defenses against such a threat. Let us deploy it nationwide and without further delay. 

So Commissioner, I look forward to discussing with you the possibilities of legislation or perhaps legislative report language to 

help provide more focus and support to the deployment of PREDICT and other improvements to FDA’s import screening. Let me 

welcome our witness, Commissioner Hamburg. 

[The prepared statement of Mr. Stearns follows:] 

PREPARED STATEMENT OF HON. CLIFF STEARNS

Today, the Subcommittee on Oversight and Investigations will examine the status 

of the Food and Drug Administration’s efforts to ensure that Americans have access 

to the safest and highest quality imported food, drugs, and medical products. 

This subcommittee has a bipartisan tradition of periodically meeting with and demanding accountability from the federal officials tasked with screening imported 

food and medicines that the American people increasingly rely on for their health 

and quality of life. As Commissioner Hamburg herself noted in February 2010, FDAregulated products are currently imported from more than 150 countries, with more 

than 130,000 importers of record, and from more than 300,000 foreign facilities. 

This hearing marks Commissioner Hamburg’s first appearance before our Subcommittee since her confirmation. Since assuming her current position, the Commissioner has touted a vision for FDA to serve as ‘‘a truly global public health agency.’’ 

In her own words, the ‘‘FDA faces a daunting set of tasks. Globalization has multiplied the scale of our responsibility, and the challenges we face.’’ I applaud the Commissioner’s expressed support for a number of important FDA initiatives. Our concern this morning, however, is less with what has been promised, and more about 

what has been achieved in the interest of the public health. 

For example, in a February 2010 speech, the Commissioner unveiled a new program developed over the previous decade, enabling FDA, for the first time, to comprehensively and intelligently screen all food, drugs, and medical products entering 

the U.S. This system, known as PREDICT, which is short for ‘‘Predictive Risk-Based 

Evaluation for Dynamic Import Compliance Targeting,’’ is a cutting-edge, risk-based 

tool that could help reduce our vulnerability to poor quality imported food, and 

counterfeit or otherwise prohibited pharmaceuticals. 

However, despite promises to begin deploying it nationwide by late-2009 and have 

it fully up and running by Spring 2010, PREDICT has only been deployed in three 

districts over the last 14 months. At this rate, it would take FDA over 5 years to 

deploy PREDICT in the remaining 16 FDA districts. 

FDA has informed Committee staff that the technical glitches holding up PREDICT’s nationwide deployment have been resolved, and that FDA anticipates deploying the system to Florida and Puerto Rico by the end of this month. If the technical issues have been resolved, why does FDA continue to deploy PREDICT in such 

a piecemeal manner. I don’t see any reason not to push more aggressively for its 

immediate deployment nationwide. I also expect to have the Commissioner back 

here before the Committee at a future time to comment on the progress of PREDICT’s deployment. 

Serious vulnerabilities in our import screening systems remain. For example, millions of parcels arrive by international mail and express couriers’ facilities every 

year. PREDICT is not deployed at any of these facilities presently; nor am I aware 

of any plans for PREDICT to be used in these settings. FDA must treat each and 

every one of these parcels just as it does imported cargo shipments—as potential 

carriers of dangerous, tainted foods and adulterated or counterfeit drugs. FDA cannot claim to be doing all it can to protect the American people from these threats 

so long as such a major entry-point for goods into the country remains largely 

unmonitored. 

FDA also should not overlook the threats posed by rogue Internet pharmacies that 

falsely market their products as Canadian in origin. A recent CBS 60 Minutes reVerDate Nov 24 2008 15:31 May 15, 2012 Jkt 037690 PO 00000 Frm 00009 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 112\112-38 041311\112-38 CHRIS
4 

port on counterfeit drug imports featured a senior FDA official admitting that his 

agency lacked the authority to destroy dangerous shipments and was forced to simply return them to the sender. This report highlighted a serious and frustrating 

problem with our current screening process. 

We need to better protect the health and safety of all Americans. In March 2007, 

FDA learned that melamine-contaminated vegetable proteins imported from China 

and found in certain pet foods were sickening and killing cats and dogs. Also, the 

Commissioner noted on 60 Minutes that over 80 Americans died in 2008 as a result 

of contaminated heparin, a blood thinner, which had also been imported from China. 

The Commissioner suggested earlier this year that ‘‘regrettably, another public 

health crisis like heparin or melamine seems inevitable’’ unless certain changes are 

made in our import screening process. We cannot and must not accept this inevitability. PREDICT is the most promising tool we have to enhance our defenses 

against such a threat. Let’s deploy it nationwide and without further delay. 

Commissioner, I look forward to discussing with you the possibilities of legislation 

or legislative report language to help provide more focus and support to the deployment of PREDICT and other improvements to FDA’s import screening. 

Let me welcome our witness, Commissioner Hamburg. I will now yield to Ranking 

Member DeGette for the purposes of an opening statement. 

# # # 

Mr. STEARNS. I will now yield to the Ranking Member, Ms. 

DeGette from Colorado, for the purposes of an opening statement. 

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

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

pleased that we are having a hearing today about the safety of imports regulated by the FDA. 

I think that the FDA plays a vital role in protecting the health 

and security of Americans, and I know we will have probably many 

oversight hearings about this role over the next couple of years. 

Although I am really happy to see Commissioner Hamburg here 

before us today, though, Mr. Chairman, I am dismayed that out of 

three of the last four hearings, the majority has denied the minority a witness, and this approach is inconsistent with the practice 

of all the other subcommittees on this committee and this Congress 

and frankly I think inconsistent with the practices of this committee in previous Congresses. 

In the case of today’s hearing, we requested testimony from Allan 

Coukell, Director of the Pew Prescription Project. Mr. Coukell is an 

expert on issues raised by the influx of imported drugs and other 

medical products, and his testimony would have enhanced our understanding of this matter. So I ask unanimous consent to put his 

testimony in the record, Mr. Chairman. 

Mr. STEARNS. By unanimous consent, so ordered. 

[The information follows:] 

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12 

Ms. DEGETTE. Thank you so much. 

Over the past decade, imports of FDA-regulated products have 

grown at an astronomical pace. In 2004, the FDA oversaw the 

entry of 12 million shipments of products like food, pharmaceuticals and medical devices. In just 6 years, the number of imports nearly doubled, reaching 21 million shipments by 2010, and 

the number of imports is expected to grow. 

Unfortunately, the FDA faces resource constraints that pose significant challenges to the agency’s ability to keep the food and drug 

supply safe. For example, the FDA is able to physically inspect less 

than 2 percent of imported shipments. 

In the face of such challenges, FDA has worked hard to become 

more efficient. One example of this is the creation of the PREDICT 

database system. This system enables the FDA to target higherrisk shipments for inspection, enhancing FDA’s ability to ensure 

the safety of imported food and drugs at ports of entry into the 

United States. The system is currently in use in New York, Los Angeles, Seattle and San Francisco, and it will soon be implemented 

nationwide. 

So given the increasing number of imports and the resource constraints facing the FDA, it is difficult to understand why we would 

be cutting FDA funding. 

In H.R. 1, for example, which was the majority’s opening salvo 

in the budget debate, the Republicans proposed cutting FDA’s 

budget by $241 million. The Republicans’ fiscal year 2012 budget, 

recently introduced by Representative Paul Ryan, calls for massive 

reductions, rolling back the agency funding to 2008 levels. In FDA’s 

case, this would mean a budget cut of over $600 million, a nearly 

20 percent reduction in the agency’s total budget. 

So make no mistake about it: a cut of this size would have a significant impact on the FDA’s ability to keep the food and drug supply safe. We are going to be voting on this budget this week, and 

I am hoping that we can reconsider these devastating FDA budget 

cuts. Even once PREDICT is implemented nationwide, it is not 

going to substitute for the budget that the FDA needs to have to 

undertake its oversight responsibilities. 

Mr. Chairman, as you so accurately noted, in the last Congress 

we took an important step forward regarding food safety, passing 

the bipartisan Food Safety Modernization Act, which gave the FDA 

new tools to protect the safety of the Nation’s food supply. Now we 

have an opportunity to provide the FDA with the additional resources and authorities it so desperately needs for pharmaceuticals. 

Nearly 40 percent of the pharmaceuticals in this country are imported, and up to 80 percent of the active ingredients in drugs 

come from foreign sources. 

The Drug Safety Enhancement Act, introduced yesterday by Mr. 

Dingell, will hold manufacturers responsible for the safety of the 

entire pharmaceutical supply chain, including components produced in foreign countries, and it will give FDA tools it needs to 

enforce these requirements. This is good legislation that deserves 

bipartisan support. 

Mr. Chairman, there is a lot of ground to cover in today’s hearing, and again, I appreciate Commissioner Hamburg coming today. 

I am looking forward to hearing about FDA’s efforts on imports, 

13 

about the PREDICT database system, about its work implementing 

the new food safety law, and its views on the Drug Safety Enhancement Act. And I hope that we can work together to explain why 

budget cuts to the FDA right now are not the way to go in order 

to protect our Nation’s citizens when it comes to drugs and food. 

Thank you. 

[The prepared statement of Ms. DeGette follows:] 

PREPARED STATEMENT OF HON. DIANA DEGETTE

Mr. Chairman, I am pleased that we are holding today’s hearing on the safety 

of imports regulated by the U.S. Food and Drug Administration. FDA plays a vital 

role in protecting the health and security of Americans, and Congress should be 

vigilant in examining ways to ensure that FDA is best equipped to carry out its mission. 

I am deeply disappointed, however, that for the third time in the last month, the 

majority has denied the minority a hearing witness. This approach is inconsistent 

with the practice in all other Subcommittees regarding minority witness requests 

and flies in the face of the bipartisan spirit we should maintain toward oversight. 

In the case of today’s hearing, we requested testimony from Allan Coukell, Director of the Pew Prescription Project. Mr. Coukell is an expert on issues raised by the 

influx of imported drugs and other medical products, and his testimony would have 

enhanced the Subcommittee’s understanding of this matter. I ask unanimous consent that Mr. Coukell’s written testimony he prepared be included in the record. 

Over the past decade, imports of FDA-regulated products have grown at an astronomical pace. In 2004, FDA oversaw the entry of 12 million shipments of products 

like food, pharmaceuticals, and medical devices. In just six years, the number of imports nearly doubled, reaching 21 million shipments by 2010. And the number of 

imports is expected to grow. 

Unfortunately, FDA faces resource constraints that pose significant challenges to 

the Agency’s ability to keep the food and drug supply safe. For example, FDA is able 

to physically inspect less than 2% of imported shipments. 

In the face of such challenges, FDA has worked hard to become more efficient. 

One example of this is the creation of the PREDICT database system. This system 

enables FDA to target higher-risk shipments for inspection, enhancing FDA’s ability 

to ensure the safety of imported food and drugs at ports of entry into the United 

States. 

The system is currently in use in New York, Los Angeles, Seattle, and San Francisco, and it will soon be implemented nationwide. 

Given the increasing number of imports and the resource constraints facing FDA, 

it is difficult to understand the recent efforts by my colleagues on the other side 

of the aisle to cut FDA funding. 

In H.R. 1, the majority’s opening salvo in the budget debate, Republicans proposed cutting FDA’s budget by $241 million. The Republicans’ FY 2012 budget, recently introduced by Rep. Paul Ryan, calls for massive reductions, rolling back agency funding to 2008 levels. In FDA’s case, this would mean a budget cut of over $600 

million, a nearly 20 percent reduction in the agency’s total budget. 

Make no mistake—a cut of this size would have a significant impact on FDA’s 

ability to keep the food and drug supply safe. The House will be voting on this budget this week, and I hope that my Republican colleagues will reconsider these devastating FDA budget cuts. 

In the last Congress, we took an important step forward regarding food safety, 

passing the bipartisan Food Safety Modernization Act to give FDA new tools to protect the safety of the nation’s food supply. 

We now have a similar opportunity to provide FDA with the additional resources 

and authorities it so desperately needs for pharmaceuticals. Nearly 40% of pharmaceuticals are imported, and up to 80% of the active pharmaceutical ingredients in 

drugs come from foreign sources. 

