[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
      DISCUSSION DRAFTS CONCERNING PRESCRIPTION DRUG USER FEE ACT 
                           REAUTHORIZATION, 
                      MEDICAL DEVICE USER FEE AND
 MODERNIZATION ACT REAUTHORIZATION, DRUG SAFETY, AND CERTAIN PEDIATRIC
                 PHARMACEUTICAL AND DEVICE LEGISLATION

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 12, 2007

                               __________

                           Serial No. 110-55


      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov

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                    COMMITTEE ON ENERGY AND COMMERCE

    JOHN D. DINGELL, Michigan,       JOE BARTON, Texas
             Chairman                    Ranking Member
HENRY A. WAXMAN, California          RALPH M. HALL, Texas
EDWARD J. MARKEY, Massachusetts      J. DENNIS HASTERT, Illinois
RICK BOUCHER, Virginia               FRED UPTON, Michigan
EDOLPHUS TOWNS, New York             CLIFF STEARNS, Florida
FRANK PALLONE, Jr., New Jersey       NATHAN DEAL, Georgia
BART GORDON, Tennessee               ED WHITFIELD, Kentucky
BOBBY L. RUSH, Illinois              BARBARA CUBIN, Wyoming
ANNA G. ESHOO, California            JOHN SHIMKUS, Illinois
BART STUPAK, Michigan                HEATHER WILSON, New Mexico
ELIOT L. ENGEL, New York             JOHN B. SHADEGG, Arizona
ALBERT R. WYNN, Maryland             CHARLES W. ``CHIP'' PICKERING, 
GENE GREEN, Texas                        Mississippi
DIANA DeGETTE, Colorado              VITO FOSSELLA, New York
    Vice Chairman                    STEVE BUYER, Indiana
LOIS CAPPS, California               GEORGE RADANOVICH, California
MIKE DOYLE, Pennsylvania             JOSEPH R. PITTS, Pennsylvania
JANE HARMAN, California              MARY BONO, California
TOM ALLEN, Maine                     GREG WALDEN, Oregon
JAN SCHAKOWSKY, Illinois             LEE TERRY, Nebraska
HILDA L. SOLIS, California           MIKE FERGUSON, New Jersey
CHARLES A. GONZALEZ, Texas           MIKE ROGERS, Michigan
JAY INSLEE, Washington               SUE WILKINS MYRICK, North Carolina
TAMMY BALDWIN, Wisconsin             JOHN SULLIVAN, Oklahoma
MIKE ROSS, Arkansas                  TIM MURPHY, Pennsylvania
DARLENE HOOLEY, Oregon               MICHAEL C. BURGESS, Texas
ANTHONY D. WEINER, New York          MARSHA BLACKBURN, Tennessee       
JIM MATHESON, Utah                   
G.K. BUTTERFIELD, North Carolina     
CHARLIE MELANCON, Louisiana          
JOHN BARROW, Georgia                 
BARON P. HILL, Indiana               
_________________________________________________________________

                           Professional Staff

 Dennis B. Fitzgibbons, Chief of 
               Staff
Gregg A. Rothschild, Chief Counsel
   Sharon E. Davis, Chief Clerk
   Bud Albright, Minority Staff 
             Director

                                  (ii)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
HENRY A. WAXMAN, California          NATHAN DEAL, Georgia,
EDOLPHUS TOWNS, New York                 Ranking Member
BART GORDON, Tennessee               RALPH M. HALL, Texas
ANNA G. ESHOO, California            BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
    Vice Chairman                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine                     MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
ELIOT L. ENGEL, New York             SUE WILKINS MYRICK, North Carolina
JAN SCHAKOWSKY, Illinois             JOHN SULLIVAN, Oklahoma
HILDA L. SOLIS, California           TIM MURPHY, Pennsylvania
MIKE ROSS, Arkansas                  MICHAEL C. BURGESS, Texas
DARLENE HOOLEY, Oregon               MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          JOE BARTON, Texas (ex officio)
JIM MATHESON, Utah
JOHN D. DINGELL, Michigan (ex 
    officio)
  
                             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.........................     1
 Hon. Nathan Deal, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     3
Hon. Lois Capps, a Representative in Congress from the State of 
  California, opening statement..................................     4
Hon. Mike Rogers, a Representative in Congress from the State of 
  Michigan, opening statement....................................     5
Hon. Anna G. Eshoo, a Representative in Congress from the State 
  of California, opening statement...............................     6
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     7
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     8
    Prepared statement...........................................     8
Hon. Darlene Hooley, a Representative in Congress from the State 
  of Oregon, opening statement...................................     9
Hon. Jim Matheson, a Representative in Congress from the State of 
  Utah, opening statement........................................    10
Hon. Jan Schakowsky, a Representative in Congress from the State 
  of Illinois, opening statement.................................    11
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................    12

                               Witnesses

Randall Lutter, Deputy Commissioner, Policy, Food and Drug 
  Administration, Department of Health and Human Services........    13
    Prepared statement...........................................    16
    Answers to submitted questions...............................   282
Caroline Loew, senior vice president, scientific and regulatory 
  affairs, Pharmaceutical Research and Manufacturers of America..    65
    Prepared statement...........................................    67
    Answers to submitted questions...............................   278
Jim Guest, president, Consumers Union............................   105
    Prepared statement...........................................   107
    Answers to submitted questions...............................   296
Steven Ubl, president and chief executive officer, Advanced 
  Medical Technology Association.................................   120
    Prepared statement...........................................   121
Diana Zuckerman, president, National Research Center for Women & 
  Families.......................................................   127
    Prepared statement...........................................   130
Steven Walker, Abigail Alliance for Better Access to 
  Developmental Drugs............................................   139
    Prepared statement...........................................   142
Richard L. Gorman, M.D., on behalf of the American Academy of 
  Pediatrics.....................................................   207
    Prepared statement...........................................   209

                           Submitted Material

``FDA Advisory Committees. Does Approval Mean Safety?'' National 
  Research Center for Women & Families...........................   228
Submitted by Ms. Eshoo:
    Jay E. Berkelhammer, M.D., president, American Academy of 
      Pediatrics, letter of June 7, 2007.........................   306
    Pamela W. Barnes, president and chief executive officer, 
      Elizabeth Glaser Pediatric AIDS Foundation, letter of June 
      12, 2007...................................................   307
    ``Potentially Incompatible Goals at FDA,'' Gardnier Harris, 
      the New York Times, June 11, 2007..........................   308
    .............................................................


      DISCUSSION DRAFTS CONCERNING PRESCRIPTION DRUG USER FEE ACT 
    REAUTHORIZATION, MEDICAL DEVICE USER FEE AND MODERNIZATION ACT 
REAUTHORIZATION, DRUG SAFETY, AND CERTAIN PEDIATRIC PHARMACEUTICAL AND 
                           DEVICE LEGISLATION

                              ----------                              


                         TUESDAY, JUNE 12, 2007

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:00 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Frank 
Pallone, Jr. (chairman) presiding.
    Members present: Representatives Green, Eshoo, DeGette, 
Capps, Schakowsky, Hooley, Matheson, Dingell, Deal, Buyer, 
Wilson, Pitts, Rogers, Sullivan, Murphy, Burgess, Blackburn, 
Myrick, and Hall.
    Also present: Representative Markey.
    Staff present: Jack Maniko, John Ford, Virgil Miller, Ryan 
Long, Nandan Kenkeremath, Katherine Martin, Brin Frazier, 
Robert Clark, Chad Grant, and Melissa Sidman.

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

    Mr. Pallone. I call the meeting of the subcommittee to 
order. Good morning, everyone. Today the subcommittee is 
meeting to hear testimony about discussion drafts concerning 
the Prescription Drug User Fee Authorization, Medical Device 
User Fee and Modernization Act Reauthorization, Drug Safety, 
and several proposals to encourage more research into the 
appropriate use of drugs and devices in pediatric populations. 
I will note, as a matter of process, that each of these issues 
has had its own hearing in the subcommittee over the course of 
the past 6 weeks. We have worked very hard to cover a lot of 
ground and I want to thank all the subcommittee members for 
their participation in these hearings and I welcome comments 
and suggestions on these discussion drafts as we continue to 
move forward.
    I will also note that while we did have a hearing regarding 
follow-up on biologics, I did not include a proposal in last 
week's drafts that would address this issue. I want to stress 
that this issue is of vital importance and its lack of 
inclusion should not be viewed as a signal to anyone that the 
door is closed on this very important topic. I am still very 
interested in developing a consensus on this issue and I hope 
to do so in the near future.
    Let me just say a few words about each of the discussion 
drafts that we circulated last week, and I think you all know 
they were on the Web site. The proposal to reauthorize the 
Prescription Drug User Fee Act or PDUFA, is largely based on 
the agreement between the FDA and the industry with a few 
changes. First and foremost, an additional $225 million in user 
fees is authorized in the discussion draft. These new fees 
would be dedicated to post-market safety activities and would 
build upon the $29 million in additional fees already included 
in the administration's proposal for post-market safety 
activities. We also include a provision that would require more 
transparency in the next PDUFA process by allowing a consumer 
or patient group to participate in the negotiations between the 
FDA and the pharmaceutical industry.
    Now, like the PDUFA proposal, the discussion draft to 
reauthorize MDUFMA is also largely based on the proposed 
agreement between the FDA and the medical device industry, with 
some modifications. Undoubtedly, the most controversial change 
is to eliminate the changes to the third party inspection 
program. I realize that the medical device industry has deep 
concerns about this provision. Over the last week they have 
come to see us about it. However, I have not been convinced 
that these changes are necessary in order to improve 
participation in the program. No one has been able to show me 
how or why the policies we are changing act as significant 
barriers to participation.
    And finally, I have a philosophical problem with the idea 
of liberalizing a program that is designed to privatize the 
core function of a Government regulatory agency. Other key 
changes to the MDUFMA proposal include a study of the 510(k) 
process and an authorization of appropriations for post-market 
activities.
    Now, we have also circulated two draft proposals to 
reauthorize the Best Pharmaceuticals for Children Act and the 
Pediatric Research Equity Act, which are designed to provide 
necessary research on the appropriate use of prescription drugs 
in pediatric populations. While these drafts make a number of 
changes to the program, the two largest changes are eliminating 
the sunset provision associated with PREA and including an 
exclusivity adjustment under BPCA. Also included amongst these 
drafts are proposals supported by Representatives Markey and 
Rogers to encourage the development of devices to be used in 
pediatric populations.
    And finally, we included a number of proposals that would 
improve our drug safety system. I realize that the drug safety 
provisions will be the most contentious. We saw how contested 
this debate was in the Senate and it is my hope that we can 
avoid having a repeat performance in this subcommittee. 
However, it is very clear that there are gaping holes in the 
current system and the public has lost a great amount of 
confidence in FDA's ability to protect them from potentially 
harmful drugs. We must work diligently to strengthen our 
Nation's drug safety system and restore the public's trust in 
FDA.
    At the heart of our drug safety proposal is the requirement 
that all new drugs include a risk evaluation and mitigation 
strategy, which outline the conditions that need to be put in 
place to ensure that FDA has the tools necessary to protect 
consumers from unknown risks associated with a new drug. I 
realize that not everyone is going to agree with the REM 
strategy or how we are proposing to implement it. The direct-
to-consumer advertising provisions included in the REMS have 
already caused great anxiety among stakeholders and members and 
I am certainly open to hearing any concerns you have.
    Other provisions included in the drug safety drafts are a 
new clinical trials registry and results database, which are 
designed to give patients and providers greater access to the 
information they need to determine the most appropriate and 
safest course of treatment. There are also new conflict of 
interest standards that are designed to ensure that FDA's 
advisory committees remain impartial and provide the best 
possible advice when it comes to critical issues that impact 
public health.
    These are the major provisions of the draft we circulated 
last week in which we will hear more about today. Again, I 
thank all the subcommittee members for their participation in 
the hearings we had and I am looking forward to getting your 
feedback today. I would like to also welcome our witnesses here 
today. We are eager to hear from you and hear your opinions and 
whatever suggestions you may have.
    And now I would recognize my friend, Mr. Deal from Georgia, 
for 5 minutes for an opening statement.

  OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF GEORGIA

    Mr. Deal. Thank you, Mr. Chairman. Many of the pieces of 
legislation before us today play an important role in ensuring 
that patients have timely access to approved, safe and 
effective medications and medical devices. Moreover, some of 
these drafts encourage the study of medications to meet the 
special needs of our pediatric population. Historically, these 
have been bipartisan pieces of legislation and recent action in 
the Senate on a similar package of proposals demonstrated that 
the two sides can work together to reach a consensus and 
preserve patients' access to lifesaving medications.
    Unfortunately, as I see the schedule, there is little time 
for the two sides to work together to move a more largely 
bipartisan package. I am sure today's hearing will highlight 
certain aspects of the legislation which could be offered in a 
way acceptable to both sides. This is especially true on 
certain reauthorization measures like PDUFA and MDUFMA, which 
must be passed in order to prevent possible personnel 
disruptions at the FDA.
    It originally was my hope that the chairman would provide 
the staff enough time to work through these issues prior to our 
markup. However, with a markup little more than a day from now, 
I am not sure that is possible. I do look forward to the 
testimony of our witnesses regarding certain provisions of 
these drafts. I certainly sympathize with the goal of providing 
the FDA adequate resources to ensure the safety of the Nation's 
drug supply. However, making the agency even more dependent on 
the industry through an even greater increase in the user fees 
to achieve this goal may not be the wisest course of action.
    I am also concerned that these drafts do not include the 
suggestions in the original MDUFMA agreement to improve the 
third party inspection program. Certain changes to the 
pediatric programs also deserve attention during this hearing. 
Pediatric device legislation ought to be carefully crafted so 
that there are not any unnecessary regulatory hurdles which 
thwart the purpose of the bill. The Pediatric Research Equity 
Act and the Best Pharmaceuticals for Children Act had been an 
effective combination to foster the study of medications in 
children. I have reservations about any attempt to de-link 
these programs which have successfully promoted the health of 
the Nation's children.
    The drug safety proposals before us deserve important 
attention during this hearing. I look forward to our witnesses' 
opinions on these matters in addition to get whatever guidance 
they can provide on the troubling preemption clause included at 
the end of some of these drafts. Ultimately, I believe there is 
room for compromise on these bills. We just need time to allow 
the negotiation process to work to reach a bipartisan 
agreement. Holding a subcommittee markup a day from now and a 
full committee markup a week later, seriously jeopardizes that 
effort. It takes time for the committee to report good 
bipartisan legislation, but I am afraid the timeframe we are 
working in make that virtually impossible. Thank you, Mr. 
Chairman.
    Mr. Pallone. Thank you, Mr. Deal. Mrs. Capps.

   OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mrs. Capps. Thank you, Chairman Pallone, and thank you to 
our witnesses, both panels. I want to commend you, Mr. 
Chairman, and the committee staff for working so diligently on 
drafting these proposals and taking into consideration our 
concerns. As you noted, this has been no easy task. One of the 
hardest things for me, from the beginning, has been the fact 
that the administration did not bring patients and consumers to 
their table for negotiations. I, like many of my colleagues, 
have always prided myself in protecting consumers. It has been 
quite a journey to draft a proposal that takes in account 
consumer protections and concerns. But I am confident that the 
draft we have before us today is an excellent start and I hope 
that today we can discuss ways in which to protect both 
consumers and innovations simultaneously. That remains my goal 
and I believe it is a possibility.
    Some of the concerns I still have and which I know many of 
my colleagues share include these: reducing conflicts of 
interest, ensuring the integrity of direct-to-consumer 
advertising, ensuring proper recourse in the event of patient 
injury. The issue of conflicts of interest is most glaring 
because I think there is a misconception about what is and what 
isn't necessary. It is hard for me to hear that the pool of 
experts is so small that it is near impossible to have a 
committee free of financial interest of the company whose 
product is under review.
    Because in reality, I have been told that there is another 
pool of equally competent experts in academia with no financial 
ties to industry who have not been solicited and who would be 
willing to serve on advisory committees. Mr. Chairman, I 
sincerely hope that as we consider the final language to be 
marked up on Thursday, we are sure to protect the newly crafted 
language regarding conflicts of interest and reject any 
attempts to weaken it.
    I would even go so far as to say that we should strengthen 
it further, that is my goal. And I hope some of our witnesses 
today, I believe they will, do agree with this. I am eager, 
also, to hear today from our witnesses regarding the integrity 
of direct-to-consumer advertising. I think there is more 
progress to be made in the way of crafting a compromise that 
protects free speech while also ensuring consumer safety. So 
thanks again for listening to our concerns and I look forward 
to hearing from our witnesses today. And I yield back.
    Mr. Pallone. Mrs. Wilson was next. I don't know if she is 
in the back. If not, we will go to Mr. Ferguson. Mr. Ferguson.
    Mr. Ferguson. I will waive, then.
    Mr. Pallone. Ms. DeGette.
    Ms. DeGette. Thank you, Mr. Chairman. I have many views on 
these issues, but I think I will save them for the questioning 
time and waive my opening statement.
    Mr. Pallone. Mr. Burgess was next, but I don't know if he 
is back, yet. We will go to Mr. Rogers.

  OPENING STATEMENT OF HON. MIKE ROGERS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Rogers. Thank you, Mr. Chairman. I hope we can come to 
some better working relationships by next week and before I do 
that, I want to thank Mr. Markey for working with us on the 
pediatric devices portion of the bill. He and his staff have 
been excellent. But in all of the drafts that were circulated, 
something that didn't come over in the Senate bill, was this 
notion of preemption of the States and what concerns me most is 
all the good work that we have done was taken away in kind of a 
last minute addition that was not in any of the drafts and was 
not worked with the minority side, something that I think 
absolutely renders these bills awful and we have made so much 
progress.
    That book of regulations to get a device or a drug to 
market, you can comply, according to these new additions in 
this law, you can comply with every single one of these rules 
and regulations and we are going to get ready to add new ones 
in addition, and you can comply with all of it and the last 
minute addition language that was put into these bills last 
week would mean that I can sue for any reason in a State court. 
So I have gone through all the compliance costs, I have used up 
all my intellectual capital investing in the compliance with 
this--as a matter of fact, the FDA could tell me certain things 
aren't eligible to be put on labels and you should not do it 
because I complied with this and I could still get sued in 
State court for what the FDA told me not to do.
    I hope that we can sit down and talk about it. This makes 
all of this work, all of the good work of so many people 
absolutely useless. It absolutely will destroy any hope of 
innovation in moving the industry forward so that we get some 
accountability, we get new innovation, we get new devices and 
we get new drugs to market. I mean, I feel pretty strongly 
about this, Mr. Chairman, and I hope that in the spirit of 
openness and working together in a bipartisan way we can have 
those kind of discussions before these things kind of get 
dropped in the bowl like this, because if you leave this 
language, it puts in jeopardy everything that this committee 
has done over the last few months and I look forward to 
hopefully we can work through this, take a look at the 
language. I am sure it was a mistake that it was dropped in, 
Mr. Chairman and we can work on it and get this language taken 
out and we will work through it for the markup coming up. Thank 
you, Mr. Chairman. I yield back.
    Mr. Pallone. Thank you. Ms. Eshoo.

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

    Ms. Eshoo. Thank you, Mr. Chairman, for holding this 
legislative hearing on the nine bills that are before us today. 
All of them are important for ensuring the safety and the 
efficacy of pharmaceuticals and medical devices available to 
the American people. Thank you also for including the 
legislation that will reauthorize two important programs that 
have helped to increase the number of drugs and biologics 
tested labeled for use in children, the Best Pharmaceuticals 
for Children Act, which I have a great source of pride in, and 
the Pediatric Research Equity Act.
    Last week I introduced H.R. 2589, the Improving 
Pharmaceuticals for Children Act, to reauthorize both of these 
successful programs. By making a number of improvements to 
current law, my bill increases the availability of pediatric 
information to doctors, parents and researchers. It improves 
transparency and accountability at FDA and of drug sponsors and 
it enhances post-market surveillance of pediatric drugs. It 
also makes permanent the FDA's authority to require pediatric 
studies. This adjustment is consistent with FDA's permanent 
authority to require studies of adult formulations.
    I have also included many of the recommendations of the 
GAO, the American Academy of Pediatrics, the Elizabeth Glaser 
Pediatric AIDS Foundation, and the FDA, in developing the 
bills. I would like to ask unanimous consent to insert in the 
record the letters of support.
    Mr. Pallone. Without objection, so ordered.
    Ms. Eshoo. Thank you.
    Ms. Eshoo. I am also pleased that the committee print 
includes many of the provisions in this bill and I look forward 
to working with it to resolve some of the differences.
    In the interest of time, I just want to highlight a couple 
of points with respect to the other bills before us. The 
funding for FDA's IT system, I think is woefully inadequate. 
The committee print allocates $4 million specifically the goal, 
but I think additional funding should be allocated for IT and I 
want to work with you to provide these resources.
    With respect to third party inspections under MDUFMA, I 
recognize that FDA is not able to conduct all of the 
inspections it needs to and that the device and the imaging 
industries are frustrated by this. I think we need to take 
another look at the user fee and appropriated funds available 
under MDUFMA and see if we can come up with a better way of 
enabling direct FDA oversight of the device and the imaging 
industries. There is a real tension, a push and a pull between 
the two, a company being able to do it; consumers saying well, 
this serves them and the whole issue of post-market 
surveillance in this, I think we can do better at it, so I want 
to work with you on that.
    Finally, I have serious concerns about the risks to public 
safety presented by direct-to-consumer advertising. I think 
that the chairman has done a good job for including provisions 
in both the PDUFA and the REMS committee print that seek to 
increase funds at FDA for the voluntary review of DTC ads, but 
most frankly, I think the voluntary review doesn't really add 
up to very much. I mean, there just isn't any teeth in it, so 
we make ourselves feel good by saying we don't like it, but it 
is not going to do anything about it, so I think that we have 
to take a harder look at that. So I look forward to this 
hearing. Thank you for the work that has been put into it. I 
think we still have some more work to do to ferret out some of 
the points that have already been made by members and I thank 
the witnesses in advance for their being here and being 
instructive to us.
    Mr. Pallone. Thank you. You guys are coming in and out on 
the other side, so I am getting confused. Mr. Buyer is next, 
but then I guess we will go back to Mr. Burgess. You waive? OK, 
Mr. Burgess.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. Thank you, Mr. Chairman, and I will be brief. 
I am glad we are taking up these bills and starting to 
legislate on these important issues. The process, so far, my 
opinion is somewhat strained. I am concerned that the bills 
have fallen victim to, in some cases, what might even be 
described as unnecessary partisanship, barring minority staff 
involvement from the drafting of even the least controversial 
of these bills is highly concerning, but whatever concerns we 
have about the process, there is also concerns about the 
policies in the draft bills we have seen.
    First would be the Federal preemption issue. The bills, as 
drafted, seem to upset the delicate legal balance set up by the 
FDA rule and would seem to open up the State courts to a 
situation that might be labeled litigation for all. Secondly, 
pediatric exclusivity. I am concerned about the revenue 
triggers set forth in the draft bill and how the FDA would 
comply with its requirements. Thirdly, the issue surrounding 
post-market surveillance. I am interested in working with 
members of the majority to modify the Risk Evaluation 
Mitigation Strategy. I believe this committee could adopt a 
more eloquent approach to this important issue.
    Finally, the conflict of interest issue. While I believe we 
should do all we can to limit conflicts of interest in 
regulatory agencies, I am concerned that the proposal on 
conflicts perhaps goes too far the other direction and would 
limit important technical institutional expertise that is 
currently available to the FDA. But Mr. Chairman, there are 
good provisions in the package, as well, and there is work to 
be done. I hope we can improve on some of the areas and I hope 
the witnesses here today will help us begin that process. And I 
will yield back the balance of my time.
    Mr. Pallone. Thank you. The gentleman from Michigan, the 
chairman of our full committee, Mr. Dingell.

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

    Mr. Dingell. Mr. Chairman, thank you for your recognition. 
Mr. Chairman, first, commendations to you and congratulations 
on the outstanding leadership that you are providing on this 
matter and other matters. The staff draft is an excellent one 
and I commend you for your vigor and the diligence with which 
you have moved this forward. Mr. Chairman, I have an excellent 
statement which I am sure everybody is going to want to read, 
so I ask unanimous consent to put it in the record at this 
time.
    I do have a few comments to make to my Republican 
colleagues. The committee is under considerable pressure to 
move a lot of legislation and as a result, we are not able to 
proceed in the way that I would ordinarily like to do it. I 
will tell my Republican colleagues and I want them to hear this 
because it is a statement made with good will. I intend, first 
of all, to see to it, on this matter, that every possible 
procedural fairness and opportunity is given to them. I intend 
to try to work with them. I know you, Mr. Chairman, intend to 
do the same thing and we will try and come up with, first of 
all, substance to which the committee may agree.
    Second of all, procedures and processes which will enable 
our Republican colleagues to not only have fair treatment, but 
to feel assured that they are having fair treatment and also to 
see to it that when we have completed the legislation, which we 
will try to do expeditiously, that we have completed 
legislation which meets with the high standards that this 
committee has always had and that we will try to see to it that 
we do so in a way which is marked by good humor and cooperation 
amongst the two parties. I will tell my Republican colleagues 
that I intend, myself, and I know you do, to see to it that 
this process is not only fair, but results in a good piece of 
legislation. I thank you, Mr. Chairman.

