[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]







      DRUG SAFETY: AN UPDATE FROM THE FOOD AND DRUG ADMINISTRATION

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                             MARCH 10, 2010

                               __________

                           Serial No. 111-103








[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]





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                    COMMITTEE ON ENERGY AND COMMERCE

                 HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan            JOE BARTON, Texas
  Chairman Emeritus                    Ranking Member
EDWARD J. MARKEY, Massachusetts      RALPH M. HALL, Texas
RICK BOUCHER, Virginia               FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey       CLIFF STEARNS, Florida
BART GORDON, Tennessee               NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois              ED WHITFIELD, Kentucky
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York             ROY BLUNT, Missouri
GENE GREEN, Texas                    STEVE BUYER, Indiana
DIANA DeGETTE, Colorado              GEORGE RADANOVICH, California
  Vice Chairman                      JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California               MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania       GREG WALDEN, Oregon
JANE HARMAN, California              LEE TERRY, Nebraska
TOM ALLEN, Maine                     MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois       SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas           JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington               TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin             MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas                  MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          PHIL GINGREY, Georgia
JIM MATHESON, Utah                   STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa
PETER WELCH, Vermont
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
JOHN D. DINGELL, Michigan            NATHAN DEAL, Georgia,
BART GORDON, Tennessee                   Ranking Member
ANNA G. ESHOO, California            RALPH M. HALL, Texas
ELIOT L. ENGEL, New York             BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
JANICE D. SCHAKOWSKY, Illinois       MARY BONO MACK, California
TAMMY BALDWIN, Wisconsin             MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas                  MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
JANE HARMAN, California              TIM MURPHY, Pennsylvania
CHARLES A. GONZALEZ, Texas           MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia
DONNA M. CHRISTENSEN, Virgin 
    Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
BETTY SUTTON, Ohio
BRUCE L. BRALEY, Iowa














                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     2
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     3
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     4
    Prepared statement...........................................     6
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, opening statement.......................................    10
    Prepared statement...........................................    12
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................    18
Hon. Steve Buyer, a Representative in Congress from the State of 
  Indiana, opening statement.....................................    19
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................    20
Hon. Bruce L. Braley, a Representative in Congress from the State 
  of Iowa, opening statement.....................................    21
Hon. Marsha Blackburn, a Representative in Congress from the 
  State of Tennessee, opening statement..........................    22
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................    23
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................    24
    Prepared statement...........................................    26
Hon. Tim Murphy, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................    28
Hon. Jim Matheson, a Representative in Congress from the State of 
  Utah, opening statement........................................    29

                               Witnesses

Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food 
  and Drug Administration........................................    30
    Prepared statement...........................................    33
    Answers to submitted questions...............................    66

 
      DRUG SAFETY: AN UPDATE FROM THE FOOD AND DRUG ADMINISTRATION

                              ----------                              


                       WEDNESDAY, MARCH 10, 2010

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The Subcommittee met, pursuant to call, at 2:17 p.m., in 
room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. (Chairman of the Subcommittee) presiding.
    Members present: Representatives Pallone, Dingell, Eshoo, 
Green, DeGette, Matheson, Barrow, Christensen, Sarbanes, Murphy 
of Connecticut, Braley, Waxman (ex officio), Whitfield, 
Shimkus, Buyer, Pitts, Myrick, Murphy of Pennsylvania, Burgess, 
Blackburn, Gingrey and Barton (ex officio).
    Staff present: Phil Barnett, Staff Director; Bruce Wolpe, 
Senior Advisor; Ruth Katz, Chief Public Health Counsel; Sarah 
Despres, Counsel; Rachel Sher, Counsel; Elana Stair, Policy 
Advisor; Katie Campbell, Professional Staff Member; Stephen 
Cha, Professional Staff Member; Virgil Miller, Professional 
Staff Member; Allison Corr, Special Assistant; Eric Flamm, FDA 
Detailee; Greg Dotson, Chief Counsel, Energy and Environment; 
Dave Leviss, Chief Oversight Counsel; Karen Lightfoot, 
Communications Director, Senior Policy Advisor; Lindsay Vidal, 
Special Assistant; Mitchell Smiley, Special Assistant; Clay 
Alspach, Minority Counsel, Health; and Ryan Long, Chief 
Counsel, Health.
    Mr. Pallone. The meeting of the subcommittee is called to 
order, and today we are having a hearing on ``Drug Safety: An 
Update from the FDA.''
    I think before I give my opening statement, I am going to 
recognize my colleague, the ranking member of the full 
committee, the gentleman from Texas, Mr. Barton.
    Mr. Barton. Thank you, Chairman Pallone. I just need to 
make an announcement to the subcommittee. The ranking 
Republican on the subcommittee is Congressman Nathan Deal of 
Georgia. As we all know, he announced several weeks ago his 
intention to resign effective last week. He has since withdrawn 
the effective date of his resignation until after the vote or 
votes on the House Floor concerning the comprehensive health 
care bill. But during that time, Congressman Deal is not 
planning on attending Congress or at least the subcommittee of 
which he is the ranking member. Therefore, today I am 
nominating Congressman Shimkus of Illinois to be the temporary 
ranking member. That is unofficial obviously because there is 
no such thing as temporary anything, but he will assume the 
duties of Congressman Deal until such time as Mr. Deal does 
effectively resign. When that happens, I will inform Mr. Waxman 
that it is my intention to make Mr. Shimkus the ranking member 
of the subcommittee subject to committee approval of such 
designation. So for today's hearing and any subsequent hearings 
that this subcommittee has, until Mr. Deal actually resigns, 
Mr. Shimkus will assume the duties of the ranking member of 
this subcommittee.
    Mr. Pallone. Well, thank you, and let me congratulate Mr. 
Shimkus. He has always been very helpful and tried to work in 
many cases on a bipartisan basis, so I am very happy to welcome 
him as the new or acting ranking member. I was going to ask, 
though, the way you described that, Mr. Barton, it sounded like 
Mr. Deal might still be here for a while, depending on the 
circumstances.
    Mr. Barton. It is up to you.

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

    Mr. Pallone. All right. We will have to see. I shouldn't 
say that actually. He probably won't be here for very long 
based on what I believe, but we will see. In any case, 
congratulations.
    Let me recognize myself for an opening statement. As I 
mentioned, today the subcommittee is meeting to discuss drug 
safety. It has been at least a year since our last hearing on 
this issue and we are here to get an update and overview from 
the FDA on current challenges and successes with respect to 
drug safety. Recently there have been a number of drug-related 
incidents that have shaken public confidence in the FDA's 
ability to ensure that consumers are using safe and effective 
drugs. In addition, reports from the Institute of Medicine and 
the Government Accountability Office highlight the shortcomings 
of our current system and provide guidance on how to strengthen 
the drug safety laws to better protect the American public.
    In response to the incidents, Congress passed the FDA 
Amendment Acts of 2007, or FDAAA, I guess it is pronounced. 
This bill was aimed to provide the FDA with additional 
authorities, specifically post-approval authorities that would 
help the agency keep drugs safe for consumers to use. For 
example, the bill provided the FDA with the authority to 
require drug manufacturers to conduct post-approval studies 
that would monitor drugs for safety as they are used in the 
broader population. The bill directed the FDA to establish a 
post-market surveillance system to improve the agency's ability 
to detect and act upon drug safety problems and gave the FDA 
the authority to require drug label changes for safety reasons. 
It also provided the FDA with the authority to impose Risk 
Evaluation Mitigation Strategies, or REMS, for drugs and 
biologics when necessary, and these REMS are designed to manage 
known or potential serious risks with a drug or biologic to 
ensure that the benefits of the product outweigh the risks it 
poses to the patient.
    Now, the FDA is here today to talk about how effective this 
law is in protecting the American people from unsafe drugs, and 
I am particularly curious to hear about the progress on the 
implementation of some of the post-approval authorities and to 
learn from the agency of potential stumbling blocks or 
challenges that will require further Congressional action.
    Outside of the FDAAA realm, however, we already know that 
we need to do more to ensure the safety of our drugs. We all 
remember that horrible incident in early 2008 that again 
intensified this committee's focus on drug safety. Baxter 
Health Care Corporation, one of the manufacturers of the blood 
thinner heparin, which is used to prevent blood clots, began 
noticing an increase in the number of adverse effects 
associated with their product. After further investigation, it 
was determined that the Baxter heparin contained a counterfeit 
ingredient that mimics an ingredient normally used in heparin 
production but that is highly toxic and dangerous to humans. 
Baxter had received this ingredient from a manufacturer in 
China, and upon further investigation by the FDA, it was 
determined that due to a processing error at the agency, this 
Chinese manufacturer had never been inspected by the agency. 
Tragically, 81 individuals lost their lives as a result of the 
contamination. Obviously this should not and cannot happen 
again and we must do everything we can to ensure that it does 
not happen again. And I am curious to hear the FDA's thoughts 
and plans for improving import and supply chain safety, 
especially since the GAO found that roughly 80 percent of the 
active ingredients used in drugs are actually manufactured 
abroad.
    I and a few of my colleagues on the Energy and Commerce 
Committee introduced a bill this Congress that aims to provide 
the FDA with additional funding authorities to better regulate 
the imported materials used in drugs. The bill would also place 
more responsibility on the manufacturers to ensure that the 
ingredients they are using are safe. As highlighted by the 
heparin case, we know the devastation that can come from an 
unsafe drug supply chain.
    So I am looking forward to hearing from today's witnesses.
    I now recognize our new ranking member, my friend, Mr. 
Shimkus.

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

    Mr. Shimkus. Thank you, Chairman Pallone. Thank you for 
your warm welcome. I want to thank Ranking Member Barton for 
his trust and confidence in me, and I look forward to 
continuing to work hard on behalf of the committee and really 
the work we need to do here.
    The FDA, with all the challenges and the inspection that we 
do, it is still really the gold standard for health and safety 
in the world. A lot of countries don't have to do all the 
research and the testing because we in essence do it for them, 
so although we will be inquisitive and we will be trying to ask 
questions, I put that first on the table because they world 
does rely on what we do here. And we have spent a great deal of 
time on the issue of drug safety and the Food and Drug 
Administration Amendments Act, and I look forward to Dr. 
Sharfstein. Welcome, and I look forward to your updates. And I 
want to continue to learn more about the Risk Evaluation 
Mitigation Strategies, known as REMS, how that is progressing 
and whether information is being disseminated in a user-
friendly manner. I am all about risk-based approach. The bills 
that we passed in a bipartisan, I continuously spoke out on 
risk-based programs. So I am very interested in that.
    Your projections for advisory committee members in the 
future and those projections, I believe it is important to 
maintain credibility and expert participants. Recent stories 
indicate the exception reductions provisions may be diluting 
the advisory committee's ability to serve in those functions, 
and we do want highly qualified and the best people to be 
helpful.
    But in general we know gaps remain when it comes to 
ensuring the safety of drugs in the United States and I remain 
committed to addressing those needs along with Chairman 
Pallone. One thing I know about my colleagues on the other 
side, they are tenacious in moving in that direction and we 
want to be helpful in that manner. The FDA continues to make 
progress in utilizing risk-based systems like PREDICT and I am 
curious how this might translate in regard to targeting 
facility inspections. Regardless of the end result, we know 
that the FDA needs proper funding. We need to identify where we 
can cut out wasteful spending and make sure funding to ensure 
the safety of food and drugs in this country does not take a 
backseat with our appropriators.
    Lastly, echoing remarks I made in the past, I hope we can 
work towards these goals using a prudent formula to get a good 
bipartisan product. Chairman Waxman, Chairman Emeritus Dingell, 
Chairman Pallone and Chairman Stupak working along with Ranking 
Member Barton, Deal and myself came up with the food safety 
bill that ultimately passed the House really in a huge 
bipartisan manner, and I think we can do that if we move 
forward in that direction.
    I look forward to continuing our work to get legislation 
signed into law and hope we can use the successes of food 
safety as our motto in any drug safety-related legislation.
    Thank you, Mr. Chairman. I yield back my time.
    Mr. Pallone. Thank you, Mr. Shimkus.
    Next is our full committee chair, Chairman Waxman.

