[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]




                REVIEWING FDA'S IMPLEMENTATION OF FDASIA

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

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           NOVEMBER 15, 2013

                               __________

                           Serial No. 113-98


      Printed for the use of the Committee on Energy and Commerce

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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky               FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois               BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania        ANNA G. ESHOO, California
GREG WALDEN, Oregon                  ELIOT L. ENGEL, New York
LEE TERRY, Nebraska                  GENE GREEN, Texas
MIKE ROGERS, Michigan                DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania             LOIS CAPPS, California
MICHAEL C. BURGESS, Texas            MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee          JANICE D. SCHAKOWSKY, Illinois
  Vice Chairman                      JIM MATHESON, Utah
PHIL GINGREY, Georgia                G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana             JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   DONNA M. CHRISTENSEN, Virgin 
GREGG HARPER, Mississippi            Islands
LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
BILL CASSIDY, Louisiana              JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky              JERRY McNERNEY, California
PETE OLSON, Texas                    BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
CORY GARDNER, Colorado               BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas                  PAUL TONKO, New York
ADAM KINZINGER, Illinois             JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina

                                 7_____

                         Subcommittee on Health

                     JOSEPH R. PITTS, Pennsylvania
                                 Chairman
MICHAEL C. BURGESS, Texas            FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               JOHN D. DINGELL, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
MIKE ROGERS, Michigan                LOIS CAPPS, California
TIM MURPHY, Pennsylvania             JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          JIM MATHESON, Utah
PHIL GINGREY, Georgia                GENE GREEN, Texas
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
LEONARD LANCE, New Jersey            JOHN BARROW, Georgia
BILL CASSIDY, Louisiana              DONNA M. CHRISTENSEN, Virgin 
BRETT GUTHRIE, Kentucky                  Islands
H. MORGAN GRIFFITH, Virginia         KATHY CASTOR, Florida
GUS M. BILIRAKIS, Florida            JOHN P. SARBANES, Maryland
RENEE L. ELLMERS, North Carolina     HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

                                  (ii)
                                  
                                  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Joseph R. Pitts, a Representative in Congress from the 
  Commonwealth of Pennsylvania, opening statement................     1
    Prepared statement...........................................     2
Hon. Phil Gingrey, a Representative in Congress from the State of 
  Georgia, opening statement.....................................     2
Hon. Leonard Lance, a Representative in Congress from the State 
  of New Jersey, opening statement...............................     3
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     4
Hon. John D. Dingell, a Representative in Congress from the State 
  of Michigan, opening statement.................................     5
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, opening statement....................................     5
    Prepared statement...........................................     6
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     6

                               Witnesses

Janet Woodcock, Director, Center for Drug Evaluation and 
  Research, Food and Drug Administration.........................     7
    Prepared statement \1\.......................................    11
    Answers to submitted questions \2\...........................    61
Jeffrey E. Shuren, Director, Center for Devices and Radiological 
  Health, Food and Drug Administration...........................     8
    Prepared statement \1\.......................................    11
    Answers to submitted questions...............................   139

----------
\1\ Ms. Woodcock and Mr. Shuren submitted a joint statement for 
  the record.
\2\ Ms. Woodcock submitted a partial response to questions for 
  the record.

 
                REVIEWING FDA'S IMPLEMENTATION OF FDASIA

                              ----------                              


                       FRIDAY, NOVEMBER 15, 2013

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:02 a.m., in 
room 2322, Rayburn House Office Building, Hon. Joseph R. Pitts 
(chairman of the subcommittee) presiding.
    Members present: Representatives Pitts, Burgess, Whitfield, 
Shimkus, Rogers, Murphy, Blackburn, Gingrey, Lance, Guthrie, 
Griffith, Bilirakis, Upton (ex officio), Pallone, Dingell, 
Engel, Capps, Green, Butterfield, Barrow, Castor, Sarbanes, and 
Waxman (ex officio).
    Staff present: Clay Alspach, Chief Counsel, Health; Sean 
Bonyun, Communications Director; Noelle Clemente, Press 
Secretary; Brad Grantz, Policy Director, Oversight and 
Investigations; Sydne Harwick, Legislative Clerk; Robert Horne, 
Professional Staff Member, Health; Carly McWilliams, 
Professional Staff Member, Health; Andrew Powaleny, Deputy 
Press Secretary; Chris Sarley, Policy Coordinator, Environment 
and the Economy; John Stone, Counsel, Oversight; Ziky Ababiya, 
Democratic Staff Assistant; Eric Flamm, Democratic FDA 
Detailee; Karen Nelson, Democratic Deputy Committee Staff 
Director for Health; Rachel Sher, Democratic Senior Counsel; 
and Ryan Skukowski, Democratic Staff Assistant.
    Mr. Pitts. The subcommittee will come to order. The Chair 
will recognize himself for an opening statement.

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN 
         CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

    The Food and Drug Administration Safety and Innovation Act, 
FDASIA, was signed into law on July 9th, 2012. The purpose of 
the bill was to bring predictability, consistency, and 
transparency to FDA's regulation of drugs and devices. To that 
end, FDASIA reauthorized two successful user fee programs, the 
Prescription Drug User Fee Act, PDUFA, and the Medical Device 
User Fee Act, MDUFA, scheduled to expire at the end of fiscal 
year 2013. It also authorized two new user fee programs, for 
generic drugs, GDUFA, and biosimilars, BSUFA. In each case the 
industry negotiated a level of user fees to be paid to FDA in 
return for the agency meeting agreed-upon performance and 
accountability metrics.
    Additionally, FDASIA permanently reauthorized the Best 
Pharmaceuticals for Children Act and the Pediatric Research 
Equity Act; reformed both the drug and medical device 
regulatory processes; addressed drug supply chain and drug 
shortage issues; and incentivized the development of new 
antibiotic drugs, among other provisions. The bill represents a 
bipartisan success not only for our committee, but for Congress 
as a whole. It passed the House by a voice vote and passed the 
Senate by a vote of 92-4.
    Now, over a year later, we are here to examine whether the 
law has been a success for the American people, resulting in 
safer drugs and devices, faster approval times, and more 
consistency and predictability in the process. There is great 
congressional interest, not only in the overall implementation 
of FDASIA, but also in the day-to-day operational challenges 
and successes. And I would like to congratulate Dr. Woodcock 
for what I understand is significant progress in the Center for 
Drug Evaluation and Research.
    I would like to welcome both Dr. Janet Woodcock and Dr. 
Jeffrey Shuren to the subcommittee. I look forward to hearing 
their testimony. And I yield 1 minute to Dr. Gingrey.
    [The prepared statement of Mr. Pitts follows:]

               Prepared statement of Hon. Joseph R. Pitts

    The subcommittee will come to order.
    The Chair will recognize himself for an opening statement.
    The Food and Drug Administration Safety and Innovation Act 
(FDASIA) was signed into law on July 9, 2012.
    The purpose of the bill was to bring predictability, 
consistency, and transparency to FDA's regulation of drugs and 
devices.
    To that end, FDASIA reauthorized two successful user fee 
programs, the Prescription Drug User Fee Act (PDUFA) and the 
Medical Device User Fee Act (MDUFA), scheduled to expire at the 
end of fiscal year 2013.
    It also authorized two new user fee programs for generic 
drugs (GDUFA) and biosimilars (BSUFA).
    In each case, industry negotiated a level of user fees to 
be paid to FDA in return for the Agency meeting agreed upon 
performance and accountability metrics.
    Additionally, FDASIA permanently reauthorized the Best 
Pharmaceuticals for Children Act and the Pediatric Research 
Equity Act, reformed both the drug and medical device 
regulatory processes, addressed drug supply chain and drug 
shortage issues, and incentivized the development of new 
antibiotic drugs, among other provisions.
    The bill represents a bipartisan success, not only for our 
committee, but for Congress as a whole. It passed the House by 
voice vote and passed the Senate by a vote 92 to 4.
    Now, over a year later, we are here to examine whether the 
law has been a success for the American people, resulting in 
safer drugs and devices, faster approval times, and more 
consistency and predictability in the process.
    There is great Congressional interest not only in the 
overall implementation of FDASIA, but also in the day-to-day 
operational challenges and successes. And, I would like to 
congratulate Dr. Woodcock for what I understand is significant 
progress in the Center for Drug Evaluation and Research.
    I would like to welcome both Dr. Janet Woodcock and Dr. 
Jeffrey Shuren to the subcommittee.

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

    Mr. Gingrey. Mr. Chairman, thank you very much for 
yielding. I, too, am pleased to see Dr. Woodcock and Dr. Shuren 
again today. FDASIA looked to address the crisis of antibiotic 
resistance with Title VIII, the GAIN Act, which I wrote with my 
colleagues Mr. Green, Mr. Shimkus, Ms. DeGette, Mr. Whitfield, 
and Ms. Eshoo.
    By focusing on incentives to bring new drugs to market we 
have seen renewed focus on the development of cutting-edge 
drugs, antibiotic. However, even with the early success of this 
program, I do believe that we do need to do more.
    And so, Mr. Chairman, CDC had a September report, CDC in my 
great capital center of Atlanta, Georgia, on antimicrobial 
resistance, highlights 18 known resistance threats. It is 
estimated that across the country more than 2 million people 
are sickened every year with antibiotic-resistance infections 
resulting in at least 23,000 deaths--23,000 deaths.
    I look forward to continuing to work with the FDA to create 
innovative pathways and processes. We must make sure that the 
agency and drug developers have as many tools as possible to 
navigate this emerging public health problem.
    And I yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    And now yields the balance of time to Mr. Lance.

 OPENING STATEMENT OF HON. LEONARD LANCE, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Lance. Thank you, Mr. Chairman.
    Today's hearing serves as a helpful pulse check of the 
FDA's implementation of the user fee agreements for the 
prescription drug, medical device, generic, and biosimilars 
industry signed into law last year. In New Jersey alone the 
life sciences support over 300,000 direct and indirect jobs and 
contributes more than $25 billion to the State's economy.
    Historically the user fee agreements have improved the 
times of drug and devices, and today's hearing will help this 
committee gain further insight on how the FDA is carrying out 
these congressionally mandated responsibilities. It is 
important that regardless of the challenges the agency faces it 
remain committed to bringing innovative treatments to market 
and in the hands of patients who need them the most.
    Thank you, Mr. Chairman. I look forward to hearing from our 
distinguished witnesses, Dr. Woodcock and Dr. Shuren, on these 
issues. And I yield back to you, sir.
    Mr. Pitts. The Chair thanks the gentleman.
    Now yields 5 minutes to the ranking member, Mr. Pallone, 
for an opening statement.

