[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]



 
                  AGRICULTURE, RURAL DEVELOPMENT, FOOD
                  AND DRUG ADMINISTRATION, AND RELATED
                    AGENCIES APPROPRIATIONS FOR 2001

_______________________________________________________________________

                                HEARINGS

                                BEFORE A

                           SUBCOMMITTEE OF THE

                       COMMITTEE ON APPROPRIATIONS

                         HOUSE OF REPRESENTATIVES

                       ONE HUNDRED SIXTH CONGRESS

                             SECOND SESSION
                                ________

     SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG 
                  ADMINISTRATION, AND RELATED AGENCIES

                     JOE SKEEN, New Mexico, Chairman
 JAMES T. WALSH, New York        MARCY KAPTUR, Ohio
 JAY DICKEY, Arkansas            ROSA L. DeLAURO, Connecticut
 JACK KINGSTON, Georgia          MAURICE D. HINCHEY, New York
 GEORGE R. NETHERCUTT, Jr.,      SAM FARR, California
Washington                       ALLEN BOYD, Florida
 HENRY BONILLA, Texas
 TOM LATHAM, Iowa
 JO ANN EMERSON, Missouri           

 NOTE: Under Committee Rules, Mr. Young, as Chairman of the Full 
Committee, and Mr. Obey, as Ranking Minority Member of the Full 
Committee, are authorized to sit as Members of all Subcommittees.
  Henry E. Moore, John J. Ziolkowski, Martin P. Delgado, and Joanne L. 
                       Orndorff, Staff Assistants
                                ________

                                 PART 2

                          AGRICULTURAL PROGRAMS
                                                                   Page
 Food and Drug Administration.....................................    1
 Farm Credit Administration.......................................  886
 Commodity Futures Trading Commission............................. 1051

                              

                                ________

         Printed for the use of the Committee on Appropriations
                                ________

                     U.S. GOVERNMENT PRINTING OFFICE

 63-888                     WASHINGTON : 2000



                        COMMITTEE ON APPROPRIATIONS

                   C. W. BILL YOUNG, Florida, Chairman

 RALPH REGULA, Ohio                    DAVID R. OBEY, Wisconsin
 JERRY LEWIS, California               JOHN P. MURTHA, Pennsylvania
 JOHN EDWARD PORTER, Illinois          NORMAN D. DICKS, Washington
 HAROLD ROGERS, Kentucky               MARTIN OLAV SABO, Minnesota
 JOE SKEEN, New Mexico                 JULIAN C. DIXON, California
 FRANK R. WOLF, Virginia               STENY H. HOYER, Maryland
 TOM DeLAY, Texas                      ALAN B. MOLLOHAN, West Virginia
 JIM KOLBE, Arizona                    MARCY KAPTUR, Ohio
 RON PACKARD, California               NANCY PELOSI, California
 SONNY CALLAHAN, Alabama               PETER J. VISCLOSKY, Indiana
 JAMES T. WALSH, New York              NITA M. LOWEY, New York
 CHARLES H. TAYLOR, North Carolina     JOSE E. SERRANO, New York
 DAVID L. HOBSON, Ohio                 ROSA L. DeLAURO, Connecticut
 ERNEST J. ISTOOK, Jr., Oklahoma       JAMES P. MORAN, Virginia
 HENRY BONILLA, Texas                  JOHN W. OLVER, Massachusetts
 JOE KNOLLENBERG, Michigan             ED PASTOR, Arizona
 DAN MILLER, Florida                   CARRIE P. MEEK, Florida
 JAY DICKEY, Arkansas                  DAVID E. PRICE, North Carolina
 JACK KINGSTON, Georgia                MICHEAL P. FORBES, New York
 RODNEY P. FRELINGHUYSEN, New Jersey   CHET EDWARDS, Texas
 ROGER F. WICKER, Mississippi          ROBERT E. ``BUD'' CRAMER, Jr.,
 GEORGE R. NETHERCUTT, Jr.,              Alabama
   Washington                          MAURICE D. HINCHEY, New York
 RANDY ``DUKE'' CUNNINGHAM,            LUCILLE ROYBAL-ALLARD, California
   California                          SAM FARR, California
 TODD TIAHRT, Kansas                   JESSE L. JACKSON, Jr., Illinois
 ZACH WAMP, Tennessee                  CAROLYN C. KILPATRICK, Michigan
 TOM LATHAM, Iowa                      ALLEN BOYD, Florida
 ANNE M. NORTHUP, Kentucky
 ROBERT B. ADERHOLT, Alabama
 JO ANN EMERSON, Missouri
 JOHN E. SUNUNU, New Hampshire
 KAY GRANGER, Texas
 JOHN E. PETERSON, Pennsylvania
 VIRGIL H. GOODE, Jr., Virginia