    Prepared Statement of Hon. John D. Dingell, a Representative in 
                  Congress from the State of Michigan

     Mr. Chairman, thank you for your leadership on these 
issues and for the opportunity to begin consideration of the 
staff discussion drafts released by your subcommittee last 
week. This hearing is an important step in crafting legislation 
that will affect millions of Americans, young and old, who need 
a medical device or take a prescription medication.
     Many of these programs will expire at the end of the 
fiscal year, less than 4 months from now. It is this 
committee's responsibility to ensure that these programs are 
reauthorized in a timely manner to avoid any personnel 
disruptions at the Food and Drug Administration. Hardworking, 
skilled employees at FDA are looking to us to do our job, so 
they can continue to do theirs.
     As we begin this process of reauthorization, we must work 
towards strengthening the safety and effectiveness of the 
Nation's supply of drug and device therapies. We must strike 
the correct balance between allowing patients timely access to 
new therapies, while ensuring that those therapies that enter 
the marketplace are monitored for safety. We must enhance the 
post-market surveillance of both devices and pharmaceuticals so 
that if another Vioxx situation should occur, it is caught 
quickly.
     Another important issue that the discussion drafts focus 
upon is the need for greater resources at FDA. We have heard 
about this need from a wide range of stakeholders. I agree. 
This legislation should provide FDA the necessary user fees to 
provide timely review of new drug applications, biologic 
license applications, and premarket approvals for devices. 
Equally important, we must work to ensure that Congress 
appropriates the funds authorized for FDA.
     This subcommittee has held a number of hearings this year 
on many of the issues contained in the discussion drafts. Those 
hearings have been very helpful in preparing us to work on 
these legislative matters. Again, I thank the chairman for 
holding this hearing on the discussion drafts, and look forward 
to the testimony of the witnesses.
                              ----------                              

    Mr. Pallone. Thank you, Mr. Chairman. Mr. Sullivan of 
Oklahoma. Are you waiving? The gentlewoman from Oregon, Ms. 
Hooley.

 OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Ms. Hooley. Thank you, Mr. Chairman. The bills before the 
subcommittee take critical steps to promote the safe and rapid 
approval of prescription drugs and medical devices. I am 
pleased to support the enhanced post-market surveillance 
provisions throughout the bills. I think these bills improve 
the Food and Drug Administration's capacity to safely approve 
drugs and devices and then monitor them for continued safety 
after they reach consumers.
    I would now like to turn to a medical device issue that I 
believe has significant impact with consumers of implanted 
medical devices. As a patient, I have had bilateral knee 
replacement. Dozens of my friends and family and thousands of 
constituents have similarly had surgeries where medical devices 
were implanted in their bodies. In many cases, those devices 
provided lifesaving or prolonged benefits. In other instances 
such as my own, people's quality of life has been greatly 
improved as a result of implanted medical devices.
    However, when a medical device is recalled, too often a 
patient may never find out there is a problem. Our current 
system of notifying patients in cases where a device is 
recalled, is simply deficient. I am particularly concerned 
about class 1 recalls that the FDA characterizes as having a 
reasonable chance the product will cause serious health 
problems or death. Device manufacturers work very hard to 
ensure their products are safe. Despite the most diligent 
efforts, products sometimes fail. In cases where a product has 
a reasonable chance of causing serious health problems or 
death, I believe that, as a patient, you or I should be 
informed. That is not too much to ask. If someone could die or 
suffer serious harm, those patients should be notified.
    As we move toward markup, I hope this committee will be 
able to take sensible and prudent steps to improve patient 
notification. A first step in that process is to allow the FDA 
to conclude its work on a unique device identification or UDI. 
It has been working hard with stakeholder groups for years as 
it considers how best to implement a UDI system. Such a system 
would greatly assist in the recall process and also improve 
supply chain efficiency.
    I believe it is critical to encourage the FDA to continue 
its rulemaking process while not tying their hands as to the 
manner or system the agency believes will best serve the public 
interest. With the unique device identification system as a 
foundation, I believe we can further empower the FDA to engage 
in a thoughtful rulemaking process to better ensure patients 
are notified in those instances where the implanted medical 
devices may malfunction. The key to any such system is to 
enable those at the FDA with expertise and recalls and 
notifications to guide the process of strengthening the system. 
The public health will benefit from patients having more 
information.
    I believe the FDA can develop a prudent and workable system 
to notify our parents, grandparents, friends and loved ones 
when their implanted medical devices present a reasonable 
chance of death or serious health problems. They deserve no 
less. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. The gentlewoman from Tennessee, 
Mrs. Blackburn.
    Mrs. Blackburn. Thank you, Mr. Chairman. In the interest of 
time, I will do as many have done and waive my opening 
statement. I do just want to register my concern with the delay 
in getting the legislation and the information to us last 
night, those of us that have healthcare industry and of course, 
we all have consumers in our districts and I think that the 
lack of orderly process is something that has been a 
disappointment to me and I hope that we will see a more timely 
process as we move forward with consideration and I yield back.
    Mr. Pallone. Thank you. Mr. Matheson.

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

    Mr. Matheson. Thank you, Mr. Chairman. I certainly 
appreciate the opportunity to hear from the witnesses today 
regarding the discussion drafts. I hope the witnesses will 
provide some insight regarding the impact the draft legislation 
will have to improve drug safety, support FDA in its mission 
and improve access for children to appropriate drugs and 
devices.
    In light of recent adverse examples brought before 
Congress, I look forward to hearing recommendations from the 
panel on how best to achieve a balance between innovation and 
public safety. I am concerned about one item missing from the 
discussion drafts. Currently, there are no provisions to 
address antimicrobial resistance, a true issue of drug safety. 
I appreciate the rich history this committee has regarding 
concern about this issue.
     Mr. Chairman, as you know, I have been working on this 
issue and look forward to working with you and others of the 
committee to pass legislation in this area. I plan on 
introducing to reauthorize and build on a program my colleague, 
Mr. Stupak, authored with our former colleague, Mr. Burr, 
section 319(e) of the Public Health Service Act, combating 
antimicrobial resistance. I hope my colleagues will work with 
me to include these provisions as we consider FDA legislation. 
It would be a shame to miss this opportunity to put in place 
provisions that will help protect us against many resistant 
infections that are out there and are placing people in danger.
    Antibiotics present unique challenges for drug safety. As 
we know, they are researched and developed to respond to 
infectious organisms that continue to mutate and build 
resistance to the product even after approval. Even if we all 
demonstrate good judgment and use antibiotics wisely, 
eventually the bad bugs become resistant. It will take a 
coordinated effort and a partnership between manufacturers, 
Federal agencies, providers and patients to truly make a 
difference in slowing the trend of antimicrobial resistance.
    It is my hope that this committee will include provisions 
to protect antibiotic safety and effectiveness, as well as 
improve access to new antibiotics. I do think we should make 
every effort to ensure that people have access to effective new 
medicines as quickly as possible and with thorough safety 
guidelines. Mr. Chairman, I will yield back.
    Mr. Pallone. Thank you. The gentlewoman from Illinois, Ms. 
Schakowsky.

 OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Ms. Schakowsky. Thank you, Mr. Chairman. I do just have a 
brief statement. I want to thank you for your leadership, Mr. 
Chairman, on these critical issues. The legislation we have 
before us today has the potential to significantly improve the 
way patients make decisions about the drugs or medical devices 
they use in a variety of ways. I appreciate the witnesses being 
here today, I look forward to hearing their insight on the 
proposals. A lot of work remains here as we work to pass these 
significant and critical pieces of legislation, but I am 
confident that the subcommittee has the ability to come to a 
consensus that is in the best interest of patient safety and 
scientific integrity.
    Clearly, a balance is being sought here, but it is crucial 
to protecting consumers of drugs and medical devices. We need 
an efficient process that brings us medicines and devices that 
are both safe and effective and we need to work to ensure that 
the agency responsible for overseeing much of this process 
maintains its integrity and reliability. Without a doubt, 
within this debate lies the difference between sickness and 
health and life and death for so many of our constituents. As 
we move forward, I remain concerned that patients continue to 
be first and foremost throughout any debate.
    I look forward to passing legislation that will truly 
enhance the way information comes out of the FDA, is made 
available to the public and is used by all parties involved to 
improve the health of those who must take prescription drugs or 
use medical devices. This of course, includes our children and 
I appreciate the chairman's efforts in making safer pediatric 
therapies more readily available to this population. I also 
commend the chairman's work to increase the resources available 
to the FDA's drug review program and to make significant 
improvements to both the pre- and post-market safety programs.
    Again, I look forward to the work we have ahead of us and 
anticipate that we will bring positive change and essential 
improvements to the legislation before us. I yield back.
    Mr. Pallone. Thank you. And I recognize our vice chair, Mr. 
Green from Texas.

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

    Mr. Green. Thank you, Mr. Chairman, for holding our 
legislative hearing on this legislation that would reauthorize 
expiring user fees or approval of both prescription drugs and 
medical devices at the FDA, as well as several bills that we 
are going to enact some much needed reforms at FDA. This 
committee, particularly the Oversight and Investigation 
Subcommittee, has spent a wealth of time investigating lapses 
in drug safety at the FDA, specifically with regard to Vioxx, 
Ketek and antidepressants. These investigations uncovered 
significant structural and cultural problems at the FDA that 
these bills should seek to remedy to better ensure the safety 
of our Nation's drug supply.
    I am particularly supportive of the legislation to enact a 
Risk and Evaluation Mitigation Strategy at the FDA whereby each 
new drug the FDA approves would be analyzed and a safety 
profile would be established for that specific drug so that 
risk and benefits continue to be monitored throughout the life 
cycle of that drug. This draft includes an important step 
forward for safety by granting the FDA much needed authority to 
require post-market studies. The FDA's post-market authority 
has been sorely lacking. I think a majority of us would agree 
that this additional authority and a dedicated funding source 
through the user fee program is a good step forward.
    The Risk Evaluation Mitigation Strategy proposal is not 
without controversy. There is no question that a point of 
contention remains over the direct-to-market, direct-to-
consumer advertising. I, for one, support the language in the 
discussion drafts that provide the Secretary with the authority 
to impose a temporary waiting period for the mass advertising 
of a drug. I understand there may be Constitutional concerns 
with the language, however I support our chairman in his 
efforts to have the strongest language possible out of the 
committee.
    There is no question that sales of Vioxx skyrocketed during 
the direct-to-consumer advertising despite the fact that the 
drug was indicated for a small subset of individuals who 
couldn't tolerate other drugs. This temporary advertising 
waiting period would help us on this post-market side to 
identify and monitor any adverse events in larger sets of 
people before a drug is mass marketed for the entire country.
    All along we said that additional authority must be met 
with a cultural change at the FDA and I am glad to see that the 
subcommittee will take up legislation that addresses the 
conflicts of interest of the FDA advisory panels. While many of 
us that prefer that the advisory committee meetings be entirely 
free of conflicts of interest, I can understand the need to 
conclude a waiver process to ensure that the panel can gain the 
appropriate expertise as long as the one waiver and the nature 
of the panel members financial interest is made public. I 
would, however, like to see additional safeguards put into 
place for FDA scientists to ensure that their scientific 
opinions are heard and not suppressed for financial or 
political purposes.
    We have heard too many times the FDA scientists consider 
the drug companies to be clients. Let there be no mistake. The 
American people are the clients of the FDA and the publicity 
around supervisors who are telling people not to do it because 
we need to move these drugs is just wrong and I hope this bill 
corrects that. The American people are the ones the FDA is 
supposed to represent, not the people paying those bills. If 
they don't have the authority to do that, to over see that, 
they pay it to get the speediest approval possible, but the 
American people are the ones that the FDA represents and I hope 
they remember that.
    I hope we can work together on these bills and move the 
process to include strong language to protect the FDA 
scientists and allow them to do their jobs on behalf of the 
American people. There are many specific issues in the bill 
that need to be analyzed and I say these are questions for 
later and I thank the FDA representatives and the stakeholder 
groups for appearing today. And also, I would like to thank the 
chair for your work in moving these bills through the 
committee, particularly ensuring that each of the issues have 
benefited from the public hearing process and I will yield back 
my time.
    Mr. Pallone. Thank you. Mrs. Wilson, did you want to make 
an opening statement? No? I think that concludes our opening 
statements, then, so I will now turn to our witness, our first 
panel. We have with us Mr. Randall Lutter, who is Deputy 
Commissioner for Policy at the FDA. Welcome you. Thank you for 
being with us today. I always say that you may, in the 
discretion of the committee, submit some written responses 
later or additional material if you can't answer the questions 
that we pose today, but if you would, I would like you to begin 
and thank you again for being here.

 STATEMENT OF RANDALL LUTTER, DEPUTY COMMISSIONER FOR POLICY, 
                  FOOD AND DRUG ADMINISTRATION

    Mr. Lutter. Thank you, Mr. Chairman, and members of the 
subcommittee. I am Randy Lutter, Deputy Commissioner for Policy 
at the Food and Drug Administration. I am pleased to be here 
today to talk about discussion drafts to reauthorize several 
statutes of vital importance. In my oral remarks, I will 
highlight only a few areas of concern. Our broader comments and 
concerns are outlined in written testimony that was also 
submitted to the committee.
    The Prescription Drug User Fee Act has produced significant 
benefits for public health, including providing the public 
access to over 1,200 new drugs and biologics since its 
enactment in 1992. We believe that the administration's 
proposal places PDUFA on sound financial footing, enhances pre-
market review and creates a modern post-market drug safety 
system that would follow products throughout their full life 
cycle. We are pleased that the discussion draft is generally 
consistent with the administration's proposal. One significant 
concern to us is the lack of clarity about funding new drug 
safety activities. In our view, the amount that could be raised 
through user fees may be inadequate to support the new 
activities.
    Similarly the user fees provided by the Medical Device User 
Fee and Modernization Act and annual appropriations have 
allowed us to make significant improvements in the device 
review program. Since MDUFMA was enacted, FDA has approved more 
than 150 original pre-market approvals. We believe our proposal 
would ensure sound financial footing for the device review 
program and would enhance the process for pre-market review of 
device applications. We have technical concerns about the 
discussion draft.
    The administration also supports reauthorization of the 
Best Pharmaceuticals for Children Act and the Pediatric 
Research Equity Act. Together, these statutes have transformed 
information about safety and efficacy for children of important 
therapeutics and promoted safety and innovation in pediatric 
drug development. We are concerned, however, that the 
discussion drafts contain provisions that could have an 
unintended and negative impact on these successful programs.
    The draft bill's creation of an internal review committee 
for both BPCA and the PREA functions are of concern. A 
legislative requirement for what are primarily staff functions 
is in direct conflict with our expertise, flexibility and 
efficiency needed to ensure rapid review of pediatric product 
development. For this reason and for related reductions and 
incentives to provide appropriate pediatric drug trials, the 
administration would favor straight reauthorization over the 
enactment of these provisions. The PREA discussion draft would 
require FDA to give priority review status for all supplements 
to new drug and biologics applications submitted as a result of 
PREA. This would remove the flexibility FDA currently has in 
determining the appropriateness of the priority designation in 
relation to other priorities.
    With respect to safe and effective pediatric medical 
devices, FDA is committed to supporting their development and 
availability. The discussion draft raises several concerns, 
however. The draft would require FDA to track separately the 
adverse events associated with for-profit sales versus not for 
profit sales of pediatric devices. The public health benefit of 
such a requirement is unclear to us. The draft also would 
require annual review of for-profit pediatric devices by the 
Pediatric Advisory Committee. This duplicative review imposes 
significant burden without a clear public health benefit.
    We have a number of concerns with the discussion draft on 
drug safety. Some changes prescribe a specific agency action 
without clear public health benefit, such as the requirement to 
present all new molecular entities to advisory committees for 
review. We are also concerned about the breadth of the proposed 
requirements for Risk and Evaluation Mitigation Strategies 
outlined in the bill. We believe it is unnecessarily burdensome 
to require REMS and periodic assessments or reassessments for 
all drugs.
    We support the addition of provisions for an active drug 
safety surveillance system that would be established through a 
public/private partnership and we want to work with you on this 
provision to ensure the most effective implementation. We are 
concerned about new language on preemption in the discussion 
drafts which state that nothing in the Act may be construed as 
having any legal effect on actions for damages under State law, 
including statutes, regulations and common law. We believe that 
State law actions that can conflict with agency conclusions and 
frustrate the agency's implementation of its public health 
mandate should not be endorsed in Federal laws.
    In conclusion, PDUFA III and MDUFMA expire on September 30, 
2007. I want to reemphasize the importance of timely 
reauthorization of these laws in order to avoid disrupting key 
ongoing and effective programs. FDA is ready to work with you 
to accomplish this goal. We welcome the opportunity to work 
with Congress to ensure the benefits of these acts will be 
enjoyed as Congress considers reauthorization of the BPCA and 
the PREA programs, as well. Thank you very much, Mr. Chairman.
    [The prepared statement of Mr. Lutter follows:]