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

    Mr. Pallone. Thank you, Chairman Pitts.
    And thank you to our witnesses for being here today. I am 
eager to hear your testimony about FDA's progress in 
implementing the Food and Drug Administration Safety and 
Innovation Act, or FDASIA.
    Over 1 year ago, FDASIA was signed into law and, among 
other things, was designed to promote timely FDA review of 
drugs, medical devices, generic drugs, and biosimilar 
biological products through the collection of user fees. It 
both renewed existing FDA user fee programs for pharmaceutical 
and medical device manufacturers and established new user fee 
programs for generic drugs and for lower cost versions of 
biotech drugs.
    The user fees are an essential component of FDA's funding. 
They help to ensure a predictable and efficient review process 
so that the American public has access to safe and effective 
healthcare products.
    For generics, at the time of enactment there was a backlog 
of over 2,500 applications for new generic drugs and a median 
review time of 31 months. These essential products typically 
cost 50 to 70 percent less than their brand name counterparts 
and have provided an estimated $1 trillion in savings to the 
Nation's healthcare system over the past decade. It is 
important that American consumers have access to these safe, 
effective, and low cost alternatives more quickly, which is why 
the provisions in the generic drug user fee agreement were so 
important, because it gave FDA the resources they need to make 
sure that happens. So I am interested to hear in that progress 
today.
    FDASIA also gives FDA additional tools to ensure the safety 
of the global drug supply chain, such as requiring registration 
with the unique facility identifier for foreign and domestic 
drug establishments, administrative detention for adulterated 
or misbranded drugs, and increased penalties for counterfeit 
drugs. The additional authorities in FDASIA allow FDA to 
strengthen cooperation with foreign regulators as well.
    These provisions were based on the ideas and proposals 
contained in the Drug Safety Enhancement Act, which I 
introduced with Mr. Dingell, Mr. Waxman, and Ms. DeGette. We 
worked hard with our Republican colleagues during consideration 
of this law to help FDA keep our medicines safer in this 
complex and ever-growing global supply chain.
    We also included provisions in FDASIA to address drug 
shortages. FDASIA enhances early notification of supply 
interruptions for certain medically important drugs and directs 
FDA to establish a task force and submit a strategic plan on 
drug shortage mitigation, which FDA submitted to Congress last 
month. Early notification started as a result of an executive 
order in 2011 and was codified into law by FDASIA, and it has 
helped FDA to prevent shortages and to decrease the number of 
new shortages.
    I will close by saying that FDASIA is the product of strong 
bipartisan collaboration and compromise that strengthens FDA's 
ability to safeguard the public health. What I outlined here 
today was only a snapshot of the promising provisions of the 
law. We strengthened both the agency and the public health by 
its passage while allowing companies to innovate in the 
process. And I am proud of the work we did in passing FDASIA, 
and I look forward to hearing about FDA's progress so far in 
implementing this law.
    So I would like to yield the remainder of my time to Mr. 
Dingell.

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

    Mr. Dingell. I thank my good friend for that.
    This legislation is a fine example of the great work this 
committee can do when we put politics aside and work together 
in a bipartisan manner. I hope the committee will return to 
this spirit when considering a lot of other issues that will 
lie before us today and in following times.
    One year ago, President Obama signed the Food and Drug 
Administration Safety and Innovation Act into law, the law 
[audio gap] user fee programs FAD. Big bold steps to improve 
supply chain safety, amongst other things. FDA now needs new 
innovative tools to deal with increasingly globalized supply 
chain [audio gap] succeed in their mission keeping the American 
people safe from harm from food, drugs, cosmetics, and other 
things.
    I look forward to hearing from our witnesses today about 
the progress made by FDA and I commend you for having this 
hearing, and look forward to hearing from Food and Drug about 
what it is they are doing, how the matter is proceeding and how 
much more this committee must do to see to it that they are 
able to carry out their responsibilities.
    Dr. Woodcock, welcome.
    I yield back to my good friend Mr. Pallone the time that he 
so graciously yielded to me.
    Mr. Pallone. I yield back the balance of my time.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the chair of the full committee, Mr. Upton, 5 
minutes for an opening statement.

   OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Upton. Well, thank you again, Mr. Chairman. And I 
appreciate this morning's hearing on the implementation of the 
FDA Safety and Innovation Act.
    You know, as many of us know, this was one of the 
committee's most significant bipartisan achievements in the 
last Congress, it really was. I particularly want to thank Dr. 
Woodcock, who is with us, and Dr. Shuren for coming today to 
provide an update on that implementation, something that we 
said we would do when it passed.
    Last Congress this committee held at least 10 hearings on 
subjects related to the legislation, and at these hearings we 
focused on improving the predictability, consistency, and 
transparency of FDA's regulations of drugs and medical devices. 
Improving FDA regs is essential to fostering innovation which 
brings life-saving and life-improving drugs and medical devices 
to American patients and boosts job creation across the 
country, including southwest Michigan, most importantly.
    I was very proud of the bipartisan work that we did in the 
last Congress, and I am pleased to hear that initial reports on 
implementation, especially at the Drug Center, are promising. 
Today is an opportunity to get an update on whether the FDA is 
meeting its commitments related to the various user fees that 
we authorized, as well as the independent assessment of the 
device center.
    It also is a chance to hear about how the FDA is 
implementing provisions related to rare diseases, drug 
shortages, an important provision that we wrote in, 
prescription drug abuse, and drug imports. These were 
provisions important to Republicans and Democrats, Americans 
across the country, and we look forward to working with the FDA 
on these issues. Our drug and device makers are global leaders 
in innovation and job growth, and we will continue working to 
ensure that they remain on top.
    And I am prepared to yield to any of my Republican 
colleagues. Seeing none, I yield back the balance of my time.
    [The prepared statement of Mr. Upton follows:]

                 Prepared statement of Hon. Fred Upton

    Mr. Chairman, thank you for holding today's hearing on the 
implementation of the Food and Drug Administration Safety and 
Innovation Act. As many of you know, this was one of the 
committee's significant bipartisan achievements last Congress, 
and I thank Dr. Woodcock and Dr. Shuren for coming today to 
provide an update on implementation.
    Last Congress, the committee held at least 10 hearings on 
subjects related to thelegislation. At these hearings, we 
focused on improving the predictability, consistency and 
transparency of FDA's regulation of drugs and medical devices. 
Improving FDA regulation is essential to fostering innovation, 
which brings lifesaving, life-improving drugs and medical 
devices to American patients and boosts job creation across the 
country, including southwest Michigan.
    I am very proud of the bipartisan work we did last 
Congress, and I am pleased to hear that initial reports on 
implementation, especially at the Drug Center, are promising.
    Today is an opportunity to get an update on whether FDA is 
meeting its commitments related to the various user fees we 
reauthorized, as well as the independent assessment of the 
device center. It also is a chance to hear about how FDA is 
implementing provisions related to rare diseases, drug 
shortages, prescription drug abuse, and drug imports. These 
were provisions important to Republicans and Democrats, and we 
look forward to working with FDA on these issues. Our drug and 
device makers are global leaders in innovation and job growth, 
and we will continue working to ensure that they remain on top.

    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the ranking member of the full committee, Mr. 
Waxman, 5 minutes for an opening statement.

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

    Mr. Waxman. Thank you, Mr. Chairman. I am pleased we are 
holding this oversight hearing on the legislation that we 
passed last year on a bipartisan basis, bipartisan, bicameral, 
and with the close working relationship with the Food and Drug 
Administration.
    The bill had a number of important provisions. It 
reauthorized FDA's drug and medical device user fees programs, 
providing resources to enable the efficient review of 
applications and give patients access rapidly to new therapies. 
It reauthorized two pediatric programs which foster the 
development and safe use of prescription for children. 
Established two new user fee programs to help FDA speed up the 
review of new generics and biosimilars. It gave FDA new 
authorities to address a wide array of issues with respect to 
drugs and devices, new incentives for the development of 
antibiotics to treat serious and life-threatening infections. 
This was designed to ensure that the drugs we most need to 
protect us from dangerous resistant pathogens are the ones that 
are developed as quickly as possible.
    This law also includes provisions to modernize FDA's 
authorities with respect to our increasingly globalized drug 
supply chain. Today 80 percent of the active ingredients in 
bulk chemicals used in U.S. drugs come from abroad and 40 
percent of finished drugs are manufactured abroad. This law 
gave FDA new and improved tools to police today's dramatically 
different marketplace. The legislation addressed the crisis of 
drug shortages that has caused many problems for access to 
medicines in our country.
    There are provisions relating to medical devices. I had 
some concerns about many of the device proposals, but we worked 
together to address these concerns with the goal of assuring 
that nothing in the House-passed bill took us backwards in 
terms of patient safety. And I hope Dr. Shuren will tell us 
today whether we succeeded in that goal or if there have been 
unintended and detrimental facts of this legislation.
    Mr. Chairman, I thank you for holding this hearing. It is 
an important part of the job of Congress not just to work 
together to pass legislation, but to continue our review and 
oversight. I hope FDA will share with us whether there are any 
refinements or improvements to any of the law's provisions that 
we need to pass through the Congress. Our goal was and still is 
to ensure that the American public benefits from this 
legislation by getting access to safe and effective drugs and 
medical devices at the earliest possible time. I look forward 
to the testimony.
    I do notice that I do have a couple of minutes left and if 
any member on our side of the aisle wants that time I would be 
happy to yield to them. And if not, I will offer the time to 
anybody on the other side of the aisle who wants to make any 
further comments. If not, I yield back the time.
    Mr. Pitts. The gentleman yields back. Chair thanks the 
gentleman.
    That concludes the opening statements.
    On our panel today we have two witnesses from the U.S. Food 
and Drug Administration, Dr. Janet Woodcock, Director of the 
Center for Drug Evaluation and Research, and Dr. Jeffrey 
Shuren, Director of the Center for Devices and Radiological 
Health.
    Thank you for coming. Your written testimony will be made a 
part of the record. We ask that you summarize your opening 
statements to 5 minutes. And at this time the Chair recognizes 
Dr. Woodcock for 5 minutes for an opening statement.

    STATEMENTS OF JANET WOODCOCK, DIRECTOR, CENTER FOR DRUG 
  EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION; AND 
      JEFFREY E. SHUREN, DIRECTOR, CENTER FOR DEVICES AND 
       RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION

                  STATEMENT OF JANET WOODCOCK

    Ms. Woodcock. Thank you and good morning. I am Janet 
Woodcock, head of the center for drugs at FDA.
    The FDASIA legislation was really landmark legislation for 
drug regulation. It authorized two new user fee programs, one 
of which was critically needed to fix a problem, the problem of 
the backlog of generic drugs, a program that had become 
burdened by its own success and the massive filing of new 
generic drug applications that we had. And another one, which 
is more or less preventive, the biosimilars user fee program, 
hopefully will help us promptly review biosimilar drugs and get 
them on the market as we receive applications.
    It also made two pediatric pieces of legislation permanent. 
And I am happy to say we passed a landmark of 500 labels that 
have been revised and updated with pediatric information 
because of this legislation. So 500 drug labels have 
information now for children that didn't before.
    Additional pressing problems that were addressed included 
the lack of new pipeline for antibiotics, particularly for 
drug-resistant organisms, the drug shortage problem, and the 
supply chain safety issues. In addition, the legislation 
included a breakthrough designation program that has been very 
enthusiastically taken up, both by the industry and by the FDA, 
and many other provisions of course.
    Congress laid out a very ambitious agenda and timeframe for 
our accomplishment of all of this, and we have been working 
hard, we have been very successful in implementing provisions. 
However, I brought our spreadsheet. This is two-sided, OK, 
tracking of all the obligations that we have under this 
legislation. And this isn't all of them, but it is certainly 
the ones that have hard deadlines. So we are trying to work 
against all these deadlines and make all of our timeframes and 
so forth.
    I am happy to discuss this year's progress with you, and I 
look forward to working with the committee. Thank you.
    Mr. Pitts. The Chair thanks the gentlelady.
    Dr. Shuren, you are recognized 5 minutes for an opening 
statement.