The Drug Safety Enhancement Act, introduced yesterday by Mr. Dingell, will hold 

manufacturers responsible for the safety of their entire pharmaceutical supply 

chain, including components produced in foreign countries. And it will give FDA 

tools it needs to enforce these requirements. This is good legislation that deserves 

bipartisan support. 

There is a lot of ground to cover in today’s hearing, and I appreciate Commissioner Hamburg coming today. I’m looking forward to hearing about FDA’s efforts 

on imports, its work to implement the new food safety law, and its views on the 

14 

Drug Safety Enhancement Act. And I hope Commissioner Hamburg can help convince my Republican colleagues to reconsider their proposed cuts to the FDA budget. 

Mr. STEARNS. I thank the gentlelady. I am just a little puzzled 

because I thought the National Journal just reported that the FDA 

got a $107 million increase, so maybe our figures are different, and 

I would also say to the gentlelady, the Hon. Hamburg is really the 

Administration’s witness. Probably the Republicans could argue 

that—— 

Ms. DEGETTE. You know, if the gentleman would yield? 

Mr. STEARNS. I would be glad to yield. I mean, we could almost 

request our witness because she is really more or less your witness, 

and as you and I discussed earlier that we want to concentrate on 

this PREDICT model, and she is the only one that can do it, and 

we just wanted one panel, and she is the top person. I yield to you. 

Go ahead. 

Ms. DEGETTE. This was the same thing, Mr. Chairman, that you 

told me the last time you denied the minority a witness when you 

called the Administration in to testify, so I talked to our chairman 

emeritus, Mr. Dingell, about this, and I said, you know, when we 

were in the majority and we called an Administration in when the 

Administration was of the other party, did we allow the minority 

a witness, and he said yes. If someone calls a witness, it doesn’t 

matter if they are a Democrat or Republican. The fact is, the minority retains the ability to call witnesses. In the case of the hearing today, the witness we would have wanted to call would have 

actually helped us understand this PREDICT system. 

Mr. STEARNS. OK. I think the Hon. Dr. Hamburg seems very 

competent and capable of handling this all by herself. 

With that, I will recognize Chairman Emeritus Mr. Barton from 

Texas for 2 minutes. 

Mr. BARTON. Thank you. Well, I want to congratulate you and 

Ms. DeGette. You at least got an Administration person to come. 

We have a hearing upstairs where apparently everybody at EPA is 

on vacation. So I want to give you two credit. You have our distinguished commissioner, and I am absolutely certain that she is 

going to be able to handle any questions either group of us posed 

to her. 

We do welcome you, Madam Commissioner. You have a very difficult job, and we are always glad to hear your input. 

This is an important issue. It is not on the front pages right now, 

which is a good thing. In the last 3 to 4 years, we have had several 

food poisoning situations that have made the front pages, so it is 

good to hold a hearing in a non-crisis situation. 

We all know how much of our food is being imported, how much 

of our medical devices, how many of our pharmaceutical finished 

products and precursor ingredients, so how the FDA regulates and 

inspects these products is extremely important. This is an area 

where there has been bipartisan support in the past. Chairman 

Dingell, Chairman Waxman, myself, Chairman Upton have all in 

the past 6 years worked together to improve our food system and 

improve the screening process. 

I am going to be very interested in your comments on the PREDICT model. I know that is being used now in four locations or 

15 

four regions. I would like to know why perhaps we can’t go ahead 

and implement it nationwide. 

So Mr. Chairman and Madam Ranking Member, this is a good 

hearing. Hopefully it will be bipartisan in nature, and we will put 

the facts before the American people. With that, I yield back. 

Mr. STEARNS. I thank the gentleman and recognize the gentleman from Texas, Dr. Burgess, for 2 minutes. 

Mr. BURGESS. I thank the chairman for the recognition, and I 

will just mention to the gentlelady from Colorado, the Ranking 

Member of the committee, that I will support her efforts to have 

a full and open hearing on the heparin issue. I tried to do that 

when I was ranking member of the minority and then-Chairman 

Waxman refused those entreaties. I was fortunate enough to get a 

briefing by Dr. Hamburg in my office but nothing substitutes for 

a full and open hearing so the American people can actually hear 

what is going on. 

Now, the Food and Drug Administration is truly at a crossroads 

of the issues that really impact our country today and will shape 

tomorrow from the food on our tables today to the cures, the drugs 

and devices that our Nation’s doctors will offer the patients of 

America. The ability of tomorrow’s doctors to alleviate human suffering is going to be something on a scale that none us have ever 

seen before if they can get through the FDA, and your agency, 

Commissioner, is obviously at the forefront of those battles. 

This committee with its oversight of Food and Drug is responsible for maintaining an active dialog with you on the full breadth 

of your jurisdiction to ensure that you have the tools that you need 

but you are using them in a way that is beneficial for the country 

at large. Primarily this hearing today will focus on food safety, and 

I have been concerned about that for years. In 2007, I introduced 

legislation that would give the Secretary of Health and Human 

Services the power to refuse admission to a food that was strongly 

associated with a suspected foodborne illness. We all remember the 

Lou Dobbs’ reports from a couple of years ago when contaminated 

tomatoes were quarantined in Texas, Georgia and Florida and it 

turned out these were peppers coming across the border. It was 

found on a Friday afternoon and nothing could be done until Monday because, after all, it was a weekend. We have to be able to stop 

that stuff when we find it. When there is a known source of contaminated food, you should be able to act without wasting time. 

Now, we all knew this hearing that coming into this year that 

another salmonella outbreak was going to happen. We passed a 

food safety law last year. We have increased the FDA budget. So 

I am interested in, do you have the tools you need with the new 

legislation that you have, the budgetary allowance that you have 

had. Now, Dr. Sharfstein came in and said you needed no more 

money for drugs and devices, so I am assuming you have put a lot 

into food safety, and we do want to know what is going to be different this April, this May, this June than previous years when 

this inevitable salmonella outbreak occurs. 

I thank the chairman for the recognition. I will yield back my 

time. 

Mr. STEARNS. The gentleman yields back. The gentleman from 

California, Mr. Bilbray, is recognized for 1 minute. 

16 

Mr. BILBRAY. Thank you, Mr. Chairman. 

Mr. Chairman, I come from a State where you can’t talk about 

health without talking about holistic issues too and the interrelationship between components, that nothing in health is isolated. One of the things that is quite obvious that we are not going 

to specifically address today but I think that we all have to be 

aware of, that the reality of what is happening with the development of drugs and the production of drugs in this country, this 

issue of importation is going to grow dynamically. Literally right 

now, you have companies that are leaving this country in droves 

and going overseas to not only produce the drugs but also the research and development, and I just think this committee needs to 

be aware that this issue may be increasingly substantially basically 

because we are seeing the next generation of innovation and drug 

development literally leaving the country, and sadly, the fact is, is 

that things like drug manufacturing and research doesn’t take a lot 

of time to leave the country and evaporate as much as, let us say, 

auto manufacturing. We are seeing that going. So this issue is 

going to grow. 

The one place where it is going to probably be reduced by this 

crisis is the reimportation, and that is something we need to talk 

very openly and frankly about, the assumption that something 

claims to being reimported so it is not reviewed, there is no oversight. As somebody who was born and raised along the border and 

seeing what happens across the largest port of entry in the world, 

the Tijuana-San Diego port of entry, this is obviously something 

that is very near and dear not just to my constituents but to my 

family, and I think that we need to address those issues and really 

talk about them extensively. 

But I just think that as we look at this, we have got to be aware 

of the crisis coming down the pike and address that with this. 

Thank you very much, Mr. Chairman. 

Mr. STEARNS. I thank the gentleman. The gentleman from California, Mr. Waxman, the ranking member, is recognized for 3 minutes. 

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

Mr. WAXMAN. Mr. Chairman, this is the fourth oversight hearing, 

and three out of the four, we have been denied minority witnesses. 

I want to join Ms. DeGette in complaining about it. Representatives of this Administration are not minority witnesses. They represent the other branch of government, and we are going to have 

a serious talk about this. This isn’t the way this committee has operated when the Republicans controlled or when the Democrats 

controlled the committee in the past. 

FDA’s ability to protect the American public is an important 

topic for oversight, and our witness would have added to that understanding of this hearing. FDA is responsible for ensuring the 

safety of food, drugs and medical devices, and if FDA does not do 

its job, lives are at stake. 

In the official hearing memo for today’s meeting on the safety of 

imports, the right questions were posed: What are FDA’s solutions 

17 

for enhancing the screening of imported food, drugs and medical 

devices? What is FDA doing to improve its IT infrastructure for 

risk-based screening? How can FDA better ensure the safety of imported products? 

But there is an enormous disconnect between these questions 

and what is happening in Congress this very week. GAO told us 

that improving the safety of our food and drugs requires that we 

provide FDA with more funding and resources, yet we are doing 

the exact opposite. 

Just last week, Representative Paul Ryan introduced the Republican budget for fiscal year 2012. The House will soon be voting on 

this proposal. There is not a lot of detail but there is enough to 

know what it would mean for FDA. Republicans propose to roll 

back discretionary funding for all federal agencies to fiscal year 

2008 levels. 

In the case of the FDA, the agency budget would be reduced by 

$600 million, a budget cut of almost 20 percent. This Republican 

budget would require a dramatic reduction in FDA’s funding to 

keep the food and drug supply safe. The result would be the reverse of what the American people want: fewer inspections and 

more adulterated and dangerous food and drugs. 

Mr. Chairman, there is a word now, I think part of the American 

language, called chutzpah. It means you have got a lot of nerve, I 

think the Republicans have a lot of nerve to haul the FDA commissioner up here and grill her about why FDA is not doing more to 

keep the food and drug supply safe while simultaneously passing 

a budget that takes away the resources she needs to do her job. It 

is chutzpah as well for the Republicans on this subcommittee to 

complain that FDA is not doing enough about food safety when the 

majority of the members on this committee voted against the Food 

Safety Modernization Act, which was the first expansion of FDA’s 

food safety authorities in 70 years. 

Commissioner Hamburg, we appreciate your being here. You are 

not here at the request of the minority. It would be ridiculous to 

have this hearing without you. 

Mr. Chairman, I want to yield the rest of my time, 2 minutes, 

to Mr. Dingell, who has been instrumental in the food safety and 

drug and medical device safety questions and it is important that 

we hear from him. 

[The prepared statement of Mr. Waxman follows:] 

PREPARED STATEMENT OF HON. HENRY A. WAXMAN

FDA’s ability to protect the American public is an important topic for oversight. 

The agency is responsible for ensuring the safety of food, drugs, and medical devices, and if FDA does not do its job, lives are at stake. 

In the official hearing memo for today’s hearing on the safety of imports, the right 

questions are posed. What are FDA’s solutions for enhancing the screening of imported food, drugs, and medical devices? What is FDA doing to improve its IT infrastructure for risk-based screening? How can FDA better ensure the safety of imported products? 

But there is an enormous disconnect between these questions and what is happening in Congress this week. GAO report after GAO report tells us that improving 

the safety of our food and drugs requires that we provide FDA with more funding 

and resources. Yet we are doing exactly the opposite. 

Just last week, Rep. Paul Ryan introduced the Republican budget for Fiscal Year 

2012. The House will soon be voting on this proposal. While there’s not a lot of deVerDate Nov 24 2008 15:31 May 15, 2012 Jkt 037690 PO 00000 Frm 00023 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 112\112-38 041311\112-38 CHRIS
18 

tail in the budget, there is enough to know what it would mean for FDA: Republicans propose to roll back discretionary funding for all federal agencies to FY 2008 

levels. 

What would this mean? In the case of FDA, it would mean that the agency budget would be reduced by $600 million—a budget cut of almost 20%. This Republican 

budget would require a dramatic reduction in FDA’s funding to keep the food and 

drug supply safe. 

The result would be the reverse of what the American people want: fewer inspections and more adulterated and dangerous food and drugs. 