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

    Mr. Waxman. Thank you very much, Chairman Pallone, for 
holding this hearing today and giving us the opportunity to 
hear from the FDA on the critically important issue of drug 
safety.
    It has been some time since we focused on drug safety, but 
we did indicate that we wanted to take up this bill after food 
safety, which was the first step, and now we are going to turn 
to drugs, medical devices and cosmetic safety issues.
    We can't forget the lessons of the 2007 heparin 
contamination catastrophe which resulted in numerous severe 
allergic reactions and the deaths of at least 80 Americans. In 
that case, the active ingredient was manufactured in China. 
Thanks to the excellent work of the Subcommittee on Oversight 
and Investigations in 2008, we know that this is not a unique 
situation: the U.S. drug supply is increasingly sourced from 
abroad.
    In order to market a drug in the United States, FDA must 
ensure that the drug meets our appropriately high safety 
standards. So when ingredients or finished drug products are 
manufactured abroad, FDA needs to expand its reach if the 
agency is to meet its responsibilities.
    As heparin illustrated, FDA clearly needs more authorities 
and more resources to do a better job policing the safety of 
imported products. But what heparin also demonstrated is that 
we cannot expect FDA alone to do this job. We need to place a 
greater onus on all manufacturers to oversee the safety of 
their own products. This principle is reflected in the work 
that Mr. Dingell, Mr. Pallone and Mr. Stupak did on their Food 
and Drug Administration Globalization Act. For instance, the 
bill would require drug manufacturers to implement Quality Risk 
Management Plans to incorporate risk identification and control 
into their production processes. We need that.
    This is a principle that should be familiar to all of us. 
The Food Safety Enhancement Act reflects this kind of approach 
with respect to food manufacturers. So I am confident we can 
get the same kind of bipartisan agreement to incorporate this 
concept into a bill on drug safety as well.
    I hope FDA will tell us today about what the agency 
believes it needs to protect us from another heparin disaster.
    I am also eager to hear about FDA's implementation of the 
2007 FDA Amendments Act. Congress made some major strides 
toward improving the safety of our drug supply in enacting this 
legislation. For the first time, FDA was given the authority to 
require manufacturers, among other things, to conduct post-
market studies, implement Risk Evaluation and Mitigation 
Strategies, or REMS, and make safety-related drug labeling 
changes. This hearing will be a great opportunity to learn 
about FDA's challenges and successes with the use of these 
authorities 3 years after the enactment of this landmark 
legislation.
    I want to thank Dr. Sharfstein for being here. He is no 
stranger to me. We worked together in the past in the Oversight 
and Government Reform Committee and on many of these very same 
issues, and I am quite pleased that you are here and feel a 
sense of confidence that you are responding to us on these 
issues because I know you share our concern about them.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Mr. Waxman follows:]


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    Mr. Pallone. Thank you, Chairman Waxman.
    Next is our ranking member, Mr. Barton.

   OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Barton. Thank you, Chairman Pallone. We appreciate this 
hearing today. We appreciate our witness from the FDA coming.
    Before I give my brief statement on the merits of the 
issue, I do want to reiterate the importance I place on this 
subcommittee and the importance I place on Mr. Shimkus assuming 
the ranking membership. On the Republican side, we have a 
bidding system for subcommittees where each member gets to rank 
one, two, three their preference for subcommittees. The most 
sought-after subcommittee on the Republican side of the full 
committee is the Health Subcommittee, as it should be, given 
the size of the health issue in our debates here in the 
Congress. Congressman Deal has done an outstanding job, first 
as subcommittee chairman and the last two terms as ranking 
member but he is pursuing the governorship in Georgia, so I 
thought long and hard about who to replace him with, and Mr. 
Shimkus is somebody who has paid his dues. He has an almost 100 
percent attendance record as a member of this subcommittee. He 
also serves on two other subcommittees and his attendance 
record there is excellent. He gets into the details of the 
issues, and while any member of the subcommittee on the 
Republican side I think would make an excellent ranking member, 
I feel Mr. Shimkus will not have a learning curve, so I welcome 
him to his new duties and I hope that he conveys to them the 
same sense of excellence he has in all the other duties he has 
assumed on the committee.
    With regard to today's hearing, it is good to review what 
we have done with the bill that we passed in the last Congress. 
We are especially interested on the minority side, as has 
already been outlined, the REMS issue, the Risk Evaluation 
Mitigation, how that is working. We also would be interested in 
hearing about the new rules that we put into statute regarding 
conflict of interest and how those rules are being used. We 
hear some concern that it has become difficult to get the 
experts needed on these review panels because of the conflict-
of-interest rules that we have adopted, so we want to hear 
about that.
    As Chairman Waxman has pointed out, there is hope that we 
can work in a bipartisan fashion on future FDA reform measures. 
Chairman Dingell and I are working on that very issue at the 
staff level, and we are hopeful that our friends on the 
majority side will adopt the model of bipartisanship that they 
exhibited in the last Congress and in this Congress so far with 
the FDA and not the model of partisanship that they adopted on 
the larger comprehensive health reform bill. I think the proof 
is in the pudding. When we work together in a bipartisan 
fashion, we certainly have differences but we end up with bills 
that pass committee with almost unanimous support and bills 
that pass the floor with over 400 votes. When the other route 
is chosen, we have bills that barely pass committee and barely 
pass the floor and as of now there doesn't appear to be a 
compromise between the House and the Senate and the President 
that can pass anywhere.
    So we look forward to your testimony, and again, Chairman 
Pallone and Chairman Waxman, thank you for this hearing.
    [The prepared statement of Mr. Barton follows:]


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    Mr. Pallone. Thank you, Mr. Barton.
    Next is the chairman emeritus, and I should say that Mr. 
Dingell, as many of you know, has had a long history of working 
on this legislation or the issue of drug safety and food safety 
and is the prime sponsor of the bill that we have been 
operating on for the last couple of sessions on the topic. 
Thank you, Mr. Chairman.

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

    Mr. Dingell. Thank you, Mr. Chairman, for those kind words 
and I wish to commend you for having this hearing. It is a very 
valuable event and it will provide us an opportunity not only 
to receive and update information on drug safety activities at 
the Food and Drug Administration but also to remind the 
American people of the hazards which exist with regard to 
unsafe food and drugs and the fact that this Congress needs to 
move forward with legislation to address problems in both of 
these areas.
    As you know, Mr. Chairman, we have reported from this 
committee a food safety bill which has passed the House. It 
came unanimously out of this committee and it has passed the 
House by an overwhelming vote. It sits, of course, safely 
ensconced in the United States Senate as these things usually 
do. We are hopeful that this hearing might trigger some 
interest in the Senate in this matter so that they can commence 
to go forward.
    I want to commend my friend Mr. Barton for his comments 
with regard to food safety and safety of pharmaceuticals. As 
you know, Mr. Chairman, you, Mr. Stupak and I and Ms. Sutton 
and Ms. DeGette sponsor H.R. 759, which is a very significant 
improvement in all the things at Food and Drug including their 
authorities to address drug problems, food problems and also 
importation problems that deal with the importation at the 
point of import and to see to it that inspections at home and 
abroad and as well as that that good manufacturing practices 
obtained abroad, and I want to observe that Mr. Barton worked 
very well with us on that and that my Republican colleagues and 
my Democratic colleagues and I will work well to get that bill 
out of here and through the House.
    I am hopeful that we can do something similar on the 
remnants of the legislation which we have passed which was H.R. 
759. We received technical comments from the Food and Drug 
Administration and we believe that those are very helpful and 
will be incorporated. As my colleague Mr. Barton has observed, 
his staff and mine are working to see to it that we can bring 
together a bill which can achieve the support of my colleagues 
on the committee, and I look forward to the enthusiastic 
support in this subcommittee and in the full committee, and of 
course, I look forward to the help of Food and Drug and the 
Department of HHS as well as the Administration.
    According to a 2004 HHS report, the Nation's medicine 
cabinets are still stuffed with enormous amounts of 
pharmaceuticals. Almost half of all people in this country take 
at least one prescription medicine and one in six has three or 
more medications that they take. Americans have come to expect 
that their prescription drugs will improve health and prolong 
life expectancy. They do not expect their drugs to cause harm 
or death. The Food and Drug Administration plays a critical 
role in ensuring the Nation's drug supply meets the safety 
expectations of American consumers. The role FDA plays is so 
critical that it has earned that agency an American Food and 
Pharmaceutical Products as the gold standard not only of 
regulatory bodies but as regulatory substances.
    Unfortunately, FDA approval of pharmaceuticals as a gold 
standard is now called into question by an unfortunate series 
of facts. Drug safety incidents have occurred and have created 
a confidence crisis in FDA. During the past 8 years, Food and 
Drug was led by leadership specialized at best in gross 
incompetence or at worst severe deception, and as a result, 
American lives have been placed in jeopardy under all the 
products that are marketed under the regulation of that agency, 
and of course, the confidence of the American people in that 
agency has been severely compromised.
    Now under a new Administration, Food and Drug has been 
taking steps to rebuild, and through Congressional and 
administrative action, the agency has gained additional 
resources, not sufficient but to begin enabling it to move 
towards doing its job properly though many including myself 
still believe that the resources and authorities of Food and 
Drug are still lacking in the wake of years of inattention and 
starvation.
    In 2007, the Congress made substantial progress in the way 
of drug safety with the passage of FDA Amendments Act of 2007. 
This law strengthened FDA's post-market safety oversight. No 
longer is it ok for the oversight to end at the mere approval 
of a drug. This is a significant step forward. However, it did 
not take long before we were aware of enormous gaps in FDA's 
ability to protect consumers from an increasingly global drug 
supply. In 2008, in one instance alone, 81 deaths of Americans 
were linked to recalled heparin that contained Chinese tainted 
API. The safety of imported pharmaceuticals and supplies as 
well as the raw materials from which these are made is a matter 
of safety and great concern that must be addressed in this 
Congress. Last year the Congress unanimously passed the 
bipartisan bill I mentioned with regard to our food safety 
supply. I believe that we can and should and will pass similar 
legislation during this Congress.
    I look forward to the deputy commissioner's testimony. I 
hope he is able to give us better testimony than the 
predecessor of the current head of FDA gave us when he came up 
to tell us that all was well and to leave a patch of skin 
behind in this committee because of the unfortunate character 
of his testimony and his lack of information.
    Mr. Chairman, I thank you again and I yield the balance of 
my time.
    Mr. Pallone. Thank you, Chairman Dingell.
    The gentleman from Indiana, Mr. Buyer.

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

    Mr. Buyer. Thank you very much.
    For the past several years, I have been studying the 
problem of counterfeit drugs entering our Nation through our 12 
international mail facilities and express carrier facilities. 
In 2008, Congress Matheson and I introduced the Safeguarding 
America's Pharmaceuticals Act to combat the flow of unapproved 
drugs into our country and to strengthen and safeguard the 
domestic pharmaceutical supply by creating also this system of 
electronic pedigree. At the beginning of last year when we 
introduced the legislation, we then submitted to the FDA and 
other stakeholders, Customers Border Protection and the 
California Board of Pharmacy to improve the Safeguarding 
America's Pharmaceuticals Act. I would ask you to look over 
your left shoulder because there are two ladies that were a lot 
of help. They put in a lot of time for the technical assistant. 
Elisa Bernstein, thank you very much. We traveled to many of 
these facilities with you. And Jeannie Ireland, thank you very 
much for the technical assistance you have given to make this 
legislation even better. Mr. Matheson and I have the commitment 
of Mr. Dingell and we want to make sure that this legislation 
becomes a reality.
    Last June, Dr. Hamburg testified before this subcommittee 
and stated that the problem of counterfeit drugs is a 
significant concern and gave her commitment to working with me 
to address the issue, so I turn ask for the very same 
commitment.
    The FDA then followed up in its response to many questions 
for the record and confirmed that the agency supports a single 
national uniform standard for a drug track and trade system. 
Additionally, the agency addressed an issue of great importance 
to me when it stated that it supports streamlining the 
destruction of these unapproved FDA drugs that constantly come 
into the market. And let us stop enabling these counterfeiters 
by this policy of return to sender. It is just awful, and I 
hope that you can address that to us. The worldwide counterfeit 
drug market is expected to grow to $75 billion, so we have to 
aggressively address this, and I look forward to working with 
Mr. Dingell to do that.
    So I know this is a great concern to you, and I look 
forward to working with you and your comments. I yield back.
    Mr. Pallone. Thank you, Mr. Buyer.
    Next is the gentlewoman from the Virgin Islands, Mrs. 
Christensen.
    Mrs. Christensen. Thank you, Mr. Chairman. I am waiving my 
opening statement.
    Mr. Pallone. Thank you.
    The gentleman from Georgia, Mr. Gingrey.