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    Mr. Pallone. Thank you. We are going to start with 
questions and I recognize myself for 5 minutes, Mr. Lutter.
    I understand that the administration is in favor of 
changing the requirement included in our discussion draft that 
requires all new drugs include a REMS. You would prefer--and 
again, I am putting words in your mouth, so if you disagree 
with me at the end here, tell me. But my understanding is that 
you would prefer that the FDA be granted the discretion to 
apply REMS when a problem arises with particular drugs as you 
currently do with RiskMAPs. First let me say, is that correct?
    Mr. Lutter. We are concerned that a broad requirement of 
REMS being applied to all products may be unnecessary and, in 
particular, to the allocation of resources to areas where there 
is no clear public health benefit.
    Mr. Pallone. OK, but then the whole point of the REMS is to 
mitigate certain unknown risks, but what you seem to be 
suggesting is that FDA wouldn't react until a risk for a 
particular drug becomes known, is that correct?
    Mr. Lutter. Well, the purpose of REMS is to mitigate risks, 
but the concern is that for many products, the need for a 
particular action beyond what is already in place is not 
obvious to us and may be unnecessary. That is why we think with 
the breadth of the requirement on REMS is excessive.
    Mr. Pallone. But why do you think that it is more 
appropriate to act only when a risk becomes apparent instead of 
having safeguards in place prior to a risk being revealed? That 
is what I don't understand.
    Mr. Lutter. Well, the REMS requirement would apply to all 
products and it may be lifted from all products only if a 
waiver is granted under circumstances that we think would be 
very rare if there was a finding of no risk to any sub-
populations resulting from use of the waiver. And the real 
question is whether this process of having REMS applied to all 
products is one that is efficient and a good use of resources 
to promote drug safety relative to an alternative one that is 
more narrowly targeted.
    Mr. Pallone. But how burdensome would this really be on the 
FDA? Opponents argue that FDA is going to be overwhelmed by 
REMS requirements, but isn't it true, for most drugs, that the 
REMS requirements will only consist of labeling and adverse 
event reporting requirements? Don't new drugs already have to 
comply with those minimum requirements?
    Mr. Lutter. New drugs do have to comply with those 
requirements, but we believe that the post-marketing 
commitments that we are currently to get from industry are 
generally satisfactory in providing a lot of information to us. 
We reported, in January 2007, the results of post-marketing 
studies and in that case, only 3 percent of open post-marketing 
commitments had been delayed, so in that sense we think our 
track record is relatively successful in that regard.
    Mr. Pallone. Well, let me get to the post-market safety 
with regard to medical devices. There is some concern about the 
lack of attention paid to post-market activities for medical 
devices. We heard that at the hearing. Specifically, FDA has 
testified before the subcommittee before that the agency does 
not feel that a specific earmark of user fees is necessary 
because the agency already has the discretion to use the fees 
that are collected on whatever functions it deems appropriate, 
whether that be pre-market or post-market. But can you tell me, 
what kinds of post-market activities are currently being 
conducted as they relate to medical devices and to what extent 
those activities are funded by user fees? And how about if you 
would comment on the idea of annual appropriations, too.
    Mr. Lutter. First, with respect to the amount of user fee 
money spent on post-marketing safety for devices, I am not 
aware of that. We can get back to you on that. Overall, the 
program of medical devices, user fees provides approximately 17 
or 18 percent of the medical device program. Our broad point 
with respect to an earmark is that we believe that the agency 
management and leadership would benefit from discretion about 
how to use funds in a most effective way to promote and protect 
public health pursuant to its mission.
    Mr. Pallone. What about the annual appropriations?
    Mr. Lutter. The specific question there, sir?
    Mr. Pallone. About annual appropriations. We have a 
provision in the draft to provide for annual appropriations for 
this purpose. Do you have any comment on that?
    Mr. Lutter. We could always do more with respect to 
additional appropriations.
    Mr. Pallone. OK. And then lastly, can you tell me, under 
the authority granted to FDA under section 522 of the Federal 
Food, Drug and Cosmetic Act, how often does the agency require 
a manufacturer to conduct post-market studies?
    Mr. Lutter. For drugs or devices, sir?
    Mr. Pallone. For devices. I am only talking about devices 
now.
    Mr. Lutter. I don't know that. I will have to get back.
    Mr. Pallone. All right, if you could get back to me, I 
would appreciate it. Thank you. Mr. Deal.
    Mr. Deal. Thank you for being here. Let me ask you about 
the third party inspection provisions in the draft. First of 
all, would you explain to us how these third party inspection 
programs, the changes that are proposed would lead to greater 
utilization of these inspections?
    Mr. Lutter. The third party inspection program that is in 
MDUFMA now has not been very extensively used by industry and 
the key idea in coming up with proposals to improve its use is 
that it could be used particularly for surveillance, which is 
essentially routine surveillance. The idea is to what extent 
should FDA delegate entirely to third parties responsibility 
for a third party review. With respect to this, the 
modifications in the third party inspection program for medical 
devices, those would be intended to promote third party 
inspections and routine surveillance where we think that is an 
appropriate use of third party inspection and also, is one that 
allows our resources to be better allocated for areas of key 
risk and concern to us.
    Mr. Deal. And my understanding is the proposed changes 
don't do anything to get rid of safety requirements or conflict 
of interest provisions.
    Mr. Lutter. That is correct.
    Mr. Deal. And you, as the FDA, could have an inspection on 
your own at any time you chose?
    Mr. Lutter. We could surely have an inspection on our own 
in addition to any third party inspection.
    Mr. Deal. Obviously, one of the areas of concern in the 
proposed preemption provisions that are included in most of 
these drafts. It is my understanding that there has been a 
Federal preemption from medical devices since 1976. Is that 
correct and if so, can you tell us what the purpose of that 
was?
    Mr. Lutter. My understanding is that there has been 
exclusive Federal preemption on medical devices for some years. 
The key purpose of that is, I believe, to ensure consistency in 
risk communications with respect to devices. One concern that 
we have with preemption broadly, is that when we make 
determinations of safety and the effectiveness of products, 
medical products that we regulate, we would like to be sure 
that these are communicated in a manner that is clear and 
understandable to stakeholders, not only patients but also the 
medical community and the industry, as a whole.
    A key concern is that if there are other views, other 
authoritative views or other dissent of the regulatory 
requirements, there may instead be a multiplicity of statements 
about risk, and multiplicity of statements about efficacy which 
serve, indirectly, to undermine our effectiveness in 
communicating to the American public about the risks and 
benefits of medical products that we regulate.
    Mr. Deal. Let me ask you about pediatric drugs. Is the 180 
days that is provided from the date of enactment a realistic 
timeframe for a final rule to be issued on how the tiering of 
exclusivity would be decided?
    Mr. Lutter. We have a variety of concerns associated with 
the 180-day deadline and also with that rule, in particular. 
Issuing that rule within 180 days would be very difficult for 
us, but the key concern is really the effect of that rule and 
consideration by FDA, subsequently, of sales relative to the 
cost of the study on incentives for the industry to develop 
trials to provide information to patients and healthcare 
professionals about the benefits and risks to children. We 
believe that the value of information about the health of kids 
is so high that it is inappropriate to reduce incentives for 
these trials and that is why we are concerned about the effect 
of this rulemaking and its implications for incentives for 
pediatric trials.
    Mr. Deal. I would like to ask you about the advisory panels 
and the provisions in the advisory panels that are proposed. 
First of all, is it difficult to obtain qualified people to 
serve on advisory panels and as I understand this, the current 
draft would allow only one waiver per advisory panel for 
potential conflicts, and what effect would this change have on 
obtaining the necessary advisory panels and would this have the 
potential of delaying the effective drugs being put on the 
market?
    Mr. Lutter. Thank you. We are very concerned about ensuring 
that the advisory committees that FDA manages operate in a 
manner that is transparent and clear and enjoys the full trust 
of the American public. We have taken a variety of steps to 
strengthen the management of our advisory committees, including 
in April 2007 we issued a new guidance for public comment that 
would not only ensure greater transparency and consistency, our 
use of waivers of conflicts of interest, but also establish 
new, more stringent criteria for granting waivers of conflicts 
of interest than are currently required by regulations of the 
Office of Government Ethics or by existing statute.
    That guidance that we issued is now being examined 
internally. We have received 77 comments from the public about 
that and we are taking steps to implement it. Broadly, with 
respect to your question, the concern that we have is that 
there are so many recognized established scientific experts in 
the biomedical innovation community who have had financial ties 
to some sort with affected industry, that it is very difficult 
to find experts with the authority and the broad recognition of 
expertise that we want on these committees.
    Evidence to this effect is in waivers that I have signed. I 
sign these waivers for the Food and Drug Administration. They 
are posted on our Web site and in a collection of recent ones, 
you will see this waiver is signed after we have looked for a 
collection of experts at the National Institute of Health and 
within FDA. We are signing these after deliberate efforts to 
search for appropriate expertise from unconflicted individuals 
and then found that we were unable to find the expertise that 
we needed.
    Mr. Deal. Thank you.
    Mr. Pallone. Thank you. Mrs. Capps.
    Mrs. Capps. Thank you, Mr. Chairman. Dr. Lutter, Avandia 
was a wildly successful drug when it came onto the market. 
Since being introduced in 1999 it has blossomed into a $3.2 
billion per year drug. However, with this success, information 
of its shortcomings has come to surface. Specifically, its 
association with increased risk of heart attacks among people 
with diabetes, a population already at higher risk for heart 
disease. I applaud the FDA for convening an advisory committee 
hearing scheduled now for July 30 on Avandia.
    I have two questions to ask you about this, briefly, if you 
would answer. One, how did your agency advertise for positions 
on this advisory committee?
    Mr. Lutter. The advisory committee is comprised with 
requirements under the Federal Advisory Committees Act as a 
collection of standing members who serve 4-year terms and are 
appointed for a 4-year term in anticipation of whatever events 
may arise during those 4 years. So in that sense, those 
standing members who will serve on that panel have been 
appointed in the past. We have greatly improved our process for 
recruiting members of all advisory committees. In February of 
this year we posted on our Web site a centralized listing of 
all vacancies so that an expert in rheumatology or pediatric 
rheumatology or cardiology with interest in serving on 
different committees or one committee at FDA doesn't need to 
track down which of our 47 panels might have a vacancy, but 
instead can submit his or her resume or nomination to a single 
source and thereby we can review that application in an 
integrated manner.
    Mrs. Capps. Let me try it this way. Do you anticipate any 
members of this advisory committee having any conflicts of 
interest with this particular hearing that you have scheduled?
    Mr. Lutter. At this point? It is too early to say. We have 
a process which involves extensive review of all the financial 
holdings of all members of the advisory committees. That 
process takes approximately 45 to 60 days, even when it is done 
on a very accelerated basis.
    Mrs. Capps. Is that ongoing now?
    Mr. Lutter. Yes, it is ongoing.
    Mrs. Capps. Will you complete it by the time of the 
hearing?
    Mr. Lutter. Absolutely.
    Mrs. Capps. So you will know how many people, but you can't 
say it now?
    Mr. Lutter. It is not completed.
    Mrs. Capps. And they will serve whether or not they have a 
conflict of interest?
    Mr. Lutter. We will review their qualifications. We will 
review their qualifications with respect to the statutory 
requirement, which is if the need for their expertise outweigh 
the potential conflicts of interest, we will grant waivers 
accordingly and in a manner consistent with the statute and 
also the guidance that we have currently in place.
    Mrs. Capps. So you might not allow some of the advisory 
members to serve on this panel?
    Mr. Lutter. As a routine matter, we occasionally decide 
that different candidates who may be considered for panels are 
not appropriate because of conflicts of interest.
    Mrs. Capps. And then they don't serve?
    Mr. Lutter. They recuse themselves, we recuse them or we 
may limit their participation based on the findings.
    Mrs. Capps. And this is a matter of public record, those 
that have been asked on different panels so that when your 
hearing is scheduled the public will know which members have 
been asked not to serve----
    Mr. Lutter. For reasons of privacy, we do not reveal the 
different reasons that they have not----
    Mrs. Capps. But you do acknowledge which ones are not 
serving who are regularly on the committee?
    Mr. Lutter. Well, the names of everybody on the committee 
is a matter of public record and the participants in the 
meeting is also a matter of public record.
    Mrs. Capps. Thank you. I want to ask you another question, 
though I am not particularly satisfied there. Maybe there will 
be a way to communicate in writing with some additional 
questions about this process.
    Mr. Pallone. The members may ask additional questions in 
writing, certainly.
    Mrs. Capps. Thank you. Let me get one more topic on this 
particular drug out and you may not have time to answer me now, 
but I would like that answer in writing, too. A New York Times 
article published yesterday the story of Dr. Johann-Liang. She 
joined the FDA in 2000 and eventually rose to deputy division 
director in the agency's Office of Surveillance and 
Epidemiology. However, soon after she recommended a black box 
warning for Avandia over a year ago, things changed. She became 
increasingly excluded from important reviews and meetings and 
eventually, she left your agency. That is what the article in 
the New York Times reported. My question is: after she made her 
conclusion regarding Avandia's heart risk, was she increasingly 
supervised by her FDA supervisors? Please answer yes or no.
    Mr. Lutter. I am sorry, I don't have enough information to 
answer.
    Mrs. Capps. Is there a way you can find out?
    Mr. Lutter. We can back to you on that.
    Mrs. Capps. I would like that in writing, then, since you 
don't know today. I do think this case illustrates a larger 
problem at FDA of employee morale and political interference in 
scientific decision making. I think it is hard for us, in this 
case, not to draw some kind of connection between industry 
influence and an incident like this. I yield back my time.
    Mr. Pallone. Thank you. Mr. Ferguson.
    Mr. Ferguson. Thank you, Mr. Chairman. Thank you, Dr. 
Lutter, for being here, as well. I just want to begin by 
echoing some of the concerns that Mr. Deal and Mr. Rogers had 
raised before. I know, from being on the other side in this 
committee and subcommittee, the best work that we do is work 
that is thorough and frankly, takes into account lots of 
different viewpoints and the work that we have done over the 
years in a bipartisan fashion, that has always been the spirit 
of this committee and I think that has largely been the case 
with regard to the legislation that we are considering today.
    It has perhaps not been as much the case the last several 
days. And I am hopeful that in the next several days and in 
weeks ahead, as we work through this legislation, that we 
really will be able to take more viewpoints into account. I 
have a particular concern, I have several concerns about the 
legislation that we are looking at.
    One in particular is preemption language that Mr. Deal had 
raised before. I think Mr. Rogers made a very eloquent, brief 
case for an alternative point of view than is reflected in the 
draft, the drafts that we are looking at and I think, my sense 
is that having something dropped into a draft mysteriously at 
the last second, I know from it happening some time when I was 
in the majority. It never serves the civility and a solid end 
product very well on this committee and I am hopeful that we 
can address that in the next several days.
    Dr. Lutter, as you know, the FDA is currently holding a 
public meeting on medication guides today and tomorrow. Just a 
couple of hours ago I actually testified at that hearing and at 
that public meeting. I presented, just this morning, the 
findings of a year-long investigation that we had been 
conducting in my office about the distribution of medication 
guides and I want to register my thanks to you and to the FDA 
and the agency for holding the public hearing and focusing on 
the issue. As I said, at the public meeting this morning, and I 
repeated at the committee hearings here, the current regulation 
of medication guides represents a potentially alarming 
situation in which young patients and their parents may not be 
receiving the information they need to make fully informed 
decisions about certain prescription medications.
    It is clearly all of our shared goal to ensure that 
patients, including children, have the access to the safest and 
most effective therapies. But taking that into consideration, 
the FDA has rightly implemented strict requirements on the 
prescribing of some drugs, including antidepressants used by 
children and adolescents by issuing black box warnings and 
requiring medication guides. Those and other requirements are 
necessary to ensure that people to whom certain medications are 
prescribed, including parents and adolescents, parents of 
children and adolescents have the information they need to make 
fully formed decisions.
    If these needed requirements are not being implemented, the 
public can't make fully informed decisions and therefore may be 
placed at risk and that may well be that in many cases, the 
children and adolescents who are being prescribed these 
particular drugs may be receiving the medication guides, but it 
can't be said with certainty at a hundred percent of the time 
these parents are receiving this information. There has been a 
breakdown in the communication between the FDA and State boards 
of pharmacy. The FDA issues the regulations on med guides. 
State boards of pharmacy are charged with enforcing the 
regulations on the distribution of medication guides.
    And I have been in correspondence back and forth with our 
New Jersey State Board of Pharmacy and with the FDA and others. 
I believe that one component to a solution to this problem that 
we face is communication, consistent dialog between the FDA and 
the National Association of Boards of Pharmacy. I think that 
can be a very helpful part of this process.
    Dr. Lutter, does the FDA currently have the ability and the 
authority to work with groups like these to keep them fully 
updated on the ever-changing duties regarding the distribution 
of medication guides?
    Mr. Lutter. We work very closely with the National 
Association of Boards of Pharmacy and with State boards of 
pharmacy in different States and I appreciate very much your 
interest in our public meeting on medication guides this 
morning. As you know, several members of the senior leaders of 
the team spoke there and I was looking forward, myself, to the 
opportunity but decided I would better spend my time preparing 
here.
    With respect to the broad question, though, we are very 
concerned about ensuring that information about the risks of 
pharmaceutical products is conveyed as effectively as possible 
to patients, to their families and to their healthcare 
providers. In that sense, this public meeting that we are 
holding today is an open, transparent, visible and we are 
grateful for our participation. We are thankful for the 
different participation of the various stakeholders and we will 
work expeditiously to ensure that medication guides provide as 
effective communication of risk as possible in the future.
    Mr. Ferguson. Thank you for that. I know the FDA has been 
engaged with pharmacist organizations and others about the 
distribution chain of medication guides. But it is my 
understanding, my sense, really, that the FDA has dragged its 
feet a little bit on enabling pharmacists to provide and 
produce medication guides electronically. Don't you think it 
makes sense to give pharmacists the ability to electronically 
print out med guides to alleviate the problems that may be 
currently in the med guide chain? I mean, one concern we hear 
from pharmacists all the time is they simply don't have the 
shelf space to store boxes and boxes and boxes of paper 
medication guides. We allow them to distribute other things 
electronically, just print them out at the pharmacy. Is it your 
sense that it would also make sense to allow them to do this?
    Mr. Lutter. I think that is one potentially very intriguing 
option that we will explore in the course of looking at all 
public comments received in the course of the public meeting on 
medication guides today.
    Mr. Ferguson. As you might guess, I am a strong supporter 
of electronic distribution of med guides. I just think it 
doesn't sacrifice the quality of information, but enhances the 
quantity of information that is available, particularly to 
parents, as they are trying to--and the great thing about 
medication guides, as you well know, is it is in English. A 
non-doctor, non-pharmacist can actually read it, understand it 
and therefore make a more informed better decision about the 
healthcare of their child. I would ask my colleagues on the 
committee to consider changes, as we work through this 
legislation and reauthorization, that would encourage or 
mandate the FDA to engage in these measures, to use some of 
these measures to streamline or enhance the distribution of 
medication guides. I think it would do a great deal to help the 
cause of public health and in addition to some of the other 
concerns and issues that I raise, Mr. Chairman, that would help 
to get to work through as we mark up and move this legislation, 
I hope that this might be something that we could consider, as 
well, and I yield back.
    Mr. Pallone. Thank you. Ms. DeGette.
    Ms. DeGette. Thank you, Mr. Chairman. Dr. Lutter, recently 
Dr. Shuren, who is here, I see, testified before this 
subcommittee and I had a whole series of questions for him 
about medical devices in pediatric populations which we 
forwarded to the FDA but which we have not received written 
responses back to yet, so I thought I would ask you these 
questions. The first one is that the Institute of Medicine 
conducted a study to determine whether the FDA's system for 
post-market surveillance of medical devices provides adequate 
safeguards for their use in pediatric populations. The study 
included a number of recommendations for the FDA and I will 
enumerate them quickly.
    Number 1, collaboration with the National Institutes of 
Health and the Agency for Healthcare Research and Quality to 
define a research agenda and priorities for the evaluation of 
short and long-term safety and effectiveness of medical device 
use with growing and developing children.
    Number 2, promotion of the development and use of standards 
and approaches for capturing and linking use and outcomes data 
for medical devices.
    Number 3, collaboration with industry, healthcare 
professionals and organizations and parent and patient 
advocates to improve adverse event reporting.
    Number 4, oversight of the management of high profile 
medical device safety issues similar to the independent drug 
safety oversight board within the FDA and finally, 
establishment of a central point of responsibility where 
pediatric issues within the Center for Devices and Radiological 
Health to evaluate the adequacy of the center's use of 
pediatric expertise and its attention to pediatric issues in 
all aspects of its work. That is a long list, but I want to 
have it in the record because I want to ask you whether the FDA 
has adopted any of those recommendations.
    Mr. Lutter. We are in the process of reviewing both your 
letter and the recommendations and I am not prepared to give 
you a more explicit answer on that. I don't know.
    Ms. DeGette. So you don't know whether they have adopted 
those recommendations?
    Mr. Lutter. I understand you sent this letter and we owe 
you a reply and I look forward----
    Ms. DeGette. Well, but the recommendations were made before 
I sent the letter and now you guys have had over a month to 
review the letter and the previously made recommendations, so 
have you all implemented any of them?
    Mr. Lutter. I am not informed about the status of this. We 
will have to get back to----
    Ms. DeGette. Did you know about my letter before today's 
hearing?
    Mr. Lutter. No, I didn't.
    Ms. DeGette. When did you find out about it?
    Mr. Lutter. This letter and the specific contents I am 
learning about now.
    Ms. DeGette. You didn't know about my letter until I asked 
you the question just now?
    Mr. Lutter. I didn't know about the contents until you 
asked me the questions.
    Ms. DeGette. OK. Mr. Chairman, I would ask unanimous 
consent for a written response to my letter, which was made 
after the last hearing within 2 weeks of today's date.
    Mr. Pallone. Without objection, so ordered.
    Ms. DeGette. Thank you.
    Mr. Pallone. I would hope that you would be able to do 
that.
    Ms. DeGette. And especially since your staff is sitting 
right here in this room who were at the hearing last week. Now, 
there were also a number of recommendations in this report; you 
probably don't know about these, either, but I will put them on 
the record. They cited recommendations for Congress, including, 
No. 1, requiring the FDA to establish a system for monitoring 
and publicly reporting the status of post-market study 
commitments involving medical devices.
    Number 2, permitting the FDA to order post-market studies 
as a condition of clearance for the categories of devices for 
which section 522 post-market surveillance studies are now 
allowed, and No. 3, allowing the FDA to extend those studies 
for devices with expected high pediatric use beyond the current 
3-year limit.
    Do you think that Congress should follow these 
recommendations and make those necessary statutory changes?
    Mr. Lutter. Could I ask you to repeat the question?
    Ms. DeGette. You bet. The same report I just referred to 
cited a number of recommendations for Congress requiring the 
FDA establish a system for monitoring and publicly reporting 
the status of post-market study commitments involving medical 
devices, permitting the FDA to order post-market studies as a 
condition for clearance for the categories of devices for which 
section 522 post-market surveillance studies are now allowed 
and No. 3, allowing the FDA to extend those studies for devices 
with expected high pediatric use beyond the 3-year limit. Do 
you think those are good ideas?
    Mr. Lutter. Now, with respect to the first one on the 
monitoring and reporting of post-marketing studies, we think we 
already have some ongoing programs in that regard, but ma'am, 
these are really areas where I need to express my apologies and 
say that I am not in a position to respond about the specific 
program and I will have to get back to you on this.
    Ms. DeGette. OK. This was a study that was conducted by the 
Institute of Medicine. Oh, it came out in 2005, so I would 
appreciate it if you would have your staff review those 
recommendations and also get back to me in writing.
    In April, Dr. Theresa Mullin, who is also here in this 
room, testified before this committee. I asked her, given the 
public's loss of faith in the FDA's ability to regulate the 
drug industry whether it would be possible to hold the next 
round of PDUFA negotiations in public and I also asked whether 
commercial, confidential or trade secret material of individual 
companies was discussed at those meetings. Dr. Mullin said to 
me there is no confidential, commercial, trade secret, anything 
of that type discussed in such meetings. So I would just like 
to confirm, does the FDA have any concern over opening up the 
PDUFA negotiation process to the public since none of these 
confidential things are discussed in the meetings?
    Mr. Lutter. Let me offer a brief comment on background 
before I offer the specific answer to your question. We think 
that the process would run with respect to developing our PDUFA 
recommendations has already complied with not only the 
statutory requirements for involving all stakeholders, but is 
exemplary in that it had a public meeting a year ago last fall; 
it had another public meeting more recently and it had a series 
of approximately a half dozen meeting with public interest 
groups, stakeholders like patient representatives and consumer 
representatives, as well as the healthcare provider community.
    In that sense, there has already been, we believe, ample 
input from non-industry participants in this process. If these 
participants, these stakeholders wanted to sit in on the 
meetings, this is something that may raise challenges from the 
viewpoint of efficient use of time and the detailed nature of 
these discussions, but it is not something that we have any 
particular objections to.
    Ms. DeGette. OK. There are a number of provisions included 
in these bills that address direct-to-consumer advertising from 
drug companies. In the PDUFA legislation we are talking about, 
drug companies may pay a user fee to submit to direct-to-
consumer television advertisements for advisory review. So 
given that it is a voluntary program, I am wondering how 
beneficial it will be and quickly, could you answer for me what 
percentage of direct-to-consumer television advertisements are 
reviewed by the FDA?
    Mr. Lutter. I don't know that answer, but I do know that in 
developing that proposal, we paid a lot of attention to how 
much work would be involved and the specific answer was that we 
expected approximately 150 television ads to come in for review 
and this suggests that it is a large number that would offer 
significant benefits to the American public in terms of 
ensuring that a large set of TV advertisements meet appropriate 
standards are truthful and not misleading.
    Ms. DeGette. Again, Mr. Chairman, I guess in the same 
answer that I am going to get in 2 weeks, if you could provide 
the information I have asked for, what percentage of these 
television advertisements are reviewed. I would appreciate it. 
Thank you.
    Mr. Pallone. Thank you. You heard our requests. If we can 
get this back in writing within 2 weeks, we would appreciate 
it.
    Mr. Lutter. We understand, thank you.
    Mr. Pallone. Thank you. Mrs. Wilson.
    Mrs. Wilson. Thank you, Mr. Chairman, and thank you very 
much for being here. I think there is a generalized agreement 
that we need to do more with respect to post-market 
surveillance of drugs and side effects and so forth. Can you 
explain how that might be achieved and what your views are on 
how we can modernize our drug safety system with respect to 
post-market surveillance. The draft of the legislation, I 
think, is fairly general, but what do we need to do to 
strengthen post-market surveillance and how might you implement 
that?
    Mr. Lutter. The draft and language in Senate proposals 
emphasized, at one point, or mentioned at one point, something 
that we think would be fair to emphasize and that is a public/
private partnership on surveillance. And the idea is that FDA 
and perhaps the Reagan-Udall Institute, which was outlined in 
some detail in the Senate provision, could work with a very 
broad collection of private parties to ensure that appropriate 
expertise is brought to bear about statistical data mining, 
signal detection, signal characterization and through the 
interlinking of different databases using electronic medical 
records and other new information technology systems.
    This is not something that may be done successfully 
overnight, but it is a vision of what would be the future of 
drug safety. It is something that we announced in a public 
meeting earlier this year, called the Sentinel Network. I think 
we held that in February and we are working with a variety of 
stakeholders inside and outside the Government to try and 
cooperate in the interlinking of electronic databases. We 
believe that further language in the discussion draft 
characterizing this public/private partnership, linking it, in 
particular, to the Reagan-Udall Foundation might be beneficial.
    Mrs. Wilson. How would it really work? And I am quite 
familiar with linking databases and doing statistical analysis 
and so forth, but as a regulator, how would this work and 
change either the information that is available to consumers or 
families, or change your regulatory approach to now how are you 
going to decide that a drug should be taken off the market or a 
special warning needs to be put on a drug?
    Mr. Lutter. Such a partnership and the system of 
interlinked databases would not change our regulatory 
standards, the standards for making regulatory decisions would 
be independent of that. But what it would do is give us 
substantially new, more and better, more timely information 
about risks and in particular, if these databases existed and 
could be analyzed more quickly than we now are able to do with 
the post-market surveillance system currently in place, we 
would be better able to detect signals about adverse events 
like heart attacks or heart failure and we would thereby have 
an ability to inform families, patients and doctors earlier 
about these risks through label changes, through black box 
warnings. It might be implemented earlier than would otherwise 
be the case and that is the way in which it would matter to 
families.
    Mrs. Wilson. Let me ask you something about device recalls. 
When a medical device recall is issued, to whom is it issued 
and can the FDA currently direct a company to notify patients 
about a recall or do you need more specific legislative 
language in order to direct them to do so?
    Mr. Lutter. Device recalls fall into several categories, 
depending on their class and depending on the level of 
information about the health risks and we do not, at this 
point, my understanding is that we do not have information to 
notify individual patients. We are working expeditiously on the 
development of a unique device identifier that may provide more 
information and a better way of communicating concerns to 
families.
    Mrs. Wilson. But do you have the authority that you need to 
direct a company to inform patients currently or is greater 
authority required?
    Mr. Lutter. Yes, we currently have authority to notify 
patients.
    Mrs. Wilson. To notify patients or direct that companies 
notify patients?
    Mr. Lutter. We have authority to do both.
    Mrs. Wilson. OK. Thank you. That is all I have, Mr. 
Chairman.
    Mr. Pallone. Thank you. The gentlewoman from Oregon.
    Ms. Hooley. Thank you, Mr. Chairman. Dr. Lutter, I have 
been working with Mr. Engel and Mrs. Capps with pharmaceutical 
groups to help address the concerns about pharmacy compounding. 
I believe that traditional pharmacy compounding provides an 
extremely valuable service to consumers. It enables patients to 
get the medicines they need that would otherwise have been 
unavailable. However, I have been concerned about a couple of 
recent events that have happened in my State where two people 
in Portland and one in Washington State died because of a 
pharmacy compounding mistake.
    I believe we need to ensure patients know they are taking a 
compounded drug, but we must do so without unduly burdening 
pharmacists. Do you believe the FDA and the State Board of 
Pharmacy have all the tools they need to ensure pharmacy 
compounding is done safely? Or what do you need?
    Mr. Lutter. Currently we are concerned about the safety of 
patients and of compounded drugs. We have taken a variety of 
enforcement actions against pharmacy compounders who may be 
making products that are unsafe through a very large industrial 
level, organizations and manufacture of products and we have 
taken enforcement action against those. As you know, there is 
pending litigation on compounding and we look forward to the 
outcome of that. But with respect to our efforts currently to 
ensure that safety of the American public and of patients from 
compounding drugs, we are currently taking enforcement action 
and since this is where we believe that compounders are 
violating the law.
    Ms. Hooley. You have small pharmacists that make a few 
compounds because that is what the patients need and then you 
have large companies doing compounding. Do you distinguish 
between the two? Do you need further authority to make a 
difference here?
    Mr. Lutter. The distinction is nuance. It depends on 
whether or not the products are being made by the pharmacist in 
response to a prescription written by an authorized healthcare 
provider for an individual patient and in that instance, it is 
an area which falls into traditional compounding and does not 
merit further new authorities on our part. We have authorities 
to take action against compounders who are essentially 
producing unapproved drugs because they are working on an 
industrial type of operation, and in instances where we find 
that there are products that are unsafe for the American public 
being sold by such compounders, we do take such action.
    Mr. Pallone. The gentlewoman is done. Mr. Burgess.
    Mr. Burgess. Yes. Doctor, let me just follow up on that 
briefly about the compounding issue. How do those compounding 
issues come to your attention if there is a small pharmacy that 
is compounding a particular medication, how does that come to 
the FDA's attention? Why type of surveillance do you have over 
the small pharmacy that is providing that service for patients?
    Mr. Lutter. Well, we have a very large collection of ways 
of getting information. It may be other pharmacists, it may be 
drug companies, it may be healthcare providers, it may be 
patients, it may be the State Boards of Pharmacy, sort of a 
variety it may come from and it would really depend on the 
individual circumstance.
    Mr. Burgess. But there is not a structured surveillance 
system at the FDA that oversees that?
    Mr. Lutter. We have an adverse event reporting for all 
drugs and I am not familiar with whether or not it has any 
information organized in it about compounded products as 
opposed to non-compounded products.
    Mr. Burgess. OK, thank you. Under the negotiation process 
for PDUFA IV, you said in your testimony you met with the 
various stakeholders. Were you meeting with patient groups 
during that time, as well?
    Mr. Lutter. Absolutely. The stakeholders included patient 
representatives, consumer representatives and representatives 
of medical organizations such as pharmacists.
    Mr. Burgess. Now, in the brief time that I have had, that 
my staff has had the ability to have the bill, there are some 
technical problems with the drafts. Has the other side, the 
majority, afforded you the opportunity to provide technical 
comments on the drafts as they have been submitted?
    Mr. Lutter. We met with staff last week. We received the 
bill last Thursday. We look forward very much to further 
opportunities to meet with staff over the next few days and 
weeks.
    Mr. Burgess. And are those discussions, are those generally 
available to the staff on both sides of the dais?
    Mr. Lutter. Absolutely.
    Mr. Burgess. OK. I also want to ask a question about the 
New York Times article yesterday. We have already heard that 
referenced at one point. Now, prior to PDUFA--I am a physician 
and practiced in the 1980s. I do remember the slow pace of new 
drug approvals and it was painful and I think it was a group 
of, actually, AIDS activists who said look, we are being denied 
significant medication that could help us because of the length 
of time it takes the FDA to approve medication, so the need for 
speed was certainly underlined in the early 1990's when a 
Democratic Congress passed the first version of PDUFA. Now we 
are in discussions that perhaps we are approving things too 
quickly, that safety needs to balance the speed. How good a job 
are we doing at balancing safety and speed under our present 
system?
    Mr. Lutter. A key point to recognize is that PDUFA gives 
FDA more resources and in that sense, the dichotomy that has 
often been described, that is between access and safety is 
false. It suggests that without additional resources and 
without the additional staff and information technology support 
that PDUFA fees can provide, we are unable to do things better 
in the same amount of time. In fact, we can. And the whole 
thesis behind the success of reauthorizations of PDUFA ever 
since 1992 is that with the additional resources we are able to 
review, not approve, but to review product applications faster, 
in a manner that preserves our ability to ensure that they meet 
exactly the same standards that existed prior to PDUFA.
    And in that sense, the strength of the statute has really 
been through additional resources. We have an ability to make 
review decisions which tend to be associated with approval 
decisions and therefore access, but from our perspective, they 
are review decisions, be they approval or non-approval, faster. 
As a result, we are able to lead to faster access of drugs to 
market in a way that promotes the access that was driving the 
AIDS activists about 20 years ago in a manner that benefits the 
American public and does not sacrifice, in our judgment, drug 
safety at all.
    Mr. Burgess. And then, just in the brief time I have left, 
would you address again for me, if you would, the issue of 
conflict of interests, the need for having the technical 
expertise to have the experts in the room. When you were 
answering the question earlier, I guess I was left with a 
question in my mind, who sort of oversees that process? Who 
oversees the overseer in that regard? How can we know that you 
did have the right experts in the room, that they weren't 
excluded because of a perceived conflict of interest, or on the 
other hand, how do we know that a conflict of interest was not 
allowed to have access to the decision making process where it 
really would have been inappropriate?
    Mr. Lutter. Well, with respect to who oversees the overseer 
within FDA, I do. I sign the waivers of conflicts of interest 
and under my jurisdiction is the Advisory Committee Oversight 
and Management Staff. More broadly, the public and you. We post 
on our Web site all of the waivers that we are permitted to 
under law. We post, also, information disclosures signed by the 
advisory committees, themselves. We reveal to the public, 
during the advisory committee meetings, the conflicts of 
interest that may be present by the advisory committee members 
or consultants that we bring to the advisory committee 
meetings. All of this is available to the public and in that 
sense, we operate under a regime of full disclosure to the 
extent that any conflicts are revealed that are material. We 
disclose them to the public through the advisory committee 
meetings, themselves, and on the Web site.
    Mr. Burgess. But if I could just interrupt and how do we 
ensure that the balance doesn't go too far the other way? Maybe 
I will submit that to you in writing because that is a concern 
of mine. Thank you for your time.
    Mr. Pallone. Thank you. Ms. Eshoo.
    Ms. Eshoo. Thank you for recognizing me, Mr. Chairman. 
Thank you, Doctor, for your testimony. First, I just want to 
make a comment about this direct-to-consumer advertising. I 
don't like any advertising of pharmaceutical companies. I just 
don't find it to be appropriate and the idea that this is 
really in-depth information to consumers, I think is a joke. I 
mean, it is on par with political advertising. I mean, how much 
do you know about a candidate in 30 seconds or less? So I just 
don't like it and I think that the way it is set up, that the 
program is almost designed to fail because companies don't have 
to submit their DTC ads for review and they don't have to pay 
fees to support the program. I don't know. At any rate, every 
time I hear about advertising, it really pushes a button with 
me. Here are my questions.
    On third party inspections, when we authorized MDUFMA in 
2002, we actually, with reluctance, established a third party 
inspection program. It was controversial and the legislation 
was not easy to get done. In fact, I think most bets were that 
it would fail. But I think that we have taken some very large 
important steps forward and I am proud of it, I am pleased 
about it. Now, the purpose of the program was to allow the 
agency to have some resources, obviously, to utilize outside 
accredited inspectors to conduct the inspections and provide 
reports back to the FDA. Now, the GAO report published earlier 
this year found that manufacturers have been reluctant to 
participate in the program because of the number of statutory 
obstacles. First, what has FDA done to increase the 
participation in the third party program and has the agency 
done anything since its inception to increase the number of 
inspections actually conducted by FDA? And do you agree with 
the GAO findings?
     I don't have a lot of time. I have some other questions.
    Mr. Lutter. We will have to get back to you on that.
    Ms. Eshoo. That is interesting. Good, I will look forward 
to hearing back from you. I have serious concerns about 
liberalizing the third party program. The reliance on third 
party has always had, as I said earlier in my opening 
statement, a real push and pull to it. While I think it has 
worked, I think the public has raised legitimate questions 
about it and it can be likened to the fox being in charge of 
the chicken coop, although I think that that diminishes some of 
the things that happen, there is that kind of take on it.
    Now, I understand that the industry is frustrated by the 
lack of direct oversight conducted by the FDA and so the third 
party program ends up being a good alternative for them. Do you 
think that this is set up so that it lessens the FDA's 
inspection authority under the law? It relates back to what I 
was asking before and you said you have to get back to me, but 
I want to probe in this area to see how far we have come since 
the 2002 legislation became law.
    Mr. Lutter. We believe that with the recommendations for 
change in our MDUFMA proposal, it would not lessen at all the 
FDA's authority. The key question is efficient use of resources 
that we have and an ability to allocate them with respect to 
risks that we believe are important. What we have is a proposal 
for a third party----
    Ms. Eshoo. But the participation, historically, has been 
low, so I am asking you what you think has worked, that the 
proposed legislation really enhances, the best of what we made 
law in 2002. There is something not working right because the 
participation is low.
    Mr. Lutter. We agree that the program currently has not 
worked. We agree with you.
    Ms. Eshoo. Now, why? Why do you think so, FDA? GAO has 
leaned in on it. Why do you think it hasn't?
    Mr. Lutter. We think it is partly for the lack of the 
changes that we are making with respect to the particular----
    Ms. Eshoo. Did you ever come up and ask for additional 
authorities or changes in this?
    Mr. Lutter. Well, the changes are ones that we are now 
asking for with respect to part of the MDUFMA proposal. The key 
concern that we have is the use of resources internally. We 
have spent, I think it is like $3 million over the years as 
part of MDUFMA, implementing the proposal. It is very little 
money for third party inspection and, that is, the use of our 
resources that aren't well spent relative to alternative ways 
of improving device safety.
    Ms. Eshoo. Can I just get a real quick one in here 
regarding the sunset of PREA and the exclusivity incentive 
under the BPCA? Does the FDA prefer any of the provisions that 
are being cast about, the blockbuster provision included in the 
Committee Print or an extension of the 6-month exclusivity?
    Mr. Lutter. We would prefer the existing statute for its 
simplicity and for the high incentives that it gives for 
pediatric trials that provide information that benefit the 
children.
    Ms. Eshoo. Thank you. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. I didn't know what your intention 
