[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]


 
     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



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                    COMMITTEE ON ENERGY AND COMMERCE

       FRED UPTON, Michigan          HENRY A. WAXMAN, California
              Chairman                 Ranking Member
JOE BARTON, Texas                    JOHN D. DINGELL, Michigan
  Chairman Emeritus                  EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               EDOLPHUS TOWNS, New York
ED WHITFIELD, Kentucky               FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois               BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania        ANNA G. ESHOO, California
MARY BONO MACK, California           ELIOT L. ENGEL, New York
GREG WALDEN, Oregon                  GENE GREEN, Texas
LEE TERRY, Nebraska                  DIANA DeGETTE, Colorado
MIKE ROGERS, Michigan                LOIS CAPPS, California
SUE WILKINS MYRICK, North Carolina   MICHAEL F. DOYLE, Pennsylvania
  Vice Chairman                      JANICE D. SCHAKOWSKY, Illinois
JOHN SULLIVAN, Oklahoma              CHARLES A. GONZALEZ, Texas
TIM MURPHY, Pennsylvania             JAY INSLEE, Washington
MICHAEL C. BURGESS, Texas            TAMMY BALDWIN, Wisconsin
MARSHA BLACKBURN, Tennessee          MIKE ROSS, Arkansas
BRIAN P. BILBRAY, California         ANTHONY D. WEINER, New York
CHARLES F. BASS, New Hampshire       JIM MATHESON, Utah
PHIL GINGREY, Georgia                G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana             JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   DONNA M. CHRISTENSEN, Virgin 
GREGG HARPER, Mississippi                Islands                      
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         
                                     
                                     

                                  (ii)
              Subcommittee on Oversight and Investigations

                         CLIFF STEARNS, Florida
                                 Chairman
LEE TERRY, Nebraska                  DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma                Ranking Member
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MICHAEL C. BURGESS, Texas            MIKE ROSS, Arkansas
MARSHA BLACKBURN, Tennessee          ANTHONY D. WEINER, New York
SUE WILKINS MYRICK, North Carolina   EDWARD J. MARKEY, Massachusetts
BRIAN P. BILBRAY, California         GENE GREEN, Texas
PHIL GINGREY, Georgia                DONNA M. CHRISTENSEN, Virgin 
STEVE SCALISE, Louisiana                 Islands
CORY GARDNER, Colorado               JOHN D. DINGELL, Michigan
H. MORGAN GRIFFITH, Virginia         HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)
  
                             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


     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, FDA-regulated 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, ``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 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, FDA-regulated 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 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 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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    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 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.
    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, 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 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 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.
    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 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 detail 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 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----
    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 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 responsibility, 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 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 
executive-level 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.
    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 
scale-up 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 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?
    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 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.
    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. 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 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 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, 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.]
    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 understand 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 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.
    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 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 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 Patient-Centered 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.
    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.
    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?
    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 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.
    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?
    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:]

                 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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