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

    Mr. Gingrey. Mr. Chairman, before I start, let me join with 
my ranking member on congratulating Mr. Shimkus as ranking 
member of this Health Subcommittee.
    Mr. Chairman, first I would like to thank you for calling 
this hearing today. Ensuring that medications are both safe and 
effective for our Nation's patients is a goal that I believe we 
can all support. Whether our inquiries include pre-market and 
post-market testing of products, domestic and foreign facility 
inspections or even the authority and resources of the FDA, 
this committee and its chairman should be commended for their 
efforts today.
    However, I want to focus for a moment on some troubling 
news that just came out of Britain. As some of you may have 
read earlier this week, the U.K.'s National Health Service 
received four independent audits on the overall state of their 
health care system. All four reports found a system that put 
the politics of the government above the health of the patient. 
One report based on the evidence of almost 200 top managers and 
doctors in the British system found that hospitals ignored 
basic hygiene so they could cram patients into beds to meet 
waiting time targets, thereby losing sight of fundamental 
hygiene requirements for infection prevention. This neglect of 
the most basic hygienic standards was credited with causing the 
deaths of 265 patients in 2005. All four reports in fact hit 
the same note: the British system placed little emphasis on 
patient care. Even more shocking, these reports are suppressed 
by the British government and only came to light recently. To 
quote the Times of London, ``These reports diagnose a blind 
pursuit of political and managerial targets as the root cause 
of a string of hospital scandals that have cost thousands of 
lives.''
    I see the same blind pursuit of political targets in our 
current health care reform debate. For the past week, I have 
seen the demonization of the insurance industry. Sure, the 
industry needs reform. We all agree with that. But insurance 
reforms alone should not be the reason for turning health care 
over to our government lock, stock and barrel, and if the 
Senate bill passes, what then? Who is going to monitor our 
government when it controls all health care decisions? If the 
British are our example, will politics supersede the needs of 
patients here like they did in the U.K.? I fear that Washington 
politics have already trumped their needs. Our constituents are 
telling us that they want reform but not this reform. They 
don't want a bill bought with political payoffs and backroom 
deals. Every day they echo these sentiments, yet their elected 
officials ignore them. They voted for a Republican to represent 
Massachusetts in the United States Senate and still Washington 
refuses to listen. If we cannot trust our government to put its 
citizens first when debating a health care reform bill, how can 
we expect it to safeguard their citizens' interests when it 
controls health care? If Britain continues to be our example, I 
fear for the safety of patients if our government controls our 
health care choices.
    Mr. Chairman, with that I yield back.
    Mr. Pallone. Thank you.
    Next is the gentleman from Iowa, Mr. Braley.

OPENING STATEMENT OF HON. BRUCE L. BRALEY, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF IOWA

    Mr. Braley. Thank you, Mr. Chairman. I am very pleased that 
we are holding this important hearing and I am very pleased 
with the scope of the testimony that Dr. Sharfstein has laid 
out in his written materials.
    I want to begin my brief remarks by echoing the concern 
raised by my colleague from Indiana, Mr. Buyer, because one of 
the things that was very obvious to me when I visited the 
Custom and Border Patrol inspection facilities in Nogales, 
Arizona, and Mexico, is that we have an enormous problem with 
counterfeit drugs entering through ports of access and other 
places that are not being controlled, which contributes 
enormously to the problem you have identified with the known 
points of products for non-counterfeit drugs. So we have got 
two major problems in terms of enforceability of the FDA's 
mandate in counterfeit and non-counterfeit production 
facilities overseas. We also have enormous challenges in terms 
of the accountability of the manufacturers of those non-
counterfeit and counterfeit drugs in this country, and one of 
the things that I hope you are able to address in your 
testimony is what the FDA is doing to promote greater 
accountability with those overseas manufacturers.
    I also want to compliment you on some of the progress has 
been made since the passage of the FDAAA because I personally 
benefited from one of the changes you identified in your 
statement where you describe the changes to the prescription 
information of a class of antibiotics to warn about the risk of 
tendon rupture. I have experienced a ruptured Achilles tendon, 
and when I was prescribed those antibiotics, as a patient I was 
given informed information to make a choice about whether or 
not to take that antibiotic in light of my own health history. 
So I can tell you that if consumers are presented with 
information that allows them to make the choices that are best 
for them based upon their own unique health conditions, the FDA 
is fulfilling the mandate that you set forth so succinctly at 
the beginning of your written remarks.
    But I also want to hear from you in your testimony about 
the Sentinel Initiative that you described, which you have 
identified as a national integrated electronic system for 
monitoring medical product safety. The concern I want you to 
address is exactly what model that Sentinel Initiative is based 
upon because I am familiar with other sentinel event reporting 
systems that have been adapted in this country designed to 
promote patient safety that have been woefully inadequate in 
reaching the level of reporting that would be required to truly 
bring about changes in patient safety.
    So I look forward to your comments. I appreciate your 
willingness to come here today. It is a very important subject 
that affects every American, and this is not a partisan issue, 
it is a bipartisan issue that every American should be 
concerned about, and I yield back.
    Mr. Pallone. Thank you, Mr. Braley.
    The gentlewoman from Tennessee, Mrs. Blackburn.

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

    Mrs. Blackburn. Thank you, Mr. Chairman.
    I am so pleased that we are doing an oversight hearing 
today. Oversight is something that we should doing a little bit 
more of, and I think that after we passed the FDA Amendments 
Act in 2007 that was supposed to help streamline some of those 
processes and procedures that it is important that we come back 
and look at what is happening with the efficiencies in this 
area as well as to look at the relationship between the FDA and 
industry, and some of my colleagues have mentioned some of the 
conflict-of-interest questions that we will have.
    I also hope that today we are going to look at whether or 
not the FDA has the appropriate resources as well as the 
institutional will to continue to evolve and review processes 
that are in place, and I know, Dr. Sharfstein, that you are 
very well aware that with the inspections process with NDA and 
ANDA, we hear from constituents who may have questions or 
concerns as they have gone through that process. So I think 
that is something we need to jointly look at to see is this 
review process working and how do we simplify it, how do we 
look at time, money, the usage as well as public safety. So I 
thank you for your willingness to look at that.
    The other point that I hope we look to is FDA's internal 
problems and see if those have improved not only with the 
decision-making process but also the oversight and the post-
market drug safety issues that are out there, the counterfeit, 
and then let us also touch on one of the things we have talked 
about repeatedly over the last few years which is your 
interagency communications and the different divisions and how 
they are transferring that information. Repeatedly we have seen 
this as a roadblock or being cited as well we didn't know they 
were doing. So I hope that you will take a moment to address 
that.
    I thank you for being here with us. We welcome you.
    Mr. Chairman, I yield back.
    Mr. Pallone. Thank you, Mrs. Blackburn.
    And next, the gentlewoman from California, Ms. Eshoo.

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

    Ms. Eshoo. Thank you, Mr. Chairman. This is an important 
hearing, and I thank you for having it.
    Before the FDA was created about a century ago, taking 
drugs was a real gamble. There were elixir potions that were 
sold door to door and ``medicines'' were really taken at one's 
own risk. Today, as was stated previously and we all know, 
there are millions of Americans that take drugs to prevent, to 
treat and to cure ailments from the common cold to cancer, and 
the science and technology progresses and I see every day the 
new things that surface in my Congressional district and 
certainly around the country, so do the complexity of drugs as 
well as our ability to regulate them and ensure their safety. 
So I think that the FDA is the gold standard in the world and I 
think that we all want the FDA to remain the gold standard in 
the world. The recent heparin incident was a stark example of 
what happens when that standard is not followed and it cost 81 
American lives. Lapses in drug safety not only harm patients 
but they cause the public, and I think this is really an 
important outcome of this, it causes the public to doubt the 
government's ability to actually ensure safety. So we have to 
maintain the trust and the support of the American people who 
rely on safe and effective drugs.
    I am very pleased to see Dr. Sharfstein here today. I would 
like to know about how the FDA is implementing two provisions 
that I offered in the Food and Drug Administration Amendments 
Act to renew and improve the Best Pharmaceuticals for Children 
Act, the BPCA, and the Pediatric Research Equity Act, PREA. The 
provisions, as you know, were designed to improve drug safety 
for children in two ways. First, under the BPCA, the 
legislation provided an incentive for a drug of the innovator 
company agrees to undertake comprehensive pediatric studies 
requested by the FDA, and second, under PREA, the FDA was 
granted the authority to require studies when there is a 
demonstrated need and the drug companies are required to submit 
a pediatric assessment. I am telling you what you already know.
    So my thanks to Dr. Sharfstein for being here today. I look 
forward to your testimony. I want to thank everyone that is 
part of helping to keep FDA as the gold standard in the world 
and to work with you and make sure that we provide the resource 
that you need in order to do that and good public policy to 
back it up.
    Thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    Next is the gentleman from Pennsylvania, Mr. Pitts.
    Mr. Pitts. I will waive.
    Mr. Pallone. Thank you.
    The gentleman from Georgia, Mr. Barrow.
    Mr. Barrow. Thank you. I will waive.
    Mr. Pallone. The gentleman from Kentucky, Mr. Whitfield.
    Mr. Whitfield. Thank you, Chairman Pallone, and I also want 
to congratulate Mr. Shimkus on his new responsibilities of this 
subcommittee, and Dr. Sharfstein, we are delighted you are here 
to bring us up to date on the implementation of this act of 
2007.
    People have already touched on a lot of these issues, the 
safety of drugs coming into the country, the approval process, 
whether or not there are adequate resources, and I just want to 
point out one additional aspect of this, which is a little bit 
different, but this committee a couple years ago passed the 
National Prescription Drug Monitoring System which I think is 
vitally important to health care providers. We continue to 
struggle on getting sufficient funds to fully implement this 
because of an unauthorized program started in the 
Appropriations Committee but we have been working with both 
sides of the aisle to try to address that issue and I certainly 
look forward to your testimony on the other part of this 
equation. Thank you.
    Mr. Pallone. Thank you, Mr. Whitfield.
    The gentleman from Connecticut, Mr. Murphy. Well, Mr. Green 
just walked in. Do you want to go first? Mr. Green.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. I would like to put my full statement into the 
record.
    Following our chairman emeritus and the earlier statements, 
first I want to thank you for holding the hearing and today 
with new FDA folks on the current status of our drug safety 
system, and a lot of our frustrated that the Senate hasn't 
moved on the bill but I had the opportunity like a lot of 
members on several hearings led by Chairman Pallone and 
Chairman Stupak, the FDA and drug safety over the past 2 years. 
All these hearings clearly show the FDA is woefully underfunded 
and neglected by Congress for far too many years and that has 
left the FDA without the resources, funding or technology it 
needs to protect the American public from counterfeit or 
tainted drugs entering our country. This committee worked over 
a year on FDA drug safety legislation passed out of the 
committee. The legislation is aimed at improving our drug 
safety system by giving FDA increased resources for overseeing 
facility inspections by the FDA, an up-to-date registry of all 
foreign drug manufacturing facilities, country-of-origin 
labeling, verification of drug purity and safety. It gives the 
FDA the ability to issue fines and mandatory recalls, and also 
the FDA's foreign drug inspection program needs to be changed 
and some hurdles to overcome. The FDA currently does not have 
the authority to conduct these inspections overseas and must be 
invited to a plant to conduct inspections. That is almost like 
me driving down the Houston freeway inviting an officer to 
watch me while I speed. That just doesn't work in the real 
world.
    And Mr. Chairman, that is why I would hope with the new FDA 
that they will not only take their job seriously, and I know 
they do, but also we need to provide the resources for them, 
and I appreciate the opportunity to give the opening statement 
and again, I would like to have my full statement placed in the 
record.
    [The prepared statement of Mr. Green follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Pallone. Without objection, so ordered.
    The gentleman from Texas, Mr. Burgess.
    Dr. Burgess. Thank you, Mr. Chairman. I will waive opening 
statement and reserve time for questions. Welcome, Dr. 
Sharfstein, to our committee.
    Mr. Pallone. Thank you.
    The gentleman from Connecticut, Mr. Murphy.
    Mr. Murphy of Connecticut. Thank you, Mr. Chairman, and 
welcome, Dr. Sharfstein.
    In your testimony, you recite some of the examples of 
safety lapses that we have seen and you summarize by saying, 
``These episodes and others are not random mistakes, they are 
driven by a common feature, which is economic incentive.'' And 
I guess it underscores what we have seen as a facet of our 
health care system for a very long time. Too often, profit is 
being put ahead of quality and safety, and everything we do, 
whether it is changing the way that the FDA works or whether it 
is the discussion surrounding health care reform, has to be 
around reversing that phenomenon. We have to be putting safety 
and quality first, profit and cash second whether it is running 
the FDA, whether it is how we reimburse providers or whether it 
is how we regulate insurers. I don't begrudge drug companies 
from making a buck. We have got a lot of very good ones in 
Connecticut. But we should never, ever be sacrificing safety 
for profit. We should never, ever be sacrificing quality for 
profit. That I think is the guiding principle behind health 
care reform and that of course I know is the principle that you 
bring to your leadership at the FDA, and I appreciate your 
testimony today.
    Mr. Pallone. Thank you. The other Mr. Murphy from 
Pennsylvania.