was there with the other gentleman and if you wanted to have 
one of them answer a question, that is fine. I didn't know if 
that is what you were trying to do there.
    Mr. Lutter. Thank you, sir. We will figure it out.
    Mr. Pallone. All right. Mr. Pitts.
    Mr. Pitts. Thank you, Mr. Chairman. To follow up, just 
briefly on Congresswoman Wilson's question about, Dr. Lutter, 
has the agency done anything to date related to establishing a 
unique device identifier system for medical devices?
    Mr. Lutter. We are currently involved in a rulemaking 
process that would allow for the development of unique device 
identifiers and we are pursuing that expeditiously.
    Mr. Pitts. Now, some claim it is not as easy to establish a 
UDI system for devices as it is for drugs. Can you please 
explain what issues make UDI for devices more complicated along 
with the steps that you are proposing to address those 
concerns?
    Mr. Lutter. I am not in a position at this time to talk 
about the rulemaking that is ongoing. I think with respect to 
the difficulties, the first question is that unlike with the 
drugs, there is a threshold issue of scope. Is it all medical 
devices or is it only a subset and what is the subset of 
special concern; is it implantable or does it go more broadly 
than that. And second, there is also a question of how the 
unique device identifiers should be linked to the device, 
itself; is it on the labeling or should it be implanted in some 
way on the device so that it can't be separated, even after the 
device is separated from its labeling. Those are questions that 
we will consider in the rulemaking.
    Mr. Pitts. Regarding preemption, some proponents of the 
labeling or language, claimed that the language only has to do 
with provisions in the current bills before us. Would it not be 
counterproductive to public health for States to impose 
different REMS requirements than those imposed by the FDA?
    Mr. Lutter. Confusion about REMS requirements or confusion 
about risks of FDA-regulated products is broadly of concern to 
us because it undermines both the trust that we need to have 
with the public to communicate the risk with them in a manner 
that lets them take appropriate action to control and to 
mitigate those risks and we think that preemption language 
would essentially have the effect of formalizing, in Federal 
statute, a collection of State actions that may be 
contradictory to or inconsistent with FDA actions on the safety 
and effectiveness of FDA-regulated products.
    Mr. Pitts. That is all I have. Thank you, Mr. Chairman.
    Mr. Pallone. The gentleman from Utah.
    Mr. Matheson. Mr. Chairman, I have a series of questions I 
am going to submit in writing. I am not, after discussion with 
the agency, I am pretty sure they are not ready to answer 
today, so I will just submit them for written response. I yield 
back.
    Mr. Pallone. Thank you. Mr. Rogers. He is not there? Mr. 
Buyer.
    Mr. Buyer. Thank you. I would like to follow-up on Mr. 
Pitts' questions. If all this legislation is intended to 
strengthen your ability to give assurances to the public about 
the products that are in the marketplace, how is it that the 
provisions that are in the bill regarding preemption actually 
allow you to do that? If we are going to allow these State 
class action lawsuits to even make jurisprudence more complex, 
how does that help you do your job?
    Mr. Lutter. We are concerned with the preemption provision 
in the discussion draft, because it may actually complicate our 
efforts to communicate risks in a manner that people 
understand. And the key question is, if we have additional 
resources through PDUFA and an additional set of information 
about risk, do we also have a system that we can convey to the 
public the risks of and the benefits of use in FDA-regulated 
products? We think that the preemption position may undermine 
our ability to do that effectively by allowing for multiplicity 
of views in State jurisdictions that may be seen as contrary to 
or inconsistent with the FDA statements about risks and 
effectiveness.
    Mr. Buyer. Mr. Pitts asked you about unique device 
identifiers. Let us talk about your present authority as 
opposed to what authority you may not have that you may need 
for us to put in a bill. Right now you have authority to 
require tracking for class II and class III devices, correct?
    Mr. Lutter. Yes.
    Mr. Buyer. Now, in the bill, it appears that there is a 
broad expansion, which would require unique device identifiers 
on about anything imaginable that we are going to put into the 
body. Now, you said you don't want to talk about your present 
rulemaking on the development of a present system, but it would 
be shocking to me that the FDA would like to create a system in 
a rulemaking whereby you would have--well, let me take another 
step back. I would think that you need to create a rule that 
would have tracking orders that would be issued based on risk, 
would it not?
    Mr. Lutter. Our focus, in general, in managing the agency 
is on risk and we try to be----
    Mr. Buyer. So earlier, when you talked about scope and 
subsets of scope, you are talking about tracking devices that 
are going to go into the body based on the risk and the impact 
that failure could have, right?
    Mr. Lutter. That is correct.
    Mr. Buyer. So when we want you to have that focus in that 
scope, how does broadening the expansion to apply to about 
every device imaginable going into the body help you do your 
job if tracking is not going to be based on assessment of the 
risk?
    Mr. Lutter. In general, our effort and our policy with 
respect to protecting and promoting public health is to 
emphasize the risks of greatest concern and in that sense we 
would be concerned about excess breadth in the design of a 
program to focus unique identifiers. With respect to the 
particular language, this is something that because we received 
this only last Thursday, we should probably welcome that 
opportunity to talk separately with your staff about the unique 
identifier language, because this is not an area that we have 
studied in this legislation in detail.
    Mr. Buyer. As you are developing your regulations for your 
own type of tracking system, what is your timeline to complete 
such system?
    Mr. Lutter. We are committed to doing it expeditiously, but 
we do not have a timeline for completion of a final rulemaking.
    Mr. Buyer. Would your counsel to us be for you to complete 
your work and for us to then provide the oversight with regard 
to your system? And then, if we have questions or have our own 
ideas or want to broaden its scope, it would be more prudent to 
modify FDA's system rather than Congress just mandating a broad 
expansion with no regard to the system you are presently 
developing?
    Mr. Lutter. Well, the present program is one that we are 
developing without any concern about limitations of authorities 
in regard. So in that sense it is one that we think is worth 
pursuing with existing authorities, yes.
    Mr. Buyer. Yes. In other hearings FDA had witnesses come 
before us, and not only myself but some other members of the 
committee have been concerned about counterfeit drugs and their 
prevalence in the marketplace. So we have seen this growth of 
adverse events reports over the last 3 years, and I have been 
trying to figure out what has been the impact of the growing 
prevalence of counterfeit drugs on the marketplace on this 
increase in adverse reports. What I am learning is that it is 
very difficult to determine this impact, and that, really, the 
system itself is not set in such a manner whereby we can have 
such retrospective analysis of that data. So I have a couple of 
recommendations that you can do on your own that we don't have 
to put into law, so I want you to please take these back to the 
FDA, and I think we can be helpful to each other.
    What I am learning also, from the current MedWatch adverse 
events reporting, on the reporting form itself--is anybody 
going to write this down? Alright, because I don't want to 
waste my breath here, otherwise I will put it in the law. It 
includes a line that calls for name, strength and then 
manufacturer, and that information is all in that one line. My 
recommendation would be that the manufacturer be given a 
separate space on the form so whenever the healthcare provider 
completes the MedWatch form, we get the correct name of the 
manufacturer, because what I am also--and I know you are 
saying, Steve, that is up to the clinicians--but what is 
happening out there is that the clinicians are putting the name 
of the manufacturer, and sometimes it is a generic product and 
they mistakingly put the name of the original manufacturer. So 
if we give it a separate line, we are actually saying that we 
hope the clinician stops and gives it some good thought and 
actually pulls the manufacturer that is from the drug label 
itself.
    Number 2 is you would also have a separate line that would 
have the addition of the purchase location of the medication. 
Now, earlier at one of the other hearings I had said, are we 
going to have to require doctors to start asking their patients 
where are they obtaining their drugs, because many of them are 
either running off to Canada or they run off to an Internet or 
they go to an Internet site and they are pulling them down from 
many different sources.
    So we have docs out there that are struggling. We have 
internists and they give their script to their patient, but 
then we have no idea where the patient then is obtaining the 
drug and they come back and the doc thinks that the drug which 
they are prescribing is supposed to get the effect but they are 
not. He is puzzled. He then switches drugs. So I am trying to 
figure out how we get to that next follow-on step as we are 
trying to deal with these counterfeit drugs. These are actions 
that you can take on your own and I wish you would consider 
them.
    Mr. Lutter. Thank you very much for sharing them.
    Mr. Buyer. Right.
    Mr. Lutter. I made careful note and we will discuss them 
internally.
    Mr. Buyer. All right. Thank you very much. I yield back.
    Mr. Pallone. Thank you. Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. Dr. Lutter, I 
wanted to go back to the subject that Congresswoman Capps 
raised and that was the New York Times article yesterday. You 
did not see it?
    Mr. Lutter. I had an opportunity to glance at it only.
    Ms. Schakowsky. OK. Mr. Chairman, I would like to have it 
included in the record, if I could.
    Mr. Pallone. Without objection, so ordered.
    Ms. Schakowsky. Well, let us talk about the substance of it 
rather than maybe the specific issue. I will just quote. ``The 
increasing number of FDA drug safety officers who say they have 
been punished or ignored after uncovering dangerous popular 
medicines.'' They talk about this one particular woman and the 
drug Avandia, but they give a number of other examples. Dr. 
Andrew Mossholder, in 2003, who discovered antidepressants led 
some children to become suicidal and the findings--Dr. 
Mossholder was prevented from speaking to an advisory committee 
about his analysis. Then Dr. David Ross, in 2006, very 
concerned about serious illness and death from patients taking 
the antibiotic Ketek. Is that Ketek? And Dr. Ross met with 
agency officials and pleaded with them to take action and 
nothing happened. It ends with a quote from someone still at 
the FDA, saying that people in this former office of Dr. 
Johann-Liang were very demoralized. There is a feeling of fear.
    Obviously, that is of concern, I think, to us as 
representing the interests of consumers, if people who do 
report problems that they have found are being suppressed or 
even feel the need to leave the agency. This particular issue, 
this culture that seems to be at the FDA, I think, shows the 
need for transparency, and there was the inclusion in the 
Senate version of this bill an action package that would 
provide the public with documents related to a drug's approval, 
including a scientific explanation of the risk-to-benefit ratio 
and a summary review of any disputes and how they were resolved 
during the approval.
    So what I am asking you is, in your experience, is there a 
culture of, let us say, bullying and intimidation and do you 
agree that allowing FDA scientists to give voice to their 
concerns and decisions is an integral piece of the scientific 
process?
    Mr. Lutter. In my experience, I am unaware of bullying at 
FDA and I think it would be appalling to me personally and to 
the FDA leadership, including the leadership of the Center for 
Drugs and the Center for Biologics and the Center for Medical 
Devices. We take these concerns expressed in the public very, 
very seriously.
    Ms. Schakowsky. Well, are you saying, then, that the 
individuals that are cited in this article are misrepresenting 
the situation at the agency?
    Mr. Lutter. I am unfamiliar with the specifics of their 
cases. I do not know the facts about their cases.
    Ms. Schakowsky. Well, what happens when something like this 
comes to light?
    Mr. Lutter. Let me tell you the commitments that have been 
made by the FDA leadership to address culture. The Institute of 
Medicine last fall issued a report that we had asked for, which 
was openly critical of the agency's ability to address 
scientific dissent. We responded in a report of our own, the 
future of drug safety that we issued in late January 2007. At 
that press conference, Dr. Gaulson and Dr. von Eschenbach made 
open personal commitments to welcome a diversity of scientific 
views as well as diversity of individuals throughout the agency 
and to a personal responsibility for ensuring that dissent 
would not be punished.
    Ms. Schakowsky. Well, let me just ask you this. There is a 
2006 survey of FDA scientists done by the Union of Concerned 
Scientists, which found that 40 percent of scientists said they 
could not publicly express ``concerns about public health 
without fear of retaliation.'' Are you saying that Dr. von 
Eschenbach's response is something new that is being done in 
response to the criticism or that that has always been the 
policy and that what you are saying is there never was this 
culture of retaliation?
    Mr. Lutter. I don't know whether there was a culture of 
retaliation. There is surely a culture of controversy and we 
acknowledge that, and that has had adverse effects on morale 
and effectiveness and we are concerned about that. But the key 
question is, A, we recognize that, and then B, we have laid 
out, in our response to the IOM report, a whole collection of 
actions, including personal commitments by the FDA leadership 
and the leadership of the relevant centers for medical products 
to ensure that the diversity is not in any way suppressed, is 
surely not punished, and does not result in any bullying or 
suppression of scientific views.
    Mr. Pallone. We have to move on. Thank you. Mr. Sullivan.
    Mr. Sullivan. Thank you, Mr. Chairman. And thank you for 
being here. A lot of the questions I was going to ask have 
already been asked and there were other members that were 
talking about preemption, and you talked about that as well. 
One thing I would like to talk about is wouldn't you think that 
conflicting State labeling requirements for drugs, wouldn't 
that be confusing to consumers and potentially adversely affect 
public health? For example, if a grandmother was living in 
Nebraska and visiting her children in Oklahoma and had to get 
her prescription filled there and had a different notice on the 
labeling couldn't that be detrimental?
    Mr. Lutter. Conflicting, inconsistent and even 
contradictory statements about the benefits and the 
effectiveness and the risk of medical products is surely of 
concern. How can people figure out what they should be doing if 
there is not a single voice? The best approach to ensuring 
safety of medical products is to ensure that there is a single 
authoritative voice which, through a process of developing the 
best available scientific information, and evaluating that in a 
timely and effective manner, can be conveyed to everybody as an 
authoritative statement, and we believe that is our job. We 
believe that is our job as a regulatory agency. We have 
responsibility for regulating the safety and effectiveness of 
medical products, devices and drugs and biologics. We have been 
asked to do that by Congress and the American public and we 
think that if those messages that we convey to the pubic are 
seen as inconsistent with other authoritative sources, then 
confusing may result to the detriment of public health.
    Mr. Sullivan. So you would say that different State 
labeling would be very confusing and bad to public health?
    Mr. Lutter. If it is seen as inconsistent and incompatible 
with ours. If we say something and a different statement is 
made by a State authority, then surely consumers may be 
confused.
    Mr. Sullivan. Wouldn't you agree that different labeling 
would be detrimental to public health?
    Mr. Lutter. Yes.
    Mr. Sullivan. Thank you.
    Mr. Pallone. Finished? Ms. Solis.
    Ms. Solis. Thank you, Mr. Chairman. My question is for the 
director.
    Has the FDA ever evaluated whether any of its mechanisms 
for warning the public, for instance, changes in labeling, are 
effective in terms of raising awareness for safety issues with 
products? And are there any plans to evaluate how FDA 
communicates with the pubic and how effective such measures are 
and if you have ever looked at that? And then lastly, what 
kinds of evaluation tools do you have for, say, consumers that 
don't speak English, whose primary language is something other 
than English?
    Mr. Lutter. We take very seriously our responsibilities to 
communicate the information about risks and effectiveness. We 
recently instituted, in this regard, a new committee on risk 
communication. Its function is to advise FDA about how to 
communicate the risks and the benefits of medical products and 
other FDA-regulated products as well. This committee was first 
initiated in response to the recommendations of the Institute 
of Medicine that I alluded to earlier. We anticipate that it 
will be up and running to have public meetings in the early 
part of next year. And we are currently soliciting, publicly, 
nominations from interested experts and people with 
responsibilities for communication to serve on that advisory 
committee. One of its functions will be to look at the 
effectiveness of our efforts generally. This is, we think, an 
area that is important and could be greatly strengthened by 
work of this committee.
    Ms. Solis. And what about reaching out to groups that its 
primary language is not English? How do you communicate with 
them?
    Mr. Lutter. We do have a plain English program at FDA. We 
have a variety of outreach efforts that run through the Office 
of External Relations to representatives of minority groups and 
people for whom English is not the primary language.
    Ms. Solis. Has that been evaluated?
    Mr. Lutter. The effectiveness of that has not been 
separately independently evaluated.
    Ms. Solis. That probably should be looked at, because of 
course there are degrees of education with different groups 
from different backgrounds and I would even say English, in 
terms of just the type of individuals that may have no more 
than an eighth grade education and may not--labeling obviously 
has to be simplified in some format; but to find also different 
groups, Asian as well as Hispanic, that may not be fluent in 
English to have appropriate culturally competently appropriate 
language that is made available to them, because that could 
even be misconstrued and obviously lead to abuses.
    Mr. Lutter. We would be very happy to take that suggestion 
into advisement as a topic for the advisory committee when it 
has its first meetings next year.
    Mr. Solis. And I would hope, just as a follow-up, too, I 
know that sometimes we often talk about the Internet and put 
posting information to the public. But by and large, the 
Hispanic community and African-American community and in rural 
areas are not privy to access to the Internet. So I would 
encourage more outreach either through form of radio, 
newspapers and things of that nature that can actually be a lot 
more helpful in terms of providing better consumer information, 
and obviously testing focus groups, I think, could be helpful 
as well. And that is a comment.
    Lastly, I wanted to ask you, what has the FDA done to 
decipitate what I see as tensions between some of the staff 
that you have doing oversight, monitoring, those that are 
evaluating and those that are actually helping to approve some 
of the drugs and devices that are coming forward? I understand 
that there has been occasion where morale has not been one of 
the highlights of the agency.
    Mr. Lutter. Before turning to that, thank you, let me first 
add a comment that I should have made earlier about the 
evaluation of risk communication. There is a reevaluation of 
risk management tools, broadly, as part of our PDUFA IV 
reauthorization. We look forward to using PDUFA IV resources to 
do that reevaluation.
    With respect to the culture issue, we recognize this is 
important. There is a variety of essentially management efforts 
in the individual centers to identify, if you will, best 
management practices and communicating, communications between 
supervisors and staff and surely to support diversity, not only 
of people according to their demographic backgrounds, but also 
of scientific views and scientific thought. We have a very 
diverse agency with respect to the multiplicity of scientific 
backgrounds and expertise that is represented. Many people 
bring different views and perspectives to the table because of 
their training. The determination of safety and efficacy for 
drugs is something that requires many, many different types of 
experts, not just MDs.
    Ms. Solis. What kind of concrete things will you be 
instituting, because my understanding, if I could just 
reiterate, the tension is between the pre-approval review staff 
and the post-marketing safety staff.
    Mr. Lutter. There are ongoing regular workshops and new 
meetings internal to CDER, to ensure that communication and 
respect among those different staffs is enhanced as much as 
possible.
    Mr. Pallone. We have to move on.
    Ms. Solis. Thank you, Mr. Chairman.
    Mr. Pallone. Thanks. Mrs. Blackburn.
    Mrs. Blackburn. Thank you, Mr. Chairman. Thank you for your 
patience. I want to be certain that I am understanding your 
remarks, since we didn't have your testimony in advance and it 
seems you have five major problems with the legislation. And 
just to recap with you, one would be that it is too focused on 
process and structural changes; No. 2 would be the breadth of 
proposed requirements for risk evaluation; No. 3 would be the 
existing FDC Act labeling requirements dealing with the med 
guides, et cetera; No. 4 would be the risk map provisions; and 
then fifth would be the DSOB oversight and review for disputes. 
So it seems as if that pretty much encapsulates the problems 
that you have with the legislation.
    Then you go on, on page 14, and you talk about a better 
overall strategy is to be sure you have appropriate resources. 
And Dr. Lutter, I would just like to highlight with you, going 
back to some of our other hearings that we have done, sometimes 
the public has a real problem with giving more resources to an 
agency that seems to have difficulty in fulfilling their 
mission or understanding their mission, maybe, and there seems 
to be a frustration when there is a lack of best practices in 
place with a certain agency and when there seems to be a 
communications problem between different divisions not knowing 
what another division is doing, and then maybe even one 
division telling another one don't take action there, we don't 
want you to do that, when a person feels as if they are doing 
their job.
    So I would highlight with you that those are concerns. We 
still are looking for that list of best practices. We still 
want to be certain that you all are putting the needed 
transparency in place when you are dealing with adverse 
reactions. And going through the process of quantifying these, 
you mention at the bottom of page 14 your analytical tools and 
approaches that you use with turning that raw data into 
appropriate questions and practical information. Some 
transparency through that process would be very helpful, I 
think, not only for you all, but for us.
    I have got a couple of specific questions before my time 
runs out. The REMS process. In the discussion draft, the way 
the changes are written there, would all safety labeling on 
drugs have to be approved by the FDA, if you were to take the 
action from the discussion draft?
    Mr. Lutter. Yes, that is our understanding.
    Mrs. Blackburn. It would all have to be approved by the 
FDA. OK. And then another place in the discussion draft they 
talk about a non-promotional summary of the results, as they 
are talking about the clinical trial registry and the results 
database. I don't see non-promotional summary defined anywhere. 
So do you all have a definition of that? And then the flipside 
of that question would be, is writing a factual summary then 
considered to be a promotional? If something has favorable 
results and you are writing, would that be considered to be a 
promotional summary? And if you need to come to that one in 
writing to us later, that is fine, but insight on that would be 
helpful.
    Mr. Lutter. If I could try and take it orally here, I will 
do what I can do. One thing I have not had an opportunity to 
talk about because part of the complexity of the legislation is 
the clinical trials registry and particularly the requirement 
for this results database that I think you are referring to. 
And a key question is what we would mean by an appropriate 
summary of the results, and the difficulty with that is that 
the studies are essentially designed to answer specific 
questions. But later on, when they find that the results of the 
study designed to answer question A may be very, very 
interesting or helpful with respect to other questions, and in 
that sense this non-promotional summary is something that may 
be actually quite problematic to implement from an operational 
perspective. So we have----
    Mrs. Blackburn. So the non-promotional would be 
problematic?
    Mr. Lutter. Yes, but we have concerns generally about this 
results database and the key question is what would constitute 
an appropriate summary of results in this results database. We 
think that may be a very difficult requirement actually to 
implement in practice.
    Mrs. Blackburn. And do you have any guidance going on 
forward on that as you look at the legislation to make it 
workable and practicable?
    Mr. Lutter. Our understanding is that there is currently a 
pilot project underway, in cooperation with NIH, to look at how 
one might summarize this information in an effective way and we 
think that might provide a way to identify, first in practice 
using this pilot project, appropriate information before 
implementing on a much broader scale.
    Mrs. Blackburn. Well, with the pilot project at NIH, I 
would just highlight with you, one of our concerns many times 
is the lack of communication that seems to exist between the 
FDA and NIH, and probably a bit more transparency there would 
be helpful as you would look at how NIH would go about trying 
to figure this out and make it workable. I have got two more 
questions. What I will do is submit those and then yield back 
my time so that everyone gets their questions in before votes. 
Thank you.
    Mr. Pallone. Are you completed? OK. Thanks. Mr. Green.
    Mr. Green. Thank you, Mr. Chairman. During the negotiations 
on the medical device fee, Dr. Lutter, the FDA and the device 
industry agreed on changes to the Third-Party Inspection 
Program that were not adopted in the discussion draft that is 
before today. If the program were utilized to increase the rate 
of inspections, I would like to see us enact improvements in 
the program. However, concerns remain about the potential for 
conflict of interest increasing with increased reliance on 
these third-party inspections. If we were to adopt the changes 
you negotiated, what safeguards are included in your proposal 
to address these conflicts of interest? And would that proposal 
limit in any way the FDA's ability to directly inspect a 
facility? And the next to the final one was, how much money 
would the FDA need to conduct its own inspections? Is it a 
question of resources?
    Mr. Lutter. Let me try to answer them in reverse order. I 
don't know the answer to how much money it would take. It is a 
question of resources, but more than just in the sense that we 
could do more with more. It is really a question of is it wise 
to be doing it and using our resources in this way, when we 
think that there is higher risk that could be better addressed 
with use of the same resources? In that sense it is really an 
efficiency concern rather than the concern with the amount of 
resources overall. I am sorry.
    Mr. Green. On the issue of if we use outside or third-party 
inspection programs, I am concerned about the third-party 
conflict of interest. Obviously, we have the problem within the 
FDA, but would we see it even worse with third-party 
inspections?
    Mr. Lutter. We believe that it would surely not be worse 
with respect to third-party inspections. We would reserve the 
right to be able to inspect any facility on our own and we 
would be verifying that the skills, the appropriateness of the 
third-party inspectors, before they go out to do their third-
party inspections. So in essence, you can see it in a way as 
double protection. We are certifying the inspectors and then we 
reserve the right to do inspections on our own.
    Mr. Green. OK. Another question. The discussion draft--
language that would require the GAO to study the 510(k) process 
for the approval of medical devices. We know that a large 
majority of devices are approved using the 510(k) process. 
However, one of our witnesses on the second panel suggests that 
we prohibit the use of the 510(k) process for implantable 
devices and mandate that each implantable device go through the 
PMA process. Your understanding is that the 510(k) process is 
utilized primarily for class I and class II devices. Can you 
quantify for us how many class III implantable devices utilize 
the 510(k) process for approval?
    Mr. Lutter. I will have to get back to you on that. I don't 
know.
    Mr. Green. OK, I appreciate it. And that last question. I 
continue to be concerned about structural issues at FDA that 
weigh the agency too heavily towards drug approval. While your 
statement suggests that the drug safety draft focuses 
unnecessarily on structural changes, it doesn't contain some of 
the structural changes such as a separate, independent Office 
of Drug Safety that some on our committee have advocated for. 
Under the REMS framework, would you support language giving the 
Office of Drug Safety the ability to request a REMS change such 
as an additional post-market study to help level the 
bureaucratic playing field for the Office of New Drugs?
    Mr. Lutter. Well, we think that a lot of the conversations 
within CDER about risk, require also a consideration of 
benefits, because the real question is, in addressing drug 
safety questions, is that the safety issue is very difficult to 
evaluate on its own, independently, without asking or 
evaluating how effective is this drug at providing the benefits 
to the patients who need it. And in that sense, we think that 
the best way to proceed is with improved communications that we 
are working on with the consideration by the relevant parties 
within the Center for Drugs and that is what we are planning on 
doing.
    Mr. Green. OK. Would you support language giving the Office 
of Drug Safety the ability to request an REMS change such as an 
additional post-market study? Could we give that authority to 
the Office of Drug Safety?
    Mr. Lutter. We would prefer that that authority not be 
prescribed through statute. That is a particular change within 
a small office within FDA. We think that the responsibility 
should reside with the management of the Center for Drugs and 
with the Commissioner.
    Mr. Green. OK. Thank you.
    Mr. Pallone. Thank you. Mr. Murphy.
    Mr. Murphy. Thank you, Mr. Chairman. Welcome here. A couple 
questions regarding the issue of allowing exclusivity for a 
limited number of months after some new treatments have been 
found. In particular, I am concerned about pediatric drugs for 
orphan diseases. As you know, there is a separate act that 
controls some of the aspects of dealing with orphan drugs, 
whereby the timeframe may be--we provide Federal grants and 
contracts for clinical trials. There is tax credits, up to 50 
percent for clinical testing costs and exclusive marketing 
rights for 7 years. This, of course, is important because some 
of the orphan drugs have such a small number of children or 
patients that they may influence. I am concerned that if we are 
too broad in our approach of saying that there is 3 or 4 or 5 
or 6 months exclusivity, that is hardly enough time to recover 
the cost of research for some of these things and we know that 
the expenses, however, can be extremely high because there are 
so few people that take these medications, in some cases, where 
the costs of development, even if it is an adaptation of an 
adult to pediatric drug.
    What I would like to know is, should Congress act in 
legislation, such as PDUFA or others, to make sure we protect 
the exclusivity rights of orphan drugs in these cases, so that 
companies are more willing to make some investments into 
research on those drugs?
    Mr. Lutter. Could I ask for clarification?
    Mr. Murphy. Yes.
    Mr. Lutter. The question is, so you are not asking about 
the exclusivity period for BPCA and with respect to pediatrics?
    Mr. Murphy. Yes. I want to make sure that we are not 
stepping on the toes of the orphan drugs, so that we still are 
providing enough incentives for companies to research 
treatments for some of these diseases where there is a smaller 
number.
    Mr. Lutter. Our understanding is that, currently, the 
sponsors can get exclusivity of 6 months under BPCA and they 
also have orphan exclusivity under 7 years, and that provides 
incentives that are fairly robust with respect to the need to 
protect children.
    Mr. Murphy. I just want to make sure, in your review, as we 
look at this legislation, if you could review it carefully in 
making sure that we maintain those issues there.
     It is very important. Let me go to a second area here and 
that has to do with us looking at some of the adequacies of 
medication to see if this is the right bill to do that. I am 
concerned about antibiotic-resistant strains for infections 
that are forming. And I am concerned that there a number of 
strains have developed, which one medication is no longer able 
to treat them. And if there are some things that we should be 
doing with this, also, that as drugs are reviewed in terms of 
their effectiveness, we are not only looking at side effects in 
terms of harmful things that may come as side effects of taking 
medication, but also reviewing side effects that may come from 
overuse or inappropriate hospital or healthcare practices that 
may also contribute to the spread of infections that whereby we 
are creating drug-resistant strains. And I don't expect you to 
answer this now, but it is one that I consider pretty 
important, because so often we name a specific drug and we say 
it has this association with heart problems or diabetes 
problems, et cetera.
     But there are also practices, I think, in the practice of 
medicine, that contribute to problems, iatrogenic effects and 
nosocomial infections that occur, which in turn can make some 
medications useless. So I am hoping that one of the things you 
could look at with us, also, is provide suggestions of how when 
reports are made on medications, that we are looking to see if 
it is the practice that is also leading to some problems with 
that as well, not just the medication itself.
    And a third point has to do with something that is more of 
using medical devices. Now, with the medical devices, as you 
know, some of these are being reused, sterilized and reused, 
and that may work in some cases, in other ones I have some 
concerns. For example, do you think that patients have the 
right to know and to choose when a medical device designed for 
single use has already been used on another patient before it 
is used on them?
    Mr. Lutter. Our broad concern is that the labeling should 
be related to risks. And if the reuse or the manipulation of 
the product to ensure reuse is one that is well enough managed 
that there is no appreciable risks or concern to the patient, 
then the need for labeling is not clear.
    Mr. Murphy. Well, that is something, I guess, when one says 
appreciable risks, does that include giving at least that 
information to the patient, that we have determined that there 
is no appreciable risk from reusing this equipment?
    Mr. Lutter. It is also a question that a patient could ask 
a doctor about whether or not the particular----
    Mr. Murphy. What if a patient doesn't know to ask?
    Mr. Lutter. Well, then there is a variety of opportunities 
for doctors to provide information to patients that may be of 
interest to the patients.
    Mr. Murphy. Well, this is another one those areas, Mr. 
Chairman, where I hope we can get some more clarification to 
make sure that in these cases where there may be some increased 
risk for infection control, to find ways we can adequately 
address that and I appreciate that. Thank you, Mr. Chairman, 
and thank you.
    Mr. Pallone. Thank you. Mrs. Myrick.
    Mrs. Myrick. Thank you. Thank you for being here. I had a 
question relative to the medical devices and the approval 
procedures. The 510(k) process, I understand, basically has 
been in use for a long, long time and that 98 percent of the 
devices are approved under that procedure. But basically, if a 
device is just an improvement over something that maybe failed 
or whatnot, it is OKed or allowed to be on the market? My 
question is because I had myself a jaw joint replacement, which 
is not real common, and there was very little information 
available about what was available to me to use, because it is 
not an area where there has been a lot of research, et cetera. 
And I am trying to find out on everything, you all had on your 
Web site and every place else I could go to see just what was 
being done.
    My question is: where do you get your feedback for knowing 
whether something is really working or not? And does this come 
from doctors, because this particular surgery is fairly rare 
and a very small percentage of doctors who do it correctly, so 
there is not a lot of background testing. It hasn't been done 
for that long. And I am just curious as to how this process 
really works, because what do you know ahead of time and how, 
in this particular case, I guess I am referring to, how much 
background information is available before you approve 
something. And then what kind of feedback do you get as you are 
going through the process?
    Mr. Lutter. Well, with respect to 510(k), the key issue is 
one of equivalence. Is it really similar to something that is 
already on the market?
    Mrs. Myrick. Right.
    Mr. Lutter. And I think, with respect to the information 
that we receive, it is useful to draw a distinction between the 
risk of use of the product and other measures of effectiveness 
or just outcomes very broadly. And in particular, one can 
imagine it with an implantable device. What matters is also the 
quality of the surgery as well as simply the device and then 
there may be measures of the effectiveness of the device that 
vary over time, if it is implantable, that are also harder to 
measure. We do track the adverse events. We get information 
from the manufacturers on that. They are obliged to give us 
information about----
    Mrs. Myrick. So they are required to do that?
    Mr. Lutter. Yes, to pass on to us information that they 
have from any source, about the adverse events associated with 
products that they produce. So in that sense, yes, we do have 
that information. But I think that, from a patient perspective, 
it is probably useful to know that there is a collection of 
information about just the--think of it as the effectiveness or 
the success, if you will, of the surgery. That is not 
necessarily in FDA jurisdiction, because it is not really the 
product that we are regulating. It is the service that is 
associated with that product.
    Mrs. Myrick. Yes. And there are a lot of surgeons who are 
not being effective in the way they do it, I know that. You 
feel that the process, the way you are doing it currently, is 
an acceptable, effective process?
    Mr. Lutter. We collect information and we collect 
information from the manufacturers, who are obliged to pass on 
all of the information that they have to us about the adverse 
events. And in that sense, we have information about the 
adverse events associated with the product that we regulate. 
That part of it is satisfactory. I think a real question is 
where one would wish to go in the future if one were designing 
a better program and we have a couple of ideas in that regard 
that I talk about here.
    Mrs. Myrick. That was going to be my next question.
    Mr. Lutter. One is with respect to unique device 
identifiers, where we might be able to better notify patients 
in the event that there is some evidence of unexpected adverse 
events or harm or recall or something like that, more broadly 
outside the area of devices, but also with respect to drugs. I 
talked earlier today about a public/private partnership with 
vigilance. That is something that is mentioned, at least, in 
the Senate draft and in the discussion draft here. We think 
that tying that with respect to the Reagan-Udall Foundation 
would be an effective way to manage it. That sort of 
partnership offers several great strengths. One is probably a 
perception of neutrality and respect. It would be FDA along 
with many other partners. And it, in principle, would allow for 
a very timely expedited access to this sort of information 
through interlinked databases that would permit and facilitate 
faster identification of safety signals that would let us 
develop the subsequent studies in a timely way, as to better 
inform patients and their doctors.
    Mrs. Myrick. But if all of that is implemented, et cetera, 
what kind of timeline are you looking at for implementing the 
process?
    Mr. Lutter. Well, it is difficult to say. This sort of 
thing has not been done previously, so it is really difficult 
to say we could do it within X months. But in terms of a vision 
of what the future might look like in a world where only 5 
years ago, people weren't walking around with BlackBerries and 
cell phones as they are today. So what would one envision the 
world of the future to look like, and that is the vision that 
we have.
    Mrs. Myrick. Thank you. My time is up.
    Mr. Pallone. Thank you. Mr. Hall.
    Mr. Hall. Mr. Chairman, thank you. We have been in and out 
here. Each of us have two or three committee hearings going on 
right now and if I ask a question that has already been asked 
and you have fear that you won't answer it the same way you did 
earlier, why I won't press it. But Mrs. Blackburn asked you and 
set out to you, I think, five of your concerns here. I didn't 
hear any concern about any constitutionality of that, Dr. 
Lutter, that you are dealing with. The draft bill contains a 
provision that would require the pre-clearance of DTC ads and 
places a moratorium on these ads for new products. Does that 
give you any constitutional concern?
    Mr. Lutter. Thank you for asking the question. It is not 
something I have had a chance to talk about earlier today. FDA 
has a repository of expertise in drugs, devices and food and 
their safety and efficacy and not in constitutional law. We are 
told, however, that this raises concerns from a constitutional 
perspective and we caution about progress in implementing a 
provision that may, because of constitutionality questions, be 
difficult to implement and enforce in an effective and timely 
way.
    Mr. Hall. Well, the reason I asked this is for a different 
reason than that and I didn't make a very good grade on 
constitutional law when I was at SMU. And I want to know the 
nature of these provisions that seem like they could expose the 
agency to some lawsuits, and I think that you all would have 
had some discussion on that.
    Mr. Lutter. We are concerned about litigation risk, 
generally, litigation ties up agency resources in a really 
dramatic way and it provides uncertainty about how we can 
implement our programs. And a real question, ensuring that the 
programs are implemented in an effective and timely way, would 
involve consideration of litigation risks and yes, we have had 
these conversations. But the advice on constitutional law is 
probably one that would best be given by parties other than 
FDA.
    Mr. Hall. Are you an attorney?
    Mr. Lutter. No, I am not, sir.
    Mr. Hall. The ladies behind you that are advising you, have 
they been into this?
    Mr. Lutter. Some of them have talked about this, but I 
think what you will hear is that there are experts in 
constitutional law that are best equipped to address this from 
outside of FDA.
    Mr. Hall. Given the Western States case, do you think that 
pre-clearance might withstand judicial scrutiny? Do you have an 
opinion on that? Come on, give me an answer.
    Mr. Lutter. I am not equipped to answer that. I don't 
have----
    Mr. Hall. Well, if I answer it for you, then if so, would 
this requirement take away resources from other drug safety 
activities? It would, wouldn't it?
    Mr. Lutter. Tying FDA up in litigation will take resources 
away from our other activities.
    Mr. Hall. Let me shift my gear here just a little bit. 
Would a mandatory REMS system improve drug safety, or could a 
mandatory REMS, for every drug, actually divert FDA resources?
    Mr. Lutter. Well, the mandatory REMS for all, if applied to 
all drugs, is going to divert it, because we think there is a 
class of drugs where that sort of attention is not needed. The 
best procedure that we have as an analog to the REMS is the 
RiskMAPs, which currently applies to a fraction of the products 
that we approve.
    Mr. Hall. It makes sense. Under one of the drafts, to shift 
again--well, not really a total shift, but on one of the 
drafts, a company could face a fine of up to 10 percent of U.S. 
sales for violating a REMS. One component of a REMS is for the 
manufacturers to ensure that a physician or a pharmacy is not 
violating the REMS and if they are to restrict access to the 
product to that entity. So my question then would be, does a 
manufacturer have direct control of the products it moves to 
the pharmacies? Does the manufacturer have a direct control of 
the products it moves to the pharmacies? Or do manufacturers 
most often sell to wholesalers?
    Mr. Lutter. They most often sell wholesale, so any control 
is at best indirect.
    Mr. Hall. Then, I guess my follow-up question and my final 
question, is it fair for a company to be subject to such a fine 
for which they have no direct control?
    Mr. Lutter. Well, only to the extent that they have 
control, would it be fair?
    Mr. Hall. If they had no direct control.
    Mr. Lutter. I guess, if they have no direct control, there 
is a real question about the appropriateness of the fine.
    Mr. Hall. Well, that is a pretty good answer and I thank 
you and I yield back my time.
    Mr. Pallone. Thank you. I think you have stayed here long 
enough to clear the podium and we appreciate it. Or clear the 
dais, I should say. But I appreciate your bearing with us. It 
has been pretty difficult, I think, to answer all of these 
questions and you have done so, for the most part. So thank you 
for being with us. I know a lot of Members asked you questions 
for which you said you would get back to us in writing, so 
please do so as quickly as you can and we appreciate you being 
here today.
    Mr. Lutter. Thank you for the questions and diversity of 
views and we look forward to working with you on implementing 
and passing this legislation in a timely way.
    Mr. Pallone. And we hope to do so in an expeditious way and 
I know that makes it difficult sometimes, but I agree that we 
have no choice, given the time constraints. Thanks again.
    Can I ask the second panel to come forward? I guess I 
should mention, while you are getting seated, that we do expect 
some votes that might interrupt the second panel or the 
questions, but right now the House is in recess, so we are 
going to proceed until there is a vote. So we may just get 
right through it. I don't know.
    OK, if everyone is seated, I want to welcome our second 
panel and let me mention who is here. I will go from my left to 
right.
    First, on our left is Dr. Caroline Loew, who is the senior 
vice president for science and regulatory affairs for PhRMA. 
And then we have Mr. James Guest, who is president and CEO of 
the Consumers Union. Then we have Mr. Steven Ubl, president and 
CEO of Advanced Medical Technology Association. And then we 
have Dr. Diana Zuckerman, who is president of the National 
Research Center for Women and Families. And then we have Mr. 
Steve Walker, who is co-founder and chief advisor for Abigail 
Alliance for Better Access to Developmental Drugs. And last is 
Dr. Richard L. Gorman, who is chair of the AAP Section on 
Clinical Pharmacology and Therapeutics for the American Academy 
of Pediatrics.
    Let me again say that you may get some questions from the 
subcommittee members that you would have to answer and follow 
up in writing. With the discretion of the chair, we will 
certainly do that. And we will start for 5 minutes with Dr. 
Loew.