Mr. Chairman, when I read the Republican budget and then look at the topic of 

today’s hearings, I’m reminded of an old Yiddish term: chutzpah. Roughly translated, it means someone who’s got a lot of nerve. 

It takes chutzpah to haul the FDA Commissioner up here and grill her about why 

FDA is not doing more to keep the food and drug supply safe . while simultaneously 

passing a budget that takes away the resources she needs to do her job. 

And it takes chutzpah for Republicans on this Subcommittee to complain that 

FDA is not doing enough about food safety when the majority of them voted against 

the Food Safety Modernization Act, the first expansion of FDA’s food safety authorities in 70 years. 

Commissioner Hamburg, I appreciate you coming today. I am looking forward to 

your testimony, and I look forward to working with you to ensure that FDA has the 

tools and the budget to continue doing its job. 

Mr. STEARNS. The gentleman is recognized for 2 minutes. 

Mr. WAXMAN. And I am pleased you are allowing him to give an 

opening statement. 

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

Mr. DINGELL. Mr. Chairman, I thank you. I thank my good 

friend from California for yielding me this time. I commend you for 

having this hearing because it is a great opportunity for us. I think 

for us to spend time caviling over whether a witness is a Democratic or a Republican witness is a prodigious waste of time. This 

committee has a fine history of having worked together to put out 

good legislation and includes the food safety legislation in the last 

Congress, also the wonderful legislation we put together over the 

question of Consumer Product Safety Commission and giving it the 

authority. 

Americans suffer from unsafe pharmaceuticals coming into this 

country. They have neither the personnel nor the money to do the 

job that we need to do to catch these things coming in. They function under inadequate law which does not enable us to seize the 

products coming into this country and to destroy them and rather 

they are turned around and sent out and come back in through another port. Americans are dying of this. They are being denied 

proper prescription pharmaceuticals in order to address the problems that they confront in terms of dealing with major problems 

like cancer, heart disease, hypertension and other things that are 

killing Americans. 

Yesterday I introduced with my colleagues, Ranking Members 

Waxman, Pallone and DeGette, H.R. 1483, the Drug Safety Enhancement Act. This legislation would require manufacturers to 

implement improved quality and safety standards including stronger supply-chain management, a matter often the concern of my Republican colleagues. It would require manufacturers to notify FDA 

of counterfeits or safety concerns and to list drugs and components 

by the country of origin to enable us to track the movement of 

19 

these pharmaceuticals as they move through commerce. It would 

strengthen importers’ and custom brokers’ oversight. It would arm 

FDA with administrative detention to structure mandatory recall 

authorities, subpoena power and clear extraterritorial jurisdiction. 

It would strengthen criminal and civil penalties for crime deterrents, and it would increase foreign manufacturing inspections to 

be on a par with those that are suffered by American manufacturers. It would also create new funding mechanisms for FDA 

inspectional activities so that globalization is not going to burden 

American taxpayers. 

I have an excellent article about the safety problems that we confront together with an analysis of the legislation, H.R. 1483. I ask 

unanimous consent that those be inserted into the record. 

Mr. STEARNS. By unanimous consent, so ordered. 

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

Mr. DINGELL. And I commend you for this, Mr. Chairman. You 

are leading an effort which I believe can bring great good to our 

people. 

[The prepared statement of Mr. Dingell follows:] 

PREPARED STATEMENT FROM HON. JOHN D. DINGELL

Mr. Chairman, I thank you for holding today’s hearing. 

For too long, Americans have suffered from unsafe pharmaceuticals coming into 

this country from foreign manufacturers and counterfeit drug operations. The Heparin crisis was a wake up call that the FDA needs greater authority to stop unsafe 

pharmaceuticals and pharmaceutical ingredients from crossing our borders. 

Just yesterday I introduced with my colleagues Ranking Members Waxman, 

Pallone and DeGette, H.R. 1483, the Drug Safety Enhancement Act. This legislation 

would give FDA much-needed authorities and resources to address the safety gaps 

in our drug supply system. 

This legislation would: 

• Require manufacturers to implement improved quality and safety standards, including stronger supply chain management; 

• Require manufacturers to notify FDA of counterfeits or safety concerns and to 

list drugs and drug components country of origin; 

• Strengthen importers and customs brokers oversight; 

• Arm FDA with administrative detention, destruction, and mandatory recall authorities, subpoena power, and clear extraterritorial jurisdiction; 

• Strengthen criminal and civil penalties for crime deterrence; 

• Increase FDA foreign manufacturing inspections to be on par with domestic facilities; and, 

• Create new funding mechanisms for FDA inspectional activities, so globalization 

doesn’t burden US taxpayers. 

This last point is an important one. At the same time this Committee and Congress is asking the FDA to do more, the new Majority is cutting their funding. 

The FDA serves as the watchdog for what food, drugs, devices and cosmetics are 

coming across our borders and they need a steady, reliable stream of funding to 

carry out their duties. Further, we need to address gaps in authorities that are leaving consumers vulnerable to shoddy practices overseas. 

I sincerely hope my colleagues on both sides of the aisle will work with me to provide FDA with the authority it needs to improve the safety of imports coming across 

our border. 

Mr. STEARNS. And I thank the chairman emeritus and his long 

serving as the former chairman of this committee. I would point 

out—I asked staff based on what Ms. DeGette and Mr. Waxman indicated—that last year under Democrat majority, they had a hearing with only the FDA commissioner on May 6, 2010. So I think 

at this point—— 

20 

Mr. WAXMAN. Mr. Chairman, will you yield to me? This is kid 

stuff. 

Mr. STEARNS. Well, no—— 

Mr. WAXMAN. I don’t know if you requested a witness or not. If 

we request a witness who we think adds to it, it is going to be 5 

minutes more out of your life to hear from that witness. 

Mr. STEARNS. All right. 

Mr. WAXMAN. I think it is very narrow and mean-spirited to try 

to deny us an opportunity to hear witnesses that we think could 

add to the hearing. 

Mr. STEARNS. Well, I appreciate your sentiments. I just don’t 

agree with you. 

OK. With that, we are very pleased—— 

Mr. WAXMAN. We will invoke rules that require it if that is the 

way the chairman wishes to deal with it. 

Mr. STEARNS. We welcome our witness today, the Hon. Margaret 

A. Hamburg, medical doctor, Commissioner of the Food and Drug 

Administration. If you don’t mind, just turn your microphone on 

and move the microphone a little closer to you and that will be 

very helpful. I have to swear you in. 

[Witness sworn.] 

Mr. STEARNS. We welcome your opening statement. 

TESTIMONY OF MARGARET A. HAMBURG, M.D., COMMISSIONER OF FOOD AND DRUGS; ACCOMPANIED BY DAVID 

ELDER, ACTING DEPUTY ASSISTANT COMMISSIONER FOR 

REGULATORY AFFAIRS FOR FIELD OPERATIONS 

Dr. HAMBURG. Thank you very much, and good morning, Chairman Stearns, Ranking Member DeGette, members of the subcommittee. I am Dr. Margaret Hamburg, Commissioner of Food 

and Drugs, and joining me here is David Elder, Acting Deputy Assistant Commissioner for Regulatory Affairs for Field Operations. 

He has been with the agency for 23 years, 15 of which he spent 

in the field. 

I appreciate the opportunity to be here with you to discuss our 

approach to import safety and the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting application, or 

PREDICT, and its role in our efforts to protect our Nation’s supply 

of food and medical products in an increasingly globalized market. 

When President Franklin Delano Roosevelt established the modern FDA back in 1938, the percentage of food and medical products 

imported into the United States was minimal. Today, the landscape, as you have already been discussing, is dramatically 

changed. FDA-regulated products are currently imported from 

more than 150 countries. This year, we expect that nearly 24 million shipments of FDA-regulated products will arrive at U.S. ports 

of entry. It is estimated that between 15 to 20 percent of all food 

now consumed in the United States originates outside our borders. 

Further, up to 40 percent of the drugs Americans take and up to 

80 percent of the active pharmaceutical ingredients in those drugs 

come from foreign sources. 

We face great challenges in ensuring that products are high quality and travel safely throughout their complex supply chain. As 

members of this committee well know, our concerns are not purely 

21 

hypothetical. The consequences of adulterated medical products 

throughout the world have already been noted, and they have been 

tragic. Pet food adulterated with the industrial chemical melamine 

in 2007 sickened several thousand pets here in the United States, 

and that same contaminant was added to infant formula in China, 

fatally poisoning about six babies and making 300,000 others 

gravely ill in that country. And members of this committee are well 

aware of the 2008 heparin contamination crisis in which adulterated heparin was associated with several deaths and cases of serious illness. 

To address these threats and others, we need a paradigm shift 

in our approach to import safety where the border is no longer our 

primary line of defense. We must partner with industry and our 

global counterparts to push responsibility for safety and quality 

further up the supply chain and to monitor the integrity of that 

supply chain throughout. That is why FDA is developing a global 

strategy and action plan, more fully detailed in my written testimony, which will allow us to more effectively oversee the safety of 

all products that reach U.S. consumers in the future. While we cannot simply be guardians at the gate, border screening, surveillance 

and intervention must remain an important part of our comprehensive import safety program. 

The task is enormous. In fiscal year 2010, FDA received a total 

of 21.2 million lines of FDA-regulated commodities imported from 

over 150 countries. FDA is currently managing 264 active import 

alerts, which flag potentially high-risk imports representing 3,100 

types of products from over 11,000 manufacturers in 150 different 

countries or areas. 

To help make our imports screening more efficient, FDA has developed the PREDICT application, a sophisticated information 

technology system which provides FDA staff on the front lines with 

more information regarding the many risks associated with products entering our borders and allows them to target for examination those shipments at greatest risk. PREDICT has been launched 

in Los Angeles, New York, Seattle and San Francisco, covering 

about 40 percent of all imports at the present time. Some technical 

difficulties, as noted, delayed our national rollout. However, I am 

pleased to report that we have addressed those issues and are back 

on track. This month, PREDICT will be implemented in our Florida and San Juan districts, expanding coverage to almost 50 percent of all imports. If successful, it will then be rolled out across 

the country. 

PREDICT is an exciting and important innovation that harnesses advances in information science to enable us to do our job 

better and to improve our service to the Nation. But as I mentioned 

earlier, it is just one step in our efforts to fully secure the supply 

chain. 

Congress has provided the agency with critical tools to assure the 

safety of imported food. New regulatory authorities for drugs similarly may help ensure that we can hold industry accountable for 

the security and integrity of their supply chains and the quality 

control systems they use to produce drugs for the American people. 

Those may include authorities in the areas of corporate responsiVerDate Nov 24 2008 15:31 May 15, 2012 Jkt 037690 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 112\112-38 041311\112-38 CHRIS
22 

bility, enforcement and information sharing, which are detailed 

more fully in my testimony. 

Thank you for the opportunity to testify this morning, and I look 

forward to answering your questions. 

[The prepared statement of Dr. Hamburg follows:] 

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Mr. STEARNS. Thank you, Commissioner Hamburg. 

We have a clip we are going to show on the screen here, which 

is from a speech you gave in January discussing the FDA’s new 

global challenges. If we can, play the clip and maybe just drop the 

lights a little bit. 

[Video shown.] 

Mr. STEARNS. That statement indicates that you believe the current threat is pretty serious and you have spoken repeatedly about 

the challenges we face in assuring the safety and quality of imported products in a global age. You mentioned that in your opening statement, and I think we can conclude that import safety is 

one of your top priorities, and you have promoted PREDICT as an 

important tool to leverage FDA’s resources in responding to this 

global challenge. 

As you mentioned in your testimony, you formally unveiled PREDICT in February 2010 in a speech and you stated that you hoped 

to have it up and running nationwide by the end of the spring of 

2010, as we recollect. The question is, what did you do to try and 

accelerate the implementation of the process considering you had 

indicated that you thought it would be up and running by the 

spring of 2010. 