                 James W. Dyer, Clerk and Staff Director

                                  (ii)



   AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND 
                RELATED AGENCIES APPROPRIATIONS FOR 2001

                              ----------                              

                                        Tuesday, February 29, 2000.

                      FOOD AND DRUG ADMINISTRATION

                               WITNESSES

DR. JANE HENNEY, COMMISSIONER
DR. BERNARD SCHWETZ, ACTING DEPUTY COMMISSIONER
ROBERT J. BYRD, DEPUTY COMMISSIONER FOR MANAGEMENT AND SYSTEMS, CHIEF 
    FINANCIAL OFFICER, FOOD AND DRUG ADMINISTRATION
DENNIS P. WILLIAMS, DEPUTY ASSISTANT SECRETARY, BUDGET, DEPARTMENT OF 
    HEALTH AND HUMAN SERVICES
DR. JANET WOODCOCK, DIRECTOR, CENTER FOR DRUG EVALUATION AND RESEARCH
JOSEPH A. LEVITT, DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED 
    NUTRITION
DAVID FEIGAL, DIRECTOR, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
    Mr. Skeen. The committee will come to order. We have before 
us today the Food and Drug Administration very ably represented 
by Commissioner Jane Henney and her associates, and I am sure 
that they are well prepared to respond to our questions about 
FDA's operations and activities. Before we recognize Dr. Henney 
for her remarks I would like to welcome Ms. Kaptur.
    Ms. Kaptur. Thank you, Mr. Chairman, and we are so pleased 
to have the Commissioner and her able staff here this morning. 
I just want to say to the chairman I am so impressed with this 
Commissioner and her quick response and her staff's quick 
response whenever we have attempted to obtain information about 
FDA. We thank her for that, for her professional service to the 
people of this country, and we look forward to her testimony. 
On behalf of all the members on this side of the aisle, 
Commissioner Henney, thank you very much for being here this 
morning.
    Mr. Skeen. Commissioner, we have received your prepared 
remarks and they are excellent and thorough as always, and they 
will appear in full in the record of this hearing. We would ask 
for you to summarize the highlights.