STATEMENT OF CAROLINE LOEW, SENIOR VICE PRESIDENT, SCIENCE AND 
                   REGULATORY AFFAIRS, PhRMA

    Ms. Loew. Mr. Chairman, Ranking Member Deal and members of 
the subcommittee, I want to than you for inviting me back to 
testify today about our shared commitment to strengthen the 
safety of America's drug supply. My name is Dr. Caroline Loew 
and I am the senior vice president for scientific and 
regulatory affairs for the Pharmaceutical Research and 
Manufacturers of America, or PhRMA.
     I return today to this subcommittee to reiterate the 
commitment on the part of PhRMA, and its member companies, to 
work with the FDA and other stakeholders to improve our drug 
safety system in a way that preserves innovation and patient 
access. No other issue carries more importance to our industry 
than patient safety.
    PhRMA believes that the FDA's proposal to reauthorize the 
Prescription Drug User Fee Act, or PDUFA, will provide the 
agency with the tools and resources necessary to make a good 
system even better, ensuring that FDA's drug review and 
monitoring systems keep pace with 21st century science.
    Since 1992, PDUFA has been a crucial program for FDA and 
the pharmaceutical industry, but most importantly for patients. 
The increased funding provided through user fees has enabled 
the agency to review new drug applications in a thorough and 
timely manner, without compromising its exacting standards for 
evaluating safety and efficacy.
     The reauthorization proposal under consideration that has 
been forwarded by the FDA includes new resources that would 
enhance and modernize FDA's Drug Safety Program, specifically 
providing nearly $150 million over the next 5 years, including 
82 additional staff for post-market safety activities. These 
additional resources would also allow the agency to increase 
its use of modernized techniques and tools for the assessment 
of drug risks. PhRMA also supports the inclusion of funding to 
advance FDA's Critical Path Initiative, as well as legislation 
establishing the Reagan-Udall Institute to conduct related 
research.
    Just as drug safety fundamentally involves a balance 
between benefit and risk, so should the process of reforming an 
already successful and effective system.
    The proposed Risk Evaluation and Mitigation Strategy, or 
REMS process, creates a complicated and bureaucratic safety 
oversight system that may not be workable in practice, and 
which if applied to all drugs would be overly burdensome for 
the FDA. At the very least, use of REMS should be limited to 
and focused on higher risk products that warrant more rigorous 
post-marketing monitoring.
    The anti-preemption language in the REMS and other 
discussion drafts is also a significant concern. This provision 
would undermine the intent of the REMS bill to reinforce FDA's 
control over drug warnings, because it would enable each State 
to require warnings the FDA specifically rejected based on its 
scientific review. Such conflicting warnings could cause 
considerable confusion for patients and their physicians.
     Further, the civil money penalties for REMS violations 
that will be allowed under the discussion draft are 
unreasonable. Punitive fines as high as 10 percent of U.S. 
sales are excessive and may be a particular issue for small to 
midsized companies.
    Limitations on direct-to-consumer, or DTC, advertising 
imposed under the discussion draft would not be in the best 
interest of patients. Restrictions on advertisements would deny 
patient access to important information, which repeated studies 
have shown to be valuable in educating patients and fostering 
patient/physician dialogue.
     Additionally, FDA's PDUFA proposal already provides the 
agency with enhanced resources to pre-review DTC advertising 
through a new dedicated user fee, further helping to ensure 
that benefits and risks are clearly and accurately communicated 
in DTC advertisements.
    Instead of the broad reforms proposed, PhRMA would favor 
targeted drug safety enhancements to address key issues. For 
example, we support the creation of a robust post-marketing 
labeling program that would give FDA greater authority to 
require a labeling change and to complete the process in an 
expedited manner when warranted.
    The current Pediatric Exclusivity Incentive Program has 
been a tremendous success and PhRMA supports continuing it as 
currently authorized.
     According to the FDA, the Best Pharmaceuticals for 
Children Act, or BPCA, has done more to spur research and 
generate information about the use of medicines in pediatric 
patients than any other Government program. Changes in the 
current program, particularly the proposed exclusivity 
adjustment, or tiering of exclusivity, could reduce the 
incentive to conduct pediatric studies.
    Ultimately, it is important to recognize that FDA's current 
drug safety system is robust and effective; however, there is 
always room for improvement. FDA needs more resources to 
enhance and modernize its already strong drug safety monitoring 
system, and the PDUFA IV proposal submitted by the FDA achieves 
this. As such, we urge Congress to quickly reauthorize it.
    Thank you for this opportunity to inform the subcommittee 
about PhRMA's perspectives in this critical public health 
arena. Thank you.
    [The prepared statement of Ms. Loew follows:]

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    Mr. Pallone. Thank you. Mr. Guest.