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

    Mr. Murphy of Pennsylvania. Thank you, Mr. Chairman.
    I would first like to mention, unfortunately I am not going 
to be able to remain here, Chairman and Dr. Sharfstein, 
although I would love to hear your testimony. You know what it 
is like, we have other things pending.
    But I would like to bring something to your attention in 
this, and if it not something you are able to respond to today, 
please, I hope you can get back to me. I wanted to tell you 
about a couple of my constituents, Russell and Robely Rosewitz 
in Mount Lebanon. They have lived a terrible tragedy. Their 
daughter, Hannah, was vaccinated for DPT, as you know, 
diphtheria, pertussis and tetanus, and 2 hours after she 
received her shot, she began experiencing seizures. She was 
once a healthy infant and now she needs 100 percent round-the-
clock care. Unfortunately, adverse reactions to complicated 
vaccines do occur and years upon years of scientific evidence 
have shown the public health benefits of vaccination are 
greater than the isolated, unfortunate adverse action. And to 
encourage families to vaccine their children and ensure vaccine 
makers continue produce lifesaving medicine, Congress passed 
the National Childhood Vaccine Injury Act in 1986. This law 
compensates victims of vaccination adverse effects and allows 
the Secretary of Health and Human Services to automatically 
award damages when a victim has experienced adverse reactions. 
But the DPT vaccine in this case was removed from the table of 
vaccines known to cause adverse events just 1 month prior to 
when Hannah's family applied for compensation. After a 10-year 
legal battle to prove that the vaccine caused Hannah's 
seizures, the case is now before the Supreme Court. Hannah's 
parents believe there were safer alternatives to the DPT 
vaccine administered to their daughter. The question before the 
Supreme Court is whether or not companies are immune to civil 
suits if they participate in vaccine victims' compensation 
fund.
    Now, I am not here to argue the merits of the case. The 
Supreme Court will decide whether or not that was the 
Congressional intent. But this case raises an important issue 
about vaccine safety. For example, if they are imported and the 
FDA is not capable of inspecting the manufacturing process, 
then where does the responsibility and liability for assuring 
safety lie? By the way, that particular DPT vaccine was later 
removed from the market after 50 years of sales.
    So I hope at some point you can get back to us and let us 
know about some of these important issues. I know you are 
deeply concerned as are we, and quite frankly, I believe that 
contrary to what some others may say, that manufacturers also 
want to ensure the safety of their products because they do not 
want to see anybody harmed from these as well. so if you could 
please get back to us and let us know how we keep up-to-date on 
the latest scientific evidence here and how you are ensuring 
vaccine makers are using the latest and safest innovation in 
vaccine design.
    Thank you so much for being here. Again, I apologize. I 
wish I could stay because I am deeply interested in hearing 
your testimony, but I look forward to hearing from you.
    And with that, I yield back, Mr. Chairman.
    Mr. Pallone. Thank you, Mr. Murphy.
    The gentleman from Utah, Mr. Matheson.

  OPENING STATEMENT OF HON. JIM MATHESON, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF UTAH

    Mr. Matheson. Thank you, Mr. Chairman. I do appreciate this 
hearing and look forward to the testimony.
    In the coming weeks, I will be introducing a bipartisan 
bill with my colleague, Representative Buyer, to develop a 
system for the protection of our Nation's pharmaceutical 
supplies for domestic and international counterfeiting threats. 
Within the past 2 years, Representative Buyer and I have 
engaged stakeholders all along the supply chain to develop a 
workable and commonsense approach. As an integral part of the 
stakeholder process, I also appreciate the recent helpful 
comments from the Food and Drug Administration and their 
suggestions of how to improve upon our approach and achieve our 
shared ultimate goal.
    Specifically, core elements of the bill that we plan in 
introducing are the creation of a system by which we will be 
able to track drugs from the time they leave the manufacturing 
facility to the time they reach patients in the pharmacy, 
hospital, nursing home or doctor's office. Counterfeiting of 
drugs is a public health concern. By implementing these steps 
now, we can go a long way towards safeguarding the medicine 
people need to get well and stay healthy.
    Another feature will be one uniform national pedigree 
system. By having one federal standard, I believe we can ensure 
our Nation's drug market is efficient, it can ensure products 
flow safely and freely throughout the country. This is a 
guiding principle that seems to unite a majority of the members 
of the supply chain.
    Third, our bill will raise the standards for drug 
wholesalers while maintaining States' rights to regulate drug 
wholesalers. I believe this is a necessary step to ridding the 
market of bad actors and ensuring that anyone handling 
America's pharmaceuticals must be held to high standards.
    Counterfeit drugs are the latest and potentially the most 
dangerous front in the long-running battle against 
intellectual-property crimes. In 2007, pharmaceuticals made up 
about 6 percent of total seizures. Last year they accounted for 
10 percent to become the third largest category with an 
estimated market value of $28 million. Counterfeiters are 
alarmingly good at their jobs. They can create pills and drug 
packages that are so close to real products that they are 
indistinguishable to consumers. By strengthening current laws 
and regulations, building upon the successful model signed into 
law in California, and by creating a uniform national standard, 
our legislation further secures the health care supply chain. 
This enhances our country's and the Food and Drug 
Administration's high standard for patient safety.
    I look forward to the witness testimony. I will yield back 
my time.
    Mr. Pallone. Thank you.
    The gentlewoman from Colorado, Ms. DeGette.
    Ms. DeGette. I will submit my statement for the record.
    [The prepared statement of Ms. DeGette was unavailable at 
the time of printing.]
    Mr. Pallone. Without objection, so ordered.
    I think that that concludes our opening statements by 
members of the subcommittee, so we will now turn to our one 
witness, which we are so pleased that Joshua M. Sharfstein is 
here today. He is the principal deputy commissioner from the 
Food and Drug Administration, and thanks for being here, or 
coming back to us, so if you would give us your statement, we 
would appreciate it.