Dr. HAMBURG. Well, as noted, PREDICT is a very important tool 

that will enable greater efficiencies in who we target resources, and 

it is very exciting to see it now in action in four of our districts and 

covering about 40 percent of all imports at the present time. As we 

rolled it out, from the very beginning it was determined that it 

should be done in a systematic stepwise way because very often 

with computer system implementations that involve extremely 

large databases, there are issues that emerge in the process. So we 

began in one location with a limited focus, expanded the focus and 

then began to roll it out. 

In the course of that, unfortunately, some issues did emerge and 

we actually at a certain point decided to stop with the actual use 

of PREDICT in the field while we brought in experts and put together a team which examined that. 

Mr. STEARNS. So really, in a sense, rather than trying to accelerate the implementation process, you really stopped it then. 

Dr. HAMBURG. Well, what we did was when the problems 

emerged—— 

Mr. STEARNS. I mean, isn’t that true? 

Dr. HAMBURG [continuing]. In its implementation, we stopped it 

in order to identify what those problems were rather than keeping 

a system—— 

Mr. STEARNS. Let me get a little more specific for you. After 

PREDICT was deployed in the New York district in the spring of 

2010, there appeared to have been a 5- to 6-month delay while a 

government contractor wrote a white paper on a performance assessment of PREDICT. Given that import safety is one of your top 

priorities, is this delay of the deployment acceptable considering 

how important it is? And you said earlier in your speech that this 

has to be enforced. 

Dr. HAMBURG. Mr. Chairman, I understand your concern about 

an unfortunate delay that occurred in the process. However, this 

system is very, very important. It is critical that it work effectively 

38 

and efficiently. We had identified problems with its implementation. We stopped the full rollout while we brought in outside experts and our internal experts to identify the source of the problem. 

The effort that you mentioned was an effort to identify the—— 

Mr. STEARNS. Can I say this morning that all the technical problems have been solved? 

Dr. HAMBURG. We believe that we identified the underlying problem that led to the—— 

Mr. STEARNS. So the answer is yes? 

Dr. HAMBURG [continuing]. Inefficiencies in the system. 

Mr. STEARNS. The answer is yes, that you think all the technical 

problems have been taken care of? 

Dr. HAMBURG. It seems to be now functioning very well in the 

sites where it is present. 

Mr. STEARNS. Can you, based upon that, make a prediction this 

morning that PREDICT will be fully implemented nationwide by 

the end of the year? 

Dr. HAMBURG. That is our absolute goal but if there are problems 

in the implementation, we will of course examine those and correct 

them, but we are moving forward. We see no barriers to the further 

implementation of PREDICT in the two additional sites at the end 

of this month and extending it to 100 percent implementation by 

the end of the year. 

Mr. STEARNS. In your opinion, wouldn’t PREDICT benefit from 

a program focused oversight structure with executive-level involvement? 

Dr. HAMBURG. I am sorry. Would it benefit from an oversight—— 

Mr. STEARNS. Yes, a more focused approach with more executivelevel involvement. Instead of having these technical white papers, 

can’t you just have your staff focus down on this and bring in the 

executives to make decisions? 

Dr. HAMBURG. You know, I feel that we have been implementing 

this in a very responsible way with a clear program plan with internal and external experts overseeing the project. When problems 

emerge, we have taken the appropriate actions to remediate them. 

We now have the system up and running in the desired way providing benefits. 

Mr. STEARNS. Well, do you think you need congressional support? 

Should we pass legislation specifically authorizing this program 

and working with the Appropriations Committee to include report 

language? Would that help you at all, or do you think that is not 

necessary? 

Dr. HAMBURG. The continuing support of Congress for our efforts 

to support import safety is extremely welcome. I don’t think we 

need targeted legislation or activities for the PREDICT program. 

As I said, I believe that it is moving forward in an appropriate and 

valuable way and that it was our responsibility as problems 

emerged to identify the source of those underlying problems, fix 

them and make sure that the program in place in fact was fully 

functional and able to do the tasks that we are asking it to do and 

it is proving to be of great value as we screen products today. 

Mr. STEARNS. My time is expired. The gentlelady from Colorado 

is recognized for 5 minutes. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

39 

So Dr. Hamburg, let me get this straight. It was about 14 

months ago, February of last year, that the FDA announced this 

PREDICT program, right? 

Dr. HAMBURG. In the speech that you saw the segment of we formally announced that this PREDICT was—— 

Ms. DEGETTE. About 14 months ago, correct? 

Dr. HAMBURG [continuing]. Going to start to unfold. 

Ms. DEGETTE. And then you started implementing it and you 

found some problems and so you had to correct those problems as 

the implementation went forward, correct? 

Dr. HAMBURG. That is correct. 

Ms. DEGETTE. And if you had just tried to implement the whole 

thing within 2 months, it is your view that it may not have worked 

because it had some problems, right? 

Dr. HAMBURG. It would not have worked. 

Ms. DEGETTE. Now, as of today, 14 months later, it is about 40 

percent implemented, correct? You need to use words. It is about 

40 percent implemented? 

Dr. HAMBURG. It is implemented in four sites that cover 40 percent of the imports. 

Ms. DEGETTE. And so is it the FDA’s view that the major problems in the PREDICT problem have now been solved by these efforts over the last 14 months? 

Dr. HAMBURG. It is our belief that through the systematic scaleup and the examination of problems as they emerge that we have 

been able to correct the underlying problem in code, which actually 

wasn’t in PREDICT, it was in an interface with PREDICT. 

Ms. DEGETTE. I see. OK. 

Dr. HAMBURG. And that now the system, you know, is working 

in the sites that it is in place and we see no barriers at the present 

time to the full implementation in a timely manner. 

Ms. DEGETTE. And the FDA believes in this program and wants 

to implement it as quickly as possible as well as us, right? 

Dr. HAMBURG. Absolutely. 

Ms. DEGETTE. So, you know, I join with Mr. Stearns in saying, 

you know, whatever we can do to help you implement this, we 

think that it is important and it should be done as soon as possible 

but it should also be done right. 

But here is my next question. You said in your testimony, PREDICT isn’t the only thing we need to do. Why is that? 

Dr. HAMBURG. Because the volume of imports coming in at the 

borders and the number of sites of importation are so huge that the 

ability to really do the hands-on inspection, even with a screening 

tool like PREDICT, limits us in our reach. We want to reach back 

further, closer to where the products are actually produced and 

manufactured and try to build in assurances of safety and quality 

from the very beginning and throughout the supply chain, so working more closely with industry in terms of the standards that are 

expected, working with sister regulatory authorities in countries 

around the world so we have this harmonization of standards, 

sharing information with others. 

Ms. DEGETTE. OK. And so let me ask you, because we passed the 

Food Safety Modernization Act last year. Do you think that the 

40 

FDA needs new authorities to begin to do what you are talking 

about and to protect the safety of the drug supply? 

Dr. HAMBURG. I think the Food Safety Modernization Act has 

clearly given us additional authorities and a new framework for addressing food safety in this context. I think we do need to very 

carefully examine the opportunities on the drug side as well. We 

know that there are huge challenges and as was noted, they are 

growing. We do need additional authorities to be able to do our job 

and of course we need resources as well. 

Mr. DEGETTE. Yes. One thing that I worked a lot on in this food 

safety bill that is also in the Drug Safety Enhancement Act is mandatory recall authority for the FDA for drugs. Do you believe this 

authority is necessary? 

Dr. HAMBURG. I do believe that authority is necessary. 

Ms. DEGETTE. And why is that? 

Dr. HAMBURG. So that we can move swiftly when there is an imminent threat to the health of the public, to take action to make 

sure that a product with risks does not get out to consumers, is 

pulled back from shelves when it is out there. It is very vitally important, and our current authorities require us to either act 

through the authorities of States to embargo or pull back these 

products or to seek the support of the courts in taking these actions. 

Ms. DEGETTE. You know, this is one thing when I worked on 

mandatory recall for the food safety, my constituents were shocked 

because they thought the FDA already had that authority, and I 

bet that is true with drugs too. I bet people just think the FDA has 

that authority with drugs. 

One last question. One of the controversial areas in this new bill 

that we introduced calls for new registration fees on importers. I 

am wondering if you can talk about what the FDA opinion is on 

these registration fees. 

Dr. HAMBURG. Well, I think it is very, very important that we 

recognize that the magnitude of the problem is huge and growing 

and outstrips available resources. Clearly, we need to bring appropriate resources to bear. Clearly, this is the responsibility that the 

American people care about as well as industry, and I think it is 

appropriate that these programs be supported with industry contributions as well, and the ability to work with industry to achieve 

common goals in reducing these threats to health and safety will 

be, I think, enhanced in this kind of an approach. 

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

Mr. STEARNS. I thank the gentlelady. Dr. Burgess is recognized 

for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Well, they can be enhanced in that kind of approach only if we 

understand the problem that we had and how to deal with the 

problem. That of course brings me back to the heparin question, 

and you were kind enough to come and brief me last year in the 

last Congress. If I could, let me just recapitulate a couple of the 

things that we talked about that day. I would like to have them 

part of the committee’s record. Can you provide to the committee 

a list of the people with whom you met in China, the Chinese officials with whom you met? 

41 

Dr. HAMBURG. A list of officials with whom I met while I was visiting China? 

Mr. BURGESS. Yes. 

Dr. HAMBURG. I could. 

Mr. BURGESS. Because you met with several. 

Dr. HAMBURG. For the record. I mean, I can’t produce that right 

now. 

Mr. BURGESS. Correct, and I understand that. That is why I was 

asking you if you could produce it for us. And did the subject of 

the adulterated heparin come up when you met with the Chinese 

officials? 

Dr. HAMBURG. It did. I raised it with them to express our—— 

Mr. BURGESS. They didn’t bring it up spontaneously? You had to 

raise it? 

Dr. HAMBURG. I believe that I raised it. 

Mr. BURGESS. OK. And what did they commit to you as far as 

action to investigate and uncover what happened? 

Dr. HAMBURG. What was indicated to me was that they felt that 

there was not anything to be gained at this point by trying to continue the investigations of the underlying cause and instigators of 

the heparin contamination but they did recommit to working with 

us to ensure that this specific problem and similar problems will 

not occur going forward, and we do have a memorandum of understanding with the Chinese government with respect to some of the 

critical public health measures that need to be in place and are in 

place to help protect—— 

Mr. BURGESS. See, that whole approach is problematic to me because now we have, with all good intentions, drug safety legislation 

being introduced but we don’t really understand what happened 

and how we are going to control it, and that then makes for legislative difficulties. But the heparin question is so fundamentally different from the melamine. Melamine, it can be argued, was the 

equivalent of a dishonest grocery putting his thumb on the scale 

when he weighed your produce, but the heparin, this was a molecule that was developed specifically to defeat the mass spect that 

was used by the manufacturer to document that in fact what they 

had extracted from the live specimen was the desired active pharmaceutical ingredient. So hypersulfated and chondroitin sulfate 

would exactly reside within the peak that normal heparin would 

provide one the mass spect, and only when it was done with an 

ultra-sensitive machine could you separate out and see, oh, there 

is actually two compounds here instead of one, and that compound 

was patented under the Chinese system. So why was it created and 

what possible use could it have had in a commercial application 

and how in the world did it find its way in to contaminate the 

pharmaceutical supply chain? I mean, these are some pretty critical questions that need to be answered, and to just say well, going 

forward we are going to be sure things are done right, I am sorry, 

maybe the heparin will be done right but what was the intent 

here? Was it simply a dishonest retailer or was there something 

more nefarious afoot? And we just simply don’t know. 

So now you have the chairman emeritus and the ranking member writing legislation which in all likelihood I could support in 

principle but we don’t know what we are trying to fix. We don’t 

42 

know how it happened in the first place. That is why we need your 

help. You were in China. You met with these officials. We need 

your help to understand how we do in fact prevent this happening 

in the future. Would you not agree with that? 