  STATEMENT OF JAMES GUEST, PRESIDENT AND CEO, CONSUMERS UNION

    Mr. Guest. Mr. Chairman and members of the committee, thank 
you for the opportunity to testify on what is crucial 
legislation to improve the safety of our Nation's prescription 
drugs. Consumers Union is the independent, nonprofit publisher 
of Consumer Reports, with 8 million online and print 
subscribers and we have been working for a long time to 
strengthen our drug safety system at the State and national 
level on behalf of the consumer interest.
    Drug safety is not a dry and abstract issue. It is a matter 
of life and death. In the room today behind me are families and 
individuals who suffered from what we believe are adverse drug 
events that could have been avoided, Mr. Chairman, with 
stronger laws. It is critical that Congress close the gap 
between the time when drug makers first learn of drug safety 
problems and when consumers learn this information. These 
individuals behind me face a lifetime of heartbreak and grief 
because Congress has not closed that gap and done enough to 
promote drug safety.
     One of those persons behind me is Patricia Slingo, who is 
described in an ad that Consumer Reports has taken out today, a 
full-page ad in USA Today, describing her situation, where she 
was prescribed Vioxx, never told about the heart safety risks 
that it could have. She ended up in angioplasty stints placed 
in her heart and bypass surgery. As she puts it, ``I can't say 
for certain Vioxx caused my heart problems, but I wish I would 
have known what the drug maker knew.'' And that statement 
really goes to the crux of the matter before us. The public is 
not being given the full story about all the potential risks of 
medications and therefore they can't make informed decisions 
about their healthcare. We need you, as the committee and the 
Congress, to significantly strengthen drug safety laws and 
adequately fund drug safety efforts at the FDA.
    My written statement, Mr. Chairman, explains how these 
measures will help prevent future Vioxx disasters, the 
uncertainty we are seeing now with the diabetes drug Avandia, 
and other threats to patient safety. But let me concentrate my 
comments here on four key points.
    First, we strongly endorse your proposal that all phase II 
through IV clinical trial results be honestly and accurately 
made public in a timely manner. If there is concern about the 
integrity of the trial data that would be made public by drug 
companies, as we have heard from some, you can study and 
recommend regulations on ways to achieve unbiased, honest 
reporting. In the interim, though, whether perfect or not, make 
all results and data public so that the world's researchers can 
help detect serious problem areas and detect them early rather 
than well after the fact.
    Second, there is great concern that the drug safety 
division in the FDA has been overshadowed and in some cases 
ignored by the division that approves new drugs to the 
detriment of public safety. Again, we urge you to raise the 
drug safety office's profile, independence, and influence in 
critical decisions. To help achieve that, you could include the 
Kennedy-Enzi section 210, which makes public the FDA drug 
action letter, including a public statement of any dissents and 
disagreements about a drug safety. We hope you will also 
include language on the right of staff to publish in scientific 
journals, and that you include whistleblower protection for FDA 
staff who raise safety concerns. We have also long supported 
legislation by Representatives Tierney and Stupak that would 
create a separate Office of Drug Safety within the FDA, a focus 
point within the agency where safety issues can be raised, 
vetted and acted on. Now, I understand if there is a concern 
that a completely separate office would slow but, as you have 
heard, we recommend at the least Senator Grassley's amendment 
that failed by only one vote on the Senate floor vote. It would 
give the Office of Drug Safety the power to ask for a safety 
change on a medication. If the director of the Office of New 
Drugs disagreed, the commissioner would be required to quickly 
settle the dispute. This would not slow actions down, but would 
clearly make someone responsible for safety and resolving these 
issues.
    Third, given the long history of abuses in direct-to-
consumer advertising, we recommend that consumers get the most 
accurate, up-to-date clear information about a drug's benefits 
and risks. Currently under the voluntary DTC User Fee Program, 
there is no incentive for a drug company to pay the user fee to 
have their ad cleared. Consumers deserve the right to have the 
full information. They should be given the truth, the full 
truth, and nothing but the truth, and that is what we recommend 
for this legislation. In the rare cases of drugs with serious 
potential health dangers, we also support including up to a 3-
year temporary delay period on DTC ads as part of the REMS 
safety tool chest, but that would be a very rare occurrence, 
but it should be available to the FDA. It is a commonsense 
consumer protection tool.
    Finally, on conflicts of interest, we would urge you to 
prohibit any conflicts of interest on drug advisory committees. 
It is critical that the public have faith in the integrity of 
our prescription drug safety system. They don't today. A survey 
a few months ago by the Consumer Reports National Research 
Center found that six out of 10 consumers feel that Congress 
and the FDA is not doing enough to protect them. The conflict 
of interest undermines public confidence, so again, we would 
say let us have a strong requirement here. Have the FDA go out 
and find the right people and take some time to find them if 
they need to.
     So those are some of our concerns, Mr. Chairman. Again, 
thank you for your leadership on this and congratulations on 
the proposals. We look forward to working for their enactment. 
Thank you, sir.
    [The prepared statement of Mr. Guest follows:]

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    Mr. Pallone. Thank you. Mr. Ubl.

 STATEMENT OF STEVEN UBL, PRESIDENT AND CEO, ADVANCED MEDICAL 
                     TECHNOLOGY ASSOCIATION

    Mr. Ubl. Good afternoon. I am Steve Ubl, president and CEO 
of AdvaMed, which is the Advanced Medical Technology 
Association. I would like to thank you, Mr. Chairman, Ranking 
Member Deal and other members of this subcommittee for the 
opportunity to provide our views on MDUFMA.
    Reauthorization of MDUFMA is critically important to public 
health and safety and ensuring FDA is on sound financial 
footing. I would like to commend you and the subcommittee for 
including the FDA industry agreement in the discussion draft, 
and for its critical role in developing the original proposal 
back in 2002, and for the restructuring of the program that 
occurred in 2005. The program has made an immense difference to 
FDA, to industry and to patients. And without your support, we 
would not be where we are today. However, we do have concerns 
with the discussion draft, which, in our view, if not address 
would jeopardize our support for the underlying measure.
    First, as we read the preemption language contained in the 
initial draft and in the chairman's mark, we are concerned to 
the degree that it would threaten our ability to support the 
overall bill, the reason being the existing statutory 
preemption provided for medical devices is absolutely critical 
to ensuring that FDA's expert and uniform regulatory regime 
will not be undermined by divergent State requirements. This 
uniform and predictable regime is critical for innovation for 
developing the most novel treatments for the most dangerous 
diseases and for maintaining the flow of venture capital to 
small firms. And those concerns are reflected in my written 
testimony.
     Essentially, what the draft would do is allow for State 
courts, State agencies and State legislators to substitute 
their views or second guess FDA's determinations around safety 
and effectiveness. I should point out that we very much 
appreciate that, in the most recent draft, we think you are 
trying to narrow the scope of this provision. But I would just 
like to point out by just referencing the clinical trials 
section of the bill. You are implicating the underlying statute 
relative to devices. So we view any insertion of ambiguity in 
this area as highly problematic.
    With regard to third-party inspections, we are disappointed 
that the program was essentially dropped in the discussion 
draft. In our view, the Third-Party Program should be a win/win 
for FDA, for the public and for industry. It benefits industry 
because it reduces the number of duplicative and costly 
inspections by numerous foreign governments and the FDA. And as 
Dr. Lutter testified, it benefits the FDA because the agency 
currently inspects facilities once every 5 years, so it enables 
the agency to get inspection reports it otherwise would not get 
to get target resources where problems are most likely. There 
are many misunderstandings about Third-Party Program and I 
would like to emphasize a few key protections that are included 
in the agreement as adopted by the Senate.
    None of the FDA inspectional authorities are reduced in any 
way. FDA can inspect a facility at any time and continue to 
receive third-party inspection reports whether FDA inspects the 
facility or not. FDA credits the third-party inspectors and 
also inspects the inspectors on a regular basis. FDA can 
disqualify an inspector at any time, and a company can continue 
to participate in the program only if it maintains a clean 
inspection record. In our sense, if the committee leaves the 
program in its current unworkable form, FDA will be deprived of 
valuable information that it would otherwise have to make 
decisions for the public health.
    With regard to pediatric medical devices, we support the 
goal of increasing access to pediatric devices, and I want to 
commend Congressman Markey and Congressman Rogers for their 
leadership in this area. However, in order for a pediatric bill 
to truly be successful in increasing the number of studies, we 
believe there should be a careful balance of carrots and 
sticks. Unfortunately, the current draft is virtually all stick 
and no carrot. The bill lacks any significant financial 
incentives to provide device companies incentives to conduct 
pediatric trials. Similar incentives on the drug side have been 
estimated by HHS to be worth billions of dollars. And they have 
worked. Those incentives have produced numerous additional 
trials.
    In terms of the stick side of the equation, the bill gives 
FDA the authority to prohibit access to a device that was 
developed for an adult or general use, if the agency foresees a 
potential pediatric use, until such time as the sponsor agrees 
to conduct a pediatric study. It could take months to negotiate 
such a study and during that time, patient access to the device 
in question would be denied. The bill could be improved in our 
view by providing an expedited waiver process to resolve such 
disagreements between a product sponsor and the FDA, when in 
the view of the sponsor, it would be impossible to conduct a 
trial due to lack of information about the target population or 
difficulty enrolling patients.
    We are also concerned with one aspect of the clinical trial 
registry provision, the requirement to disclose information on 
a clinical trial before the device is approved. Unlike drug 
companies, patents provide only limited protection for device 
companies, because it is often easy to engineer around a patent 
for a device. Clinical trial design is critical intellectual 
property for device companies. If a company's trial design is 
known to competitors before the device is approved, a 
competitor can drastically shorten the period of market 
exclusivity or even beat the originator company to market. We 
recommend the approach taken in the Senate to require device 
trial registry, but to delay public disclosure data until the 
device is cleared or approved by FDA.
    In summary, AdvaMed strongly supports reauthorization of 
MDUFMA. We have had a number of concerns which we have 
outlined. We ask that you consider these changes going forward, 
and I appreciate the opportunity to provide my views.
    [The prepared statement of Mr. Ubl follows:]

                      Statement of Stephen J. Ubl

    AdvaMed, the Advanced Medical Technology Association, 
represents more than 1,600 medical technology companies, 
affiliates, and subsidiaries. Our members develop and 
manufacture medical devices, diagnostic products and medical 
information systems that represent nearly 90 percent of the 
health care technology products purchased annually in the 
United States, and nearly 50 percent of those purchased around 
the world. AdvaMed members range from the largest to the 
smallest medical technology innovators and companies. More than 
70 percent of AdvaMed's core members have less than $30 million 
in sales annually. AdvaMed is pleased to offer this written 
testimony on behalf of our members.
    AdvaMed believes that the reauthorization of the Medical 
Device User Fee and Modernization Act (MDUFMA) is good for the 
public health. It will facilitate the timely and effective 
review of new medical technologies and bring them to patients 
as soon as those products can be shown to meet the necessary 
rigorous FDA requirements. It also ensures that FDA's medical 
device program will be on sound financial footing. FDA's device 
program needs sufficient funding to do its job in a timely way, 
and this bill will ensure that the agency has that funding for 
the next 5 years. However, we have serious concerns that other 
provisions in the proposed discussion drafts will not serve the 
public health and instead will undermine the intended impact of 
user fees and FDA's authority to ensure safe and effective 
devices.
    The constructive goals that emerged from FDA and industry 
discussions to improve medical device regulation are frustrated 
by the proposed preemption section that would overturn previous 
clear Congressional intent and court precedent and elevate 
individualized state decisions over FDA's expert science-based 
determinations of product safety and effectiveness. On this 
issue, we have great concern that the draft not only harms the 
agency's ability to fulfill its mission to safeguard public 
health, but also disincentivizes research and development of 
life saving technologies and diminishes patient access to 
beneficial technologies. This represents a substantial step 
back and will cede our nation's leadership in health care 
innovation. Inclusion of the proposed preemption section may 
jeopardize industry support for the legislation.
    The following summarizes our concerns with the proposals 
and identifies areas that we believe members of the 
Subcommittee should examine closely in order to further the 
public health.

                    Limitation on Federal Preemption

    Section 108 of MDUFMA, which purports to be a ``rule of 
construction,'' is (1) unnecessary and (2) damaging to medical 
device innovation and FDA's authority. Specifically, section 
108 states ``Nothing in this Act or the amendments made by this 
Act may be construed as having any legal effect on any cause of 
action for damages under the law of any State (including 
statutes, regulations, and common law).'' It is hard to 
understand the point of the inclusion of this language in the 
proposed House bill except as an attempt to create ambiguity 
regarding the preemptive effect of fee-based agency actions, 
including approval of premarket applications (PMAs), and to 
deconstruct the clear Congressional expression of preemption 
included in the 1976 Medical Device Amendments. Consideration 
of an issue that would so fundamentally change the FDA 
regulatory structure should not be included in a bill designed 
to reauthorize the hiring of additional reviewers at the 
agency, especially given the importance of reauthorizing the 
bill before expert reviewers at FDA are notified that the 
funding, and therefore their jobs, may be in jeopardy.
    Manufacturers (and their third party sources of capital 
that fuel further research and development) require a level of 
certainty that they will not be subject to state tort liability 
after spending the vast amounts of time, money, and other 
resources to adhere to stringent FDA requirements for PMA 
devices and to obtain FDA's full safety and effectiveness 
approval of a PMA device. Whether or not section 108 of MDUFMA 
is an attempt to muddy the waters regarding the preemptive 
effect of PMAs and device specific reviews, we believe it could 
have that effect and for that reason should be struck from the 
proposed House MDUFMA legislation.
    Express preemption for medical devices is governed by 
section 521 of the Federal Food, Drug, and Cosmetic Act (or the 
FDCA), which expressly preempts state requirements that are 
``different from or in addition to, any requirement applicable 
under . . . [the FDCA] to the device, and which relate ``to the 
safety or effectiveness of the device or to any other matter 
included in a requirement applicable to the device under'' the 
FDCA. According to the House Committee Report for the 1976 
Medical Device Amendments, section 521 was included in the 1976 
Amendments because consistency in requirements for medical 
devices was considered necessary to avoid unduly burdening 
interstate commerce.
    Device specific reviews, such as a PMA, entail a 
comprehensive review of safety and effectiveness by FDA's 
expert scientists, physicians and other analysts. The PMA 
process established by the 1976 amendments required the most 
exacting review for the riskiest devices, those in class III. 
Additionally these devices were of the most concern, and 
included those which are either for use in supporting or 
sustaining human life, or are of substantial importance in 
preventing impairment of human health or present an 
unreasonable risk of illness or injury. The safety and 
effectiveness of class III premarket approval devices must be 
determined with respect to the persons for whom they are 
intended, with respect to the labeled conditions of use and by 
weighing any probable benefit to health from the use of the 
device against any probable risk of injury or illness from such 
use.
    The PMA process is a rigorous, device-specific FDA review 
as has been recognized by the courts. To obtain PMA approval, a 
manufacturer must, among other things, submit full reports of 
investigations that provide a reasonable assurance of the 
safety and effectiveness of the class III, PMA device, 
typically one or more clinical investigations. Breakthrough PMA 
devices normally are reviewed by an outside panel of experts. 
The amount and type of data necessary to meet the PMA approval 
standard of a reasonable assurance of safety and effectiveness 
requires expert scientific analysis that Congress long ago 
assigned to FDA and which the agency is uniquely qualified to 
render. FDA has vigorously advocated preemption in defending 
its role in determining the safety and effectiveness of devices 
in recent years.
    A substantial majority of courts, including Federal circuit 
courts, have held that the PMA process is the type of device 
specific review entitled to preemptive effect over state tort 
claims under section 521 of the FDCA. Nonetheless, there is a 
small minority of courts that have reached a different 
conclusion, including one Federal circuit court. The Supreme 
Court has not directly addressed the question, thus some 
uncertainty remains despite the majority consensus favoring 
preemption in the Federal circuit courts.
    In sum, elevating individualized state actions and 
decisions through tort lawsuits over FDA's expert determination 
not only undermines FDA's authority regarding product-specific 
determinations, such as the requirements necessary for PMA 
approval and adequate device labeling, but also diverts 
resources from research and development to litigation and 
insurance. The PMA process applies to the approval of the 
newest, riskiest, most complex, and some of the most 
transformative and beneficial devices developed. Innovation 
leads to earlier disease detection, less invasive procedures, 
and more effective treatments. The cost of section 108 will be 
an unnecessary unsettling of the law and resulting additional 
uncertainty that will likely discourage investment and 
innovation and delay or deny patients access to devices.

        Omission of Third Party Inspection Program Improvements

    The MDUFMA discussion draft fails to address the problems 
currently plaguing third party inspections, a statutorily 
authorized program widely recognized as falling short of its 
potential to improve the inspection process and free up agency 
resources. AdvaMed was pleased to work with FDA and others in 
industry to design improvements to the FDCA to both encourage 
more participation and streamline the currently burdensome 
third party inspection program. We are extremely disappointed 
that these much needed improvements were not included in the 
House bill.
    The reality of the situation is that FDA does not conduct 
inspections as often as they would like. In fact, they inspect 
facilities every 6 years on average rather than every 2. So to 
reject a streamlining of this process that allows FDA to better 
focus their resources where they are most needed is short-
sighted at best. In fact, the agreement reached by industry and 
FDA ensures that more, not less, information about facilities 
will be made available to FDA. And at any time, FDA can choose 
to pursue its own inspection of any facility.
    The changes included in the FDA/industry agreement are 
designed to streamline the process but do not change in any way 
the strong conflict of interest prohibitions for industry and 
third party inspectors. For example, the agreement contains 
provisions that would simplify the eligibility criteria and 
process by which establishments request an inspection by 
accredited parties. Those changes were included in the Senate-
passed version of the reauthorization. For example, the owner 
or operator of an establishment is required to submit a notice 
to FDA that identifies, among other things, the most recent 
inspection and its classification. Establishments for which FDA 
classified the most recent inspection as ``official action 
indicated'' would be ineligible for a third party inspection 
and, unlike under current law, could not submit a petition 
seeking such an inspection. The Senate bill also eliminated an 
eligibility requirement that was impractical to satisfy, namely 
that the owner or operator submit to FDA a statement that the 
government in a foreign country where the device is, or is 
intended to be, marketed recognizes an FDA or third party 
inspection.
    Another important change to the program is the elimination 
on the number of times a company can use a third party 
inspection. Currently, a company is limited on the number of 
times it may use a third party inspector to two times. After 
two third party inspections, FDA must conduct an inspection. 
The Senate bill eliminates this limitation and allows a company 
to continue to use third party inspectors as long as the 
company maintains a good inspection record. Although this 
limitation is removed in S. 1082, the statute would require 
that an establishment must continue to have its inspection 
reports classified as compliant to continue participating in 
the program. Under current law, if a manufacturer received a 
noncompliant inspection from an accredited third party, the 
company could appeal to the Secretary to remain in the program. 
This provision is removed from S. 1082.
    The authority to conduct inspections at any time remains at 
the discretion of the FDA. The MDUFMA agreement and the Senate 
bill allow FDA to consider the goals of international 
harmonization of quality systems standards thus streamlining 
overlapping international inspection requirements. 
Specifically, it would allow FDA to accept international 
standards reports of certifications, thus providing the Agency 
the opportunity to receive additional information on a facility 
so they can focus their resources where they see the most risk. 
This is another provision that was omitted from the House 
discussion draft.
    The failure to include these process improvements threatens 
the tenuous existence of the current third party inspection 
program.

      Requirements for Unique Device Identifiers for All Implants

    The proposed amendment that would require FDA to establish 
a medical device registry and unique identification system for 
medical device implants represents a broad expansion of current 
law without delineating any criteria to govern which implants 
would be subject to the unique identifier requirements, i.e., 
it is not risk-based and encompasses all implants regardless of 
their risk. Under the existing authority of Sec. 510(e) and 
502(o) of the FDCA, FDA is currently developing regulations for 
a system of unique device identification for all medical 
devices. Also, FDA currently has authority to require tracking 
for the useful life of any class II or class III device the 
failure of which would be reasonably likely to have serious 
adverse health consequences, which is intended to be implanted 
in the body for more than 1 year, or which is life sustaining 
or life supporting and is used outside a user facility. FDA 
considers the following factors in determining whether a 
tracking order will be issued: likelihood of sudden, 
catastrophic failure; likelihood of significant adverse 
clinical outcome; and the need for prompt professional 
intervention. The agency has issued tracking orders for a 
number of devices including abdominal aortic aneurysm stent 
grafts, cardiovascular permanent pacemakers and electrodes, 
mechanical replacement heart valves, and silicone gel-filled 
breast implants.
    The proposed identification and registry system would be a 
wholesale and unnecessary expansion of the present system. It 
could include devices not likely to have catastrophic failures 
or that are only implanted short term. For example, under the 
proposed language, sutures and dental implants would be 
covered. In sum, the proposed new UDI and registry requirements 
are duplicative and an unnecessary and unduly burdensome 
expansion of the current system without real public health 
benefit.

               Availability of Pediatric Medical Devices

    The device industry is committed to the goal of providing 
children access to life-saving, life-enhancing medical devices, 
and we commend Representatives Edward Markey and Mike Rogers 
for their work on the Pediatric Medical Device Safety and 
Improvement Act of 2007. AdvaMed has engaged in discussions 
with the offices of Representatives Markey and Rogers about the 
device industry's concerns (outlined below) and we are hopeful 
we can reach an acceptable agreement.
    Because FDA has indicated it already has authority to 
require postmarket surveillance for any device at any time, 
including at the time of approval or clearance, we believe the 
language giving FDA authority to require postmarket 
surveillance as a condition of approval or condition of 
clearance is unnecessary. Importantly, the language as 
currently drafted has the unintended consequence of adversely 
impacting the availability of safe and effective medical 
devices for the broader population.
    We are also concerned that the postmarket surveillance 
database duplicates an effort that FDA has already undertaken--
to create a database of all postmarket surveillance device 
studies. There is no need to legislate the creation and 
maintenance of a new database--a costly and expensive 
proposition.
    In addition, as we attack the problem of limited 
availability of pediatric devices for children, we need to 
address the root causes--lack of knowledge of pediatric needs 
and lack of incentives. The market for pediatric uses is often 
very limited, while the cost of development and regulatory 
clearance or approval can be comparable to the adult market. 
Unlike drugs, the kinds of incentives that exist in the Best 
Pharmaceuticals for Children Act are not available to the 
device industry. Creating incentives such as improvement in the 
pediatric HDE program, establishing a new compassionate use 
pediatric device provision, using existing regulatory 
mechanisms to facilitate device clearance and approval without 
reduced safety and efficacy standards for children, or creating 
tax credits or grant programs for companies developing 
pediatric devices could improve pediatric device access.
    We thank Congressmen Markey and Rogers for their leadership 
on pediatric issues and look forward to working with them and 
members of the Subcommittee and the Full Committee to resolve 
the important, outstanding issues on this legislation.

             Clinical Trial Registry and Results Databases

    AdvaMed supports patient and doctor access to important 
information about the health benefits and risks of medical 
devices. The current language, however, would harm device 
innovation without any benefit to patients. We support the 
Senate language which requires disclosure of all clinical trial 
information once a device is actually available to patients.
    In the competitive device environment, protecting 
proprietary technology is especially important because patents 
provide little protection for devices. Engineering or design 
changes can readily negate device patents whereas for drugs, 
entire molecules are patented, frequently before the first 
trial begins. As a result, disclosure of the existence of an 
Investigational Device Exemption (IDE) or related data in a 
registry could unfairly reveal important proprietary 
information to competitors who could speed competing devices 
into trials, obtain FDA clearance or approval and take 
advantage of the significant benefits associated with being 
first-to-market. When there is no FDA-approved product, 
information related to the device design and to the design of 
the trial and its endpoints is the only intellectual property a 
company may have.
    Such disclosures could have the unintended consequence of 
eliminating many small device companies from the marketplace. 
Small companies account for the vast majority of device 
innovation and contribute greatly to maintaining strong price 
competitiveness across the industry.

                 Differences Between Drugs and Devices

    We encourage the House to consider including a recognition 
of the differences between drug and device trials in their 
database requirements. The Senate bill, for example, requires 
early registration of device clinical trials but protects 
sensitive intellectual property and trade secrets until the 
device is cleared or approved. In addition, S. 1082 recognizes 
that the vast majority of device companies are small and allows 
a link to the FDA-required PMA Summary of Safety and 
Effectiveness (SSE) or the 510(k) Summary to satisfy the bill's 
results requirements. More than 70 percent of AdvaMed's members 
have less than 50 employees and fewer than $30 million in sales 
annually. They will be unable to manage the extremely 
burdensome requirements of this legislation. The SSE and 510(k) 
Summary include a detailed summary of information on the 
clinical trials that supported the PMA or 510(k) application 
including information on any adverse events during the trial.
    Finally, the discussion draft includes a requirement that 
any agreement that prohibits an investigator from discussing or 
publishing the results of a trial must be included in the 
clinical trials registry and results databases. The provision 
indicates a fundamental misunderstanding of the current nature 
of most device clinical trials which are multi-center trials 
(multiple sites and investigators conduct the trial). While 
device trials are much smaller than drug trials, they typically 
require multiple sites to assist with recruitment. FDA may also 
require multi-center trials in order to see experience over 
several sites. It is standard procedure to require 
investigators to withhold discussing or publishing the results 
of a trial at their particular site until the data from all of 
the sites has been aggregated. Discussion or publication of 
information from one site could provide false or misleading 
information about the trial and could introduce bias (positive 
or negative) into the study that could jeopardize the integrity 
of the trial. Further, premature discussion or publication of 
one site's trial information could jeopardize publication of 
the aggregate data later in a peer-reviewed journal. Most 
medical journals refuse to publish information that has 
previously been released. Thus, there is a legitimate need for 
restrictions on discussion or publication until the data has 
been aggregated. Although there are rational and legitimate 
reasons to restrict individual investigators from premature 
release of information, the legislative requirement to reveal 
these restrictions will unfairly paint sponsors as bad actors.
    To ensure continued medical device innovation for patients, 
AdvaMed recommends that the House legislation:

     Delay disclosure of device clinical trial 
registration information until the device is cleared or 
approved.
     Allow device companies to satisfy results 
requirements via a link to the PMA SSE or 510(k) Summary.
     Eliminate the faulty provision requiring 
disclosure of agreements that prohibit investigators from 
prematurely discussing or publishing clinical trial results.