   STATEMENT OF JOSHUA M. SHARFSTEIN, M.D., PRINCIPAL DEPUTY 
           COMMISSIONER, FOOD AND DRUG ADMINISTRATION

    Dr. Sharfstein. I thank you very much. It is good to be 
back here. Good afternoon, Mr. Chairman and members of the 
subcommittee. I am Dr. Joshua Sharfstein, the principal deputy 
commissioner at the Food and Drug Administration. Thank you for 
the opportunity to discuss the safety of the U.S. drug supply.
    Protecting Americans from unsafe or contaminated drugs is 
not just an important responsibility of FDA, it is our core 
charge. Drug safety was the primary reason for the passage of 
our guiding statute. In 1937, more than 100 people, including 
many children, died from ingesting Elixir Sulfanilamide, which 
contained the deadly poison diethylene glycol. Congress then 
passed, and President Franklin D. Roosevelt signed, the Food, 
Drug, and Cosmetic Act to prevent future catastrophes. And yet 
as you know, many years later, the threat of unsafe drugs 
remains.
    I would like to thank the subcommittee for its leadership 
on this issue twice. First, thank you. There have been numerous 
hearings in this chamber have helped the public understand the 
challenge of regulating a global marketplace. And second, 
members of this subcommittee, along with the chairman of the 
full committee and the chairman emeritus, were the key 
architects of the Food and Drug Administration Amendments Act 
of 2007, which gave the agency significant new authorities and 
resources to address the safety of drugs. In this testimony, I 
will cover both of these important issues: import safety and 
the implementation of the drug safety authorities in what we 
call FDAAA.
    Globalization has created new risks and challenges for the 
safety of the drug supply. Where Americans once used drugs that 
were mostly manufactured domestically, now up to 40 percent of 
the drugs we take are imported, and up to 80 percent of the 
active pharmaceutical ingredients in these drugs are from 
foreign sources. This makes oversight significantly more 
difficult and leads to weaknesses through which counterfeit, 
adulterated and misbranded products can infiltrate the 
legitimate supply chain. That was the case with the 
contamination of heparin in 2007 and 2008 and most recently 
with the counterfeit Tamiflu discovered during the H1N1 
outbreak.
    When the modern FDA was created in 1938, imports were a 
tiny part of the products used in our country. Now that an 
estimated 20 million shipments of FDA-regulated imports come 
into this country ever year, FDA must adopt a new approach, one 
that addresses product safety by preventing problems at every 
point in the global supply chain from the raw ingredient 
through production and distribution all the way to U.S. 
consumers.
    In the food arena, this approach to prevention is embodied 
in legislation passed by this subcommittee and the full House 
of Representatives, which is now awaiting action in the Senate. 
In the area of drugs and other medical products, we are taking 
a number of steps to begin making this shift as best we can 
with our current authorities. But there is much more to be 
done.
    As Secretary of Health and Human Services Kathleen Sebelius 
noted when she appeared before this committee, FDA needs 
additional tools to move our oversight capabilities into the 
21st century. FDA needs to access regulatory information 
quickly, hold all parties responsible for the quality of 
products in the supply chain and have reasonable and reliable 
options for enforcement.
    I will now turn to the drug safety authorities in FDAAA, a 
milestone legislative achievement that has helped the agency 
protect the public health in many ways. FDAAA provided 
important new authorities to enhance our ability to monitor 
approved drugs after they are marketed and to take definitive 
action when needed. With our new authority, FDA has required 
drug sponsors to conduct around 200 post-marketing studies or 
trials. The agency has required safety-related labeling changes 
in individual or classes of drugs 32 times and has developed 
and put into place 10 evaluation and mitigation strategies with 
elements to support safe use into the REMS, all with the goal 
of better identifying and managing the risk of drugs on the 
U.S. market.
    To give you one example, FDA has established a program to 
support the safe use of a product, a medication in patients 
with a very severe bleeding disorder in which the blood does 
not clot because of low platelets. This medication, however, 
has serious side effects which include blood cancers, bone 
marrow fibrosis, a risk of blood clots, and even worse platelet 
counts when the therapy is stopped. However, it is an important 
treatment option for patients who have failed to respond to 
other therapies. By requiring elements to ensure safe use, the 
benefits of the drug can outweigh the risks and we can provide 
patients access to this critical product without being 
concerned that it would be used in other patients and could 
cause them more harm than good.
    I also want to know that FDAAA also reauthorized and 
amended the Best Pharmaceuticals for Children Act, which 
continues to provide valuable safety and dosing information for 
the use of drugs in children. As a pediatrician, I echo the 
comments of Congresswoman Eshoo, who worked so hard on this 
issue. This legislation represents a fundamental shift in 
prescribing for the pediatric population, even since the 
passage of the FDAAA legislation, 109 labeling changes related 
to the use of medications in children. It has been a tremendous 
step forward for pediatrics. We are very happy to discuss the 
lessons we have learned over the last 2 years in implementing 
FDAAA and work together to fine-tune the program.
    Over the last 7 decades, so much has changed in 
pharmaceutical science and drug regulation, yet in 2007, when 
scores of patients died from contamination of medications in 
Bangladesh, and in 2006 when children died in Panama, the 
culprit was familiar. It was diethylene glycol, the very same 
poison that had led to the passage of the Food, Drug and 
Cosmetic Act in 1938.
    FDA's work is far from done. The scientists, doctors, 
nurses, inspectors and other public health professionals, some 
of whom are here with me today, who make up FDA thank you for 
your support for our mission.
    I appreciate the opportunity to testify today and am happy 
to address any questions you may have.
    [The prepared statement of Dr. Sharfstein follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Pallone. Thank you, Dr. Sharfstein. I appreciate your 
testimony. It is good. We are just going to have questions, as 
you know, alternating between the Ds and the Rs, and I will 
start out.
    I mentioned in my opening statement that this committee 
worked very hard to pass the Food and Drug Administration 
Amendments Act of 2007. We call it FDAAA. And as part of FDAAA, 
Congress gave FDA the authority to require manufacturers to 
implement the so-called REMS, or Risk Evaluation Mitigation 
Strategies. They can require REMS when the agency believes it 
is necessary to ensure that a drug's benefits outweigh its 
risks. So I wanted to ask you initially, could you provide the 
committee with an update on how FDA has made use of this 
authority, how many REMS have been required and approved, and 
what has been the public health impact of REMS?
    Dr. Sharfstein. Sure. There are about 80 or 90 REMS that 
have been approved since the passage of the legislation. The 
vast majority of those are called medication guide only REMS 
where the REMS just consist of the fact that we have a 
medication guide for patients about the drug.
    There are about 10 REMS for 10 drugs that have what we call 
elements to assure safety. This is sort of the next level of 
control, and that can include restrictions on which pharmacies 
can provide the medication, whether the doctor needs special 
training and whether there needs to be a patient registry, and 
these have been used for medications for seizures, for the low 
platelets that we were talking about before, for medications 
for schizophrenia, and they really make it possible for FDA to 
approve the treatment because without this ability to put some 
restrictions and some safeguards in place, we would be very 
worried that these medications could do more harm than good. I 
think that this is very clearly a work in progress.
    There are certain things that in the implementation of this 
provision we have learned about. One of the issues is the 
differential treatment between generic medications and brand-
name medications when it comes to communication plans. We can 
require that companies that make brand-name drugs do 
communication plans for health care professionals but when it 
comes to generic drugs, the FDA would have to pay for and run 
the communication plan.
    So there are a few specific issues, and I am happy to talk 
about them more if you want, where we think that we could be 
more effective with REMS. One of the others is that we have the 
authority to require a REM but we don't necessarily have the 
authority to require a specific type of REM, so that leads to 
negotiations that can go on for a while between the company and 
FDA, and recently we did a REMS for certain medications that 
can stimulate the bone marrow that took, you know, over a year 
to develop.
    So I think that there are definitely areas where this could 
be improved but in general our view is that this is a 
tremendously important authority and we are really making a lot 
of progress with it.
    Mr. Pallone. Well, I want to use an example of a drug that 
came to my attention, and I heard you say you have the 
authority to require REMS but not a particular type, and I 
would like you to comment on that. But let me throw this 
example out and then I don't know if this relates to what you 
said about the type, and I would like you to answer that too so 
maybe give me a response to that, what you mean by type that 
you don't have the authority but also this example. I am using 
as an example that there are three types of fast-acting 
Fentanyls, I guess is the way, or rapid-onset opioids, on the 
market right now, and I think it is an example where REMS would 
be critically important because these are extremely powerful 
pain relievers or opioids intended to treat breakthrough pain 
in adult opioid-tolerant cancer patients but a dose in a non-
tolerant patient could be deadly. So it is my understanding 
that one of these products has a REMS with very different 
elements from the REMS that is required of the other two. For 
example, the REMS dictates that only especially trained, tested 
and registered health care professionals can actually prescribe 
the product and distribution and dispensing must be done 
through a specially trained and registered distributor and/or 
pharmacist. So explain why there would be differences between 
the elements of REMS for these three fast-acting Fentanyls, and 
does that relate back to what you said before about how you can 
only require the REMS but not different types?
    Dr. Sharfstein. It does relate back to that, and I don't 
think all of them have what we would call formal REMS. Some of 
them are sort of in the intermediate stage because they had a 
risk management program in place when the Act was passed. But I 
think for the purpose of your question, it definitely relates 
to what I was saying. The way the law works is, it says that we 
need to take steps to assure safe use, and the company comes to 
FDA with a proposal on how to accomplish that, and there may be 
more than one path to get to that goal. One company might say, 
you know, the path that we want to take is to really work 
through a series of just a couple pharmacies or a central 
pharmacy. Another might want to put particular restrictions on 
which physicians so that we have the responsibility of making 
sure that they work. We are not going to approve something that 
we don't think is going to hit the mark. But they won't 
necessarily all look exactly the same.
    In the case of the Fentanyl products, there is one that is 
for a film that does restrict the pharmacies, and there is 
another that is more of a lollipop that you put in the mouth 
and that one has an older risk management plan that we haven't 
announced the form REMS for.
    Mr. Pallone. Well, then, does this difference in authority 
make sense to you or would you like to have the power to 
dictate the type?
    Dr. Sharfstein. Well, I think it is very important for us 
to work with companies to come up with something that works 
and, you know, there is no question there is a lot we learn 
from the inner chains of companies and what we can hear from 
others, but I think that it is--when you find that it is taking 
a long time to come to agreement and when there may be a level 
of consistency that we would like to see if one approach really 
makes sense, I think that we would be very open to discussing 
ways that we could be able to more effectively move to closure 
on REMS in a way that makes sense for public health.
    Mr. Pallone. Well, my time has run out, but I have to say, 
this is kind of disconcerting to me, the fact that you don't 
have the ability to dictate the type and therefore we end up 
with these big differences, but I guess we will have to take it 
up at another time because I want to move to my ranking member, 
Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman. I am going to follow 
up on this line of questions also on the REMS.
    So I think the last question was, the time it takes in 
negotiations. We see that across the board in the federal 
government, and we always say that there should be a stop 
clock, a backstop that eventually there is a time when you have 
to make a decision. You let the folks negotiate but eventually 
you have got to get the closure. Would a backstop provision be 
helpful?
    Dr. Sharfstein. You know, some of the REMS that we are 
putting into place are coming at the time of approval, and 
there is a lot of incentive for the company to get its drug 
approved, and with REMS, the standard is, we wouldn't approve 
the drug without it. So----
    Mr. Shimkus. So they have an incentive to get an agreement?
    Dr. Sharfstein. Those are happening, but it is when the 
drug is already marketed----
    Mr. Shimkus. Well, let me go to the generic/brand name. You 
did allude in your opening testimony that there is a difference 
between your ability to effect, I thought I heard, negotiations 
between a generic and a brand name. Can you clarify that a 
little better?
    Dr. Sharfstein. Sure. That relates to this provision about 
communication plans, so one of the things that we can do is 
require a company to make certain communications to health care 
professionals.
    Mr. Shimkus. Why can't that be placed on the generic 
producer of the drug?
    Dr. Sharfstein. Someone is going to tap me on the shoulder 
if I get this wrong, but I think that the law doesn't allow us 
to do that for generics.
    Mr. Shimkus. So the issue would be a responsibility for us 
to address if we are going to move forward to help assist that. 
OK. Thanks.
    The other question I wanted to talk about was also alluded 
to in my opening statement, and in the FDA Week Inside 
Washington on January 22nd, on the second page it says, ``As 
FDA struggles with whether to relax conflict-of-interest 
policies that have made it difficult to fill slots in the 
pharmaceutical advisor panels,'' so you all, the FDA, is saying 
we have problems filling these slots. We have a tendency, the 
unforeseen consequences of legislation, and I think what we are 
seeing to some extent is these advisory panels because of which 
we can't fill. We pulled up from the Web site gastrointestinal 
drug advisory committee where there is five openings that you 
all identified. Our office has personal experience with someone 
who had a catastrophic death because of this. What do you tell 
us and is there anything we need to do ease legislatively? I 
mean, the response was to make sure there was no conflict of 
interest and people weren't benefiting from their advisory role 
while benefiting financially but we have got to be careful that 
we don't go overboard and that we lose all this expertise. You 
alluded to some of that in your opening statement. What can you 
tell us and what advice can you give us?
    Dr. Sharfstein. Sure. Well, this is an issue which clearly 
requires a balance and it is a balance that Congress faced in 
writing the law, it is a balance that the agency faces. On one 
hand, we clearly would prefer advisors who don't have conflicts 
of interest and it is really important for us to look for 
qualified advisors who don't have a conflict of interest. On 
the other hand, the agency needs to get the best advice in 
order to make the best decisions, and there are certain 
situations where the people who have the best advice and unique 
expertise are going to have conflicts of interest. We have got 
to somehow, you know, balance those two things, and I think the 
bill did a very good job and gives the agency some leeway to 
figure out how to do that, and within the scope of what the 
legislation has done, it gives us the ability to figure out the 
right spot, and I will be more specific. The legislation sets a 
cap on the number of waivers that we can have for advisory 
committees, and that cap goes down over time. I think it is 
somewhere in the ballpark of 13 percent. But we are right now 
well under that. I think we are granting waivers, like 4 to 5 
percent of the people who are on the advisory committees are 
getting waivers. So without changing the law, we have the 
ability if we think that it is important to get certain members 
to grant more waivers. If----
    Mr. Shimkus. Well, let me ask a question because my time is 
running. On this from the FDA Web site, you have quite a few 
vacancies listed there. Now, I don't know what to relate that 
to you because I didn't pull up the previous month or I didn't 
look at last year's. Is this excessive vacancies? I mean, we 
have got anywhere from 21 in one of the areas. Well, in fact, 
pharmaceutical science, there are 21 vacancies. Advisory 
committee reproductive health drugs, there are eight vacancies. 