Dr. HAMBURG. I agree that this is a very serious concern and I 

agree that the heparin contamination was a very sophisticated example of a broader phenomenon in fact, which you note, the economic adulteration of products, and I think it speaks to the urgency of our really strengthening the activities to ensure import 

safety, the importance of additional resources and authorities, the 

importance of stronger authorities to enable us to do investigations 

when there are problems outside of our—— 

Mr. BURGESS. Right. It almost requires that we think like the 

criminal because after melamine, you know, melamine, shame on 

us, but heparin, why didn’t we see it coming. 

Let me just ask you a question though because it is so important 

that I get this in too. We have a hearing with device manufacturers. We hear from drug manufacturers. There is a lot of complaints 

that the process that people have to go through with FDA to get 

drugs and devices approved is in fact at this point unknowable and 

it makes the investment community nervous and in fact it makes 

the investment dollars dry up, or worse yet, go overseas so these 

drugs and devices are developed in other markets rather than the 

United States so it is an outsourcing, it is an offshoring problem 

as well. What are you doing within the agency to ensure that those 

pathways can in fact be known before someone starts—so that you 

can actually tell people what they will need to provide and then not 

change the rules of the game as they go through it? 

Dr. HAMBURG. You raise a really important issue, you know, for 

our Nation in terms of supporting innovation, critical industries, 

economic and global competitiveness, and FDA clearly has an important role to play. We are looking very carefully at our regulatory 

pathways and how we can be more transparent and predictable, 

also looking at how we can bring the best possible science to bear 

so that we have better knowledge and tools and approaches to 

make the regulatory pathways more effective and efficient. We are 

working in partnership with academic scientists and industry scientists and government scientists to really try to strengthen the 

underlying science because some of the problem with the regulatory pathway is in fact scientific uncertainty about how do you 

take a good idea and make it into a real-world product, and of 

course, a bit outside of the FDA’s bailiwick is the important question of what are the economic incentives to help ensure investments in important candidate products that hold real promise. 

Mr. BURGESS. I think we both have to agree that the timeline is 

a strong economic disincentive. I heard from a physician who developed a product as he watched his son being circumcised and decided there had to be a better way to do some of these things. His 

son is going to college and it is still tied up in the FDA. 

Thank you. I yield back. 

Mr. STEARNS. The gentleman’s time is expired. The gentleman 

from Michigan, Mr. Dingell, is recognized for 5 minutes. 

Mr. DINGELL. Mr. Chairman, I thank you. 

43 

Commissioner, I want to focus on the adulterated drugs that are crossing our borders. Some have said it is as much as $75 million 

a year. I think it is rather more. And recent scares like heparin 

and other matters show how much needs to be done to monitor imported drugs and pharmaceuticals. Now, having said that, in recent 

reports by CBS News, more than 36 million Americans have unknowingly purchased drugs on counterfeit-drug Web sites. Often 

these purchases are being dropped in the mail where they may not 

be tested either by Customs or Border Patrol. It is my understanding that under current law, if FDA recognizes counterfeit or 

adulterated drugs, FDA cannot detain or destroy products on site 

without going through a lengthy process providing notice and an 

opportunity for hearing so that FDA often ships these drugs back 

to the sender. Is that correct? 

Dr. HAMBURG. That is correct. 

Mr. DINGELL. So under current law, it is possible for a drug operation that is counterfeiting or adulterating drugs to put it in a 

package that was rejected by the FDA at one mail facility and to 

simply resend it through a different mail facility or again through 

the same fiscal year? Yes or no. 

Dr. HAMBURG. Unfortunately, yes. 

Mr. DINGELL. I believe I am correct in believing that if FDA had 

the authority to destroy drugs believed to be adulterated, misbranded or counterfeit that this would help to keep counterfeit 

drugs from reentering our country through alternative mail facilities or other facilities. Yes or no. 

Dr. HAMBURG. That is correct. 

Mr. DINGELL. Now, section 201 of the Drug Safety Enhancement 

Act, which I introduced yesterday with my colleagues, Mr. Waxman, Mr. Pallone and Ms. DeGette, would give FDA’s officers or 

employees the authority to order destruction. Section 202 of the bill 

would authorize the destruction of any drug valued at $2,000 or 

less or that the Secretary deems to be a significant adverse health 

risk. Anything valued at more than $2,000 could not be destroyed 

until notice and opportunity for hearing occurred. Do you believe 

having this authority would discourage counterfeit drug operations 

from shipping their products into the United States? Yes or no. 

Dr. HAMBURG. Yes. 

Mr. DINGELL. Now, we know that these counterfeit and adulterated drug operations are a lucrative business. These operations 

make money out of the pockets of consumers who may not know 

that their prescriptions are either unsafe or ineffective. I believe 

that we must impose severe penalties at least equivalent to similar 

violations relating to different kinds of products so as to discourage 

their continued operation. The legislation introduced yesterday proposes strengthening civil and criminal penalties for any person who 

knowingly distributes unsafe pharmaceuticals. Do you believe that 

criminal and civil penalties discourage the counterfeit and adulterated drug operations? Yes or no. 

Dr. HAMBURG. Yes, I believe they would. 

Mr. DINGELL. Now, Commissioner, the Drug Safety Enhancement 

Act would also require FDA to inspect every establishment, foreign 

and domestic, at least once every 2 years following registration. 

You at FDA have been continuously and chronically underfunded. 

44 

Personnel from FDA have said publicly that FDA’s resources do not 

keep pace with the volume of products coming into the United 

States. The majority proposed the 2012 budget cut $600 million 

from FDA in spite of the fact there are new safety authorities for 

food safety that you are required to implement. Would you agree 

that a fee system could help provide a stable funding source for 

drug safety activities? Yes or no. 

Dr. HAMBURG. I believe we need additional resources to do the 

task before us. 

Mr. DINGELL. Would you support such a fee system, Commissioner? 

Dr. HAMBURG. Pardon me? 

Mr. DINGELL. Would you support a fee system? 

Dr. HAMBURG. Yes, I would. 

Mr. DINGELL. Now, can you give us an appreciation of how many 

people you have in charge of dealing with imports of pharmaceuticals? You don’t have to tell us this morning. Submit that for 

the record. Would you also submit to us how much that costs and 

would you submit to us how many people you need to do this work 

and how much that would cost, please? 

Dr. HAMBURG. I would be delighted to put that together and submit it for the record. 

Mr. DINGELL. I believe we need to know that. Now, this committee going back as far as when I was chairman of Oversight used 

to have people in to discuss these matters and we never got around 

to doing anything about it. Last year, we passed by overwhelming 

vote, it came unanimously out of this committee, if my memory 

serves me correctly, the food safety bill. Is that working well? 

Dr. HAMBURG. We are still very early in the implementation but 

it is a huge contribution and historic shift really in how we are able 

to address food safety issues giving us a new—— 

Mr. DINGELL. It gives you lots of new and added authorities? 

Dr. HAMBURG. It does. 

Mr. DINGELL. And you recognize many of those authorities in the 

pharmaceutical safety bill introduced yesterday, do you not? 

Dr. HAMBURG. I think we would like to see parallel authorities 

in the drug area in many key arenas. 

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

me. I hope that we will be able to use this hearing as a mechanism 

to move forward towards safety of our people from bad pharmaceuticals as we have done with regard to bad food safety, and I 

would hope my colleagues would work with me in a bipartisan 

fashion towards this end. Thank you, Mr. Chairman. 

Mr. STEARNS. I thank the gentleman. Dr. Gingrey is recognized 

for 5 minutes. 

Mr. GINGREY. Mr. Chairman, thank you. 

Mr. Hamburg, thank you for being here today and for your leadership at the helm of the FDA. I greatly appreciate your efforts and 

focus on efforts to encourage the FDA to adapt and improve its 

functions including the use of the PREDICT software at our borders and ports of entry, and we appreciate that. Going to the PREDICT model, one that is flexible and able to meet new and emerging threats to our borders and ports, in many respects I see the 

45 

FDA reform in much the same light and I think from your previous 

statements here, I know you do as well. 

Federal initiatives to develop new drugs and diagnostics, whether in the antibiotic space or elsewhere, can be greatly supported by 

an FDA that is flexible, adaptable to new technologies, and understanding of the human body and genome is critical. How important 

of a role do you think that the regulatory science—you referenced 

that earlier—how important of a role do you think regulatory 

science can be to support the FDA in its work in the coming years 

and decades? 

Dr. HAMBURG. You know, I think it is enormously important, and 

I truly appreciate your question. It is an important area of science. 

It is the knowledge and the tools that are needed to really effectively and efficiently evaluate a product for safety, efficacy, quality 

and performance, and there have been huge advances in science 

and technology that can be brought to bear on the regulatory process as well as on the drug development and medical product development process to make it more streamlined and more modern, and 

will give us tools so that we can really shorten the timeframe for 

the regulatory process in key ways using innovative clinical trial 

models, using biomarkers to help us identify early concerns like 

toxicity—— 

Mr. GINGREY. Dr. Hamburg, thank you, and I think you know I 

am currently working on some proposals in support of regulatory 

science and I am hoping that I can get your commitment that you 

will sit down and work with me and my staff in support of this 

worthy goal. 

Dr. HAMBURG. I am extremely eager to work with you on that. 

Mr. GINGREY. I really appreciate that. Thank you, Dr. Hamburg. 

You expressed support for developing a track and trace and authentication system to help combat the counterfeit drugs. Can you 

update us on FDA’s efforts in this area and give me your thoughts 

on the scope of drug counterfeiting and diversion in the United 

States? What else can we as a Congress do? 

Dr. HAMBURG. Well, with respect to the big picture, we know 

that counterfeit drugs represent a very large and growing problem. 

It is most—the burden is most pronounced in the developing world 

where in some countries 30 to 50 percent of drugs for serious diseases being used in fact are not what they purport to be. It is a 

smaller problem in this country in large part because we have a 

very strong regulatory framework and we work very closely with 

counterpart agencies to minimize the problem but with the growing 

complexity of supply chains and globalization and the fact that we 

know that especially in the absence of strong civil and criminal 

penalties that counterfeiting is an increasingly attractive area for 

some bad guys, I am sad to say. We cannot be complacent and we 

need to make sure that we have the programs and policies that—— 

Mr. GINGREY. Well, before the hearing started, I had spoke with 

you briefly about the 60 Minutes clip that I am sure a lot of folks 

on both sides of the aisle saw recently, and the magnitude of the 

problem is downright scary, and certainly this is a timely hearing. 

Real quickly in the last minute that I have, the events and controversy related to the approval and subsequent price increase of 

a drug manufactured by KV Pharmaceuticals for the prevention of 

46 

premature birth—premature labor and possibly premature birth. 

While not directly tied to import screening, it does involve FDA’s 

mission to ensure the safety and efficacy of our Nation’s drug supply, and it was initially thought that pharmacies would be precluded from compounding versions of this product which they had 

been doing for some time and selling for much less than the product marketed by KV, and because of the controversy that ensued, 

KV ultimately significantly lowered the price and FDA announced 

that it would not initiate enforcement against the compounding 

pharmacies. I have a couple of questions in regard to that issue. 

Are you aware of any safety concerns with patients taking a compounded version of this drug versus the Makena product? 

Dr. HAMBURG. As far as I know, we have not had reports of adverse events associated with compounding of this particular product. 

Mr. GINGREY. And then the last thing, and I realize I am a little 

bit over time, are any ingredients for the compounded version imported as far as you know? 

Dr. HAMBURG. You know, I would have to get back to you. I honestly don’t know the answer to that question. 

Mr. GINGREY. And then real quickly, Mr. Chairman, I just wanted to ask you, Dr. Hamburg, in regard to Dr. Burgess’s line of 

questioning about the heparin. Have we then abandoned the heparin investigation? Is that pretty much over and done with? 

Dr. HAMBURG. In terms of the investigation of who actually instigated this economic adulteration of the heparin product, the investigations have come up dry and there are not active new leads. I 

think the other side of it that is important for you all to understand, for the American people to understand, is that we do have 

a very large number of steps in place and safeguards to protect 

against the importation of contaminated heparin if there were 

those who chose to try to begin again with this contamination of 

this important product. 

Mr. GINGREY. Dr. Hamburg, thank you. Mr. Chairman, thank 

you for your indulgence. I appreciate it. 