                 STATEMENT OF JEFFREY E. SHUREN

    Mr. Shuren. Thank you. Mr. Chairman and members of the 
subcommittee, I am Dr. Jeff Shuren, Director, Center for 
Devices and Radiological Health, or CDRH, at the Food and Drug 
Administration.
    FDASIA includes a third authorization of the Medical Device 
User Fee Act, or MDUFA III. Reauthorization of the medical 
device user fee program has helped to speed innovative new 
products to market without compromising safety and 
effectiveness. It did so by establishing new policies, 
procedures, and performance goals, and by boosting review 
capacity. It represents our commitment to increase the 
predictability, consistency, and clarity of our regulatory 
processes.
    In exchange for the additional user fees, we work with 
stakeholders to develop much enhanced performance goals. We are 
committed to meeting those goals, and preliminary data 
indicates that we are on track to meet or exceed all of our 
fiscal year 2013 performance goals, and that includes a new 
shared goal with industry of average time to decision.
    Since the early 2000s, CDRH's performance on several key 
measures had been steadily declining each year, reaching its 
lowest point in 2010. In 2010 we conducted an extensive 
assessment of our premarket programs, identified the problems, 
proposed solutions, sought extensive public input, and then 
issued a plan of action in January 2011, with some corrective 
action starting in 2010. Since 2010, due to the reforms we put 
in place in MDUFA III, we have seen improvement in these key 
measures. For example, our backlogs of 510(k) submissions and 
PMA applications are each down by about one-third. Our average 
total time to decision of PMA applications is down 37 percent. 
The percent of 510(k)s cleared and percent of PMAs approved are 
back up, in the case of PMAs back to where it was about a 
decade ago.
    To provide greater transparency we are would providing 
substantially more detailed reporting on our progress in 
implementing performance goals. These reports are publicly 
available online and are discussed at quarterly meetings with 
industry.
    FDASIA also includes provisions to streamline the de novo 
pathway for novel devices of low to moderate risk. Since 
passage of FDASIA, we have seen the number of de novo requests 
roughly double. We have also implemented process improvements 
and are seeing our review times for de novos trending downward 
as a result. As part of our MDUFA III commitments we agreed to 
implement our benefit-risk determination guidance we issued in 
March 2012. For the very first time and with public input we 
described the factors we would use in determining whether or 
not the benefits of the device outweigh its risk.
    The framework we developed is flexible and patient-centric. 
For example, one factor we may take into account is patients' 
tolerance for risk and perspectives on benefits. Because 
patient viewpoints matter and to further implementation of the 
framework, earlier this year we launched our Patient 
Preferences Initiative. The initiative seeks to identify and 
validate tools for assessing patient preferences, establish an 
approach when incorporating those preferences into our device 
approval decisions, and then communicating that information 
publicly so that patients and practitioners can make better-
informed decisions.
    CDRH implemented the FDASIA provisions relating to 
investigational device exemptions, or IDEs. We have trained our 
staff and modified our decision letters to align them with 
FDASIA's requirement that FDA may not disapprove the clinical 
investigation on the basis that it would not support approving 
the device.
    We have also taken several steps to facilitate first-in-
human studies in the U.S. and to streamline our clinical trials 
program. As a result, the mean time for giving approval for 
manufactures to proceed with clinical studies of their devices 
has been cut almost in half.
    We also recently announced a final rule for unique device 
identification, or UDI system, which will provide a 
standardized way to identify medical devices. The UDI reflects 
substantial input from the clinical community and from the 
device industry during all phases of its development. Once 
fully implemented the UDI system will provide improved 
visibility for devices as they move through the distribution 
change to the point of patient use, greatly enhancing our post-
market surveillance capabilities and offering a way of 
documenting device use in electronic health records. We have 
also made good progress on classifying the remaining pre-
amendment devices. Since passage of FDASIA we have issued 13 
proposed orders.
    Implementing the device-related provisions of FDASIA is a 
massive undertaking, but we are committed to doing it in a way 
that provides lasting improvement to public health. Mr. 
Chairman, I commend the subcommittee's efforts and am pleased 
to answer any questions.
    [The prepared statement of Ms. Woodcock and Mr. Shuren 
follows:]

[GRAPHIC] [TIFF OMITTED] 