There are nine in drug safety and risk management. That looks 
like there is a lot of vacancies, and if that is, then maybe we 
need to----
    Dr. Sharfstein. Right. Well, I don't like vacancies on the 
advisory committees. We definitely want to fill them. I 
actually asked the advisory committee dean whether they felt 
that there were more now, and they said that they have always 
had vacancies. They couldn't say that there are more now. 
Having said that, I think it is important for us to strike the 
right balance, and it is not a question for the statute because 
the statute gives us more room. If we feel the right decision 
is to grant people more waivers, we have got plenty of room 
under the statutory cap. It is really up to what the people at 
FDA want to do. I think the way Dr. Hamburg and I are looking 
at this is, there are situations where it is important for us 
to get the best advice from someone who requires a waiver. We 
need to take into account the type of conflict they may have, 
the type of decision that is being asked for and make a 
decision, but we understand that that will be necessary.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Thank you, Doctor.
    Mr. Pallone. Thank you.
    Chairman Dingell.
    Mr. Dingell. Thank you.
    Dr. Sharfstein, I want you to understand these are friendly 
questions. I want yes or no answers. You are familiar with the 
heparin crisis which caused 81 American deaths. Does FDA 
currently have the adequate resources, personnel authorities to 
prevent another heparin crisis?
    Dr. Sharfstein. No.
    Mr. Dingell. Do you have the ability to control the safety 
of imported pharmaceuticals?
    Dr. Sharfstein. Not to the extent we would like.
    Mr. Dingell. Do you have the authority and resources to 
address the safety of components now being imported into this 
country?
    Dr. Sharfstein. No, not to the extent we would like.
    Mr. Dingell. Do you have the authorities and resources to 
see to it that good manufacturing practices are properly 
observed overseas?
    Dr. Sharfstein. No, not to the extent we would like.
    Mr. Dingell. Would you please submit to the committee the 
number of people that you have at the different ports to assure 
the safety and the inspection of pharmaceuticals coming into 
this country, and also would you give us the number of people 
that you need to see to it that this is done? Please submit 
that for the record.
    Dr. Sharfstein. Sure.
    Mr. Dingell. Do you have adequate authority to keep out 
unsafe drug shipments at the border?
    Dr. Sharfstein. No.
    Mr. Dingell. Do you have authority to require manufacturers 
to assure the safety of their supply chain?
    Dr. Sharfstein. No.
    Mr. Dingell. Do you have the authority to see to it that 
good manufacturing practices are observed in this country in 
both food and drugs and abroad, yes or no?
    Dr. Sharfstein. Not to the extent we would like, no.
    Mr. Dingell. Does FDA have the authority to require 
mandatory drug recalls?
    Dr. Sharfstein. No.
    Mr. Dingell. Now, do you have authorities, or rather do you 
have cooperative management agreements or letters of 
cooperation between Food and Drug, the Department of Homeland 
Security and other agencies that have personnel at the points 
of entry?
    Dr. Sharfstein. We do work closely with other agencies at 
the point of entry.
    Mr. Dingell. Do you have the----
    Mr. Pallone. Mr. Dingell, excuse me. Can you speak more 
into the mic because I can barely hear you.
    Dr. Sharfstein. I am sorry about that.
    Mr. Pallone. That is all right.
    Mr. Dingell. Do you have adequate authority to require 
mandatory drug recall?
    Dr. Sharfstein. No.
    Mr. Dingell. Do you need that authority?
    Dr. Sharfstein. We would like that authority, yes.
    Mr. Dingell. Would you like it, or do you need it?
    Dr. Sharfstein. I would say we need it.
    Mr. Dingell. You have also the legislation down there in 
H.R. 759 which gives you additional authorities that was 
introduced by Mr. Pallone, Mr. Stupak, Ms. Sutton, Ms. DeGette 
and I. That would give you significant authorities to address 
your current lack of capability. Is that right?
    Dr. Sharfstein. That legislation has some very important 
elements, yes.
    Mr. Dingell. It would also give you the resources which you 
need of a financial character by enabling you to collect fees 
from both manufacturers of food and from pharmaceuticals. Is 
that right?
    Dr. Sharfstein. It does have that provision, yes.
    Mr. Dingell. And you can do that both at home and abroad. 
Is that right?
    Dr. Sharfstein. I believe so, yes.
    Mr. Dingell. And are those resources and those fees 
included in your budget submissions to the Congress that the 
Administration has submitted?
    Dr. Sharfstein. I don't believe so.
    Mr. Dingell. You don't? I understood they were.
    Dr. Sharfstein. I am sorry. For food, it is, yes.
    Mr. Dingell. For food?
    Dr. Sharfstein. Yes, for food.
    Mr. Dingell. How about pharmaceuticals?
    Dr. Sharfstein. I don't believe so, no.
    Mr. Dingell. But that is built into your budget with regard 
to food?
    Dr. Sharfstein. Correct.
    Mr. Dingell. Now, it is a curious situation that I have 
observed that you were in the awkward place at Food and Drug of 
having somebody being able to bring unsafe foods into the 
United States and you can't catch them at the point of entry. 
But you also have the problem if you do catch them, you don't 
have authority to seize, impound or to destroy. Is that right?
    Dr. Sharfstein. Yes.
    Mr. Dingell. So you send them back out. That is right?
    Dr. Sharfstein. I believe so. Often that is what happens.
    Mr. Dingell. And they then bring them back in. Is that 
right? Through another port of entry.
    Dr. Sharfstein. I think they can try, yes.
    Mr. Dingell. Do you have that same problem with regard to 
pharmaceuticals?
    Dr. Sharfstein. Yes.
    Mr. Dingell. So that problem exists in both places. Now, 
you have problems with unsafe commodities being brought in, 
foods and pharmaceuticals, and you also have some that are 
overaged, improperly stored, contaminated, filthy, improperly 
packaged, counterfeit, and you also have some that are full of 
inert substances. You mentioned talcum powder and things like 
that coming in. Do you have authority to deal with those?
    Dr. Sharfstein. We have some authorities but not enough.
    Mr. Dingell. Do you have enough?
    Dr. Sharfstein. We don't have enough.
    Mr. Dingell. As proven by heparin.
    Dr. Sharfstein. Yes.
    Mr. Dingell. And of course, you have coming into this 
country from China on a fairly regular basis, from Mexico and 
other places, unsafe foods and pharmaceuticals and I can recall 
mushrooms, I can recall berries, I can recall tomatoes and 
jalapeno peppers. I can recall the heparin scare and a large 
number of others. This an ongoing and continuing problem, is it 
not?
    Dr. Sharfstein. Absolutely.
    Mr. Dingell. And you lack the Congressional support in both 
authority and money to do the job that you need to do to 
protect the American people. Isn't that right?
    Dr. Sharfstein. Well, we very much want to do more.
    Mr. Dingell. I don't want you to be afraid to say that we 
haven't given you the authority you need----
    Dr. Sharfstein. We want more authority.
    Mr. Dingell [continuing]. If it is the truth because we are 
going to try and get it for you.
    Mr. Chairman, I thank you for your courtesy.
    Mr. Pallone. Thank you, Mr. Dingell.
    The gentleman from Pennsylvania, Mr. Pitts.
    Mr. Pitts. Thank you, Mr. Chairman. Going back to this 
concern for counterfeit drugs, there is a growing global threat 
from counterfeit medicines. For example, in 2008, counterfeit 
medicine article seizures rose 118 percent in the European 
Union, and 8.9 million counterfeit medicine articles were 
seized by E.U. customs officials. Over just a 2-month period in 
2008, the European Commission seized 34 million counterfeit 
pills including antibiotics, cancer, cholesterol and 
antimalaria medicines. Does this staggering increase in 
counterfeiting in places like the E.U. present concerns to the 
United States, and can you quantify it for us?
    Dr. Sharfstein. It definitely does present concerns, and I 
think, you know, the problems with counterfeit products, first 
of all, they can be dangerous in and of themselves, but second 
of all, they can fail to treat the condition that the patient 
has and the patient can get much sicker if they are taking 
medicines that are ineffective or subpotent. So it presents a 
serious problem and I think the problems that we see globally 
are very much a potential threat to the United States.
    In terms of quantifying, I can't unfortunately quantify how 
many counterfeits are in the United States. We do that reports 
that we have been investigating have gone up over the last 2 
years so that our investigators at FDA are hearing about this 
problem more, but we do think that in general we do not have a 
huge problem with counterfeit in part because we have a 
closed--a generally closed system. When pharmacies order 
medications, they can get them through licensed wholesalers, 
they can get them from licensed manufacturers, but we know that 
there are ways for other products to enter the legitimate 
supply chain and that makes us concerned. You may remember in 
2003 there were several million, I think, pills of Lipitor that 
were counterfeit that got into pharmacies, and there are other 
problems too. Recently we had a situation where a truck full of 
insulin was stolen and then the insulin started showing up 
later, and we didn't know whether the insulin had been 
adequately refrigerated and it had sort of reentered the supply 
chain in a way that could potentially have been quite dangerous 
to patients. So there is no question that the problems seen 
around the world are of concern to us and we think that we do 
need additional work here to really secure the supply chain in 
the United States against this potential threat.
    Mr. Pitts. When the U.S. authorities interdict counterfeit 
drugs here in the United States, what occurs? What is done with 
those drugs?
    Dr. Sharfstein. When we actually find the drugs and we know 
that they are counterfeit? I am not sure, but I think they are 
destroyed. If we identify products that are, you know, in the 
supply chain that are counterfeit, I can double check, but I 
think they get destroyed.
    Mr. Pitts. Where are the major gaps, in your opinion, as 
far as interdiction of counterfeit drugs here in the United 
States?
    Dr. Sharfstein. The major gap is that we don't require a 
pedigree for the product to go all the way from the 
manufacturer to the final sale. If people are ordering from the 
right places, they can get medicines that are safe and not 
counterfeit. There are opportunities for counterfeit products 
to potentially get in without a clear requirement where we are 
holding each person in the chain responsible for making sure 
that they only have legitimate products. So the kind of 
provisions that we would like to see are that each person in 
the supply chain as it goes from the manufacturer to the 
wholesaler, they are responsible. If they let something in that 
is not legitimate, then there is a real penalty for that and 
every single person in the supply chain, every single company 
is responsible for making sure those products are legitimate, 
and that would require a new authority.
    Mr. Pitts. Do you have a regular system or procedure for 
testing drugs that are coming in the United States that you 
pursue?
    Dr. Sharfstein. We do do some tests. We do some targeted 
sampling based on where we think the risk is but it is really 
only a small part of the solution, the testing. There is no way 
we could test our way out of the problem just because of the 
sheer volume of imports.
    Mr. Pitts. What is the greatest need that you have as an 
agency as far as addressing this problem?
    Dr. Sharfstein. I think the greatest need is the ability to 
enforce the supply chain requirements across the supply chain. 
You know, we have been working on and are about to come out 
with a process for unique numbers for each kind of bottle of 
pills but we don't have the authority to say you are 
responsible for making sure that every person when they get the 
medication that it is legitimate medication. That is what we 
would like.
    Mr. Pitts. Thank you, Mr. Chairman.
    Mr. Shimkus. Would the gentleman yield for one second?
    Mr. Pitts. I will yield.
    Mr. Shimkus. But that discussion was all about the legal 
distribution chain. You haven't even addressed the illegal Web 
sites and the illegal mail order sites that if some senior goes 
on a Web site, clicks on 90-day supply of Lipitor and it gets 
mailed to them, there is no way. We don't know. Is that 
correct? I mean, that was a good discussion about legal 
process, of all the good actors. I think the concern that most 
of us have is the bad actors.
    Dr. Sharfstein. We have brought some cases recently against 
bad actors and legitimate chain and the ability of products to 
infiltrate the legitimate supply chain is something that we 
need to be very vigilant about, but you are right. You are 
raising a separate issue that is very important and I think 
this gets a little bit to the issue that Congressman Buyer and 
Congressman Matheson were raising about destruction authority 
and other things, and that is also an issue that we care about.
    Mr. Shimkus. Yes, and I only bring it up because there is 
really--I agree with your statements but I think for both of us 
it is that other issue that has us more concerned than 
anything.
    I appreciate the gentleman yielding.
    Mr. Pitts. Thank you, Mr. Chairman. I yield back.
    Mr. Pallone. Thank you.
    The gentlewoman from the Virgin Islands, Mrs. Christensen.
    Mrs. Christensen. Thank you, Mr. Chairman, and thank you 
for holding this hearing, and welcome back, Dr. Sharfstein.
    First of all, I can attest to the fact to the answer to 
Chairman Dingell's question about collaboration with other 
agencies because Customs and Border Protection acts on behalf 
of FDA at the Puerto Rico transit station--and your staff knows 
where I am going, I can see them nodding--to confiscate 
medication going to and from the Virgin Islands, but I am not 
sure if you are aware of this problem but I have to bring it 
up, and your staff is aware of it. We are outside of the U.S. 
customs zone. We are fully part of the United States. We are 
outside of the U.S. customs zone. All of our pharmacists are 
U.S. trained, and while they are locally licensed, they have 
their U.S. DEA license and are governed like the Virgin Islands 
are in general by all the U.S. laws and they are governed by 
all FDA rules and regulations. They order their medication 
including my hospital pharmacies, which are also overseen by 
JCAHO and CMS. They order their medication from distributors in 
the States. These are either U.S.-made medication or something 
that FDA has approved for importation into the United States. 
They cannot send it back to their distributor. They are 
prohibited because we are outside of the customs zone from 
sending it back to their distributor if they are oversupplied, 
if they are damaged, if they are expired. It is an extreme 
burden on my pharmacies. My hospital pharmacies were cited by 
one of the certifying agencies for having too many expired 
drugs in the pharmacy.
    If we could craft some narrow language, and we have tried, 
that would just allow our pharmacies to send their medication 
back to the place that they brought it from, would you be 
willing to take a look at that?
    Dr. Sharfstein. Absolutely, and I do recall your raising 
this issue before and I know that there are people at FDA who 
have been actually in touch with entities in the Virgin Islands 
to work on this.
    Mrs. Christensen. Yes, we have had some conference calls.
    Dr. Sharfstein. So I am extremely sympathetic to the 
situation that they were in and I think we would like to find a 
solution.
    Mrs. Christensen. I appreciate that. And the other question 
is about importation. Well, I don't consider ours importation 
or reimportation of drugs because they are U.S.-made drugs, 
U.S. pharmacies, it is U.S. jurisdiction. But Congress and FDA 
acknowledge that there have been numerous safety issues related 
to drug importation, and I voted against it when I had the 
opportunity. One of the issues I am concerned about from a 
safety perspective is the importation of products subject to 
the REMS requirements that have been discussed in other ways 
here today. Does the FDA support this posture that they can be 
reimported subject to the REMS requirements, and how does FDA 
view the reimportation safety concerns as they relate to the 
REMS process? And would FDA ever under any circumstances 
consider an exemption of certain drugs under reimportation 
policy if it would lead to the obfuscation of the REMS 
requirements? Is that clear?
    Dr. Sharfstein. I think I understand. You know, the 
Administration supports finding a safe and effective way for 
patients to obtain medications from other countries but it is a 
challenge because there are a lot of safety concerns, and 
certainly one of the safety concerns that would have to be 
overcome is trying to figure out what to do with the products 
that have a narrow therapeutic window. Another way of saying 
that, where you are worried that they could actually do more 
harm than good where you have a REMS in place or other 
medicines where it depends on how they are used, and that very 
much would be an issue for us, I think, and we would not want 
people to get medications without the kind of controls that are 
needed to ensure their safe use.
    Mrs. Christensen. Is there something that we need to do to, 
or is there something the improvements that need to be made or 
becoming more assured of the safety and use of the REMS 
process? Is there something that we need to do? Is there 
something that FDA can do administratively?
    Dr. Sharfstein. I don't think there is an issue before 
Congress on this point right now, but if there is, we can be in 
touch. But I think the premise of your question that there are 