 Availability of Advisory Committee Members With Appropriate Expertise

    The House bill prohibits an advisory committee member from 
voting on a matter if that member, or an immediate family 
member, has a financial interest that could be affected by the 
committee's advice to FDA. The agency may grant a waiver of 
this prohibition if a waiver is necessary to afford the 
advisory committee essential expertise; however, only one 
waiver may be granted per committee meeting. AdvaMed is 
extremely concerned that the limitation of one waiver per 
committee meeting could prevent FDA from convening a panel of 
experts with the appropriate expertise to address the matter at 
hand. Because the waivers will be publicly disclosed, thus 
making the committee process transparent, we do not believe 
there is any harm in granting more than one waiver to highly 
qualified experts who bring unique expertise to the committee 
meeting. Advisory committees have been challenging to form 
because of the difficulty in recruiting the persons most expert 
in a type of device. We believe the House's one waiver 
limitation undermines other elements of this legislation which 
require FDA to conduct outreach and recruit potential members 
to advisory committees, including those who have waivable 
conflicts.

                 IOM Report on Premarket Notifications

    The MDUFMA discussion draft requires an Institute of 
Medicine (IOM) ``study on the appropriate use'' of the 510(k) 
process ``to clear medical devices as safe and effective.'' 
Although commonly referred to as a ``clearance'' system, the 
premarket notification system actually is a classification 
system which regulates classes of devices according to their 
risk profile. Congress developed the premarket notification 
process to mirror the incremental innovation process that 
occurs in medical technology and where appropriate to help 
expedite incremental improvements in devices through the 
regulatory process. Upon submission of a premarket 
notification, FDA determines whether the device is 
``substantially equivalent'' to a predicate device. To be 
substantially equivalent, the device must have the same 
intended use and the same technological characteristics as the 
predicate, or if it has different technological 
characteristics, there must be information submitted to FDA 
that demonstrates that the device is as safe and effective as a 
legally marketed device and does not raise different types of 
safety or effectiveness questions from the predicate device. 
Many 510(k) devices or their predicates have been on the market 
more than 30 years (i.e., prior to the Medical Device 
Amendments of 1976) and their benefits and risks are well-known 
and well-qualified.
    Congress has fine-tuned the 510(k) process over its 30-year 
history to ensure that FDA has the necessary tools and can 
devote appropriate resources to devices as needed, including 
those which present a higher risk. Importantly, The Safe 
Medical Devices Act of 1990 (SMDA) strengthened the 510(k) 
premarket notification process by requiring substantial 
equivalence decisions to be made to currently marketed 
technology--not to technology that is no longer on the market. 
This has the effect of ensuring that FDA's substantial 
equivalence decisions are made to the most advanced technology 
available. SMDA also required that premarket notification 
submissions include detailed information concerning potential 
adverse health effects. Finally, SMDA gave FDA authority to 
impose a wide range of special controls including performance 
standards, postmarket surveillance, the submission of clinical 
data, the development of patient registries, and any other 
appropriate action needed to provide a reasonable assurance of 
the safety and effectiveness of a device.
    While AdvaMed supports any independent analysis of the 
premarket notification system to ensure the system is operating 
to its full potential, because of the complexity of device 
regulation, any such analysis must be fully informed and 
include the perspectives of all potentially affected parties. 
It is important that any IOM review of the 510(k) process 
include a device representative. AdvaMed would want to ensure 
that any review of the 510(k) process thoroughly consider the 
views of its members.
    In summary, AdvaMed strongly supports the reauthorization 
of MDUFMA. However, we have serious concerns with the draft 
legislation as proposed, and we ask that you consider the 
changes we have requested to ensure that the final draft 
accomplishes the goal of ensuring that Americans have access to 
safe and effective medical technology as soon as possible. We 
thank the Subcommittee again for its interest in these 
important regulatory issues. We look forward to working with 
Congress and the FDA on this legislation.
                              ----------                              

    Mr. Pallone. Thank you. Dr. Zuckerman.

  STATEMENT OF DIANA ZUCKERMAN, PRESIDENT, NATIONAL RESEARCH 
                 CENTER FOR WOMEN AND FAMILIES

    Mrs. Zuckerman. Thank you for the opportunity to testify 
today. I am Dr. Diana Zuckerman, president of the National 
Research Center for Women and Families, an independent think 
tank that analyzes and evaluate health programs and policies. I 
was trained as an epidemiologist at Yale Medical School and I 
have worked on health policy issues for more than 20 years.
    Every American relies on medical devices and more than 
5,000 medical devices were cleared or approved by the FDA last 
year. Ninety-eight percent were cleared through a quick and 
easy 510(k) process that usually does not require clinical 
trials to prove that the products are safe and effective. So I 
am going to start by focusing on that 510(k) process and the 
relevance to your legislation.
    We strongly support provisions in your discussion draft 
that would address concerns with the 510(k) process. We applaud 
your decision to keep the user fees for each 510(k) application 
at the current level, and your decision not to speed up the 
already speedy review process for the 510(k). Keeping the 
status quo will put less strain on CDRH, since almost all the 
devices are reviewed that way. You have asked for an IOM report 
on the 510(k) process and we think that is a great idea and I 
have some slides to show you why.
    [Slide]
    Unlike drugs, most medical devices do not need to be proven 
safe and effective, and under the 510(k) process, devices are 
cleared if they are deemed substantially equivalent to other 
devices that were on the market prior to 1976. Originally, the 
term substantially equivalent was expected to mean that they 
were very similar, but that definition has changed over the 
years and today, as long as the products are used for the same 
purpose, they don't need to be the same shape, made from the 
same materials, use the same mechanism of action, or be 
equivalent in any other substantial way. And so if you look at 
this first slide, steak and milk are more substantially 
equivalent than the FDA would require. Both are food; both are 
from cows. But let us look at some medical device examples 
instead. Next slide.
    [Slide]
    Here is a jaw implant made by Vitek, the one on the left. 
It was cleared as substantially equivalent to silicone 
sheeting, which you see on the right. You can see they are 
completely different. They look different and they are even 
made from completely different materials. The Vitek implants 
were made with Teflon and clinical trials were not required and 
so nobody knew that the Teflon would flake off inside people's 
jaws and that that would cause the jaw bone to degenerate, to 
basically disintegrate. Patients ended up unable to speak or to 
eat and some with holes in their skull with their brain no 
longer protected. Vitek jaw implants were recalled, but they 
could not be safely removed from all patients. Next slide, 
please.
    [Slide]
    Last month a contact lens solution was recalled because it 
causes serious eye infections that can cause blindness. That is 
completely different from the contact lens solution that was 
recalled a year ago, a completely different solution which also 
caused a different eye infection which could also cause 
blindness. Both of these contact lens solutions were approved 
as substantially equivalent to older, safer contact lens 
solutions, and you can see that those eye infections caused by 
those new solutions are really terribly serious. Slide 3, 
please.
    [Slide]
    Bladder slings are used to treat stress incontinence in 
women. The slings made by Boston Scientific called ProteGen 
were made from a different material than slings that looked the 
same. You can see these are diagrams are identical. The slings 
look the same but they are made of a different material. So the 
ProteGen was made out of a new synthetic material, whereas the 
old slings are made of Gor-Tex or other materials that had been 
found to be safe. The ProteGen slings were recalled because 
they caused more infections, they caused vaginal erosion and 
other serious problems. The last slide, please.
    [Slide]
    Yes, apples and oranges are both fruit, they are both round 
and they are both good for you, but they have different 
advantages and they are not substantially equivalent. That is 
why we have the expression apples and oranges. They are 
different. And the FDA needs to define substantially equivalent 
to make sure that the products that they are reviewing really 
are the same. If they are not, clinical trials are needed.
    So for all its faults and despite Vioxx and Avandia and 
other lapses, the FDA approval process for prescription drugs 
is really much more cautious and rigorous than the device 
approval process. And in speaking with physicians, scientists 
and consumer advocates, we have developed several suggested 
changes in the 510(k) process, which is in my written 
testimony. From a policy point of view, when new devices are 
approved through the 510(k) process, if there are no studies 
published, they are not going to be covered by the Center for 
Medicare and Medicaid Services and they are not covered by 
insurance. So all the rush to get them to market doesn't really 
help patients, if they are not reimbursed through health 
insurance.
     So when you ask the IOM or the GAO to examine the 510(k) 
process, which is going to take at least a year or two, I urge 
you to consider a temporary moratorium on approving implanted 
medical devices that have not been carefully evaluated with 
clinical trials. And I just want to finish by saying that the 
FDA has made it clear that post-market analysis is very 
important and it is especially important for medical devices 
because so many are cleared without clinical trials. We think 
registries with unique identifying numbers on products are very 
helpful and important, and we think the adverse reporting 
system needs to be improved. So we are very pleased that your 
discussion draft includes additional funding and we urge you to 
specify how that funding will be spent.
    Finally, I just want to say a couple of words about direct-
to-consumer advertising on medical devices.
    Mr. Pallone. OK. Quickly, though, because you are almost at 
2 minutes.
    Ms. Zuckerman. I promise. Sorry.
    Mr. Pallone. Over, I mean.
    Ms. Zuckerman. OK. Medical devices are also advertised 
through direct-to-consumer advertising and any restrictions for 
DTC ads for drugs should also be considered for devices. And we 
also support your decision not to expand the third-party 
inspections. Since the current program has not worked very 
well, we think it would be foolish to expand it before you can 
figure out why it isn't working better and what needs to be 
done. Thank you very much.
    [The prepared statement of Ms. Zuckerman follows:]

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    Mr. Pallone. Thank you. Mr. Walker.

   STATEMENT OF STEVE WALKER, CO-FOUNDER AND CHIEF ADVISOR, 
   ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS

    Mr. Walker. Mr. Chairman, Congressman Deal, members of the 
committee, we at the Abigail Alliance wish to express our 
thanks for this hearing and for inviting us to testify. I am 
Steven Walker, co-founder and chief advisor to the Abigail 
Alliance. I receive no compensation of my efforts as an 
advocate and I pay my own expenses.
    The Abigail Alliance for Better Access to Developmental 
Drugs is a nonprofit, nonpartisan patient advocacy organization 
dedicated to serving the needs of people suffering from serious 
and life-threatening diseases.
    Based on our firsthand experience with the harsh regulatory 
realities faced by patients with life-threatening diseases, we 
have proposed a solution called Tier 1 Initial Approval to ease 
the regulatory barriers our constituents face, while 
simultaneously protecting the clinical trial system. Tier 1 was 
submitted to the FDA in a citizens petition 4 years ago 
yesterday and we are still waiting for a response, and I wonder 
if I could have the 2-week thing that Congresswoman DeGette got 
on that?
    Last year a bill called Access Act passed based on our tier 
1 proposal. It was introduced in both houses of Congress and it 
is going to be reintroduced this year and we strongly urge 
Congress to pass the bill. Incidentally, legislation to address 
the needs of our constituents should have been included in the 
discussion draft today.
    In July 2003, we filed a suit against the FDA in Federal 
court, claiming that the FDA's denial of access to promising 
investigational drugs for patients with no other option but 
death from their disease, violates their constitutional rights 
of due process and privacy. Last year a three-judge panel of 
the DC Federal Court of Appeals agreed, but the FDA moved for a 
rehearing by the full appeals court and almost 4 years after 
filing the suit, we are still awaiting a trial on the merits of 
the claim. Over those 4 years, 2.2 million Americans died from 
cancer alone. This is not just a regulatory policy issue. It is 
a civil rights issue. Now I am going to turn to a few of your 
discussion drafts.
    The Abigail Alliance has long sought readily available and 
more complete listings of clinical trials and access programs 
for investigational drugs, and we support the proposed clinical 
trials registry in the discussion draft. We also support in 
concept the idea of making the results of clinical trials 
public. But we think the clinical trials results database as 
proposed in the discussion draft has all the earmarks of a 
major regulatory misstep. The evidence for this can be found in 
the recent flap over Avandia. The publication of 
scientifically-weak analysis results in the New England Journal 
of Medicine was a statistical drive-by hit on the integrity of 
our regulatory system. If the results database is enacted as 
proposed, the FDA will become the regular target for poorly-
constructed statistical hand grenades and spend far too much of 
its time trying to clean up the mess after each one explodes in 
sensational fashion in the media. We ask that the committee 
schedule future hearings to receive additional input on how to 
make trial results public, while at the same time preserving 
the integrity of our regulatory system.
    On advisory panel conflicts of interest, we think you are 
missing the point. We think you are putting the cart before the 
horse. The Federal Advisory Committee Act prohibits 
inappropriate influence by the appointing authority of its 
advisory committees. But FDA review office directors are 
empowered to manipulate the ideological makeup of their 
advisory committees, and potentially use that power to pursue 
the outcome they want regarding policy matters and votes on 
specific drugs. We believe that this has, in fact, happened 
with some cancer drugs. Congress should start by looking at the 
FDA's process for selecting advisory committee members at the 
detail level and then take up the conflict of interest 
measures.
    On REMS, we oppose the proposal to require mandatory Risk 
Evaluation and Mitigation Strategies, or REMS, because they are 
mandatory, making them yet another one-size-fits-all solution 
that won't work. The FDA already has and uses the authority to 
impose what they call risk management plans, or RiskMAPs, on 
drugs at the time of approval. RiskMAPs has so far been a mixed 
bag of safety controls burdened with unnecessary approval 
delays and proscribing restrictions, coupled with requirements 
for highly unethical post-approval clinical trials. Remember, 
people are put into these clinical trials. They are not just 
exercises in data collection. RiskMAPs also have resulted in 
major intrusions by the FDA into the practice of medicine. 
Mandatory REMS, even though proposed as being flexible, are 
likely to evolve quickly into an over-applied defensive 
mechanism for FDA, instead of its intended use of being a 
rational, sober post-marketing tool. We need post-market 
monitoring of drugs, but we do not need anymore one-size-fits-
all solutions. We suggest that the flexible model for what must 
be included in the REMS be used to replace the current RiskMAP 
model, but that the need for a REMS be determined on a case-by-
case basis. And believe me, I find it odd that I am in 
agreement with the FDA. I am usually not.
    The Reagan-Udall Institute for Applied Medical Research is 
a very good idea that could be made even better. The goal is 
regulatory modernization and that can only come through real 
change in the way the FDA does its job. Consequently, the 
institute should be moved inside the FDA and given line 
authority to issue new policies and guidance and to initiate 
rulemaking on its own.
    I have some closing comments. This entire debate regarding 
FDA reform has its roots in a decades-old feud raging within 
the FDA and the medical research community, between two groups 
of statisticians: those who believe the forward-looking trials 
used for pre-approval testing, and those who support the 
backward-looking trials who try to find drug safety needles in 
haystacks. Neither statistical camp should win this feud. 
Patients should win. And for that to happen, we need to move 
away from the rigid, often unethical statistical approaches we 
have now and move toward real science. We need to remember that 
the FDA's mission is not to control and punish the drug 
companies, but rather to protect and promote the public health, 
and it is on the promote side where we will find better 
treatments and cures for diseases like cancer.
    I would like to close with an important fact. Every 
investigational drug for which the Abigail Alliance has sought 
early access was eventually approved by the FDA. We knew that 
patients would be better off if they could get the drug than if 
they could not, usually years before the FDA enacted to make 
those drugs available. If the FDA was less a barrier to 
progress, millions more would have gained access to that 
progress over the last 7 years. Thank you.
    [The prepared statement of Mr. Walker follows:]

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    Mr. Pallone. Thank you. Dr. Gorman.

   STATEMENT OF RICHARD GORMAN, M.D., CHAIR, AAP SECTION ON 
  CLINICAL PHARMACOLOGY AND THERAPEUTICS, AMERICAN ACADEMY OF 
                           PEDIATRICS

    Dr. Gorman. Thank you, Mr. Chairman and members of the 
committee. I am Dr. Richard Gorman, a practicing pediatrician 
who has taken care of infants, children and adolescents for 
over 25 years. On behalf of the American Academy of Pediatrics, 
I would like to thank the subcommittee for holding this 
legislative hearing and for considering bills necessary to 
address the need for safe and effective drugs and medical 
devices for children.
    The American Academy of Pediatrics urges the committee to 
reauthorize BPCA and PREA with necessary improvements, and to 
pass the new pediatric medical devices legislation to begin to 
close the gap between medical devices that children need and 
the devices that are available. I would like to thank 
Representatives Edward Markey and Mike Rogers for championing 
the pediatric medical device legislation, and express our 
continuing gratitude to Representative Anna Eshoo for leading 
the efforts on BPCA and PREA. Thank you, Mr. Chairman, as well 
as Chairman Dingell, for addressing these bills along with the 
user fees and drug safety legislation.
    In previous testimony before this committee, I have 
credited BPCA and PREA with giving healthcare providers and 
families a great increase in the useful information on medicine 
for children. The American Academy of Pediatrics strongly 
supports the Improving Pharmaceuticals for Children Act of 
2007, H.R. 2589, introduced by Representative Eshoo. We thank 
the committee for including much of H.R. 2589 in draft 
legislation we are considering here today. H.R. 2589 not only 
reauthorizes BPCA and PREA, but makes several needed changes to 
ensure their continued success. The reauthorizing legislation 
under consideration does four major things: it increases the 
dissemination and tracking of pediatric drug information; it 
integrates and strengthens BPCA and PREA's administrative 
process by affirming and institutionalizing an internal review 
committee that has already been created by the FDA to provide 
guidance and oversight for the FDA review divisons when issuing 
written requests under BPCA and pediatric plans under PREA. 
This legislation also expands the study of off-patent drugs by 
expanding the role of the NICHD to include studies of gaps in 
pediatric therapeutics, and it makes PREA a permanent part of 
the Food and Drug Act, and continues to give Congress the 
opportunity to regularly reevaluate the BPCA's incentives.
    As I have testified in the past, the AAP evaluates proposed 
changes to BPCA's exclusivity incentive by asking two 
questions: would these proposals reduce the number of pediatric 
studies, and would these proposals be administratively 
burdensome to the FDA? The blockbuster proposal contained in 
the Committee Print is troubling, in that it does not protect 
against a potential reduction in pediatric studies and leaves 
open the question of whether regulations would be 
administratively burdensome. The AAP is on record for 
supporting the compromise crafted by Senator Chris Dodd in 
Senate bill 1082. We urge the committee to retain this approach 
to adjusting the market exclusivity incentive.
    The Pediatric Medical Device Safety and Improvement Act of 
2007 will help children get the safe medical and surgical 
devices they need by strengthening safety requirements and 
encouraging research, development and the manufacture of 
pediatric devices. This bill, included in the committee print, 
strikes the right balance between new incentives and increased 
post-market surveillance, and puts forward a comprehensive 
package that serves as a critical step forward for children. 
The pediatric device legislation will help define the need for 
pediatric devices by better organizing the Federal response. It 
will create a device development mechanism of nonprofit 
consortia that will facilitate pediatric device development and 
manufacture through mentorship from experienced companies. It 
improves the humanitarian device exemption by eliminating the 
profit restriction for pediatric HDEs, which will increase the 
incentive for small companies to enter the pediatric device 
market and allow others to make a reasonable return. It makes 
needed improvements in the way the Food and Drug Administration 
tracks pediatric devices, and it strengthens post-marketing 
safety.
    As recommended by the Institute of Medicine, this bill 
grants the FDA increased authority to ensure that approved 
medical devices are safe for children. Under this proposed law, 
the FDA would be able to require post-market pediatric studies 
as a condition of approval or clearance of certain devices. 
This legislation also allows the FDA to require a study of 
greater than 3 years, if necessary, to ensure that the study is 
long enough to capture the effect of a child's growth on the 
safety and efficacy of the medical device.
    I would like to thank the committee for allowing me the 
opportunity to share with you the strong support of the 
American Academy of Pediatrics for the reauthorization of BPCA 
and PREA, as well as the new pediatric medical device 
legislation. We urge swift passage by this committee for the 
sake of all children. Thank you.
    [The prepared statement of Dr. Gorman follows:]