Mr. STEARNS. The gentlelady from Illinois, Ms. Schakowsky, is 

recognized for 5 minutes. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman. 

Thank you, Dr. Hamburg. The job that you have taken is so expansive from baby food to medical devices in between, and I know 

that imports of FDA-regulated products have dramatically increased over the last 7 years. In 2004, FDA oversaw 11.8 million 

shipments of products like food and pharmaceuticals and medical 

devices, but by 2010, the importation of FDA-regulated products 

had nearly doubled, totaling in 2010, 21.1 million shipments. That 

is a lot. And so I wanted to ask you about the resources that you 

really have to deal with that. 

The President’s budget for 2012 asks for a significant increase in 

the FDA’s budget, approximately 33 percent, which actually includes the new user fees that Mr. Dingell had mentioning, bringing 

it to a total of $4.3 billion, but the Republican budget as presented 

by Paul Ryan we understand would likely roll back FDA funding 

to the fiscal year 2008 funding levels, which means the agency 

would be cut by about $600 million. So what I am concerned about, 

47 

and my first question is, what effect would a funding cut on have 

the ability as specifically as possible to be able to do its job? How 

would that affect ordinary consumers and what would you have to 

do? 

Dr. HAMBURG. Well, the magnitude of the cut you described, you 

know, would be enormously difficult for our agency to absorb without taking serious cuts in critical programs to the health and safety 

of the American people with respect to our ability to inspect and 

support the safety of the food supply, our ability to ensure the safety of the drug supply, our ability to approve new and promising 

medical products for the American people, our ability to protect the 

safety of the blood supply and other critical FDA-regulated products that people depend on every day, and it would certainly make 

it very, very hard for us to move forward to more fully and effectively address the challenges of import safety. 

Ms. SCHAKOWSKY. And what then would be your priorities were 

the increases to go through, if the Congress were in fact to give you 

more money? For example, would we be able to—as Dr. Burgess 

mentioned, would there be any possibility of speeding up the permits for new pharmaceuticals or new products? 

Dr. HAMBURG. We are trying to target additional resources and 

additional energy in the area of supporting innovation and really 

modernizing our regulatory pathways. Dr. Gingrey mentioned the 

importance of regulatory science, and investments there are making a difference in really moving our systems forward. But a lot of 

what matters in moving a product swiftly and surely through the 

regulatory pathway involves having the staff resources to work 

with the sponsor companies to lay out the expectations for what 

kinds of data and evidence they need to put forward to support the 

approval of their product and to work with them as they are collecting that data, analyzing that data and presenting it to us. 

So if we have deep cuts, we will not be able to achieve some of 

what we know makes a difference in terms of the review teams and 

what needs to be done. We won’t be able to apply advances in 

science and technology to modernize our regulatory pathways. And, 

we won’t be able to do the important work every day both to ensure 

the safety and quality of the manufacturing and production of 

drugs and the important work to make sure that once those drugs 

are approved and they are being used by people in the real world, 

we continue to monitor for the safety and the efficacy of those 

drugs so that the American people can actually trust and depend 

on these important products. 

Ms. SCHAKOWSKY. Thank you very much. 

Mr. STEARNS. I thank the gentlelady. Ms. Myrick is recognized 

for 5 minutes. 

Mrs. MYRICK. Thank you, Mr. Chairman, and thank you both for 

being here, and we do appreciate the work. I know you have got 

a very difficult job. 

As was previously mentioned, Dr. Hamburg, you and Mr. Elder 

were interviewed on that 60 Minutes special regarding the threat 

of counterfeit imported drugs to the U.S. pharmaceutical supply. 

Would you mind if we just play the clip so everybody could see? 

Dr. HAMBURG. OK. 

[Video shown.] 

48 

Mrs. MYRICK. It is really frightening, I think, to all of us because 

we share your concern, and I know you have already answered the 

questions that you don’t have the authority, etc., but in 2009 and 

2010, the U.S. Customs and Border Protection seized approximately 2,000 parcels of pharmaceuticals coming through the mail. 

Do you have any way of knowing how many of those were screened 

by the FDA that were destroyed or returned to the sender? Do you 

have way to track any of that? 

Dr. HAMBURG. The way the system works is that the products 

come into the mail facility. Customs and Border Protection screens. 

Those that look like they contain drugs or medical products get 

then targeted to the FDA. We work closely with CBP, of course. 

And then we undertake the examination of a subset of those products that have been targeted to us through Customs and Border 

Protection, and unfortunately, we cannot screen all of those products because of limited resources, and we do lack the authority 

when we find violative products to actually detain and destroy 

them. 

Mrs. MYRICK. And when they are returned to the sender, I mean, 

that is kind of the majority of the work that you do. In other words, 

you can’t destroy them so you have to return them to the sender. 

Is that correct? 

Dr. HAMBURG. We have a couple of options. We can hold the 

product and seek support from the courts to destroy them. 

Mrs. MYRICK. I know it would be helpful to you if you had some 

authority from us to be able to—— 

Dr. HAMBURG. Absolutely. It would make much more sense in 

terms of addressing important public health problems and efficient 

use of resources. 

Mrs. MYRICK. This is a separate question. I hear a lot from patients and doctors in my area. They have really big concerns about 

the FDA’s risk-benefit analysis. FDA threatens to remove certain 

drugs and devices from the market that have relatively low risk 

compared to a patient’s risk of death without access to the drugs 

or devices, and in some cases we are talking about terminal illnesses, and patients are often willing in that case to take a little 

extra risk because it means they can live longer. So how does the 

FDA take these patients into account when it comes to approval 

and sometimes withdrawing the approval, and can the approach 

that you use be improved in any way, in your opinion? 

Dr. HAMBURG. Well, it is such an important part of how we think 

about and use drugs in this country. We obviously do look at the 

risks and benefits in the context of a given disease and what other 

treatments are available, and people are willing to accept many 

more risks if they have a fatal disease and they have no other option. 

Mrs. MYRICK. So you do take that into account? 

Dr. HAMBURG. Yes. We are in the middle of a process of really 

trying to make this all more transparent and really systematic and 

lay out the criteria for weighing risks and benefits in different contexts both in terms of the understanding that our own staff have 

about how to think about it and the training but also so that medical product sponsors and the public including patients can underVerDate Nov 24 2008 15:31 May 15, 2012 Jkt 037690 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 112\112-38 041311\112-38 CHRIS
49 

stand this as well, and we are doing this in an open way, getting 

input as we try to shape this model. 

Mrs. MYRICK. I really appreciate it, because it is heartbreaking 

when you sit with somebody who is using a drug and it has successfully prolonged their life and they are living a normal life and 

then the drug is pulled or it can’t be used for that particular disease. So it presents a big challenge, and it just breaks your heart. 

So I appreciate your looking at it. Thank you. 

Mr. Chairman, I yield back. 

Mr. STEARNS. The gentlelady yields back. The gentlelady from 

the Virgin Islands is recognized for 5 minutes. 

Mr. CHRISTENSEN. Thank you, Mr. Chairman, and welcome, Dr. 

Hamburg. I regret that I have been in and out, and I may be repeating some of the questions, but I think it is important for us to 

understand the implementation of PREDICT, so I have some questions about the PREDICT database and realizing that it is a new 

tool that was created to enhance FDA’s risk-based screening efforts 

at ports of entry and recognizing, of course, that FDA can’t inspect 

every import shipment. The system enables the agency to target 

shipments that are more likely to violate FDA regulations. 

So as I understand it, now PREDICT is fully operational for all 

FDA-regulated products in Los Angeles, New York, Seattle and San 

Francisco. Did you say San Juan as well? 

Dr. HAMBURG. Not yet in San Juan. It is being implemented in 

a staged way and so components even aren’t as fully fleshed out 

as they will be over time but the major components are fully operational and covering 40 percent of imports out of those four districts. 

Mr. CHRISTENSEN. Thank you. And I know that the chairman 

asked several questions about the delay, and you said that there 

were problems, and if you have already specifically stated what 

those problems are, I apologize, but why specifically, what were the 

problems that caused the delay in the full deployment of PREDICT? 

Dr. HAMBURG. Well, as we started to implement the system, it 

was operating much more slowly than people expected. It was 

much more cumbersome. And so questions were asked about why 

that would be. It was initially thought that it was an infrastructure 

problem that we were overlying a very large data management set 

of tasks onto our existing infrastructure. That was systematically 

looked at. It actually turned out that the problem was really most 

focused on a piece of software that interfaced with the PREDICT 

system that was slowing it down because it was doing a series of 

initializations underlying the entry process and that was corrected 

and it is now working in a very efficient way and we are seeing 

measurable improvements in our ability to quickly move low-risk 

products through and target high-risk products. 

Mr. CHRISTENSEN. And then you convened a high-level group of 

FDA officials to identify and fix the problem. Just to clarify, did the 

problems that you identified with PREDICT cause any risk to the 

public health or food or drug safety at any time? 

Dr. HAMBURG. I really appreciate that question because I should 

emphasize that even when we were having problems with PREDICT, we still had underlying systems that were supporting our 

50 

screening, and while not as robust and rich as PREDICT, they 

were still able to provide the core set of public health responsibilities that go with our import screening activities. 

Mr. CHRISTENSEN. Thank you. You know, I think it is important 

not to make a mountain out of a molehill here. The FDA is implementing a brand-new IT system to help keep the food and drug 

supply safe, and it seems to me the agency is doing exactly the 

right thing in the right way. No IT system is implemented without 

problems. But the key is that when you found the problems, you 

acted rapidly to identify and fix them and to make sure that the 

public health was not harmed. So we are looking forward to the full 

implementation. 

Let us see if I can get another question. I would like to ask you 

about courier fees because millions of shipments of FDA-regulated 

products enter the U.S. through express courier facilities like 

FedEx and UPS every year, and the President in his budget for 

2012 proposes a new international courier fee that would be assessed. The President’s budget requests a new international courier 

fee not to exceed $5.3 million. What activities would that fee support? 

Dr. HAMBURG. It would enable us to do the kind of review and, 

when necessary, examination of products coming in through that 

mechanism. It is a growing component of imported products. It is 

one that operates on a 24/7 time frame. Because of our limited resources, we haven’t been able to target the courier services in the 

way that would most benefit them and so actually this is something that I think they are very eager to work with us on in order 

to support greater deployment of FDA personnel. 

Mr. CHRISTENSEN. So you don’t expect that this fee would cause 

hardships for the couriers and importers, do you? 

Dr. HAMBURG. I think it will benefit them because they very 

much are committed to very rapid transit of the materials that 

they are importing and this will enable FDA to be able to support 

their business model in terms of transit of products that are safe 

and low risk. 

Mr. CHRISTENSEN. Thank you. 

Thank you, Mr. Chairman. 

Mr. STEARNS. I thank the gentlelady. The gentleman from California, Mr. Bilbray, is recognized for 5 minutes. 

Mr. BILBRAY. Thank you. 

Mr. Hamburg, I appreciate your being here. In the last 2 years 

prior to the new majority being here, how has your budget been impacted by the new Administration proportionally from the previous 

Administration? Has the budget been severely reduced or has it 

been enhanced to some degree, or what is the deal? 

Dr. HAMBURG. Well, actually, beginning in the last Administration we began to see some significant increases in our budget 

though over the last few years we had had increases in our budget 

that have been very, very welcome. We do have—— 

Mr. BILBRAY. Do you have any idea what kind of percentages you 

have seen in the last 24 months? 

Dr. HAMBURG. In the last 24 months? 

Mr. BILBRAY. Since you have been there. 

51 

Dr. HAMBURG. Well, we have had—in the last year, it was—you 

know, it is a little hard to—— 

Mr. BILBRAY. But it has been a healthy increase? 

Dr. HAMBURG. We have had significant increases in the last couple of years. 

Mr. BILBRAY. OK. I appreciate that. I want to get back to this 

issue that we have got China demanding that research be done in 

China for drug development for anything sold there, so we are 

going to see a shift there. We will see a shift in the emphasis why 

manufacturing should go to China with this basic extortion game 

going there. You have got Europe that is really reducing their review of drugs and devices to a point way below basically it looks 

like much more efficient. They are getting more efficient going out. 