certain drugs we have to be very careful about, that does 
underlie FDAAA and that is something that FDA feels very 
strongly about.
    Mrs. Christensen. Thank you.
    Thank you, Mr. Chairman.
    Mr. Pallone. Mr. Burgess.
    Dr. Burgess. Thank you, Mr. Chairman, and again, Dr. 
Sharfstein, thank you for being with us and staying with us 
late this afternoon.
    On the issue of resources, we have heard I don't know how 
many times in this committee and the Subcommittee on Oversight 
and Investigations about inadequate resourcing of the agency 
and that the resources haven't kept pace with the increase in 
demands placed on the FDA, the fact that now you are having to 
really function as almost a global agency with budgets that 10 
years ago seemed adequate but now you seem significantly 
underfunded. It always happens. In fact, I was on this 
committee for several years before I realized that the funding 
actually comes from the USDA appropriations bill, not through 
HHS. That funding structure something that you all have to deal 
with but should we consider some way modernizing how Congress 
funds the FDA?
    Dr. Sharfstein. You know, I think over the last few years 
FDA has gotten a tremendous amount of new resources and the 
subcommittees, both of which I testified at last year, were 
extremely supportive of the agency, and the agency really has 
been using those resources to develop a real foundation for the 
future on these issues. I think that it is not just resources 
that are an issue when it comes to an issue like safe drugs and 
imported safe drugs. We need to be able to secure the supply 
chain, hold people in the supply chain accountable, set good 
standards----
    Dr. Burgess. I don't mean to interrupt you, but I will run 
out of time here.
    Mr. Chairman, if you will just make note that the witness 
testified that they have all the money they need and Congress 
does not need to supply any more.
    But it begs the next question, and I know it is a drug 
safety hearing, but you must get a tremendous volume of new 
drug applications. Is that correct?
    Dr. Sharfstein. I think that there is a tremendous amount 
of work when it comes to the new drug applications and 
additional indications for existing drugs, so there are a lot 
of different types of applications that the agency has to 
handle, yes.
    Dr. Burgess. Do you have any idea as to the magnitude of 
the backlog?
    Dr. Sharfstein. Well, there is not really a backlog when it 
comes to the new drug applications. We are on a clock and we do 
our best to hit the goals of reviewed timetables. When it comes 
to generic drugs, there is a backlog. It is a different type of 
review process, a different type of application, and there are 
several thousand applications that are kind of in the queue to 
be approved.
    Dr. Burgess. Well, for example, we got funding for the 
National Institute of Health in the stimulus bill, a 
significant amount of money, and the idea was, of course, to 
generate new research and new discoveries. Do you have what you 
need to keep pace with the rapidity of those new discoveries 
and new developments?
    Dr. Sharfstein. That is an excellent question, and slightly 
different than just reviewing the applications. I think that 
FDA, and Dr. Hamburg has been very engaged on this issue. We 
feel that the agency needs to do a lot more to be able to 
review the products of the 21st century, and that involves 
updating and upgrading our scientific standards for review and 
it involves a lot of needed investments, not just by the 
government but by academia and others, in what we call 
regulatory science, which is the science of how you know 
whether something is safe and effective. For example, we want 
to be able to identify a safety problem very quickly in the lab 
and not have a company spend all this time and money in 
development and then find the safety problem; let us identify 
that quickly. If there is a way on the effectiveness side to 
find a marker that a drug will be effective without having to 
require a tremendous and long amount of time before we show 
that it works, that is just an enormous benefit to the drug 
development process, and that is separate from the review of 
any one application but that area of regulatory science and 
those kinds of investments are extremely important. The 
President's budget for the first time has an initiative on that 
but over the course of the future this is where we think that 
there needs to be a lot more done.
    Dr. Burgess. Well, just as a case in point, a real-world 
example, yesterday the Alzheimer's association was on the Hill 
visiting every office asking for a significant plus-up in 
funding for Alzheimer's research, a noble goal, a worthwhile 
goal. This comes on top of the reauthorization we did at NIH 
back in 2006, level funding of $30 billion a year to increase 5 
percent a year. I don't know that we have ever met those goals. 
But then the $10 billion in addition to the authorized amount 
that we gave in the stimulus bill, now we are asking at least 
in the Alzheimer's legislation that Mr. Markey has, another $2 
billion to put forward to the research for new Alzheimer's 
drugs. Can you guys keep up with that if you have that kind of 
push in the pipeline for new products coming down?
    Dr. Sharfstein. I will tell you the analogy that Dr. 
Hamburg uses when she talks about is of a rower with one very 
muscular arm and one kind of scrawny arm, and if we are pouring 
a lot into basic medical research but we don't have the science 
to decide whether the products are safe and effective, then you 
don't get a system that moves forward. It kind of goes in 
circles. You don't see the treatment----
    Dr. Burgess. And are you aligning yourself to that, to 
making a more muscular----
    Dr. Sharfstein. Yes. And in fact, a few weeks ago, 
Secretary of Health Kathleen Sebelius went out to NIH with Dr. 
Collins and Dr. Hamburg and we announced a whole set of 
collaborations with NIH to bridge the gap so that it is not 
that money goes to NIH and then here is FDA on the other side 
but that we are going to have in addition to a public meeting 
and open docket for suggestions on how we can work together, we 
can have a council that is going to meet and oversee a whole 
new range of collaborations, and for the first time both 
agencies are putting in money to fund this kind of research in 
academia around regulatory science.
    Dr. Burgess. But at the present time, to the extent that 
those new discoveries are arriving on your doorstep, there is 
no backlog? Those applications are receiving timely review 
and----
    Dr. Sharfstein. It is not a question of the timeliness of 
the review, it is the tools we have. We would like to upgrade 
the tools we have for the new types of products.
    Dr. Burgess. Are all those applications online? Is that all 
in an electronic database?
    Dr. Sharfstein. We are moving towards full electronic 
submission but the problem is----
    Dr. Burgess. So the applications are paper applications?
    Dr. Sharfstein. In some cases, but I think we are moving 
pretty quickly to electronic, but I think the issue is----
    Dr. Burgess. But, you know, here, and I will just give you 
a real-world example. If this were a class-action lawsuit, for 
example, a big law firm, any of the big law firms downtown or 
in downtown Dallas would hire the people to digitize that data 
and then have it done within a couple of months' time in order 
to make their case either pro or con in the legal action. This 
is something that is done all the time but outside 
organizations. The FDA should be the leader on this.
    Dr. Sharfstein. There is no question that we need to have 
electronic data submissions, and we want to do it in a way that 
the data comes in so that it can be analyzed very efficiently. 
The challenge is, it is not so much the review of the 
application that comes in, it is that we don't get the 
applications, products don't make it all the way to the point 
where they have enough evidence to get to FDA's doorstep. That 
is the kind of gulf we are trying to cross by working with the 
NIH, that they do the research, they go, oh, maybe this product 
works. Then how do you get it from there to the point where you 
can do clinical trials? I mean, how do you--what is the right 
kind of clinical trial to do, what is the right tool to know, 
how do you get the companies in, ready to invest.
    Dr. Burgess. And after companies have made that investment 
and they come to you for the approval, that is the part of the 
chain that I am worried about, that you have the tools you need 
to be able to get these things to the people who so desperately 
need them.
    Dr. Sharfstein. I agree with that completely, and we also 
want more drugs to come to our doorstep than are coming now, 
more applications. We would like to see that happen because 
there are a lot of people who have diseases that need medicine.
    Dr. Burgess. I don't know what time frame would be the 
correct unit, but how many new drug applications per month or 
quarter or fiscal year?
    Dr. Sharfstein. I think it is a ballpark of about 25 new, 
completely new drugs getting approved by the FDA roughly every 
year.
    Dr. Burgess. How many applications, though, how many new 
drug applications that seek approval will you get a year? So 25 
make it through the----
    Dr. Sharfstein. This is Dr. Woodcock from FDA. About 30 to 
35. You know, that is my point about we would like to see more. 
But to do that, we have to help the discoveries bridge the way 
to the point of FDA application.
    Dr. Burgess. Interestingly, Dr. Zerhouni at NIH 8 years ago 
told me that they were working on, I think it was no fewer than 
88 drugs to deal with obesity. With that kind of pressure in 
the research pipeline, you guys are going to have to be really 
precise and efficient to be able to handle that kind of 
research coming in your direction.
    Dr. Sharfstein. I think that is true. What we want to do is 
help NIH as it is investing in those 88 or however many it is 
products, pursue that investment so it is pushing the products 
closer to an FDA application rather than, you know, being all 
these different steps to get there. And so that is one of the 
things we are going to work with them on. If NIH is going to 
pay for a trial, what is the right way to design that so that 
we get really good usable data for an application. So it is not 
so much once the application comes in, we need better tools to 
review them, but it is how you get more applications of 
promising therapies. That is what Dr. Hamburg is extremely 
committed to and why we are doing this big product with NIH.
    Mr. Pallone. Dr. Burgess, we are actually going to have a 
second round, so I just want you to know.
    Mr. Braley.
    Mr. Braley. Thank you.
    Dr. Sharfstein, I want to start with a word that we hear 
still today frequently called mail order drugs, and in this 
Internet age, isn't that somewhat of an oxymoron? There is a 
very specific reason I am asking you this question. We heard 
our colleague Dr. Gingrey spend his time that he had in his 
opening instead of talking about drug safety blasting the 
health care legislation we are considering right now. But when 
you have 47 million Americans without access to health 
insurance and a lot of people losing their jobs with employer-
based health care coverage and you have got people who are in 
prescription drugs who suddenly have no means because they 
can't afford to pay their COBRA payments without a job who go 
online like many of us and surf for some answer to their 
medication needs. There are endless Web sites out there of 
predatory companies looking to see what may or may not be an 
actual pharmaceutical to somebody desperate for treatment. 
Would you agree with that?
    Dr. Sharfstein. I think it is a recipe for tragedy.
    Mr. Braley. And we all know that the problem is, your 
agency has limited resources you are dealing with. Research 
applications, you are dealing with enforcement issues overseas, 
you are dealing with enforcement and compliance in domestic 
manufacturers. So I guess my question is, if we do nothing to 
improve access and affordability for prescription drugs, aren't 
we just inviting chaos as consumers look to these disreputable 
online companies, and I am not lumping all online companies 
into that category but there are plenty of them out there. 
Aren't desperate people going to resort to desperate measures 
to try to solve their health care needs?
    Dr. Sharfstein. I think there is no question that health 
care reform that gets more Americans access to prescription 
drug coverage is extraordinarily important for avoiding the 
kinds of problems we are talking about.
    Mr. Braley. Thank you. One of the things that I wanted to 
talk to you about was your remarks about the Sentinel 
Initiative because I am interested in learning more about that, 
what it was based upon, what model it was based upon and how it 
is going to achieve the objective of a national integrated 
electronic system for monitoring medical product safety. And 
Dr. Christensen mentioned JCAHO, which is looked to by many 
people as a forerunner in setting up a Sentinel Event Reporting 
System with root cause analysis and an integrated approach to 
trying to get to the bottom of patient safety issues. In its 
first 10 years of existence, the Sentinel Event Reporting 
System averaged annually 300 reports, which is an abysmal 
statistic given the high number of medical errors that occur in 
this country every year. So tell me how this Sentinel 
Initiative that FDA is pursuing is going to achieve the 
objective and the access data goals that you have identified 
and truly reach a comprehensive reporting system that is going 
to get to the heart of patient and drug safety?
    Dr. Sharfstein. Sure. I appreciate the question. What we 
are doing and the sentinel system at JCAHO are very, very 
different. They have the same word but they are very, very 
different. They are, I think what you are describing is sort of 
a reporting system where people actually have to report. That 
is not what the FDA's sentinel system is based on. The concept 
is that there are data resources out there, generally large, 
integrated health systems, where you have data for millions of 
Americans who are taking medications and that we can use that 
information in a way that is completely protective of their 
confidentiality. In fact, the data we are looking at doesn't 
come to the federal government, it is done by the systems 
themselves. They look into their system to answer key questions 
about drug safety and over time we put into place a system to 
look in advance. In other words, if we have a concern that a 
particular product might cause a problem, we can program it so 
that if we see that when patients are getting it, it 
automatically lets us know. That is the long-term goal. So----
    Mr. Braley. Let me just interrupt you briefly to add 
another component to this, because my time is running out. 
There has been a big push not only in the American Recovery and 
Reinvestment Act that we passed earlier in 2009 but also in 
this health care bill that we have been talking about to move 
aggressively toward electronic medical records, which we all 
know is one way to try to deal with drug interactions and to 
dramatically reduce the number of drug errors. So is that 
another reason why getting it right on EMR is so important in 
addressing some of the goals of this Sentinel Initiative?
    Dr. Sharfstein. Absolutely. If we have more patients with 
effective medical records and we are working with the Office of 
the National Coordinator to make sure the standards on those 
records are good for this kind of work, then we will be able to 
tap into more Americans' experiences with medications to 
identify whether there are legitimate safety issues that we 
have to respond to. So where we are now if that we are working 
with certain health care systems that have data and we are 
setting up basic standards so that they will be able to respond 
to inquiries. It is a system where we don't need anyone to 
volunteer anything. Once we have a question, they go out and 
they just program their data set and they tell us whether they 
are seeing that, and it is a network so it is not just one big 
database. It is, you know, we are going to go up to New England 
and there is a data set there, there is a data set in 
California, and we are going to be able to look in a much 
quicker way than we can do to see if there are safety signals 
emerging. And there has been a lot of work done at FDA. We are 
constantly reviewing how this is going to make sure we are 
keeping it on track. It is a very ambitious project but there 
has been a tremendous amount of leadership at the agency on it 
and we are very appreciative of the support we have gotten.
    Mr. Braley. Thank you. I will yield back, and I would just 
encourage you to keep us informed on the progress you are 
making in the rollout of that system.
    Dr. Sharfstein. Sure.
    Mr. Pallone. Thank you.
    The gentleman from Kentucky, Mr. Whitfield.
    Mr. Whitfield. Thank you very much.
    I have a relatively simple question. As you continue to 
work and develop the REMS program, and I had mentioned in my 
opening statement about NASPER, the national prescription drug 
monitoring system. I was curious, have you yourself worked or 
your agency worked very much with the DEA or SAMHSA in 
implementing this national prescription drug monitoring system?
    Dr. Sharfstein. It is an excellent question, and that 
system is primarily dedicated to the schedule drugs, and we 
have been having some public meetings about how to ensure the 
safe use of certain schedule drugs that have very important 
medical uses. They are long-acting opiate medicines. You know, 
our reach in the REMS program goes really to the manufacturers 
and what they can do, but we are very aware that there are 
other key players and we have been in discussions with DEA and 
others to try to figure out what the right balance is. We 
clearly know that patients benefit from pain relief and it is 
extremely important. On the other hand, we don't like to see 
the fact that patients can die of unnecessary overdoses or 