    Mr. Pitts. The Chair thanks the gentleman. That concludes 
the opening statements. We will now begin questioning. I will 
recognize myself 5 minutes.
    Before I begin, Dr. Woodcock, would you submit that 
spreadsheet for the record?
    Ms. Woodcock. I will confer with my folks and see what I 
can send you. We definitely will give you something.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. All right. And I have a number of questions for 
both of you that I will submit for the record. Would appreciate 
that you respond promptly.
    Dr. Woodcock, we enacted FDASIA in order to bring greater 
predictability, consistency, and transparency to FDA's 
regulation of medical devices and drugs. FDASIA included some 
significant changes to the review process on the device and 
drug side. How have you translated the FDASIA policy changes 
into the regulatory review process? And how have you 
communicated these changes to your staff? How are you ensuring 
that your staff implements the law correctly?
    Dr. Woodcock, you want to begin?
    Ms. Woodcock. Well, some of the primary changes that we 
received, we negotiated with the industry under the PDUFA 
agreements for a new review program for new molecular entities. 
They are the most innovative drugs. We are now having midcycle 
meetings during the review process. So this mainly changes how 
we run the review process, allows for more communication 
between industry and the review staff during the review 
process. And it is hoped we can clear up any confusion, answer 
questions and so forth, and get to a complete response that 
includes all the issues at the end of the day.
    So we are running that as a pilot. We are going have an 
independent assessment of that. We have had a number of new 
molecular entities that have been approved. I believe six have 
been approved that have gone through that program. So it is in 
its early stages, though, because we are going to run several 
years of the program and then evaluate its success.
    And the other major change, of course, has been the 
breakthrough designation program, and I could talk about that 
if you want. So we have received almost up to 100 applications 
for designation under this program. We have designated more 
than 25 different products for a range of different diseases as 
potential breakthrough products. And we have just approved two, 
one last week and one on Wednesday. On Wednesday we approved a 
drug for mantle cell lymphoma, which is a rare kind of immune 
system or blood tumor.
    So we feel this program has been fairly successful so far 
in bringing greater attention to drugs that are potential game 
changers for people with serious diseases.
    Mr. Pitts. All right. Thank you.
    Dr. Shuren, under MDUFA III industry and the FDA agreed to 
have an independent two-phase assessment and program evaluation 
to objectively assess the FDA's premarket review process. Can 
you explain how FDA was involved in setting the parameters of 
this assessment?
    Mr. Shuren. Certainly. We have put out calls for an 
independent contractor to perform the work, and that was 
assigned to--oh, my apologies.
    We have put out a call to have an independent contractor 
perform the assessment, and Booz Allen Hamilton is that 
contractor. We worked on a draft statement of work which we put 
out to the public for comment. We had discussions with industry 
on what should go into that statement of work.
    And then finally we have been overseeing the process for 
the contractor. We get updates on the progress they make. But 
it is independent, so we don't know what they are actually 
going to report to us. Our understanding is they have gone out, 
they have had conversations with stakeholders, particularly 
industry, they have conducted focus groups. And we are 
expecting to get their first report very soon, and we have a 
public commitment to make that available to the public in 
December, which we will do. And that first phase includes their 
at this point preliminary findings, a lot of their more of the 
low-hanging fruit. Six months thereafter, so in May, they will 
have the second phase, where we will get all of their 
recommendations. At that point, too, we have a public 
commitment to issue our plan for implementation of the 
recommendations.
    Mr. Pitts. Would you agree to submit a detailed accounting 
of the agency's involvement with the contractor relating to the 
review and any recommendations or directions you provided them?
    Mr. Shuren. Yes, we can provide you with information.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. And would you agree to submit a compiled list of 
recommendations in its entirety to the committee upon its 
completion?
    Mr. Shuren. We are going to make it available to the entire 
public.
    Mr. Pitts. OK.
    Mr. Shuren. But we will include you on that, too.
    [The information appears at the conclusion of the hearing.]
    Mr. Pitts. All right.
    Dr. Woodcock, the President's Council of Advisors on 
Science and Technology's September 12th report included 
specific recommendations on how the Federal Government might 
propel innovation in drug discovery and development. PCAST 
expressly recommended, quote, ``It could be valuable for the 
Congress to establish that encouraging innovation and drug 
development is a clear component of the FDA mission,'' end 
quote.
    Do you agree with the President's advisors that including 
innovation in the mission statement would be valuable?
    Ms. Woodcock. Well, I think it is a double-edged sword. We 
don't encourage innovation for innovation's sake. OK? 
Innovation can end up being bad as well as being good, right? 
But innovation is essential to treat current unmet medical 
needs. So absolutely we should foster innovation and be open to 
it and allow new methods of both treating patients and 
manufacturing drugs to have progress. So I think it is really 
how you state that support for innovation that is important.
    Mr. Pitts. All right. My time has expired.
    The Chair recognize the ranking member, Mr. Pallone, 5 
minutes for questions.
    Mr. Pallone. Thank you, Mr. Chairman.
    My questions of Dr. Woodcock--first, welcome back. I can 
guess you have had quite a busy year. And I wanted to start 
today talking about the new Office of Generic Drugs. I was glad 
to see the decision FDA made last year to elevate the Office of 
Generic Drugs to a ``super office'' on equal footing with the 
Office of New Drugs within the agency. And as you know, I 
introduced a bill last year that included a provision to do 
just that and I have long been an advocate for the structural 
change within FDA to enhance the role of the Office of Generic 
Drugs.
    I would like to ask you, Dr. Woodcock, whether the Office 
of Generic Drugs has officially been set up in its new elevated 
position? And how is it structured? What kinds of changes have 
been made? And when do you expect the change to be finalized?
    Ms. Woodcock. The organizational change has been not 
finalized. We are in the final stages of that, and I hope it 
would occur very soon. What it will do is recognize the fact 
that generic medicines treat most people in the United States. 
Eighty-four percent of dispensed prescriptions are for generic 
drugs. And so the new generic drug office will have a much more 
clinical focus. We will have more doctors there, more clinical 
staff, very much focused on therapeutic equivalents, the 
adverse event reporting, making sure those generic drug labels 
are up to date and so forth.
    So as a super office it is proposed to have a 
bioequivalence office, a research office, because under GDUFA 
we negotiated and received money so that we can do research to 
get new categories of drugs like inhalers to become generics, 
right? So they have a research office and then an office that 
will run the operations, including a clinical safety staff.
    Now, as part of this, what we are proposing, though, is 
that quality regulation, drug quality regulation be reorganized 
and that we centralize that, and that is a plan that I am 
working very intimately on. And this would ensure that generic 
drugs, new drugs, over-the-counter drugs, any kind of drug we 
regulate have the exact same quality expectations across the 
industry.
    Mr. Pallone. OK. Then I wanted to speak about the FDA's 
progress in implementing GDUFA. I commend the FDA on meeting 
its GDUFA hiring goals for the fiscal year, and I know the 
difficulties associated with implementing a brand-new program. 
But how many FTEs have you hired to date and how many do you 
plan to hire in the first two quarters of next year? And given 
the backlog of pending ANDAs, can you give the committee an 
estimate on how many of these new hires will be dedicated to 
ANDA review? I have others, but let's start with that.
    Ms. Woodcock. OK. We have hired upward of 300 people. I 
mean, that number changes every day. We are aggressively 
hiring. And we exceeded our GDUFA goal, which was 25 percent of 
the total number of people that were to be hired. OK?
    We have acted on 900, I think, of ANDAs in the backlog in 
different ways, so we have reduced that pending backlog, but it 
is still formidable. I wouldn't diminish that. And we have done 
a lot of things to try and aggressively address this backlog. 
So your other question?
    Mr. Pallone. Well, I was going to ask you if the government 
shutdown affected the progress for those 2 or 3 weeks?
    Ms. Woodcock. Well, the major effect on our review 
programs, because we were able to continue to operate under the 
user fees. However, the inspections stopped for those several 
weeks. So the inspectional programs were not operating. And of 
course that is one of the things that we really need to ramp up 
under GDUFA, is to increase the number of facility inspections 
that we do if we are going to tackle this backlog and get into 
a steady state.
    Mr. Pallone. And the last thing, it is my understanding 
that FDA recently advised sponsors that it has restricted 
communications with sponsors during the ANDA process. 
Specifically, rather than providing ongoing status updates, the 
FDA has a new policy of only providing approval answers. Can 
you explain the reasoning behind this, why you feel the need to 
have less communications than before, given that we have the 
user fee funds available?
    Ms. Woodcock. We have upward of 8,000 items pending in the 
generic drug review program. The previous practice was 
companies would call all over the place to try to find their 
status. If every chemist and bioequivalence reviewer is 
answering questions from 8,000 different sites asking them what 
is the status, we are never going to get done.
    So we are trying to bring order to this process, like we 
have for PDUFA, and what we want to do is have predictable 
deadlines so that every company knows their application is on 
track and going to get out of the agency and they are going to 
get a complete response within the timeframe that has been 
established under GDUFA.
    So I think some of this is a transition issue where we are 
going from one state to another and we are going to have to get 
through this period. We are doing everything we can and we are 
considering additional steps to notify industry as their 
application approaches an action so that they can prepare, say, 
for launch or whatever they need to prepare for. We understand 
that need. However, we can't have companies' thousands of calls 
to reviewers or we are not going to get this program done.
    Mr. Pallone. All right, thanks a lot.
    Mr. Pitts. The Chair thanks the gentleman.
    We are presently voting on the floor. We will try to get 
through a couple more members. The Chair recognize Mr. 
Whitfield for 5 minutes for questions.
    Mr. Whitfield. Well, thank you very much, and thank you all 
for joining us this morning.
    Last April I attended a meeting with a group of 
dermatologists and they were talking about the approval process 
for over-the-counter in general and sunscreen in particular. 
And they had indicated that there were, like, eight sunscreen 
applications that had been at FDA waiting for a decision for, 
like, 10 years. Some of these have been used in Europe.
    We all are very much aware that you all have a very heavy 
workload and you have limited resources. And I know in 
conversations with Congressman Dingell, and I know on the 
Senate side Senators Reid and Isakson have been discussing this 
issue, and Congressman Dingell and I have draft legislation to 
try to expedite the process and we had submitted to you all for 
technical assistance. And I was going to ask, one, are you, 
with the multitude of issues you deal with, are you even aware 
of legislation that we have submitted? And if you are, could 
you give us any idea of maybe when we could expect a response 
from you?
    Ms. Woodcock. We hope you would get a prompt response.
    Mr. Whitfield. OK.
    Ms. Woodcock. This is a very intractable problem. I think, 
if possible, we are more frustrated than the manufacturers and 
you all are about this situation. We have to do regulations to 
get these ingredients into the monographs. That is the problem. 
And they are backlogged and they are slow to get through, and 
we have to do a proposed regulation, sometimes we have to do 
advanced notice of proposed regulation, then do a proposed 
rule, and then do a final rule, which can take 6 to 8 years. 
And we have multiple categories of these over-the-counter 
products that we have to handle. But the sunscreens, there is a 
public health issue here.
    Mr. Whitfield. Right. And who on your staff specifically 
can we be in contact with on the technical assistance?
    Ms. Woodcock. Well, I think that our lead in this is Dr. 
Sandra Kweder, who is acting head right now of the office that 
oversees this, but, of course, work through our legislative 
staff and we will provide any assistance needed.
    Mr. Whitfield. OK.
    Mr. Dingell. Would the gentleman yield?
    Mr. Whitfield. I would be happy to yield.
    Mr. Dingell. Briefly. First of all, I want to thank the 
gentleman. Second of all, I want to commend him. And third of 
all, I want to note that this is important. This matter has 
been dawdling by prodigious overlong delay, and it has simply 
got to come to a halt. Your assistance would be extremely 
important. I want to work with my good friend. And I urge you 
to resolve this problem. It is a significant problem that does 
do the Food and Drug Administration no credit whatsoever.
    Mr. Whitfield. I yield back the balance of my time.
    Mr. Pitts. The Chair thanks the gentleman.
    I think we can get one more in. We will reconvene shortly 
after the second vote. There are two votes. That will be about 
11 o'clock. The Chair recognize the gentleman, Mr. Dingell, 5 
minutes for questions.
    Mr. Dingell. Mr. Chairman, I would like to defer. I move 
rather slowly.
    Mr. Pitts. All right. Then we will at this point recess the 
committee until after the second vote, and hope you will be 
patient with us. We will get back as soon as we can. Thank you. 
The committee is in recess.
    [Recess.]
    Mr. Pitts. The time for our recess having expired, the 
subcommittee will reconvene. And the Chair recognize the 
gentleman from Texas, Mr. Green, for 5 minutes for questions.
    Mr. Green. Thank you, Mr. Chairman, for holding the 
hearing.
    And, Dr. Woodcock and Dr. Shuren, thank you for taking time 
to be here today.
    One of my top priorities is fostering a regulatory 
environment that would promote the development of the new 
antibiotic drugs to address the growing public health threat of 
drug-resistant bacteria. I am proud to have worked with leaders 
on this committee, Dr. Gingrey and a coalition of other 
members, to advance the GAIN Act last year. We have always said 
that this was a good first step, but more must be done. And I 
know from your testimony today that is true. Thank you for your 
leadership on the GAIN Act, Dr. Woodcock, and also promoting 
the new antibiotic development.
    In April, CDC released a report on drug-resistant bacteria. 
In that report, CDC states that antimicrobial resistance is one 
of the most serious health threats to our country. Dr. 
Woodcock, does the FDA agree with the CDC on the nature of this 
threat?
    Ms. Woodcock. Absolutely. We are very concerned about this.
    Mr. Green. In this report, the CDC highlights a handful of 
strategies to address this threat. One of the main methods they 
suggested was to develop new antibiotics. As I understand it, 
part of the challenge of the new developing antibiotics is that 
drug resistance oftentimes begins in limited populations and 