So we have got this potential of this big increase of imports coming 

in as we are watching our manufacturing capabilities be exported. 

Are you reflecting that? Are you planning on that increase in your 

inspection at the borders that looks which everybody in the industry is saying is basically an indication we are seeing across the 

board? 

Dr. HAMBURG. Let me first address some misperceptions. There 

is a sense that we are much slower than Europe, our counterparts 

there, in reviewing drugs and devices. In the drug area, in fact, we 

went back and looked over the last couple of years and the majority 

of new molecular entities, new drugs that both of us approved were 

approved first in the United States. In fact, if you look at priority 

drugs, the number is actually higher. 

Mr. BILBRAY. I would like to see that because the applications 

were made here first many times and they were basically moved 

on others because of the perception but the fact is that from the 

data we have, from the data I have received basically reflects the 

fact that even though you had major increases—and I think this 

is an issue about what do we do with the money, you know, we are 

looking at a 28 percent slowdown of the review of drug processing 

by FDA at a time your budget was expanding. So there are a lot 

of these institutional changes that we have to address, and just 

sending money across over doesn’t necessarily guarantee the job is 

going to be done efficiently or—you know, not efficiently but basically the mindset of the bureaucracy does affect timeline and performance, does it not? 

Dr. HAMBURG. Let me just assure you, we take very seriously the 

timeliness of our reviews, and through the user-fee program we actually negotiate with industry about timelines for performance. 

Mr. BILBRAY. Doctor, let me just say, we have got industry people 

that we are going to have to testify about your operation behind 

closed screens because they are that scared of the process. But in 

all fairness, at a time when you had major expansion of resources 

to get the job done, the numbers that we have got before our committee is that 28 percent longer period for drugs, a 43 percent extension of time for devices. That means that just by giving you 

more money doesn’t mean the system is going to run more efficiently. 

Dr. HAMBURG. I don’t know those numbers, and we would be delighted to sit down with you and go over the numbers, but I think 

52 

the bottom line is that we need to do better, we can do better. We 

are working with industry—— 

Mr. BILBRAY. Related to this issue, that means we have a vested 

interest in safety to try to make the system more efficient here as 

it relates to not just safety and efficiency but also the timeline because that timeline affects the decision of do you produce it in the 

United States or do you go overseas and then we buy our own inefficiency here, our lack of reform here in processing, we create a crisis for ourselves to have to review that much more coming in to address this issue. And I hope we have that kind of commitment by 

your agency showing that slowing down the process is not just an 

issue that makes it safe for the bureaucracy, it something that 

makes it more risky for everybody because it may have unintended 

consequences such as causing us to have to now import more drugs 

and have to be reviewing those. 

Dr. HAMBURG. Well, I understand your concerns and we are very 

committed. We do take the performance timelines very seriously 

and we are meeting the majority of our goals. I am also systematically reaching out, listening to industry and their concerns. I just 

met yesterday most of the day with a group representing both device and pharmaceutical industry representatives or former representatives to hear more about some of these specific concerns and 

how we can identify areas to work on together to streamline the 

process, to help support the need to move critical products into the 

marketplace. 

Mr. BILBRAY. OK. I would just like to ask one last question. Were 

you consulted about the potential of the device tax that was placed 

in the bill last year, the potential that device tax being an incentive 

to bootleg devices into this country? 

Dr. HAMBURG. I was not. 

Mr. BILBRAY. OK. Do you have a position on that device tax and 

its impact? 

Dr. HAMBURG. You know, it is a complex issue and it is not within our jurisdiction. 

Mr. BILBRAY. I appreciate that. 

Mr. Chairman, I think before we do things like device taxes, we 

should be asking regulators about how it is going to impact their 

job. These things are all related, like I said. It is holistic. You can’t 

do one without impacting the other. And I yield back. 

Mr. STEARNS. The gentleman’s time is expired. I think we will 

go a second round here. As the Chairman, I have the prerogative 

to start but I am going to let Dr. Burgess, who has to leave, if he 

will start on our side. So Dr. Burgess, you are recognized for 5 minutes. 

Mr. BURGESS. Thank you, Mr. Chairman. And just on Mr. 

Bilbray’s point about the devices, I can hardly go anywhere and 

speak to any group without someone pulling me aside so I am 

heartened by the fact that you are hearing some of these same 

things but also his point that people are afraid to come forward. 

When I have someone come and tell me their particular tale of woe 

about what they have developed and where they are in the process, 

and I say would you be willing to come to the committee and talk 

about this, and they say no, you know, I don’t want to jeopardize 

whatever chance I might have now with the FDA, I wouldn’t want 

53 

to put myself out there and jeopardize it. That is an unfortunate 

place for us to be. 

And Mr. Bilbray is also correct, the device tax essentially zapped 

the research and development budget for many of these small 

startup companies. Also, in addition to your agency’s regulations, 

we also have the comparative effectiveness, PCORI, the PatientCentered Outcomes and Research Institute, that was funded in the 

Patient Protection and Affordable Care Act. All of these things now 

interplay with the bringing of new drugs and devices to market. 

Witness the controversy that has existed over Provenge and 

Avastin since the first of the year. We have certainly heard a lot 

about Provenge for prostate cancer and the period of time that it 

provides for survival, it is not cost-effective to provide it to prostate-cancer patients but I think there was recently a relaxation of 

that ruling, breast cancer with Avastin, some of the same considerations. 

I also hear people ask me why can we not talk about surrogate 

endpoints. It was very effective in developing the drugs that are 

now useful for treating HIV/AIDS, if survivability is the only endpoint that can be used and we are not certain how reduction of 

viral load will affect that survivability. In the early days of that, 

having a surrogate endpoint actually allowed those products to 

move forward with a great deal more facility and provide relief to 

a segment of the population that previously had been denied relief. 

So these are not just abstract issues that we are talking about. 

They are very real issues. And again, I know that because I can’t 

go anywhere in the country without someone telling me that, you 

know, I was delayed 4 years with this anti-cancer drug, I am saving 2,500 people a year now so I have to assume 10,000 died while 

I was put on hold by a regulatory agency. I mean, that is pretty 

severe when we put it in those types of numbers. So I am encouraged that you are considering this, but please also understand that 

we don’t even have the freedom to brings these folks to committee 

and ask them questions because they are fearful of retaliation from 

the FDA. Surely you have heard that before. 

Dr. HAMBURG. You know, I can assure you that we make our decisions based on the best available data, not on, you know, other 

information. They do not need to worry about retaliation. I think 

what we need to focus on together, though, is to make sure that 

our regulatory pathways are as well defined and as predictable as 

possible for sponsors who are bringing new candidate products before us. We need to make sure that we are able to work with them 

closely so that there is clear understanding of what is expected of 

them and why we need to make sure that we are bringing the best 

possible science to bear in terms of making sure that the data that 

is being collected in support of a product is the right data and that, 

you know, things you just mentioned about surrogate endpoints, we 

do use surrogate endpoints, but we need to be undertaking a massive effort working with scientists and industry and government to 

really develop more much more innovative clinical trial models that 

will enable o us to get the robust scientific answers we need but 

with shorter times, lower costs and fewer patients and other areas 

where we can apply better science to both the drug and medical 

product development and the review. 

54 

Mr. BURGESS. And we can’t move the goalpost, which again, is 

a frequent criticism that I am hearing. 

Let me just ask you question. I was talking about heparin in the 

first round of questioning and the molecule, hypersulfated 

chondroitin sulfate. Am I correct that that was actually patented 

under a Chinese patent? 

Dr. HAMBURG. I don’t know the answer to that. 

Mr. BURGESS. What is the purpose in developing a molecule like 

that? Does it have a use in industry? 

Dr. HAMBURG. I don’t know the answer to that. I would be happy 

to get our experts at the agency to provide you with additional information. 

Mr. BURGESS. Well, it might be something that is useful to know. 

Again, we are talking about the committee developing legislation to 

prevent these products from coming into the country. We kind of 

need to know what was involved and why even develop such a 

product if it wasn’t to cheat somebody who is buying heparin. 

Thank you. I will yield back, Mr. Chairman. 

Mr. STEARNS. The gentlelady from Colorado is recognized in the 

second round for 5 minutes. 

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

Mr. Hamburg, how many drug approval applications do you 

know offhand does the FDA get in a year? Do you know offhand? 

Dr. HAMBURG. Let me see if one of my other experts knows. I 

don’t know offhand but that is easy information for us to actually 

get. 

Ms. DEGETTE. Well, the reason I am asking the question is because I know that the FDA is working on trying to streamline the 

approval process but at the same time making sure that the process for each new drug is thorough, correct? 

Dr. HAMBURG. Right. 

Ms. DEGETTE. If we have a large budget cut to the FDA in next 

year’s budget, is that going to help or hurt our ability to expedite 

the drug approval process? 

Dr. HAMBURG. Well, unfortunately, it will clearly hinder our ability, and we are talking about very large numbers, especially if you 

look at the drug and the device side. And as we have been talking 

about already, the ability to really support sponsors in their efforts 

to bring products before us does require—is a resource-intensive, 

staff-intensive activity to be able to provide the best possible and 

the most timely review. 

Ms. DEGETTE. You know, you can streamline processes, and I assume you are doing that, but at some point it does take the resources to pay for the staff to review the applications and to do 

what needs to be done. Is that right? 

Dr. HAMBURG. That is correct. 

Ms. DEGETTE. A second question I have is, this discussion that 

a lot of folks have been having in this hearing about the approval 

process resulting in a slow and more cumbersome process than in 

the EU, and I hear this a lot and I have read it a lot in the media. 

I am wondering, I don’t think you got to fully explain what the 

FDA found when they looked at this claim that the EU is much 

more fast and efficient and does a better job. I am wondering if you 

can just finish your answer to that question. 

55 

Dr. HAMBURG. OK. You know, we did take a very serious look at 

the exact numbers because we were hearing more and more questions raised in this area, and what we found was very striking. I 

may get the numbers slightly wrong because I didn’t review them 

before coming to this hearing. I was more focused on the import 

safety issues. But I believe that between 2006 and 2010, there were 

about 53 or 54 new molecular entities that were approved by both 

the EU and the U.S. and that we were in fact significantly more 

rapid in approving those drugs in well over 50 percent, I think it 

was 43 or so of those products. If you actually look at cancer drugs, 

and the time frame that we looked at that was a little different, 

I think it was 2003 to 2010, but there were 23 new cancer drugs 

that were approved by both entities and we were first in approving 

those. 

So, there clearly is a misperception that we are slower than our 

counterparts in the European Union, and for the priority drugs we 

were almost twice as fast in approving these drugs. 

Ms. DEGETTE. Was this a study that you did? 

Dr. HAMBURG. It was a systematic review. I mean, I fear I probably should not have even tried to give numbers—— 

Ms. DEGETTE. If you could supplement your testimony with that 

today, that would be great. 

Dr. HAMBURG. OK. 

Ms. DEGETTE. And I just have a couple more questions. One is, 

we have been talking about this terrible adulterated heparin so I 

guess my view would be, under this Drug Safety Enhancement Act 

which Mr. Dingell and some of us introduced yesterday, would that 

give the FDA new authorities to address issues like intentional economic adulteration like in the heparin situation? 

Dr. HAMBURG. I think it could very well give us important authorities that would make a difference, additional authorities to 

really pursue investigations in places outside of our borders when 

there are public health concerns, our ability to share information 

with counterpart regulatory authorities so that we can get a richer 

understanding of potential or emerging threats. Those would certainly make a difference, and I think that enhanced civil and criminal penalties could reduce the attractiveness of pursuing some of 

these kinds of nefarious activities as well. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Dr. HAMBURG. Thank you. 

Mr. STEARNS. Mr. Hamburg, I am just sort of curious about these 

150 countries that export food and drugs to us. If you don’t mind, 

if you could send us a list of those countries, that would be helpful. 