there can be diversion. So it is a combination, and we have 
some tools to put on the table to help with this balance and we 
are very aware that the other agencies do and the prescription 
drug monitoring program is very much part of the discussion.
    Mr. Whitfield. Well, I appreciate that, and of course, REMS 
is designed to minimize risk for patients and certainly that is 
the same goal of NASPER as well to give the health care 
providers more information. So I hope that you all will keep 
that in your minds as we move forward on trying to obtain 
adequate funding to fully implement NASPER.
    Dr. Sharfstein. Thank you. That is an excellent point.
    Mr. Pallone. Dr. Sharfstein, you describe in your testimony 
the importance of moving from a reactive approach to drug 
safety problems to one that prevents such problems from 
occurring in the first place. Obviously prevention is what we 
are all about in every aspect of health care. As you know, the 
committee worked very closely with the FDA to develop and pass 
the Food Safety Enhancement Act this past summer. We are now 
waiting and waiting for the Senate to pass its version, which 
we hope will be very similar to our bill. I understand they did 
pass a bill out of committee. In my view, one of the most 
critical components of the food safety legislation was giving 
the food industry more responsibility to ensure the safety of 
their foods and giving FDA more authority to ensure the 
preventive safety controls are in place, and you mentioned this 
provision in your testimony and stated that FDA is taking steps 
to begin making this kind of shift within your current 
authorities. And what I am trying to understand is whether your 
current authorities are adequate to accomplish this.
    The Food and Drug Administration Globalization Act of 2009, 
that is the bill that was developed by Mr. Dingell, myself, Mr. 
Stupak and others, and that contains a similar provision to 
that in the food safety bill. Specifically, section 204 of that 
bill would require drug companies to develop and implement a 
quality risk management plan to incorporate risk identification 
and control into the production processes. The plan would, for 
example, require the company to assess the competence of 
potential suppliers of raw materials or ingredients. It would 
also require the company to conduct periodic onsite audits and 
carefully monitor the safety of drug ingredients, and this plan 
would be available for FDA review during inspections. So what I 
am trying to find out is whether you think this approach is 
workable and necessary for drugs as we did for foods, and would 
it help FDA's efforts to shift to a more preventative-based 
drug safety system if the agency had that kind of enforceable 
authority?
    Dr. Sharfstein. Thank you. It is a great question, and it 
is in fact true that the same principle that underlies the food 
safety bill and a lot of the authorities that is needed in the 
medical product arena also. We do think that new authorities 
are going to be necessary for FDA to have confidence in the 
preventive-oriented approach. Right now, FDA inspectors are at 
the border under a legal standard that we can hold something if 
there is an appearance of adulteration, but we can't require, 
we don't have access, because we can't require people to have 
current registration for, you know, just those facilities that 
they are making. We can't require them to present information 
about their products meeting key safety standards like having a 
preventive plan in place. And so we are not operating under a 
paradigm that is really focused on prevention, and we would 
like to make that shift and there are definitely elements in 
the bill that would accomplish that.
    Mr. Pallone. I appreciate that. When we did this 
Globalization Act, we had the four areas you mentioned, medical 
devices, there is also cosmetics, and of course ultimately we 
would like to develop legislation or pass legislation for all 
four, but we separated out the food safety because we were 
making more progress and we felt that that was the most likely 
that we could move. But now we want to move to certainly deal 
with the drugs and ultimately with the others as well. So I 
just ask that you--you know, I know that you provided a lot of 
help to us as we developed the food safety legislation. We 
would like to have the same cooperation and help as we move 
towards drug safety and the others.
    Dr. Sharfstein. Well, we really appreciate the 
subcommittee's leadership in this area.
    Mr. Pallone. Thank you.
    Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman.
    This is a good line of questions and debate and 
instruction, so I am glad we are going down this route. I want 
to go back. We were involved with the legislation that is 
pending over on the Senate side now and so it is a template for 
where we want to move but we need to get some clarification. 
Does the FDA have tools at its disposal to have a company take 
its drug off the market? Do you have the tools right now?
    Dr. Sharfstein. There are mechanisms for FDA to have 
drugs--you mean if a drug is unsafe?
    Mr. Shimkus. Right.
    Dr. Sharfstein. Yes, there is a process for that.
    Mr. Shimkus. So we do have the tools?
    Dr. Sharfstein. If there a safety problem with the medicine 
so it is no longer safe and effective, yes, there is a process 
for that.
    Mr. Shimkus. And so in the past years you have asked drug 
companies to take drugs that are identified as being bad off 
the market, have you not?
    Dr. Sharfstein. Yes.
    Mr. Shimkus. Has any company ever refused to do so?
    Dr. Sharfstein. I have to go back, but not that I know of.
    Mr. Shimkus. There has been----
    Dr. Sharfstein. I shouldn't say not that I know of. I think 
we would have to get back to you because there may be some 
examples of that. But I think that you have to distinguish 
between--there are two things. One is the products and the 
other is the manufacturing, whether there are manufacturing 
issues that could come up as well.
    Mr. Shimkus. A follow-on question, because we really want 
to drill down because we know you have got the ability to do--
we just don't want you to say boom, here is all this new stuff 
if there are things that are doing successfully now. We don't 
want to create multiple additional new levels of bureaucracy, 
we want to build on what is working now. And so that is why we 
want to be very specific with our questions.
    Dr. Sharfstein. Sure. The one thing I would say is that it 
is important that, you know, there may a process to accomplish 
something but if that process is so burdensome and time 
consuming, it may not be fully protective of public health. So 
as we get back on these things to provide technical assistance, 
it may be that, yes, there is a process but we would like a 
better process, a simpler process that can be more effective.
    Mr. Shimkus. In your response to Chairman Dingell, you 
stated that you needed additional authority to require 
manufacturers to implement quality risk management plans. And 
the follow-up question is, do you actually need this authority 
or is that something you can do now? Could you just incorporate 
this into your good manufacturing practice regulations?
    Dr. Sharfstein. We feel like we would need the authority.
    Mr. Shimkus. I think we need to talk more.
    Dr. Sharfstein. I am always happy to talk more, but I think 
that we----
    Mr. Shimkus. That is the whole thing. When we move 
legislation, we are going to get more specific. You can help 
educate us and we are going to be getting you all the resources 
you need.
    Dr. Sharfstein. They are very different, and it is similar 
to the food safety language, because even though there are food 
GMPs that we get authority that the food safety to set 
preventive standards.
    Mr. Shimkus. But having been in the room on that, we struck 
a good balance, that we didn't go overboard and that we brought 
industry at the table so that we didn't duplicate things.
    Dr. Sharfstein. I agree.
    Mr. Shimkus. And that is where we want to be very, very--
because we want to be helpful. We don't want to be harmful. We 
don't want to create such--and we talked about this gap. You 
talked about really this gap from NIH to FDA, and you know what 
ties the companies over to continue to develop these new drugs, 
and that is the certainty that if they are successful, they 
have a patent and they have a return on that investment. And of 
course, we are always attacking that patent. We do want to 
attack--I have always been in the position that when they game 
the system and extend that, but I have always supported these 
folks who are taking the risk all these years, that gap, the 
only thing that keeps them going is that assurance that there 
is going to be a return on that investment based upon at least 
some period of time where they have exclusive rights to sell 
that drug. Isn't that correct?
    Dr. Sharfstein. I think it is very important that companies 
have some protection.
    Mr. Shimkus. And I am going to end on this as far as my 
line. I do appreciate this. As we move forward, I have great 
respect for the chairman of this committee. There are times 
that we have agreed and we worked well together and there are 
times when we fought and we still are friends. And so I look 
forward to both times as we move forward.
    But I also want to be careful, and I am also on the high-
tech committee here and I understand the benefits of digital 
records, and we are always going to fall into this concern on 
privacy and the collection of data, and it is a tough balance. 
So when we hear words about collecting data, information on 
personal records that help us do something, I think that is 
going to be easier said than done.
    Dr. Sharfstein. Right. And just to be clear, what I was 
talking about, the sentinel system, there is no personal data 
at all that comes to FDA. It is done by the health systems 
themselves, the studies.
    Mr. Shimkus. I am just telling you, most data breaches are 
people stealing data and----
    Dr. Sharfstein. It is a very serious issue----
    Mr. Shimkus [continuing]. Selling it with flash drives and 
stuff, so thank you, Mr. Chairman.
    Mr. Pallone. Thank you.
    The gentleman from Texas, Mr. Burgess.
    Dr. Burgess. Thank you, Mr. Chairman. This is a good 
hearing and a good discussion. I hope we actually have an 
opportunity to have a similar discussion regarding medical 
devices at some point in the future because they deserve no 
less of our scrutiny.
    Dr. Sharfstein, I wasn't in the room when Mr. Dingell was 
asking questions, but some of them have been sort of 
reintroduced now by Mr. Shimkus. On the border authority--we 
all remember the story of the tomatoes a couple years ago and 
the unfortunate discovery at 5:00 on a Friday afternoon that it 
was Mexican peppers that were causing salmonella outbreaks that 
had riveted the news shows for the whole summer, but the FDA 
lacked the authority to actually stop the importation at that 
point. Have you identified the authority that you need there to 
keep this occurrence from happening in the future? Are there 
things you need from us to be able to have that authority if 
you have identified the authority and you lack it?
    Dr. Sharfstein. With respect to food particularly?
    Dr. Burgess. Particularly with respect to food, but we are 
going to get into some of the pharmaceuticals in a minute.
    Dr. Sharfstein. There is no question we need more authority 
because we want to shift to prevention. We need to be able to 
see----
    Dr. Burgess. So can you identify for us specifically what 
that authority is that you need?
    Dr. Sharfstein. Well, I think that that is where we worked 
with the committee on the legislation that is hopefully going 
to pass, is going to address that gap. There are sections that 
relate to what is required to import food.
    Dr. Burgess. And is the language in the bill that Mr. 
Dingell said was languishing safely in the Senate, is that 
language enough? Is it going to provide you enough of the 
authority of what you need to have?
    Dr. Sharfstein. Yes, we support that legislation because it 
is going to be an enormous step forward for how we can assure 
the safety of imported food and domestic food.
    Dr. Burgess. So any changes that occur over the other body 
then would need to be scrutinized pretty carefully to make 
certain that they didn't strip away the authority that you have 
identified that you will need?
    Dr. Sharfstein. Well, there is no question. All these 
provisions are extremely important, and it is very important 
that, you know, we look at all of them as they get modified in 
the legislative process.
    Dr. Burgess. Another story that really just riveted the 
headlines 2 years ago was the Chinese heparin story. What has 
happened? We had a hearing I think in April or May of 2008. It 
hasn't really been in the news stories. What is happening in 
that investigation now? Is there anything new that has come up 
from your looking into the manufacturer of the isolation of 
heparin overseas? Are we still importing the active 
pharmaceutical ingredient from overseas? Where are we with 
that?
    Dr. Sharfstein. There is certainly a huge level of import 
from China for heparin. What has really happened since that 
time is after the source of the problem was identified, there 
was a new standard written for heparin that has been adopted by 
companies and regulators around the world. It has been 
incorporated into the USP, which is sort of the standard-
setting body, so that now--previously it wouldn't have caught 
the problem, oversulfated chondroitin sulfate.
    Dr. Burgess. Right. It was a clever contaminant to hide 
behind.
    Dr. Sharfstein. Right. Much cheaper than heparin, but 
evaded the tests, went below the radar. FDA played a critical 
role in identifying how you can find that contaminant, 
demonstrated that when you add that contaminant to heparin you 
get the problem in animals, and then set up a standard that has 
been incorporated around the world and we haven't seen those 
kinds of reports that we were getting since that time.
    Dr. Burgess. Well, now, heparin wouldn't truly be regarded 
as a biologic but there has been some question in this 
committee about how your agency would administer the follow-on 
biologic approval process. So in light of everything, do you 
feel like you have an adequate ability to safely and properly 
monitor and implement the approval process for follow-on 
biologics or what are referred to as follow-on biologics?
    Dr. Sharfstein. From the perspective of the supply chain, I 
think for all, you know, medications and biologics, we would 
like to see strengthening of the supply chain including the 
things that are there now but----
    Dr. Burgess. Right. The supply chain in this instance just 
showed the weakness, though, of the process used to identify 
contaminants. In approving follow-up biologics, I mean, it 
underscores how important the safety aspect is. Do you feel 
that with what you have available to monitor and screen the 
follow-on biologics in that process? We have had that debate 
somewhat in this committee. We have never had you guys in to 
ask you about that. We have had the Federal Trade Commission 
in, which I never understood. So now that I have got you here, 
what about the discussion on follow-on biologics?
    Dr. Sharfstein. I think that the follow-on biologics sort 
of supply chain issues are the same as for the regular. In some 
cases, they are the same companies making them. So----
    Dr. Burgess. No, outside the supply chain, just the overall 
safety of follow-on biologics.
    Dr. Sharfstein. That is something that is very important to 
base on individual products and the best science available, and 
FDA believes that with adequate resources and the right----
    Dr. Burgess. You said you had all the money you needed, 
remember, the previous question.
    Dr. Sharfstein. I don't--we could check the transcript on 
that one. I think that what we would like is the flexibility to 
have standards that are based on the best available science for 
particular products, and with that in place, we would explain 
how we are setting up those standards and be able to do it in a 
way that could get products on the market that could be 
enormously important to the public.
    Dr. Burgess. So where are we in that process now? We had 
some language in the bill that we passed, and goodness knows 
what is going to happen to that bill, but are you all waiting 
for Congress to do something?
    Dr. Sharfstein. I think we are certainly waiting to see 
what happens with health care reform because there is some 
language in there, but I think that we would also look to the 
authority we have to decide whether it would make sense for us 
to move forward without new language, but that is not something 
we have reached final decision on.
    Dr. Burgess. Is there a product out there right now that is 
awaiting your ability to be able to offer those approvals or 
direct further study?
    Dr. Sharfstein. There is certainly a lot of interest in the 
industry but I don't know if I could point to a particular 
product.
    Mr. Pallone. OK.
    Dr. Burgess. Thank you, Mr. Chairman.
    Mr. Pallone. You are welcome.
    Let me thank Dr. Sharfstein. Thanks a lot. This was very 
helpful, and we appreciate it, and obviously we would like to 
move forward on the drug safety issue as we did on food safety. 
You actually said that you are going to follow up with certain 
written responses in some cases, so I would appreciate those as 
soon as possible, and members can submit additional questions 
for the record as well. I am going to try to get those 
submitted to the clerk within the next 10 days, so I would ask 
members if they want to submit written questions, to give them 
to us within the next 10 days, and then after that we would ask 
you to get back to us as quickly as possible.
    Dr. Sharfstein. OK. Great.
    Mr. Pallone. Thank you again, and without objection, the 
hearing of the subcommittee is adjourned.
    [Whereupon, at 4:22 p.m., the Subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]


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