approving a drug through the FDA for use in a limited 
population can be difficult.
    Dr. Woodcock, on June 4th of this year you were quoted by 
the National Public Radio as saying that you hope Congress 
would pass legislation soon to make it easier for FDA to 
approve new antibiotics. What type of legislation were you 
referring to when you made those statements on NPR?
    Ms. Woodcock. Well, there have been discussions, and the 
PCAST report referred to earlier--I am sorry. There have been 
discussions, and the PCAST report referred to earlier have 
talked about a program for limited use that is specifically 
directed where there is subpopulation of broader population. 
Because one of the problems we have with the antibiotics, as 
you well know, is overuse. And what we are concerned about if 
we approve an antibiotic for a limited use, just for drug-
resistant organisms, that there would be temptation to use it 
more broadly and thus lose its effectiveness. And so we feel 
that it should be explored that Congress could make some kind 
of program that would really send a signal about limited use 
and then good antibiotic stewardship.
    Mr. Green. Well, I am working on legislation with my 
colleague Dr. Gingrey, and meant to be the next step from GAIN, 
focused primarily on promoting antibiotics meant to be used in 
limited populations. Is there anything that you believe we 
should keep in mind as we draft this legislation?
    Ms. Woodcock. Well, I feel that a strong signal from 
Congress to the healthcare community about stewardship would be 
extremely important. FDA frequently approves drugs for limited 
populations, but usually there isn't that sort of, let's say, 
an orphan population, there isn't that sort of temptation or 
ability to use it broadly in a much broader population.
    So one of the main things is a signal from Congress that it 
is fine to do limited populations out of a broader disease with 
a very small development program, but then there should be that 
stewardship by the healthcare community to not use it more 
broadly.
    Mr. Green. Well, and I know if you deal with any of the 
infectious disease specialties, they talk about that. And can 
we statutorily, because I know in medical practice a doctor can 
make that decision on their own, and that may be part of the 
problem. But you can't limit it to just, for example, people 
who deal with infectious diseases, I guess.
    Ms. Woodcock. We feel that there shouldn't be an overt 
limitation like that, because it is not feasible. Patients come 
in, they have infections, there is a resistant strain 
circulating in the community, doctors should have the 
discretion to use appropriate antibiotics. However, I think a 
signal of prudence and stewardship would be a mechanism I think 
would be very effective.
    Mr. Green. And I am almost out of time, but the other issue 
on that is we need to make sure we keep this, because what may 
be successful a year from now or 10 years from now, we will 
still have people who develop those resistance, so we need to 
keep that pipeline going for these new levels of antibiotics 
and other ways to treat these terrible illnesses.
    As health care gets more advanced and threats to our health 
get more complicated, it is important that both Congress and 
the FDA be responsive to this changing world. Many of the 
processes at FDA are decades old. Drug resistance, medical 
software, and personalized medicine are going to strain the 
limits of the outdated statute. I hope we can work together and 
have FDA as an active partner when we are drafting this and 
protect not only public health, but foster that innovation we 
need for that long term.
    So, Mr. Chairman, thank you for your time.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize the vice chair of the committee, Dr. Burgess, 
for 5 minutes for questions.
    Mr. Burgess. Thank you, Mr. Chairman. I apologize I wasn't 
here earlier. I had some obligations on the House floor.
    I do want to take this opportunity just to recognize the 
fact that this subcommittee, and in fact the Energy and 
Commerce Committee as a full committee, did its work in what 
was sometimes a very difficult election year of 2012. Food and 
Drug Administration reauthorization of user fee agreements was 
going to expire. All of the people who write in the important 
papers around town said we couldn't do it. And you and Mr. 
Upton did it. The bill went through regular order, passed the 
subcommittee, passed the full committee, went over to the 
Senate, conference with the Senate, and the President signed it 
into law on July 9th of 2012. No one knows that because there 
was no signing ceremony and there was no press present. But 
Congress, when pressed, can actually function in a very 
reasonable way.
    Dr. Woodcock, as you will recall, during the 
reauthorization discussion, actually I worked with Ranking 
Member Pallone on the concept of the advisory committees to 
make certain that they were staffed with the very best experts 
to serve patients well, serve you and your agency well, and 
reduce backlogs and save resources. And so it looks to me like 
the initial thing, reports I am getting are good. Do you have 
any updates for the committee today?
    Ms. Woodcock. Yes. We have been able to remove several 
steps that were very time consuming within the vetting of the 
advisory committee process for members for a specific 
committee. That has helped us streamline that program. Of 
course, all advisory committee members are still subject to the 
broad Federal conflict of interest requirements, and that is, 
you know, fairly stringent as well. But the additional steps 
have been removed, and that has been helpful.
    Mr. Burgess. And sometimes it is helpful to have someone on 
an advisory committee who actually has some knowledge of the 
pathophysiology that might be involved in the disease under 
which we are contemplating treatment? Would that be a fair 
statement?
    Ms. Woodcock. I would say it is essential.
    Mr. Burgess. I think so, too.
    Now, there is going to be a rare disease meeting in January 
of this year. Is that correct?
    Ms. Woodcock. I believe so.
    Mr. Burgess. And looking forward to improving the 
regulatory process for approving drugs for rare diseases. You 
held a similar meeting in 2010 and issued a report with 
recommendations. Can you kind of update us as to the 
implementations of those recommendations made 3 years ago in 
advance of this next meeting in January?
    Ms. Woodcock. Well, I think we are doing extremely well on 
rare diseases. We have established a rare disease staff. We are 
tracking all the rare diseases. In 2013 we approved a large 
number of products for rare diseases. Every one of them was 
approved based on a surrogate in fiscal year 2013. That is 1, 
2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 were products for rare 
diseases. And then one was approved on an animal rule without 
human efficacy testing. So we do have a robust program, and we 
are going to try to take it to the next level as we have more 
meetings, public meetings.
    Mr. Burgess. Dr. Shuren, as you know, for some time I have 
been interested in the research use only application. And there 
is recent guidance put out by your department that only 
products that could significantly restrict patient access and 
restricting sales of these products. Is there any evidence out 
there of patients being harmed by research use only products?
    Mr. Shuren. Well, we do have evidence of companies who are 
putting those products out for research use only, but actually 
promoting them for clinical diagnosis in cases where those 
research use only, because they are research use only, haven't 
been shown necessarily to be accurate. And in times where we 
have taken action, it is predominantly where there is an 
already available approved or cleared test that would be there 
as an alternative.
    We have recognized some of the concerns, I will tell you, 
with the guidance. And one of the things in there was about 
putting on the makers of research use only that they should 
reasonably know about the people they are selling it to and 
their intentions. That is something we heard loud and clear. I 
want too tell you we have heard those comments. That will come 
out of the final guidance. And that final guidance will come 
out probably by the end of this month, and we will get you a 
copy of that, too.
    Mr. Burgess. And I appreciate that. But specifically, do 
you have evidence that patients have been harmed by using the 
research use only designation?
    Mr. Shuren. I am not aware of a specific patient for one of 
those. I don't know. We can look a little bit further.
    Mr. Burgess. Thank you. And I would appreciate your further 
investigation of that.
    Finally, Dr. Woodcock, I just have to ask a question. 
January 1st of 2012 I lost access to a low-cost over-the-
counter asthma inhaler. When am I going to get it back?
    Ms. Woodcock. Well, I can't talk, as you know, publicly 
about applications that might be pending and so forth. But 
certainly that monograph status remains. And we certainly heard 
your concern.
    Mr. Burgess. Thank you.
    Mr. Pitts. The Chair thanks the gentleman.
    And now recognize the gentlelady, Ms. Castor, for 5 minutes 
for questions.
    Ms. Castor. Well, thank you, Mr. Chairman.
    And welcome. Dr. Woodcock, in September, in Tampa we had 
the BioFlorida Conference with researchers and device 
manufacturers and folks that are developing drugs come from all 
across the State. And FDA was kind enough to send Dr. Richard--
--
    Ms. Woodcock. Moscicki.
    Ms. Castor. Moscicki, thank you, from the Center for Drug 
Evaluation and Research. And I want to thank you very much, 
because it is, I know, the budgets are very tight, but to have 
folks that are leaders at FDA be able to interact directly with 
the folks in my State was greatly appreciated. So thank you. 
And the conference focused a lot on the future of drug 
approvals.
    So we are pleased that the Federal laws are working well. I 
think the number one fear of everyone, the topic of this 
conference turned to sequestration, because people are rather 
surprised that even though FDA relies a lot on user fees, the 
user fees are subject to sequestration. This is not smart.
    Some of the analysis I have seen, and tell me if these 
numbers are right, that to your budget, I don't know if this is 
the entire FDA budget or just your section, that in fiscal year 
2013 you were subject to sequestration of $209 million. And on 
top of that, $85 million in private funding, the user fees, 
were sequestered at the same time. And then in fiscal year 
2014, if the sequester is not replaced, you are looking at a 
cut of $319 million. And $112 million of that, or you can 
explain that, on top of that or as part of that is the private 
funding user fees.
    I mean, this has got to have a harsh impact on development 
of new therapies, on review of devices, on review of innovative 
drugs. Tell us what you are facing now in your shop.
    Ms. Woodcock. Well, the sequestration has been very 
difficult. Of course, it cuts the appropriated support for 
these programs as well as where there are use fees, some of the 
user fee programs have been subject. My understanding is that 
total for user fees has been $79 million in the last fiscal 
year. But, frankly, how these are calculated is above my pay 
grade, all right? But what certainly has happened, there are 
user fees that we are not able to access, across the device and 
the PDUFA program, and that would continue.
    And what happened with PDUFA, we negotiated and the bill 
was passed. It recognized the new agreements on rare diseases, 
patient-focused drug development, and these other programs. And 
then the sequester removed practically the whole amount that 
was negotiated for these new programs, these patient-focused 
programs, and other programs.
    Now, we have put on the patient-focused drug development 
meetings regardless, but our implementation of our rare disease 
staff has been delayed because of the sequester, and similarly 
with a number of the other programs that we agreed to.
    Ms. Castor. So that is not good news for families across 
the country, families with rare diseases that rely on your 
agency. It seems like we have taken a step forward with the 
Federal laws that have given you certain authorities and 
expanded user fees, but then it seems like on the other hand 
sequestration, brought by the Congress, is going to handicap 
you. I mean, this is a bad time to shortchange FDA. Can you 
characterize what it means, where you are very concerned? And I 
would assume you would recommend that sequestration be replaced 
going forward.
    Ms. Woodcock. Well, as I said, the whole financial issues 
are above my pay grade. That is really up to Congress. However, 
we are in a threshold, and I think with devices, too, of a 
revolution in biomedicine, and we are starting to see the 
benefits of that. And we need to have the programs that can 
respond to that, and also programs that can get for those older 
drugs, get low cost, affordable generics out on the market 
promptly, and at the same time, shepherd those innovations, 
both devices and drugs, that are going to make a difference for 
people who are still suffering from untreatable diseases.
    And we really, I passionately feel we have to deliver this 
to the public. We have to make sure our regulatory programs are 
up to the task of dealing with drug-resistant organisms, of 
dealing with the new science that is coming forward.
    And we are always close to the bone, as you know, in FDA. 
We have to shepherd our resources very carefully. More is at 
stake here than just having our staff. What is at stake is are 
we going to translate these innovations into benefit for the 
public.
    Ms. Castor. Thank you.
    Mr. Pitts. The Chair thanks the gentlelady.
    Now recognize the gentleman from Illinois, Mr. Shimkus, 5 
minutes for questions.
    Mr. Shimkus. Thank you, Mr. Chairman. I am glad to follow 
my colleague from Florida, because obviously history, it is 
interesting in that this was the President's proposal to go 
into sequestration. It was passed by the House. I voted for it. 
And the real way to solve sequestration is understand debt, 
deficits, and our entitlement programs, and get those reforms.
    My fear for any agency, that without that the expansion of 
our entitlement programs is going to squeeze out the 
discretionary budget, whether that is the military, whether 
that is your agency. And the sooner we as a Nation own up to 
that, then we wouldn't be having this debate.
    One of the great things I love about the job of being a 
Member of Congress is working with our constituents. So right 
during votes I had one of my constituents go, and we measured 
the Ohio clock, because I have a constituent who is building a 
replica. So we were tape measuring and stuff. So that is an 
example of kind of the things that we do.
    And it is just lucky that you are testifying when I was 
approached by a constituent, a member of my church. And so I am 
going to get a privacy release statement and we are going to 
follow up with the FDA, but he was supposed to be in clinical 
trials in September. They have not been called. He has asked me 
to ask why. So if you all would just be prepared for when we 
get involved with that, I would appreciate that on behalf of my 
constituent.
    So having said that, really my questions are to Dr. Shuren 
on the 510(k), some issues revolving with that, which I have 
been trying to follow closely. Many companies are providing us 
feedback that they are experiencing a significant shift in 
requirements for various 510(k)s. Particular concerns have 
arisen about new requirements being communicated by the FDA 
during the 510(k) review that go beyond previously sufficient 
data requirements.
    If true, this concerns me because in many instances FDA has 
not issued any new guidance on public communication regarding 
policy changes. So the question is, has the FDA changed its 
data requirements for submission types without issuing updated 
guidance documents? And if so, can you tell me why the change 
in consistency?
    Mr. Shuren. Well, first of all, I will say that oftentimes 
if we are asking a company for additional data, sometimes it is 
in response to the data they provided to us, that there may 
have been issues in what was submitted.
    One thing I will ask you is, if you have companies who 
believe that something has been changed and changed 
inappropriately, you are very welcome to send them to me 
directly, and I promise you I will look into it.