Dr. HAMBURG. OK. 

Mr. STEARNS. Going to your Web site, I noticed that just for this 

year alone it lists countries that there have been alerts on. For example, Bangladesh had 10 alerts, Cambodia had one. Indonesia, 

there are 27 alerts. The Ivory Coast, considering what is going on 

there, had three, Nicaragua had nine, Thailand had 47 and 

Zimbabwe had one. Do you have the authority to stop all imports 

when there is, shall we say, turmoil, war, a revolution, civil war 

that is going on over there? Do you stop imports from those countries considering the potential danger? 

56 

Dr. HAMBURG. Well, our import alerts are based on public health 

risks but certainly they are targeted to events in the world. 

Mr. STEARNS. Do you have the authority to stop, for example, imports from Thailand where there is unrest and they had 47 alerts? 

Isn’t that enough to say you are going to stop imports altogether? 

Dr. HAMBURG. Well, I think an important and timely example 

is—— 

Mr. STEARNS. Do you have the authority to do that? 

Dr. HAMBURG. We do an import alert based on—— 

Mr. STEARNS. Just yes or no. 

Dr. HAMBURG [continuing]. A public health threat. 

Mr. STEARNS. I would just like to know, yes or no, do you have 

the authority to stop—for example, the Ivory Coast had three alerts 

this year. Do you have the authority to stop all imports from Ivory 

Coast? 

Dr. HAMBURG. No, we would have to be able to show that there 

was reason to believe that a product or set of products was violative. 

Mr. STEARNS. But if you had three alerts in Ivory Coast and 27 

in Indonesia, isn’t that enough to suddenly stop imports—especially 

if there is a civil war? 

Dr. HAMBURG. I know that for particular products where there 

are concerns—— 

Mr. STEARNS. So you don’t have the authority? You have to identify the risk in detail before you do that. Otherwise you don’t have 

the authority. 

Dr. HAMBURG. Right. We don’t do blanket restrictions based on 

circumstances within a country. 

Mr. STEARNS. OK. Mr. Bilbray had talked a little bit about the 

budget, and I mentioned it earlier, that your budget went up by 

$107 million. Did you know that? 

Dr. HAMBURG. We have, as I said, had, you know, very significant increases in our budget in the last couple of years. It has 

made a difference. I think it is important to recognize, though, that 

we have been underresourced for literally decades. 

Mr. STEARNS. But you understand the budget has gone up for 

this fiscal year? 

Dr. HAMBURG. I do, and I have been appreciative of that. 

Mr. STEARNS. But as I understand it, when you were talking to 

Mr. Bilbray, you weren’t sure by what percentage the budget had 

gone up and you weren’t really clear what your budget number 

was. Is that correct, that you weren’t quite clear on that? 

Dr. HAMBURG. You know, this has been an unusual budget period. He was asking me what the budget increase was in the last, 

did he say 24 months? 

Mr. STEARNS. Yes. 

Dr. HAMBURG. But, you know, we certainly do have that information. 

Mr. STEARNS. So you don’t really know your budget numbers at 

this point. You don’t know that they have gone up. Is that correct? 

Dr. HAMBURG. Well, we are still looking forward to learning our 

budget numbers for this year. 

Mr. STEARNS. OK. We have a chart here that has come from you 

folks, the Fiscal Year 2010 ORA Field workplan. I just want to 

57 

show you this, and staff has given it to you. If you go down to the 

fifth line, I know President Obama has talked about food safety 

being one of his top priorities, and he has indicated that it is very 

important for the Administration, yet when you look at imported 

foods in general on this line and the work plan for FTEs, which I 

understand to be full-time equivalents, which are not people but 

are just block-outs. It appears to me that in 2009 to 2010, 2009 was 

the Bush Administration and 2010 was the Obama Administration, 

it actually has gone down in terms of the work power that has actually been expended on imported foods. Is that correct? It is a little surprising considering the priorities which you have talked 

about, to think that the man-hours in this area have gone down, 

and I just want you to explain, why have they gone down? 

Dr. HAMBURG. I am going to let my colleague, Mr. Elder, respond. This is a very specific question of a line. It is less than one 

full-time equivalent person. 

Mr. STEARNS. But at the same time—— 

Dr. HAMBURG. But I will let him—— 

Mr. STEARNS. You know, the imports have increased—but the 

point is, with the increase of the imports, and the fact that your 

manpower has gone down on this is just a little puzzling. 

Yes, Mr. Elder, you are welcome to take the mic. Is it turned on? 

Mr. ELDER. I believe it is, Mr. Chairman. Thank you. The highlighted decrease involves one particular program within our overall 

foods program. It is what we call program assignment code 03819 

A and B. It is import foods in general. It does reflect a 0.7 FTE 

decrease from the previous year. It is not the only program, however, in which we cover imported foods. You can see that imported 

seafood products were raised by 7 FTEs in the fiscal year. There 

was an overall increase of 61 FTEs—— 

Mr. STEARNS. But Mr. Elder, you would agree that that is the 

biggest program you have. When you look at all the other figures, 

it is multiples of all the other programs. So I think you are sort 

of discounting a program, which is the top program, and to see the 

top program actually in man-hours go down in terms of the FDA’s 

work plan is quite startling. 

Dr. HAMBURG. I think that Mr. Elder was indicating, though, 

that this is just one component of our overall import safety program for foods and that that program has actually expanded. 

Mr. STEARNS. But wouldn’t you agree, Dr. Hamburg, that all 

these things should have a positive, they should not have a negative? 

Dr. HAMBURG. Well, I think we want to make sure that we are 

deploying our resources in the most responsible and efficient way 

possible. I don’t—— 

Mr. STEARNS. But I would think imported foods is one of your 

highest priorities. 

Dr. HAMBURG. But I think we also need to look at the overall 

program and how individuals are being deployed, and this does not 

mean that the overall food import program has decreased. In fact, 

it has increased in terms of—— 

Mr. STEARNS. Well, I would say that your workplan does not 

show an increase, rather, it shows a decrease. 

58 

My time is expired. The gentleman from Michigan is recognized 

for 5 minutes. 

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

Mr. Hamburg, you have in response to a question from Ms. 

DeGette said that review times in United States and Europe vary 

and that FDA is faster in reviewing drugs. We have also been hearing that Europe is 2 years faster in clearing devices than our FDA. 

Is that statement true, and if so, why? 

Dr. HAMBURG. You know, first of all, it is not a competition and 

we obviously have different regulatory frameworks, but when you 

look at the numbers in both drugs and devices, the lag times are 

not what have been put forward. In fact, in the drug area, as I 

said, in key areas we clearly have approved critical products more 

swiftly. The device system in Europe is quite different than that 

here but we are not—— 

Mr. DINGELL. It is a difference in what is done over there as opposed to—— 

Dr. HAMBURG. They have a very different approach to device review, and it is also—— 

Mr. DINGELL. Would you submit to us a statement as to why that 

is so, please, for the record? 

Dr. HAMBURG. We would be happy to, the numbers that are 

available about comparative times. 

Mr. DINGELL. Thank you, Doctor. I want to get now to some 

other things. I would like to come back to the new authorities given 

FDA in the Food Safety Modernization Act and how they are going 

to make the food supply and imported food safer. Is that statute 

working and do you have the authorities now you need? Do you 

need new authorities or do you need more money? 

Dr. HAMBURG. We are obviously very early in the implementation of this historic piece of legislation, but we are making good 

progress. And we can see that it will very significantly strengthen 

our ability to protect the safety of the food supply to be able to really shift to a preventive approach and to work in greater partnership with our State and local partners, with foreign governments 

and with industry. Clearly, in terms of being able to implement all 

of the requirements, and there are many in that Food Safety Modernization Act, you know, we again face the resource limitation 

issue and we are hoping to be able to work Congress on—— 

Mr. DINGELL. Let me interrupt you. I remember, Doctor, that 

when one of your predecessors, Frank Young, for whom I had great 

respect and still do, used to call me up and say John, we are going 

to move this situation forward, we are doing a real fine job and we 

have a great new plan and we are going to do this without new 

money. And I said Frank, that is a lot of hooey. And a couple days 

later he would call me up and say well, John, we just can’t do it 

because we don’t have the money for this, and this brings us back 

to the question of registration fees. 

The House bill as it came out of this committee had registration 

fees in it with the support of the industry, which still supports that 

idea. It was taken out in the Senate. So user fees in that regard 

both with regard to food and with regard to pharmaceuticals would 

ease your financial stresses and strains, would it not? 

59 

Dr. HAMBURG. We clearly cannot fully implement this bill without additional resources. 

Mr. DINGELL. The other thing I remember that is very troublesome to me is, we had a movie before this subcommittee one time 

when I was the chairman and it showed a bunch of stuff coming 

into this country, mostly pharmaceuticals and things of that kind, 

and most of these pharmaceuticals were unsafe, misbranded, counterfeit, and some of them, believe it or not, were controlled substances, and they were just coming in through the mails. Everybody was sort of waving them as they went by. And I see you confronting the same problem, and I would be willing to bet if somebody were to put movies down there at some of the points where 

these things are imported, we would find the same situation is 

going on. Now, this situation happened to relate to the center at 

Miami where they would come in, and so I think that something 

here has to be done. 

Mr. Chairman, I just want you to know that I appreciate your 

holding this hearing. It my hope that we can work in a bipartisan 

fashion with us all working together as we have done in the past. 

It makes great good sense. It is something that the public needs. 

Americans are being killed either by bad stuff coming into this 

country that poisons them or makes them sick or they are being 

killed by being denied workable and worthwhile treatments and 

pharmaceuticals because people are sending in things like chalk 

and sugar as part of the medicines that we are receiving. 

So I want to commend you and thank you for the hearing and 

hope that as we go forward that we will be able to use this hearing 

as the beginning of an honest effort to work together to do something that we can do by working together, and I think it is a lot 

better than quibbling about whether we have got Democratic or Republican witnesses because that is not really important. I will be 

happy to take credit for the presence of Dr. Hamburg, and I am 

sure you would too, and not to quibble about whether she is a Republican or a Democratic witness. 

So I commend you, Mr. Chairman, for your leadership in this 

matter and I thank you for your recognizing me, and I again appreciate the opportunity to start moving on something that is in the 

public interest. 

Mr. STEARNS. I thank the distinguished chairman emeritus of the 

Energy and Commerce Committee and I appreciate his past leadership and his spirit of bipartisanship, that he continues to reach out. 

I think it is a good example for all of us to remember in this process. 

Mr. Hamburg, I want to thank you very much for your forbearance and patience for this hearing. 

All members have 10 days in which to submit any extraneous 

material they would like to, and with that, the subcommittee is adjourned. 

[Whereupon, at 12:26 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

60 

PREPARED STATEMENT OF HON. FRED UPTON

Few subjects have a more direct impact on public health and the safety of the 

American people than our topic today, and I applaud the Chairman for convening 

this hearing. 

The Food and Drug Administration has the daunting task of screening the millions of shipments, packages, and parcels that traverse our borders by air, ship, 

truck, and by land—responsible for preventing the entry of food, pharmaceuticals, 

and other medical products that violate our laws or pose a threat to the public 

health. This effort has not been made any easier by the growing number of imports 

we are seeing every year, as well as the increasing globalization of the supply chain. 

For this reason, FDA must use its resources intelligently, and in a manner geared 

to most effectively target higher-risk shipments for further inspections while expediting the passage of low-risk products. Today, FDA has the tools and technologies 

to enhance its risk-based review of imported food and medicines without obstructing 

the free flow of commerce into our country. 

However, I am concerned FDA may not presently be bringing all of its resources 

to bear in fulfilling its crucial gate-keeping responsibilities. I believe the Commissioner is serious about attaining her vision of an FDA that better assures the safety 

and quality of imported goods. I agree with the Commissioner that it is simply not 

possible, regardless of the amount of resources devoted, to inspect our way to safety. 

Therefore, I believe that FDA should get to work immediately on deploying all of 

the high-tech, intelligent, risk-based tools at its disposal. The American people deserve nothing less. 

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