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    Mr. Pallone. Thank you, Dr. Gorman. We will start with 
questions and I will begin. I wanted to ask Mr. Guest, first, a 
couple of questions. The Consumers Union urges a zero conflict 
of interest policy for FDA advisory committee members. I have a 
couple of questions about that. How will this affect 
recruitment of advisory committee panelists? Will this hurt the 
level of expertise of the panels? Will we be setting up 
advisory committees with second-rate experts? You mentioned 
that CU does not believe the FDA has tried hard enough to find 
experts that are not conflicted. What makes you think this? I 
am just asking a bunch of questions. If you could try to answer 
them.
    Mr. Guest. I know that one group did a small survey. They 
called the deans of medical schools around the country and 
said, have people within your medical schools been asked by the 
FDA to be members of panels? And apparently the results were, 
in many cases, no. They said that there is not one person. 
There doesn't seem to be a concerted effort within the FDA to 
really do an extensive search for people that would be without 
bias, and that is a real concern at Consumers Union, and I 
mentioned that our Consumer Reports National Research Center 
did a survey; six out of 10 Americans do not believe that the 
FDA and Congress, in terms of laws, are doing enough. There is 
a real lack of confidence right now in the FDA. We know 
Consumer Reports is an exceedingly trusted organization, 
because people know we are absolutely free from bias of 
manufacturers. We don't take free advertising and don't take 
free samples and so forth. We think a similar kind of 
credibility, we would hope, a similar kind of creditability 
could be developed at the FDA and we think this legislation, 
the various parts of this legislation will help restore faith 
in the organization that we as consumers ought to depend on to 
protect us.
    Mr. Pallone. All right, let me go to my second question. 
This is about direct consumer advertising. One area of interest 
since the discussion drafts were released has been the 3-year 
waiting period on direct-to-consumer advertising and I keep 
stressing to everyone that this is not a moratorium. This is a 
case-by-case analysis in each. To some extent, I think it has 
been misrepresented as a 3-year moratorium, but it is actually 
case-by-case analysis. But the question keeps coming up about 
the constitutionality of the proposal in the draft, why do you 
think such a provision would be constitutional?
    Mr. Guest. Well, again, like the doctor from the FDA, I 
don't purport to be a constitutional expert on it, but I would 
suggest that the committee might consider having the Library of 
Congress, as a law division, maybe convene a group of 
constitutional scholars, who have no connection to special 
interests in this, to look at that question further. The 
reality is that every country but the U.S. and New Zealand 
actually prohibit direct-to-consumer advertising, because it is 
not, as members have said here earlier, it is not out there to 
try to educate consumers so they can make informed choices. It 
is out there to try to sell a product. And so there is great 
danger that direct-to-consumer advertising are not helping 
consumers. They are having the opposite effect. We actually did 
a survey, also, of doctors and said, how often do you feel 
pressured by consumers who come in, who saw these happy people 
living forever after, and pushing for a drug? Well, the fact 
is, what you don't hear is that a lot of people who push these 
drugs are not living happily ever after. We have got some 
people in this room who can talk about that.
    Mr. Pallone. I know and you know, I appreciate your 
comments. I wanted to ask one more thing of Dr. Gorman before 
my time is up, but I just want to stress again that my concern 
is that if we just have a voluntary system with this 
advertising, that you have a bad actor and that essentially you 
have a bad actor who, even if the FDA determines that there are 
enough questions about a new drug to suggest that there be no 
advertising, that they don't have the power to stop it, other 
than the deceptive advertising, which is a separate issue, 
because something may not rise to the level of deceptive 
advertising, yet we have serious questions about it. And so I 
keep stressing this is not a moratorium. It is just a case-by-
case analysis. But there has to be some stick at the end, 
otherwise you have a voluntary system and you don't get at the 
bad actor.
    I just wanted to ask Dr. Gorman. You expressed concern with 
the way we adjust the exclusivity period for blockbuster drugs 
in our draft. Does the academy have any recommendations, other 
than the Senate proposal, which I know you said you support, 
that would achieve the goal of reducing the exclusivity period 
for blockbuster drugs, based on annual gross sales? We tried to 
come up with something that was a little different than the 
Senate. I know you don't like it, but do you have any other 
ideas other than the Senate, other than what is in the Senate 
proposal?
    Dr. Gorman. Before the beginning of this discussion, the 
academy set up those two criteria that would judge any proposal 
to limit exclusivity, which was that it would not reduce the 
number of studies, and two, it would be administratively simple 
for the FDA. And we didn't think that the committee markup 
language met those tests, so we felt unable to support them. 
But we would be willing to entertain other recommendations 
other than the one from the Senate bill, although we have 
supported that in public.
    Mr. Pallone. OK, thank you. Mr. Deal.
    Mr. Deal. I am going to have a question for everybody and I 
think maybe it will be a yes or no as you go down the line. Do 
you agree that the FDA should be responsible for approving all 
safety-related label changes for drugs? Dr. Loew, I will start 
with you.
    Ms. Loew. Yes, we do believe that FDA should have that 
authority.
    Mr. Guest. We are opposed to preemption. We think that the 
States ought to continue to have the authority that they have. 
The preemption provision that is in the FDA regulation has 
never been actually passed by Congress. That was something that 
the FDA put into the preamble of----
    Mr. Deal. Your answer is no?
    Mr. Guest. The answer is no.
    Mr. Deal. Mr. Ubl?
    Mr. Ubl. I will defer to the pharmaceutical side. But if I 
could amend your question and presume it applies to devices----
    Mr. Deal. Yes.
    Mr. Ubl. Well, we believe that FDA should have that sole 
authority.
    Mr. Deal. Dr. Zuckerman?
    Ms. Zuckerman. No.
    Mr. Walker. No.
    Dr. Gorman. Yes.
    Mr. Deal. Mr. Walker, your answer surprises me.
    Mr. Walker. In all honesty, sir, it is an issue that I 
don't have a full understanding of.
    Mr. Deal. Well, if we are going to allow labels on drug 
products to be amended because of safety concerns, who besides 
the FDA do you think ought to make that determination, trial 
lawyers in the lawsuits, in the States?
    Mr. Walker. Well, sir, it is a loaded question and the----
    Mr. Deal. Well, that is what I am up here for.
    Mr. Walker. Yes, sir. The reason it is a very loaded 
question is because the Abigail Alliance has a very, I guess, a 
very high lack of confidence in the FDA's ability to make good 
safety decisions. And the reason for that is that the FDA is an 
entirely statistical agency and the statistical tools that are 
used to determine, to essentially find the safety needle in the 
haystack, are weak. You are working with very dirty--now 
understand, I am a scientist. I am not a scientist in the 
medical field. I am a scientist in the environmental field, but 
I know a great deal about data. We think that the FDA needs a 
complete rebuild in the way it does its science. We think that 
the idea that we practice our medical science and all clinical 
research, limited by the very restrictive rules of statistics, 
has caused the FDA to be an institutionally incompetent agency, 
in terms of being able to determine and to balance risk versus 
benefit. It is not that the people are incompetent. It is that 
the tools they use aren't working.
    Mr. Deal. Well, unfortunately, we don't have within the 
realm of any of these pieces of legislation an effort to 
rebuild a new organization for purposes of determining patient 
safety.
    Mr. Walker. Actually, sir, you do. It is the Reagan-Udall 
Institute and it should be pumped up and put on steroids.
    Mr. Deal. Well, it is contained in one of the bills that we 
have here. Dr. Loew, your testimony, I believe, states that the 
legislation places the responsibility of policing physicians 
and pharmacists on drug sponsors. Would you elaborate on what 
you mean by that?
    Ms. Loew. That is correct. There is a provision under the 
distribution and use restrictions that FDA can apply in the 
REMS which would require sponsors effectively to police how 
physicians and pharmacists dispense the drug, and we believe 
that is well beyond the ability and in fact the authority of 
pharmaceutical companies, and those are authorities that should 
rest with existing bodies, such as State boards of pharmacies 
who regulate pharmacists.
    Mr. Deal. Mr. Ubl, would AdvaMed withdraw its support for 
the user fee legislation of the preemption provision that is in 
the package? And what would this provision ultimately mean for 
patients and small device manufacturers?
    Mr. Ubl. Well, reluctantly, sir, with consultations with 
our board and our extended membership, it does rise to a level 
of putting the package in overall jeopardy, in our view. And to 
get your second point, particularly for small companies who 
rely on a more certain environment, particularly those that are 
funded by venture capital, we view the preemption danger as, 
again, literally hundreds of State courts, State agencies, 
State legislators, second guessing the scientists and 
physicians at FDA. And it was mentioned earlier on the 
statistic side of things, I think it is important to point out, 
these cases are going to be decided on an individual basis and 
the multiplicity of these individual determinations are going 
to become part of a larger case law that will become what is 
determined as safe and effective by FDA, and we just think that 
is a very slippery slope that would raise serious objections.
    Mr. Deal. Mr. Walker, you mentioned in your testimony the 
phrase manipulating the ideological makeup of the advisory 
committees. Isn't an ideological conflict of interest just as 
damaging and even perhaps potentially more damaging to the 
credibility and impartial nature of an advisory panel, as is a 
financial conflict of interest?
    Mr. Walker. Absolutely. And if I could expand a bit. In 
order to understand what is wrong with the advisory committees, 
you first have to understand precisely how the FDA staffs their 
advisory committees. The FDA doesn't ask people to join their 
advisory committees. People can either be nominated or self-
nominated. Then those nominations come into the agency and they 
are given to the office directors in the various offices. That 
office director goes through that stack of nominees and decides 
who he wants.
    In the case of the advisory committee we watch most 
closely, which is the oncologic drugs advisory committee, the 
director literally picks the people he wants and those are the 
ones that get sent for rubber-stamp approval to the top of the 
agency. What has happened with the ODAC is that every member of 
that advisory committee has precisely the same background, 
precisely the same view of how to conduct clinical trials, and 
how to make decisions about risks and benefits of drugs, as the 
office director. And in addition, the office director decides 
when to call a meeting. The office director decides what 
questions will be asked. The office director decides what 
briefing materials they will get. And the office director also 
decides if he needs consultants who are not current members of 
the committee, who will sit on the committee. And we have seen, 
over the last several years, drugs that should have been 
approved rejected on more or less majority votes based on a 
single point of view. The Federal Advisory Committee Act 
requires that these committees be entirely independent of the 
FDA, in terms of their advice, and they are not.
    The other problem we have is that the office directors, and 
again, with ODAC, can assign members of the committee to work 
on specific drugs behind the scenes and we think this has 
happened. In fact, we think we have proof that has happened. 
And then those people then sit on the committee and vote 
without disclosure. So we have manipulation of advisory 
committees and an inappropriate process for putting people on 
the advisory committees at the FDA.
    And in the case of cancer drugs, we call it decelerated 
approval. There is an initiative underway that was developed by 
the director of the Office of Oncology Drug Products, on his 
own, about 4 years ago, to require every single drug, no matter 
how compelling the data coming out of phase II, to go into 
phase III, and it has resulted in 2-year delays in a large 
variety of drugs, all of which are now approved. But during 
those delays, people died and it wasn't a small amount of 
people. It was a lot of people.
    Mr. Pallone. Ms. Schakowsky.
    Ms. Schakowsky. Thank you, Mr. Chairman. I apologize to the 
witnesses that I didn't hear directly, but I have the 
testimony.
    Dr. Zuckerman, in your written testimony you mentioned 
recommendations for improving drug safety, including the need 
to clarify FDA officers' rights to publish scientific articles, 
as well as the need for strong whistleblower protection 
provisions. And you said that the right to publish could have 
meant earlier warnings about the risks of Vioxx and Avandia and 
others, and I wonder if you could tell us how these additions 
to FDA law would help us avoid future disasters?
    Ms. Zuckerman. Sure. Thank you for asking. I have seen 
numerous examples where data are presented in public at FDA 
advisory committee meetings, so it is not a trade secret. It is 
clear what the data show for a particular product, whether it 
is Avandia or jaw implants or whatever it is. And when those 
data show problems, they are basically never published. They 
are data that a company controls and doesn't choose to publish. 
They publish the results showing the good news about the 
products, not the bad news. I don't think that most FDA 
scientists have a lot of spare time to be writing up articles, 
publishing these data, but at least if they had that authority 
to do that and didn't have to worry about losing their jobs. 
They would have the opportunity to take the data that is 
already publicly available and publish them in medical 
journals, and that could have given us a lot of advance notice 
on Avandia specifically, but other products as well.
    Ms. Schakowsky. Are they currently prohibited from doing 
that?
    Ms. Zuckerman. They are not prohibited so much as they are 
working in an atmosphere where they are worried about losing 
their jobs if they do.
    Ms. Schakowsky. Right.
    Ms. Zuckerman. So it is more having whistleblower 
protection that is very clear, that people can't lose their 
jobs for publishing data that are already public. The other 
issue is whether they would have to do this in their spare time 
on weekends and at night, or whether it could be part of their 
job, which would be great if that were possible.
    Ms. Schakowsky. Mr. Guest, did you want to comment at all 
on that, the right to publish and the whistleblower protection?
    Mr. Guest. Well, I agree with both of those and that is all 
part of our notion that there ought to be real transparency 
about the full information that is available for drugs. Whether 
it is all clinical trials being public or those who looked at 
the drug at the FDA and being able to say what they feel about 
the drug without being in fear of loss of their job, the goal 
is to get that information out there. We are also supporting, 
as I said in my testimony, that the action letters that the FDA 
produces when they approve a drug, that that information also 
ought to be public and the fact that some people may have 
dissented in their review. So again, it is all out there so 
that the public knows, doctors know, and especially 
importantly, that other researchers know so they can work with 
that information at an early stage to either identify or dispel 
the notion that there may be safety problems. So for all of 
those reason, we certainly support that notion.
    Ms. Schakowsky. I wanted to ask a bit about the direct-to-
consumer advertising. And again, Dr. Zuckerman, I was looking 
at this document. You talk about that there is going to be--we 
are going to be seeing, or maybe it is already out and I have 
missed, campaigns for gastric lap bands, for Botox, for 
Juvederm, and that there is also going to be an ad campaign for 
silicone gel breast implants, and that the individuals who give 
those testimonials are then given free treatment. I don't know. 
It raises, to me, some ethical questions, but I am wondering--
and also, certainly, potential health concerns. I wondered if 
you would comment on that.
    Ms. Zuckerman. Yes, and I got that information from the 
company's own Web site. There is one company that sells all of 
those products, Allergan, and it just happens that this one 
company has decided that direct-to-consumer ads are the way to 
go, especially for aging baby boomers, and so they are putting 
a lot of money into really a very attractive ad, an ad 
campaign. I have seen them on TV. They have a Web site and it 
says right on there that at least some of the patients who are 
giving testimonials have gotten free treatment. And as you can 
imagine, free treatment for some of these things are thousands 
of dollars, worth a lot of money for what is essentially 2 
minutes of taped testimonial.
    So there is the concern about--primarily about the fact 
that these kinds of ads are showing beautiful people very happy 
and they don't have the risk information provided and maybe 
they will have, for more information, see our Web site. Or, for 
more information, see this month's issue of Ladies Home 
Journal. But they are not providing real risk information. It 
is not really educating consumers. It is selling a product.
    Ms. Schakowsky. And we baby boomers, who are on a never-
ending quest for the fountain of youth, it seems like they may 
be appealing in a way that could be dangerous to our health.
    Ms. Zuckerman. Yes, it really does make it look very quick 
and easy, whether it is a gastric lap band, which is far from 
quick and easy, or Juvederm, which is an injection into the 
face for wrinkles. It is like putting on baby cream or 
something. I mean, it looks very simple and it doesn't tell you 
what the risks are.
    Ms. Schakowsky. Thank you. Thank you, Mr. Chairman.
    Mr. Pallone. Thank you. Mr. Burgess.
    Mr. Burgess. Thank you, Mr. Chairman. Dr. Loew, you heard a 
minute ago a comment made that the Reagan-Udall bill on 
steroids would be a better way to go with our approach to the 
FDA. Is that a statement that you would agree with?
    Ms. Loew. I think it is where you fundamentally think about 
the sort of a system of drug development and approval and 
managing drugs in the post-marketing setting. There is sort of 
a big picture hierarchy that is very informative. Essentially, 
through the development process and into the post-marketing 
setting, we are doing two things that are distinct and we need 
to think about a little differently. One is that we are in the 
process of sort of assessing and managing things that we know 
about that. Those can be risks. Those can also be benefits as 
well, things that we are trying to determine.
    The other thing that we are trying to do is to detect 
unknown risks. So we are in a detection mode as well. And the 
tools to do those things are quite different, and what FDA has 
attempted to do through their Critical Path Initiative, which 
we strongly support, is to develop a new suite of technologies 
to support both of those things. And so the concept of the 
Reagan-Udall Institute as a mechanism to further evolve these 
technologies, and I think particularly relevant to some of the 
discussions today and also the drug safety hearing that this 
committee recently held, the concept of developing new tools to 
monitor risks in the post-marketing setting, through public/
private partnership involving many stakeholders, I think is 
something that is very valuable and that we would very much 
support.
    Mr. Burgess. Going further into the bill that deals with 
the risk evaluation and mitigation, what is your opinion about 
that? Is it overly burdensome? Does it hit the mark?
    Ms. Loew. I think it is a question of focus. Certainly, I 
think we applaud the committee's efforts to increase the tools 
available to FDA to manage products in the post-marketing 
setting and particularly to manage product risks. However, I 
think there are a couple of things that are important to note. 
First, focus is important. It would be, I think, unproductive 
and in fact counterproductive to public health to have FDA's 
resources thinly spread across all products, when as a matter 
of practice, they could focus on products and focus more effort 
and more focused safety activities on products where there are 
known risks that they wish to continue to manage and assess in 
the marketplace.
    In addition, to go back to the principles that I just set 
forth to you, we do need to develop new systems to improve the 
detection of unknown risks. But I think the current construct 
for the REMS is certainly not an appropriate way to do that and 
would just lead to unnecessary diversion and dilution of FDA's 
resources.
    Mr. Burgess. It almost strikes me as if we might be over-
legislating and there might be the possibility to take some of 
the reasonable approaches in the REMS bill and incorporate that 
into the Reagan-Udall Institute as a single package to try to 
get the results that we all want.
    Ms. Loew. I think there are a couple of things that I would 
specifically suggest. There are almost certainly targeted 
additional authorities that FDA could use productively in the 
post-marketing setting to help manage drug risks. Those relate 
to use of post-marketing studies when there is a serious risk 
that FDA perceives with a product that needs to be assessed. 
The second is the use of an expedited labeling authority for 
the FDA to ensure that, in the presence of risk, they are able 
to go through a process, in discussion with a company, that 
will bring about rapidly a change to the label that physicians 
then use to inform their prescribing decisions with patients. 
And the third is some great focus used in distribution 
restrictions.
    So on the one hand we have, I think, real sort of focused 
powers that we could give FDA to help. On the other hand, under 
the concept of the Reagan-Udall Institute that you described, 
the idea of evolving new technologies and new tools to try and 
assess risk in the post-marketing setting is a very valid one 
and I think one that we would certainly support augmenting.
    Mr. Burgess. Thank you. And I thank all of you for your 
testimony today. It really has been very interesting to listen 
to. Mr. Walker, I wanted to ask you a question. You heard 
referenced earlier the articles in the New York Times 
yesterday.
    Mr. Walker. Yes.
    Mr. Burgess. And your opinion about the conflict of 
interest being along the ideological lines, when you read that 
article, was that something that concerned you, that there was 
some of this ideological restriction involved?
    Mr. Walker. It concerned me so much that I immediately 
wrote an e-mail to the author. And there is an ideological 
problem, but there is also a misperception of what the job of 
the FDA is and what the jobs of the various people within the 
structure of the FDA are. The FDA is not a democracy. It is an 
executive branch agency. They have to make extremely important 
decisions and they have to be decisions that the public can 
rely on. We can't have 10 FDAs within the FDA. We can't have 
anyone who works there deciding they are going to the press and 
make their own judgment about an FDA decision. I think what 
happened with Avandia is, again, another great reason why the 
FDA is far from perfect, but it is our FDA and we have to 
figure out a way to make it better and we have to figure out a 
way to make it reliable.
    Now to expand on that a little bit more. I own a business. 
I have been managing scientists for 24 years. Just because 
someone is a scientist and just because someone feels strongly 
about their opinion does not mean their opinion is right and it 
does not mean that it is actionable. And there is a person who 
was Dr. Lang's boss, whose job it was to make those decisions 
and it was his or her responsibility to do that. Now, they have 
made the wrong one, but at that time, that decision may not 
have been actionable. And what bothered me the most about the 
article was that there are people that could have given the 
author that side of the story and it wasn't in the article.
    Mr. Burgess. Well, I would agree with you. I would have 
never thought I would have come down on the side of defending 
the FDA, but it is funny how things turn out, isn't it, sir?
    Mr. Walker. And a very strange day for me.
    Mr. Pallone. We have got to move on here, gentlemen. Thank 
you. Mrs. Capps.
    Mrs. Capps. Dr. Zuckerman, I have only 5 minutes, but I 
can't help but offer you a short time, if you wish, to respond 
to that last statement. But I did want to ask you about 
advisory committees.
    Ms. Zuckerman. OK. Well, I will respond. Thank you. Meta-
analysis is a respected, appropriate statistical analysis and 
what it does it combines a lot of small studies that are too 
small to have appropriate power for statistical significance 
and you put them all together and it is a legitimate way. It so 
happens that my dad was taking Avandia, so I am particular 
interested in that particular issue because he was swelling up. 
His whole body was swelling up and now I know why. But the 
doctor just kept him on it because she thought this was a known 
side effect and that is OK.
    So just to quickly say there are different opinions in 
science. Yes, FDA has to make a decision, but if a scientist 
disagrees and then they are punished for it, that is a 
different issue.
    Mrs. Capps. Thank you. I wanted to also follow up with you, 
if I could, on the questioning I gave to Dr. Lutter this 
morning and maybe it was my way I did it, but I wasn't 
particularly satisfied with that answer. In your testimony, I 
was pleased to see that you mention the need for members of the 
FDA advisory panels who have the need to have members who have 
no conflicts of interest, and I understand that your 
organization, the National Research Center for Women and 
Families, has done some research on advisory committee meetings 
and patterns in participation among members. So I would like to 
give you the chance to explain briefly, again, there is not 
much time, the results of the study that you conducted, why it 
illustrates the importance of prohibiting scientists with 
conflict of interest from not only voting but also being part 
of the discussion because of that persuasive ability? And also, 
could you touch on the inadequacies of posting vacancies? 
Again, I wasn't satisfied with the response. The inadequacies 
of posting vacancies without outreach or some kind of--
particular to academia.
    Ms. Zuckerman. Yes. Most people in academia do not even 
know that there are advisory committees at the FDA and that 
they could participate in them. So if there is no outreach, a 
whole lot of people will never volunteer, will never self-
select. The study that we did looked at about a third of all 
the advisory committee meetings held between 1998 and 2005, so 
it was 89 meetings at that time. And we looked at randomly-
selected committees and we found that the vast majority of 
advisory committees were recommending approval, usually 
unanimously. And when they weren't unanimous decisions, they 
were usually very lopsided. There were very few where you had a 
sense that there was a lot of dissention and discussion going 
on.
    So what we found was that one or two people could really 
control the outcome of any of the votes, because the first 
people to talk and the people who talked the most were 
frequently people who had a lot of direct knowledge from 
financial ties that they had to the company because they had 
been paid to speak about a product, had received honoraria and 
so on.
    So it was clear that it doesn't matter if the minority of 
people on a committee have conflicts of interest. Even just one 
or two people have a lot of sway. And it is a consensus-driven 
experience. You don't have a lot of argument. It is a very 
collegial consensus-driven process and very frequently does end 
up with everyone agreeing to something.
    The other thing that I wanted to mention and I do have 
copies of the report, it is filled with direct quotes that we 
got from the FDA transcripts, where you have scientists and 
doctors saying things like I am really not persuaded that this 
product works, but I am going to recommend approval anyway. Or 
they will say, gee, I am not sure if this is going to work out, 
but I hope that it will and I hope that post-market studies 
will show that it will. And so you have people recommending 
approval who don't actually think the product is proven safe or 
effective, and the FDA is sitting there and not saying a word. 
They are not saying, ``well, but you should judge it on whether 
you think it is safe or whether you think it is effective.''
    So for whatever reason, there is a lot of decisionmaking 
going on at the advisory committee meetings that don't seem in 
the best interest of patients, because it is not based on 
whether a product is proven safe or effective, and a lot of 
people being persuaded by other people on the panel to vote a 
particular way.
    Mrs. Capps. Thank you very much. I want to make sure, Mr. 
Chairman, that we have that report entered into the record, and 
I just want to get on the record, also, I don't have time, Mr. 
Guest, and I don't know if we will do another round, but I 
wanted to express my support for the clinical trial database in 
the discussion drafts and I wanted you, in writing, if you can, 
to present a rebuttal to an argument that even the publishing 
of the presence of a clinical trial is proprietary information. 
I would like to have more information like that in our records. 
And can you also write about why it is important for the public 
health to have a clinical trials database? I am particular 
interested in how all results, positive and negative, will 
boost public health. And I think we need to have on the record, 
even if a drug or a device isn't approved, can't the results of 
clinical trials perhaps be useful for future innovation and 
research? And I know there is not time.
    Mr. Guest. I would be happy to supply a prompt and full 
response to your questions.
    Mrs. Capps. Thank you very much.
    Mr. Pallone. I just have to ask, Mrs. Capps, that the 
report that you are asking to be put in the record is which 
one?
    Mrs. Capps. The one just now that Dr. Zuckerman mentioned. 
Maybe it is already in the record.
    Mr. Pallone. Is it something that we have in front of us, 
Dr. Zuckerman, or not?
    Ms. Zuckerman. I didn't include it as part of my testimony, 
but I am happy to provide it for the record. I have copies 
here.
    Mrs. Capps. It is the report of the National Research 
Center for Women and Families on the advisory, on the study 
that they did with all of the advisory committees that they 
reviewed.
    Mr. Pallone. OK. Without objection, we will include that.
    Mrs. Capps. I would hope so, too. I think that would be an 
advantage as well.
    Mr. Pallone. Yes, we will get it and we will include it and 
we will certainly make it available. Thank you. Thank you. Mr. 
Markey is here.
    Mr. Markey. Thank you, Mr. Chairman, very much. Dr. Loew, 
at the time of approval, did the FDA know that Vioxx was going 
to cause heart attacks and hurt the many patients and families 
that it did?
    Ms. Loew. I am not able to comment on a product-specific 
question. I am afraid I have no knowledge to answer that.
    Mr. Markey. Dr. Loew, at the time of approval, did FDA know 
that Paxil would actually increase the risk of suicide in kids 
and result in many parents losing their children to suicide?
    Ms. Loew. I am not able to answer any product-specific 
questions.
    Mr. Markey. Dr. Loew, how about fen-phen, did the FDA know 
about the problems there at the time of approval?
    Ms. Loew. Again, I am not in a position to answer any 
product-specific questions.
    Mr. Markey. Dr. Loew, Avandia. Did the FDA know the harm 
that Avandia was going to do to families in America at the time 
that the FDA approved it?
    Ms. Loew. I am not in a position to answer any product-
specific questions.
    Mr. Markey. Dr. Loew, I will inform you, then, Dr. Loew, 
that at the time of approval, neither the companies, I don't 
think the companies, I hope the companies didn't know, but the 
FDA did not know about all of the risks of those drugs. Do you 
agree with that?
    Ms. Loew. I am not in a position to answer that question.
    Mr. Markey. Yes, I am afraid that is the problem, that 
PhRMA--I understand why PhRMA doesn't want to have lifecycle 
monitoring to continue to check in on these drugs to see their 
impact, and I understand PhRMA's position. It is a legitimate 
position, but that is not the position which families in 
America want for these drugs. They want ongoing monitoring of 
the drugs, after they have been approved, to make sure that new 
and dangerous information hasn't been developed. So your view 
is, is that correct, Dr. Loew, if you could, that PhRMA wants 
to limit the REMS to only those drugs with known serious risks 
at the time of approval, is that correct?
    Ms. Loew. That is our position and there are currently a 
number of processes that are in the post-marketing setting to 
continue to monitor products to try and assess whether there 
are unknown risks, to detect those risks and then to manage to 
deal with those. So we actually do support ongoing monitoring, 
because that exists today and companies do it in a very 
thorough and rigorous fashion. In addition, we do support and 
companies do undertake substantial post-marketing commitments. 
In fact, a recent study by the Tufts Center showed that 73 
percent of drug conducting post-marketing studies, those 
involved in excess of 900 patients. Those are substantial 
clinical studies. That is in addition to very rigorous post-
marketing monitoring, ongoing continuous assessments of adverse 
event reporting from the passive systems.
     In addition, we support, as I discussed earlier, 
development of new technologies to assess risks. I think that 
it is widely acknowledged that there are limitations with the 
current passive adverse event reporting system and we would 
certainly support, and particularly if we can in a public/
private partnership involving all key stakeholders, the 
evaluation and development of new technologies to assess risk 
in the post-marketing setting.
    Mr. Markey. So you object to the language which Mr. Waxman 
and I have that is recommended by the Institute of Medicine, 
that would require that the risks are put into a system to 
regularly review the drugs for the first couple of years that 
they are on the market?
    Ms. Loew. I think there are a number of things. Firstly, 
there is already, as I said, in place a system which requires 
regular assessments of events that are reported.
    Mr. Markey. No. Why do you object to our language? What is 
the problem with our language?
    Ms. Loew. Specifically, with regard to the REMS, we believe 
that the additional authority should be targeted on products 
where the risks have previously been detected----
    Mr. Markey. How can you know that, Doctor? You just told me 
you don't know anything about Vioxx, about Paxil, about fen-
phen, about Avandia. You just said you don't know anything, 
even today, after the fact, you don't know anything.
    Ms. Loew. With the checks.
    Mr. Markey. So how can you possibly identify the drugs that 
are going to have the high risks? Don't you need to put in 
place a system which is going to be able to monitor this risk 
to families? How can you possibly determine which drugs are 
going to have these high risks and which aren't?
    Ms. Loew. With respect, I do not have specific knowledge 
about specific products.
    Mr. Markey. Precisely why you need a system.
    Ms. Loew. That is because I am not in a position to----
    Mr. Markey. You are testifying on behalf of the industry. 
You are here on the last hearing before we begin to mark up.
    Ms. Loew. Thank you. Right.
    Mr. Markey. If you can't testify on this issue, then no one 
in your industry knows, because that is what we are debating.
    Ms. Loew. I can't testify about policies. I cannot testify 
about specific drug examples. What I can testify is that there 
is actual pre-market testing of drugs provides indication of 
issues that should be assessed in a post-marketing setting----
    Mr. Markey. In order to have successful testimony, Doctor, 
you are----
    Ms. Loew. In order to have legitimacy for supporting a new 
authority for post-marketing----
    Mr. Pallone. All right, we are over the time here, so I am 
going to end it, although it was an exciting ending, I must 
say. Thank you, Mr. Markey. Let me just say in closing, I want 
to remind all of the members that you can submit additional 
questions for the record to be answered by the witnesses. I 
will say to our witnesses, you may get additional questions 
within the next 10 days and the clerk will notify your offices 
if that is the case. I do want to thank all of you for being 
here today. I thought this was a really good, this panel as 
well as the FDA representative, this was a really good analysis 
of our drafts and I appreciate the in-depth analysis that you 
did give them. So thank you very much. And without objection, 
this meeting of the subcommittee is adjourned.
    [Whereupon, at 2:00 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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