    Mr. Shimkus. Thank you.
    At hearings in this committee prior to the enactment of 
FDASIA you acknowledged that in some cases the CDRH reviewers 
were asking for data to support product applications that they 
should not be asking for. You also indicated in an October 2011 
document that you planned to work on training reviewers to 
avoid these sorts of data requests. Can you give us an update 
on this and what steps have you taken to address this?
    Mr. Shuren. So we have taken a variety of steps to assure 
that the questions that we ask are need to know rather than 
nice to know. And I will tell you even from our own analysis it 
is not common, but it happens, and it concerns us.
    So one of the things we have done is we have been 
reorganizing in our premarket review offices, and thanks to 
MDUFA III we have been bringing in additional managers for more 
oversight of the process. We have changed policies and 
procedures to put more checks into the system.
    Under MDUFA III, we have also put in a back check. So with 
our high-risk devices, we actually have a dedicated staff who 
will review any and all major deficiency letters that go out 
for accuracy and appropriateness. We have biweekly premarket 
review rounds, where if issues get raised we are dealing with 
them with the reviewers and the managers at that point. And of 
course we have done training for everyone for starters.
    Mr. Shimkus. And I will end up on this. What, if any, 
consequences are there for reviewers who ask questions beyond 
what is appropriate? And are those annotated on their 
performance review evaluation so that if it happens numerous 
times? Many of us have been managers of personnel. And, you 
know, the reality is you have got to document, document, 
document, especially on a Federal employee who may not be 
responding to the proper directions.
    Mr. Shuren. Well, I will first say, and I am going to put 
this in because my folks get sometimes a hard rap, they are a 
great group of people. They are very smart, they are dedicated, 
and they have been working exceptionally hard to implement 
FDASIA and to make changes. And I think it is reflected, quite 
frankly, in our premarket review numbers. The bottom line is 
our performance is getting better, and it is getting better for 
the first time in a decade of worsening, and that is a lot of 
credit to them.
    Making changes is hard when it is a large organization, and 
there are going to be blips along the way. And it is our 
responsibility to keep good oversight in the center. And when 
things do arise, we do engage with the individual. We try to 
educate and work with them and keep on top of it.
    Mr. Shimkus. If the chairman would for just a follow-up, of 
course, annotating if there is numerous examples and writing it 
down is part of a good personnel status. So I hope you would 
consider and do that.
    Mr. Shuren. Yes. And I will say for anyone who is not 
performing appropriately, and that goes for anything, then 
appropriate documentation in the file, and also discussions 
with the employee, because you always want to, if an employee 
isn't doing well, to try to help them to get back on par with 
performance.
    Mr. Pitts. The Chair thanks the gentleman.
    And now recognize the gentlelady from California, Ms. 
Capps, for 5 minutes for questions.
    Mrs. Capps. Thank you, Mr. Chairman.
    And thank you to our witnesses for being here today. I am 
so pleased that we were able to reschedule what I consider to 
be a very important hearing. And I am very pleased that FDASIA 
included parts of my Sentinel Assurance for Effective Devices 
Act, also known as the SAFE Act, in its final form.
    One section of that bill was to ensure swift release of the 
UDI, the unique device identifier rule, for public comment to 
improve device tracking and aid in any potential recalls. So, 
Dr. Shuren, I want to commend you for getting the final rule 
out on UDI. I know it has been a long time coming, and I am 
glad that you finalized it so things can finally move forward.
    One concern we have heard from consumer groups has been 
that the final UDI, unique device identifier--I want to make 
sure people know what I am talking about--rule does not require 
the identifier to actually be on the individual product itself. 
Can you explain the decision to not require the UDI to be on 
each one of these products?
    Mr. Shuren. One of the principal drivers was cost, cost to 
the companies. And we want to make sure that in implementing 
and putting forward this important regulation that we keep in 
mind what the burdens may be for companies to try to comply. So 
that was the major reason.
    We do still keep in marking the devices in really one 
exception, and that is if you make a device that is going to be 
used more than once and it is going to be reprocessed. Because 
in that case, the labeling that came along with the product 
that had the UDI got thrown away, now it is moving over to 
someone else, and you wouldn't know what that device is unless 
you marked those devices. And that is a requirement in the 
rule.
    Mrs. Capps. OK. OK. That is good to know.
    My SAFE Act also built upon the existing Sentinel program 
at FDA, a program that enables FDA to actively query automated 
healthcare data to evaluate possible drug safety issues quickly 
and securely. The SAFE Act, and section 615 of FDASIA, both 
broadened that usage to the medical device space, which will 
benefit producers and consumers alike by catching problems 
early and ensuring that data, not conjecture, but data 
determine our device safety policies.
    Unfortunately, the rollout of Sentinel on the drug side has 
taken many years, more than many in the field think is 
necessary. So I hope that expansion to the device side will not 
be plagued with the same delays. And can you each give me a 
brief update on where the agency is with Sentinel? I would 
appreciate a longer update for the record.
    [The information appears at the conclusion of the hearing.]
    But just quickly, can you also explain for us how UDI fits 
into FDA's postmarket surveillance of medical devices? Will it 
be good for patients and for providers and for manufacturers?
    Mr. Shuren. So the UDI is absolutely essential. It is a 
condition precedent for having Sentinel for medical devices. 
And the reason is right now it is very hard to link a device 
with a patient's experience with that device in electronic 
health information, electronic health records. Unlike drugs, 
which had a new drug code that they could use right away, we 
didn't have anything for devices. So the UDI we need to have in 
place. And that is going to take a few years.
    But in the interim, what we are also doing is the 
following. We are identifying, helping to develop new and 
validating tools for active surveillance, being able to go 
through information to find out what are better understanding 
of benefits, risks, and problems with devices, And we are 
working with our conflicts in CDER on that.
    Also, Sentinel will be part of a broader National Medical 
Device Postmarket Surveillance System. So electronic health 
information and registries will be the backbone. And we view 
this not so much as an FDA system, but truly a national system 
to meet the needs of industry, healthcare providers, insurers, 
FDA.
    So moving forward, the Brookings Institution is very soon 
going to call for the creation of a multistakeholder planning 
board to start to lay out the governance structure, policies, 
and procedures for such a surveillance system, which we think 
is important not only for identifying problems, but being able 
to use postmarket information to help lower burden and better 
inform decisions on premarket approval, help products get to 
market, help doctors and patients make better-informed 
decisions.
    Mrs. Capps. Thank you very much.
    And finally and briefly, another piece of FDASIA was a key 
component of my HEART for Women Act, bipartisan legislation 
that focused on doing all we can to address women's heart 
health and address health disparities. Section 907 of the 
FDASIA required an examination of the extent to which data on 
how approved medical products affect women, minorities, and 
ethnic groups be collected, analyzed, and publicly reported. 
This is an important step, but concerns persist I know, and I 
will be submitting many questions for the record, and I 
appreciate your team's attention to this matter.
    And I don't think there is much time for you to respond. I 
just wanted to put that out. We will follow up with you. Thank 
you.
    Mr. Pitts. The Chair thanks the gentlelady.
    And now recognize the gentleman from Pennsylvania, Dr. 
Murphy, 5 minutes for questions.
    Mr. Murphy. Thank you, Dr. Shuren and Dr. Woodcock. I 
appreciate you for being here today.
    I would like to take just a moment to ask you about an 
important medical device issue, although it was not part of 
FDASIA. The FDA has regulations about proper maintenance of 
complex medical devices such as radiation therapy and imaging 
equipment, and manufacturers are required to recommend 
maintenance standards to hospitals and physicians and collect 
data on how that equipment is kept and serviced.
    My understanding is that the Center for Medicare and 
Medicaid Services may issue guidance telling hospitals they are 
free to vary from the manufacturer's maintenance recommendation 
on these types of devices. But we are not dealing with an 
automobile or refrigerator here. These are highly specialized 
pieces of equipment. And when a medical device is improperly 
serviced, the consequences can be pretty deadly, as you know.
    When a New York Times series in 2010 raised concerns about 
patient deaths from improperly calibrated diagnostic and 
therapeutic equipment, this committee held hearings in the 
matter. I am concerned that weakening of equipment maintenance 
standards could have some severe consequences for patient 
safety, and the party responsible for that device is the 
manufacturer. If something goes wrong, it is that company's 
name on the label, even though they are not the ones that made 
the maintenance changes. I believe the FDA has weighed in on 
this possible action by CMS. Is that true, Dr. Shuren?
    Mr. Shuren. Yes, that is true.
    Mr. Murphy. Can you discuss the FDA's position on this and 
you concerned about anything there?
    Mr. Shuren. Our concern is that the maintenance schedule is 
really part of assuring that that device remains safe and 
effective. And we work with the companies on what is the 
appropriate maintenance schedule to assure just that. And as 
you mentioned, these are technologies that may be emitting 
radiation, and we want to make sure not only are you getting 
accurate images of patients, you want to make sure they are 
also getting the right amount of radiation, not too much. And 
so a good maintenance schedule is essential. And that is why we 
had raised certain concerns and shared those with our 
colleagues at CMS.
    Mr. Murphy. OK. Let me ask another issue here. And I will 
gave you a little briefing material on this a little bit ago, 
but I want to make sure we have it in the record. We are all 
concerned about hospital-borne infections. E. coli, MRSA, and 
other infections which spread in hospitals are particular risks 
for people in hospitals, particularly in an ICU, or people who 
are immuno-compromised, et cetera, in transplant patients, et 
cetera, and that people use substances that are put into paints 
and plastics and clothing to try and reduce infections. But 
there also is the element of copper, which in research I 
understand has shown that basically E. coli, MRSA, and some 
other diseases are killed in minutes, whereas those same 
diseases can last for weeks on plastics and stainless steel.
    The EPA has said that any sort of regulation on this is in 
the FDA's hands and they are not going to do anything about it, 
even though they have other jurisdiction over copper. I wonder 
how this will work at the FDA in terms of expediting this. I 
mean, it is obviously not a new element. It has been around for 
billions of years. And it seems to me it ought to be something 
we can use, copper itself, or copper-nickel alloys and other 
alloys which we know that can be on handles, on trays, on other 
equipment and supplies where these diseases can be killed right 
away.
    Can you comment on the procedures you could take on this? 
And could anything be sped up on this process?
    Mr. Shuren. So we are happy to look into it. If it is a 
medical device and it has copper on it, if it has an anti-
infective, that is something that my center would generally 
take care of. If it is not on the medical device, so it is just 
the anti-infective, it tends to work by a chemical action, 
becomes a drug issue. And that is why if there is a company or 
companies dealing with it, it is important that we connect so 
we figure out exactly what we are trying to do and help them as 
best we can.
    Mr. Murphy. Just help me understand this, because I want to 
make sure we handle it in the right way. So if it is a door 
handle or a touch plate entering an ICU, if it is a switch 
plate in a hospital room, would those be medical devices or 
would they be------
    Mr. Shuren. So a lot of those basics oftentimes are not.
    Mr. Murphy. What category would they be in?
    Mr. Shuren. If you are talking about surgical instruments, 
you are now getting into------
    Mr. Murphy. I understand that. I understand that. So what 
category would they be in? Because the EPA is saying that FDA 
has to approve them.
    Dr. Woodcock, do you have------
    Ms. Woodcock. They would only considered a drug if they 
actually had a disease claim in humans. And we don't usually 
regulate door knobs as drugs, all right. I think we are talking 
about some jurisdictional, like, murkiness here that we would 
need to sort out.
    Mr. Murphy. Well, I would just hope. Let's put that on the 
record. We will get you the information on it. But I hope that 
is something that you and the EPA can discuss fairly quickly. 
Obviously, the 100,000 people who die every year from hospital-
borne infections and the fifty billion dollars we spend, if 
this can be reduced by several, then we ought to work together.
    Thank you so much. I appreciate it.
    Mr. Pitts. The Chair thanks the gentlemen.
    Now recognize the gentleman from New York, Mr. Engel, 5 
minutes for questions.
    Mr. Engel. Well, thank you very much. And welcome to both 
of you. Followed both of your work. And thank you for your 
service.
    I believe that the good work done by this committee on the 
Food and Drug Administration Safety and Innovation Act was 
likely the best healthcare-related legislating done by Congress 
last year. A little more than a year after its passage, I am 
pleased that this hearing is taking place so we can continue to 
monitor the implementation of this important bipartisan law.
    I have always fought for those with rare and orphan 
diseases. I am the author of the ALS Registry Act, and both the 
Paul D. Wellstone Muscular Dystrophy Community Assistance 
Research and Education Amendments of 2008 and 2013, which I 
have done with Congressman Burgess. I am particularly 
interested in the development and approval of drugs for rare 
diseases.
    Therefore, one of the aspects of FDASIA I am most 
interested in is the improvements made to the accelerated 
approval pathway as part of the law. To me, diseases like 
muscular dystrophy are why the accelerated approval pathway is 
so important. Duchenne muscular dystrophy is the most common 
lethal genetic disorder of children worldwide, affecting one in 
every 3,500 live male births. There is no cure. It is always 
fatal. And the best hope for those with Duchenne is to treat 
the symptoms and delay its progression. I have a group of 
people in my district that called this disease to my attention.
    However, in recent years the Duchenne research pipeline has 
held much promise, as potentially life-saving therapies appear 
on the horizon, making elements of FDASIA particularly relevant 
to this research community. Earlier this week, the FDA informed 
Sarepta Therapeutics that its experimental drug for Duchenne 
muscular dystrophy was not a candidate for the accelerated 
approval pathway at this time. I recognize that since Sarepta 
has not filed its new drug application most of the discussions 
between Sarepta and the FDA are confidential. But I hope that 
Sarepta will continue to pursue their treatment for Duchenne 
muscular dystrophy, and I hope that the FDA will continue to 
provide clear feedback to the company as they move through 
their various clinical trials.
    So, Dr. Woodcock, can you elaborate on how you envision the 
enhanced accelerated approval pathway working?
    Ms. Woodcock. Certainly. As I said, in fiscal year 2013 we 
approved a large number of rare diseases, and all of them were 
based on surrogate end points, which is the foundation for 
accelerated approval. However, we granted a number of them full 
approval because we felt enough information had been provided 
that a confirmatory trial would not be necessary.
    So we certainly are using the accelerated approval in rare 
diseases. And what the FDASIA instructed us to do was to really 
consider additional end points, including intermediate clinical 
end points, in other words clinical end points that are 
reasonably likely to predict clinical benefit, and we intend to 
do that.
    Mr. Engel. Thank you. Let me ask you another question. 
Recognizing the challenges in developing therapies within the 
rare disease space, how is the FDA working with companies to 
ensure proper parameters for success and failure are being 
established through the clinical trial process in order for 
experimental medications to possibly be considered under the 
accelerated approval pathway?
    Ms. Woodcock. We try to work one by one, because of course 
each one of these diseases is different. One of the most 
important things that can be done by the patient communities is 
to establish a natural history of the disease through data so 
that we understand and can predict what will happen. If there 
is an intervention, you can calculate how many patients you 
need in your trial and so forth.
    And this hasn't been done before. And so we have really 
been pressing on that, and I think we have seen a lot of 
progress. But we work with the companies one by one to help 
them design their trial. And as I said, we have set up a rare 
disease staff, although that has been inhibited because some of 
that money has been influenced by the sequester.
    Mr. Engel. Well, thank you. And let me talk about the 
sequester and building on what Ms. Castor asked. I didn't vote 
for the Budget Control Act of 2011, thankfully, which created 
this huge sequestration mess. I am very frustrated that the 
user fees paid as part of agreements reached in FDASIA are 
being sequestered. So why don't I ask Dr. Shuren, can you talk 
about how sequestration impacts the ability of the FDA to meet 
goals agreed upon as part of FDASIA?
    Mr. Shuren. It is making it challenging. I mean, we are 
meeting the goals now. But in 2013, we saw about an 8 percent 
cut. Critical funding for training of our staff, of our review 
staff who we want to be on top of cutting-edge technology. Saw 
a 15 percent cut in our ability to recognize national and 
international standards, which provides predictability for 
industry. We had a 50 percent cut in our investment in 
regulatory science to have better tools for assessing medical 
devices faster and at lower cost, which is a big deal for 
industry. And I had to shift 50 percent of my operating dollars 
into payroll in order to hire the people I committed to hire 
under MDUFA III.
    So most of my extra money, if you will, beyond paying for 
employees, is to pay for the rent, keep on the lights, put 
money in the photocopier. I have very little to actually put in 
to really improve a program that still needs a lot of help. And 
if we go into 2014 and this continues, I am not going to have 
the money to be able to hire and maintain the people we 
committed to hire and maintain under MDUFA III. It is a big 
deal for us.
    And sequestration, it is important on user fees. Most of 
our program is still funded by appropriated dollars. And those 
cuts, they are killing us. And we are a program, like drugs, 
where years before trying to actually turn the program around, 
and this is making it very challenging for us to do that.
    Mr. Pitts. The gentleman's time has expired.
    Mr. Engel. Thank you.
    Mr. Pitts. The Chair recognize the gentleman from Virginia, 
Mr. Griffith, 5 minutes for questions.
    Mr. Griffith. Thank you very much, Mr. Chairman.
    Dr. Woodcock, greatly appreciate the passion you showed 
earlier in your testimony. I would agree with you on that 
passion, particularly about bringing innovative treatments for 
rare and terminal diseases. I have a little bill that would 
allow folks to get early access or early approval to those 
drugs in order to help them, and what we believe will actually 
lower the costs of some of that experimentation. We will talk 
about that another time.
    I do want to talk about a bill, I know what we are doing 
here today is important, but I do want to talk a little about a 
bill we have waiting over in the Senate. The House passed the 
Drug Quality and Security Act. It was a bipartisan, bicameral 
compromise to prevent another fungal meningitis outbreak like 
the one associated with NECC's tainted sterile products, where 
we had 64 Americans unfortunately died as a result of that 
situation.
    I am proud of the legislation that I worked on with 
Congressmen Gene Green and Diana DeGette. Ultimately, although 
we had a different package originally, we came to a compromise 
with our Senate colleagues and with your agency, and I look 
forward to the Senate getting around to it. It is held up for 
other reasons, but I look forward to the Senate passing the 
bill and it being signed into law.
    And I am committed to engage in oversight to make sure that 
patient safety is being properly protected. I also look forward 
to the agency developing the notification system that 
Congressman Green, Congresswoman DeGette, and I authored to 
ensure that the FDA works more closely with those State boards 
of pharmacy to prevent another public health crisis.
    That being said, there were some areas that we thought we 
might be able to get fixed that we didn't in that bill that 
have raised some concerns. And I would like to ask you about 
those in regard to that Drug Quality and Security Act. In its 
previous draft guidance the FDA recognized the importance of 
maintaining an office stock of compounded drugs that doctors 
can readily access and administer to patients in their offices. 
Can we rely on the agency to continue to allow doctors and 
hospitals to order and keep compounded drugs on hand for office 
use?
    Ms. Woodcock. Well, we are going to have to see what is in 
the final bill, if it is enacted. And then as I understand it, 
it really removed the court disparity, which I didn't fully 
understand, but was a problem. And so it leaves the previous 
statute more or less intact, and we can implement it 
aggressively. And obviously, that is one of the considerations 
in there, is what are the four walls of what is Federal, what 
is State, and what is permitted.
    Mr. Griffith. And we didn't change anything in regard to 
office use, and so there is some concern that maybe we should 
have put it in. It was compromised that we would just leave it 
silent. And I hope that we can count on the FDA. I know you 
maybe can't answer that today. But I would hope that we can 
count on the FDA to leave that part of it that was working very 
well, which the FDA had previously done, leave that intact, 
because I don't think there was any intention, certainly not on 
our side, that that be changed in any way.
    Likewise, repackaging of sterile drug products has 
typically been regulated by the agency in the same fashion as 
compounded drugs. Repackaged sterile drugs are vital for many 
patients, especially those in ophthalmologic health issues. 
Likewise, can we rely on the FDA not to go in and create chaos, 
and to preserve the access to these repackaged sterile drugs 
and limit the impact of burdensome regulations on that 
practice?
    Ms. Woodcock. Well, our intent certainly is not to create 
chaos.
    Mr. Griffith. Yes, ma'am.
    Ms. Woodcock. All right? I think one of the goals, mutual 
goals, is to prevent contaminated drugs. And that is really our 
goal, and your goal as well, I believe.
    Mr. Griffith. It is. There were some clarifications that 
everybody decided to let go and hope that it works out. And so 
I am just worried about those areas.
    The last of the three that I have is the nuclear 
pharmacists. They compound drug products that have a short 
radioactive half life and must be quickly delivered to a 
healthcare entity for administration to a patient. Sometimes 
this must be done in advance of a patient-specific 
prescription. Can we rely as well on the FDA to continue to try 
to monitor that in the same fashion that they did before this 
bill was passed? And I know that the Senate is either going to 
pass it today or next week. But anticipating that, since it was 
a compromise worked out between the two bodies and the FDA, 
what are your thoughts on that?
    Ms. Woodcock. Well, the nuclear pharmacies have not 
represented a problem here. We have a scheme with them. We have 
been very successful in implementing a regulation of positron 
emission tomography facilities, and that has gone very well. 
And so I think we should continue along that path.
    Mr. Griffith. And I appreciate that greatly. And I would be 
remiss, you know, it is good to see a witness with passion and 
your dedication. We may not always agree on how to get there, 
but I always appreciate the fact that you come in with honest 
answers and a willingness to try to work things out, and I 
appreciate that.
    Ms. Woodcock. Thank you.
    Mr. Griffith. With that, Mr. Chairman, I yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    And recognize the gentleman from Maryland, Mr. Sarbanes, 5 
minutes for questions.
    Mr. Sarbanes. Thank you, Mr. Chairman.
    I just want to pick up on the end of those comments, and 
thank you, Dr. Woodcock, for being here, and say you are one of 
the most professional and knowledgeable witnesses we have the 
pleasure to bring before this committee from time to time. I 
thank you for your testimony, and yours as well, Dr. Shuren.
    And I want to thank the chairman for convening this panel 
today and the committee hearing so we can get a sense of how 
things are progressing. These days, sort of bipartisan 
legislation that we all get behind is hard to come by, so it is 
nice to have the opportunity to hear that good things are 
already resulting from the passage of this reform, and we 
appreciate your testimony in that respect.
    I was going to ask as well about how the kind of user fee 
resource has gotten caught in the switches of sequester, which 
I think you have answered that. It is particularly jarring I 
think to the industry, the notion that they are putting forward 
through the user fees resources from the industry, and even 
that gets implicated by the sequestration that has been put in 
place. And hopefully, we can address that for all the reasons 
that you have raised.
    I don't have a lot of questions necessarily on the topics 
you have been covering because I think you have done a good job 
addressing them. I did want to ask something slightly off 
topic, which is, as a result of redistricting in Maryland, I 
now have the privilege of representing some portion of the 
White Oak facility and had the opportunity to get a tour 
recently and see the tremendous facilities that are provided 
there. And I wondered if you could just speak to the benefits 
of now being able to collocate so many of the FDA personnel and 
have the labs there near each other and what that represents in 
terms of the ability of the agency to function.
    Ms. Woodcock. Well, we really appreciate this, because 
CDER, when I took over CDER, first it was in 14 different 
locations scattered around the metropolitan area here. We 
expect a move this summer that will move the generic drug 
program to the White Oak campus, and also move the biologic 
therapeutics regulation, which has been located on the NIH 
campus, with their associated laboratories, to White Oak. And 
also our colleagues in the biologic center, with whom we work 
on policy very closely.
    So for the drug center, this is a tremendous advance, will 
allow us both to have our new generic office on campus, as well 
as build our quality regulation organization, which I spoke 
about earlier, where we are going to have the same unit 
regulate pharmaceutical quality across all different types of 
drugs.
    And also it will enable us to work with our colleagues at 
CBER very closely. And the benefits of having the device center 
right near us are tremendous, because there are many 
combination products with this new technology that is coming 
about that combine device elements and drug elements. So this 
has been a tremendous advance for us.
    Mr. Shuren. It has been a big deal for us as well. I would 
also put a plug in on personalized medicine. So much of it 
depends upon having the right diagnostics tied up with the 
therapeutics, and we work very closely with our colleagues in 
CDER. Having them down the hallway is essential.
    And having the lab facilities to do absolutely critical 
work. And that is work that also helps companies. Getting 
product to market is so important. And one of the challenges we 
face in the current budget climate is we are getting to the 
point, getting very close to the point of starting to turn off 
lights in some of those labs.
    Mr. Sarbanes. Thank you very much. I yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    Now recognize Mr. Guthrie 5 minutes.
    Mr. Guthrie. Thank you. Thank you for coming. And this is a 
good hearing. And it is one of those things that when you run 
for Congress you don't think about these kind of issues. You 
have other things that you more readily read about. But when 
you get here, you realize they are vitally important to your 
constituents. We have people come continuously, and they are 
looking for devices, they are looking for approvals. And I 
think Mr. Shimkus talked about one specifically that is in a 
desperate situation. So it is important that we work together.
    And I have a couple of questions. One is on the custom 
devices. And, Dr. Shuren, this would be for you. Those that are 
made by manufacturers for specific patients upon request by 
their physician are critically important for patient care, but 
are not viewed by many as efficient or lucrative. And so 
therefore, in section 16 of the FDASIA, we established that 
manufacturers could modify an existing device for which data 
already existed instead of making an entirely new device.
    The FDASIA language limits the manufacture or production of 
five units per year of a particular device type. And some in 
the industry have expressed concerns that the FDA may interpret 
this to say it can only be for five patients per year versus 
just five devices--only five patients who needed a custom 
device. And I think that might render that kind of ineffective. 
And so I just wonder how you interpret that provision.
    Mr. Shuren. No, we are not putting such a strict limitation 
on it. In the next few weeks we are going to put out draft 
guidance to try to better clarify implementation of that 
provision, which we think are very important provisions. And we 
support custom devices, and we think it is so helpful that 
Congress actually put in a much more clear standard for what is 
a custom device. And we are going to provide that clarity then 
in terms of interpreting it.
    I would also add that companies do not need to come to us 
in order to go out with a custom device. There is no premarket 
review on it. They simply report to us annually. So hopefully 
in the next few weeks we will have out that guidance so we can 
have a fuller discussion with industry about it.
    I will also say in those cases where they don't meet the 
statutory definition of a custom device, there are other 
mechanisms we have in place to help assure that patients who 
need a device that isn't otherwise approved on the market can 
get it. So many of those cases, even if the law doesn't allow a 
custom device, could be for compassionate use and still get it 
to the patient.
    Mr. Guthrie. I know in the reporting that it makes it 
quicker and better for the patient. I guess there was some 
concern it might just be five patients. So in a couple weeks 
you are going to have that guidance, and if you could keep us 
informed, that would be fantastic.
    I do want to point out that, I know we talked about 
sequestration, and we are dealing with budget issues here, and 
the budget conference committee is meeting as we speak through 
December, but the FDA has experienced a dramatic increase in 
appropriations over the past decade. And since the beginning of 
MDUFA, CDRH has gone from approximately 1,000 MDUFA full-time 
equivalents to over 1,400. And since 2004, CDRH has doubled its 
budget from 179 to 385. That is from 2004 to fiscal year 2011. 
And during this time PMA and 510(k) submissions have decreased.
    However, studies have shown, and that is the CHI/BCG report 
we are all aware of, that review times have gotten 43 percent 
slower in the past few years and PMA 75 percent longer. So 
sequestration does have an effect, I am not saying that it 
doesn't, but there has been some substantial increase in the 
budget at the FDA as well.
    So, Dr. Woodcock, one of the central tenets of the 
Prescription Drug User Fee program is to provide more certainty 
and predictability on the timeline for FDA to make decisions to 
approve a drug. And why is it important for companies in terms 
of continued innovation and patient access to new medicines for 
companies to have predictability on the FDA and when it will 
make decisions on application?
    Ms. Woodcock. Well, because these companies invest up to a 
billion dollars in a development program, and then they need to 
launch, and they have to do a lot of activities to get ready 
for launch. They have to get their facility all ready, 
distribution chain, all sorts of things. And so just knowing 
what the sequence of events is going to be and when that time 
on to market will be is extremely important to keep this 
enterprise afloat.
    Mr. Guthrie. I agree with you. And then do companies 
receive patent term restoration based off the time it takes for 
a company to go through the FDA process?
    Ms. Woodcock. Well, I don't understand this very well. They 
get restoration at the time of approval. So they get that. But 
there can be things eating away at their patent in the interim.
    Mr. Guthrie. OK. And it is important, because our 
investment in research is second to none in the world. And I 
know, we talked in my office, Dr. Shuren, on some of the device 
companies that are going to other countries for better 
opportunities to get approval of their processes. And I 
appreciate the work that you have done on that, because we 
don't want to lose our industry and our leadership in research, 
and certainly not because of slow and unpredictable processes. 
So thanks for working to make that better.
    And I yield back.
    Mr. Shuren. Thank you. If you may, Mr. Chairman.
    Mr. Guthrie. I have three seconds. Go ahead.
    Mr. Shuren. And we are starting to see some changes. I just 
got called this week by a company who said we were actually 
going to conduct our first-in-human study overseas, and given 
the changes at the FDA they were going to start it in the U.S. 
And we are hearing that from other companies as well.
    The numbers you gave in terms of our performance, they are 
from a report from 2010. And that is actually what I would say 
was the high point, the watershed mark for the program after 
about a decade of worsening. And since that time those numbers 
are actually down a fair bit. They are improving in review.
    Mr. Guthrie. I understand. And I hope I didn't insinuate 
that. But I was just saying the funding has doubled since 2004. 
So there has been increased funding even though you are under 
sequestration now. So I just want to make that point.
    Mr. Pitts. All right. The gentleman's time has expired. 
That concludes the first round of questionings. We will go to 
one follow-up per side.
    Dr. Burgess, you are recognized for 5 minutes for a follow-
up.
    Mr. Burgess. Thank you, Mr. Chairman.
    Dr. Woodcock, can I just ask you briefly about the decision 
by the FDA to reschedule hydrocodone? Is there any update you 
can provide us on that?
    Ms. Woodcock. Well, let me explain the process. What we do, 
we were asked, along with NIH, the National Institute for Drug 
Abuse, to provide a recommendation to HHS, who then provides a 
recommendation to DEA, who then go through a formal 
notification and comment process. And DEA actually does 
upscheduling. So what we announced was simply the fact that we 
intended to recommend that the combination products be 
upscheduled.
    Mr. Burgess. Now, is there a report pending from FDA that 
we have not yet seen or has not yet been made public?
    Ms. Woodcock. Correct. What we need to do to actually any 
scheduling action, we send something called an eight factor 
analysis, which is stipulated under the Controlled Substance 
Act, and findings based on that. And we write that up and send 
that to HHS, who then will evaluate it and then send 
recommendations to DEA. And that process, we should be moving 
that process along fairly soon. We expect to.
    Mr. Burgess. So we will have access to that report?
    Ms. Woodcock. I don't know what point it becomes public. We 
can get back to you on that part of it.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. OK. Thank you. Well, you know, and it is a 
concern, there being practicing physicians all over the country 
who--sure, there are some things that require--State law 
requires triplicate prescription in Texas, those things can't 
be called in over the telephone in the middle of the night. But 
someone who has run out of a postoperative medication and still 
needs help, the doctor has the ability to get that help to that 
patient without an emergency room visit. So it is important, 
and it is something I don't want to see us lose.
    We had a hearing here on, I guess it was on putting the 
EpiPen over the counter, an over-the-counter Epinephrine 
treatment for bee stings. And I don't remember now, quite 
honestly, who was here from the Food and Drug Administration 
that day, but I asked the question was there any thought to 
putting Narcan over the counter, Naloxone, so people would have 
the availability for that if they got into trouble abusing 
drugs that either they got legitimately or illegitimately. And 
then that was a feature of a story on Sanjay Gupta on CCN not 
too terribly long ago.
    So where are we in that process? We have gone to great 
lengths to make levonorgestrel not just over the counter, but 
down there with the Snickers bars in the front of the pharmacy. 
Is there ever going to be any effort to make Narcan over the 
counter?
    Ms. Woodcock. We are certainly encouraging development of 
forms of Naloxone. As you know, now it is compounded as nasal 
sprays and so forth and used by paramedics. So we are certainly 
encouraging development of sort of dosage forms that can be 
used out in the field under emergency situations. And then we 
would certainly consider whether over-the-counter access would 
meet the criteria for over the counter and then would improve 
emergency treatment of overdoses by friends and relatives, for 
example.
    Mr. Burgess. Well, thank you. Again, it was a pretty 
startling film clip that Dr. Gupta showed on that series, and 
again made me think again about the possibility that--again, no 
one wants to condone the use of illicit drugs, but on the other 
hand you hear about it where you lose--usually it is a teenager 
in our community and it is a terrible tragedy when it happens. 
And if there were another option maybe that would be a good 
thing.
    Ms. Woodcock. We totally agree with you, and if lives could 
be saved that way then that is something we should really drive 
toward, and we are very aggressively pursuing this.
    Mr. Burgess. Don't misunderstand me, Mr. Chairman, it would 
be better if they never abused the compounds in the first 
place, but as a matter of first aid perhaps that is something 
should be considered. Thank you for the recognition. I will 
yield back.
    Mr. Pitts. The Chair thanks the gentleman.
    And now for follow-up, Mr. Sarbanes for 5 minutes.
    Mr. Sarbanes. Thank you, Mr. Chairman.
    Dr. Shuren, I know when last year we were debating the 
various proposals around this reform one of the issues was 
where to draw the line, what the proper balance should be in 
terms of regulating medical devices. We wanted to make sure 
that, you know, on the one hand we had sufficient regulation in 
place and you had sufficient authority at the FDA to ensure 
that these devices are safe and effective and so forth. At the 
same time not have so much regulation that it becomes 
burdensome on industry to a point of sort of quashing 
innovation and investment.
    And I would be curious generally for your thoughts on how 
industry has responded to where we kind of put that line where 
we struck the balance. And in particular I would be curious to 
hear you talk about the new, more streamlined process you have 
with respect to classification of devices from class 1 up to 
class 3, where I gather now you can use a kind of 
administrative process that doesn't necessarily involve full-
blown rulemaking and comment, so forth, in every instance. And 
maybe you can give some examples of how you have used that 
authority in an effective way.
    Mr. Shuren. So, I mean, to answer the first part, I think 
after much discussion that occurred last time around FDASIA 
there was, I will say, general support for the U.S. standard of 
reasonable assurance of safety and effectiveness. And the 
question then becomes, what does that actually look like for 
particular kinds of devices?
    What we have done is put in place this new benefit-risk 
strength work that is much more flexible and patient-centric to 
try to set the needle, if you will, in the right place.
    One of the things that we are going to be following up in 
the coming months is to start talking about those circumstances 
under which data we might otherwise collect premarket can be 
shifted to the postmarket setting and not compromise patients, 
but do an appropriate reduction of burden on companies and 
address some of those cases in the postmarket setting. And that 
will include some new pathways for high-risk devices as well, 
and I think that is important.
    Regarding classification, FDASIA provided some important 
changes to the process. One is the fact that we can now issue 
an order rather than a regulation. So in some respects it has 
gotten a little easier, and it has been helpful.
    But let me tell you one wrinkle we have, and that is where 
if we do want to in fact reduce burdens on companies, 
appropriately so because with more experience we realize we 
should lower the classification, we should go from class 3 to 
class 2, or class 2 to class 1, we actually now have more steps 
to go through. We must hold an advisory committee meeting where 
before we didn't have to do that. And that is actually making 
it more challenging for us under appropriate circumstances to 
reduce regulatory burden on companies.
    Mr. Sarbanes. Thanks very much.
    Mr. Pitts. The Chair thanks the gentleman.
    We have had a couple of members detained on the floor and 
missed the first round, so I will ask unanimous consent to 
recognize them as they come in for 5 minutes.
    Dr. Gingrey, you are recognized for 5 minutes.
    Mr. Gingrey. Mr. Chairman, thank you for that courtesy.
    Dr. Shuren, the Office of Combination was created to deal 
with products that combine drugs, devices, or biologic 
products. For instance, some companies are toying with the idea 
of combining drugs and devices into solutions for antibiotic 
infections, something that I care about personally, as you 
know. However, the current approval method forcing companies 
with a mainly device product to go through a drug pathway 
because it induces a chemical reaction may discourage companies 
from investing in new and breakthrough technologies because the 
pathway is not best suited to what their product is.
    The drug and device pathways were originally created 
decades ago when the reality of combination products were not 
yet realized. What steps is the FDA taking in light of its 
current 1970s framework to work directly with these companies 
who present the agency with 21st century technology like these 
combination products?
    Mr. Shuren. So the agency in setting up the Office of 
Combination Products, which sits in the Office of the 
Commissioner, is there to try to help determine what is the 
appropriate pathway for those combination products to go 
through. And they have been more recently trying to provide 
clarification for when the primary pathway would be device or 
drug.
    But when it is a combination product there are needs that 
would be met for both, let's say, if it is a device and a drug, 
for the device side and for the drug side. So even if it is a 
product that we have primary responsibility for, if it has a 
biologic component, we go to our Center for Biologics for a 
consult. If it has a drug component we go to our Center for 
Drugs.
    This is a very challenging area, I have to tell you this, 
because given the way the law is we have been able to try to 
minimize duplicative burden, if you will, and challenges on the 
postmarket side for reporting, or on good manufacturing 
processes, but when it comes to the standard for approving 
products the law right now is very challenging for combination 
product makers.
    Mr. Gingrey. Dr. Shuren, thanks you very much.
    Dr. Woodcock, the bipartisan GAIN Act took important steps 
to encourage the new development of antibiotics by focusing on 
incentives to new companies to keep companies in the 
marketplace. At this time can you provide me the number of 
qualified infectious disease products that have been designated 
since the law was passed last year, what, last year?
    Ms. Woodcock. Certainly. We have designated, as far as I 
know, 27 products with 16 distinct active modalities. And that 
number will continue probably to increase.
    Mr. Gingrey. Well, I really have to commend the FDA on that 
and realizing the desire and need for new antibiotics and 
acting quickly to implement the program. I have received plenty 
of positive feedback from companies, not just in my district, 
who have been able to achieve benefits through the GAIN Act.
    I think you would agree with me that more needs to be done 
to combat resistance. One issue that needs attention involves 
susceptibility tests, interpretive criteria or breakpoints. 
Now, as you know, Dr. Woodcock, a breakpoint is criteria used 
to determine a particular infection's susceptibility or 
resistance to a specific antibiotic, and they are used by 
physicians in clinical decision making.
    With the growing public health threat of antibiotic 
resistance, it is increasingly important to ensure that 
physicians have these tools they need to prescribe the right 
dose, of the right antibiotic, for the right patient, in the 
right situation.
    Given what we know about the science behind breakpoints and 
our failure to keep pace with regulatory science in Europe, are 
U.S. patients receiving the best medical care, using the most 
up-to-date science, if the breakpoints for antibiotics are not 
accurate?
    Ms. Woodcock. Well, they would not be. We have updated 
these criteria for about 121 of the 200 main antibiotic labels 
that exist. However, we feel that it would remain more up to 
date if we would not have this information remaining in the 
drug labels but rather would be able to point to a Web page and 
possibly to standard development organizations who are actually 
out there on the ground in the communities and are getting the 
information on an ongoing basis.
    Even when we approve an antibiotic, we only look at a few 
organisms. As you well know, physicians have to use diagnostic 
criteria in the devices, the test for susceptibility, for a 
wide range of organisms, many of which may not be in any drug 
label. So we think we need a more dynamic and effective process 
that reflects the ongoing experience in the community.
    Mr. Gingrey. Dr. Woodcock, I have about 2 seconds. I want 
to ask you to commit to me today to work with my office to fix 
the breakpoint issue, as well as look toward other ideas to 
address the epidemic of antibiotic resistance, one of the chief 
threats to public health today.
    Ms. Woodcock. We would be delighted to do that.
    Mr. Gingrey. Thanks, Dr. Woodcock.
    And I yield back, Mr. Chairman. Thank you.
    Mr. Pitts. The Chair thanks the gentleman.
    That concludes the questions for the members. I am sure 
members will have follow-up questions. We would ask you to 
please respond promptly once you get them.
    I remind members that they have 10 business days to submit 
questions for the record, and that means they should submit 
their questions by close of business on Tuesday, December 3rd.
    A very informative hearing. Thank you very much, and thank 
you for your patience.
    Without objection, the subcommittee is adjourned.
    [Whereupon, at 12:17 p.m., the subcommittee was adjourned.]
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