                           Opening Statement

    Dr. Henney. Mr. Chairman and members of the committee, it 
is my privilege today as Commissioner of Food and Drug to 
present FDA's plans and expectations as reflected in the 
administration's proposed budget for fiscal year 2001. One year 
ago I told you that I was lured from the enchantments of New 
Mexico to renewed public service by the dedication, energy and 
commitment of the talented people in FDA. I was equally 
attracted by the enormity of the changing demands upon the 
agency and the differences this agency can make in improving 
the public health.
    Patients, researchers, health professionals, manufacturers, 
educators, grocers, public sector administrators or just 
ordinary citizens want a public health regulatory agency such 
as the FDA to be fair, competent, and above all credible. I 
have heard this message in different words on many occasions in 
many settings this year. I believe the accomplishments of this 
past year will demonstrate that FDA has done a remarkable job 
in maintaining the public's confidence and credibility even 
though we face numerous unpredictable issues on a day-to-day 
basis.
    It may be far too easy for Americans to assume FDA's 
competence and credibility because we have long enjoyed public 
confidence in the past. However, from listening to my European 
counterparts, public confidence once lost is not easily or 
quickly restored.
    A series of highly publicized crises in Europe over the 
past several years have caused my counterparts to ask what is 
FDA's secret and how does FDA utilize science and build 
consensus answers to so many inherently contentious issues?
    The answers are not found in FDA's organizational diagrams 
or job titles. We find ourselves explaining modern day versions 
of two very old history lessons: What Alexis de Tocqueville 
reported long ago in Europe about the uniquely open processions 
for American lawmaking and its modern derivative rulemaking and 
Dr. Harvey Wiley's discussion with President Theodore Roosevelt 
at the beginning of the last century about the importance of 
science based regulatory decisions.
    From a world perspective, FDA's utilization of public issue 
meetings, access to agency information, voting advisory 
committees, requirements for scientific evidence and reliance 
on scientific facts in its decision-making process are more 
uniquely American than we may realize.
    The interplay of these features into an independent 
regulatory function that coexists with prescribed congressional 
and judicial roles constitutes the most envied regulatory model 
in the world.
    Today I share with you my priorities for preserving this 
capability and for preserving the agency's commitment to and 
credibility with the American public. As we begin the 21st 
century, fiscal year 2001 will be critically important for FDA 
because so much of our environment is changing rapidly and our 
capability to understand, adapt and respond will be stretched 
to new limits. To maintain our strength we must strengthen our 
science. We must address the highest priority risk. We must 
engage in effective collaborative and leveraged activities and 
we must design ever more predictable, timely and transparent 
regulatory processes.
    Stronger science. FDA's commitment to assuring safe 
products rests squarely on our ability to keep pace with the 
explosion in scientific advances and then to use our knowledge 
to assure safe products. We must apply our intellectual capital 
at every point in the life cycle of the product.
    Timing is everything. Wayne Gretzky of ice hockey fame was 
asked to tell what made him a successful player. He said, I 
skate to where the puck will be. FDA is in a similar position. 
We must be able to anticipate and access the cutting edge 
science that will be needed to regulate the products of future 
technology. When this is possible, we can apply this science at 
the point when the new technology arrives and when it is 
absolutely essential to steward these products, many of them 
life saving, to the market.
    FDA is the regulatory gateway through which an estimated 
$50 billion in annual biomedical research and development 
investment must pass and be judged. During the President's 
State of the Union address last month, he noted that 
innovations in science and technology will be the key to 
miraculous improvements in the quality of our lives andadvances 
in the economy as we enter the 21st century. He discussed the 
remarkable fruits of research, much of it taxpayer funded, that promise 
to improve both our health and the way health care is delivered. You 
and your colleagues in the Congress have overseen a major expansion of 
Federal research in recent years and these investments will no doubt 
pay dividends many times over for all of us.
    FDA can deliver when properly resourced. Congress' 
authorization and support of the Prescription Drug User Fee Act 
and its reauthorization in the FDA's Modernization Act is a 
prime example. Review of drugs and biologics in the U.S. is now 
as fast or faster than anywhere in the world, and this has been 
accomplished without lowering our very strict and high standard 
for safety and effectiveness. We want to be able to perform 
this well in all of our products that require premarket 
evaluation.
    Assuring safety by managing risk. A strong FDA science 
capability is equally critical in understanding and managing 
risk associated with products that are already in the 
marketplace. Each year hundreds of thousands of adverse 
experiences are reported in association with foods, drugs, and 
medical devices. When we can apply cutting-edge science to 
these problems, particularly in cooperation with our health and 
regulatory partners, as well as those in the regulated 
industry, we can quickly identify significant risks and 
minimize them.
    In managing risk, FDA has always adhered to the principle 
that the most serious risks should be addressed first. The idea 
takes on added meaning given the complexities of our 21st 
century environment. You will see evidence throughout our 
budget that the most serious problems are on the top of the 
list. To illustrate, the medical errors initiative in the 
budget emphasizes FDA's working with other agencies in the 
Department of Health and Human Services and with other 
departments across government as a part of the President's new 
comprehensive plan to improve health care through the 
prevention of medical errors and the enhancement of patient 
safety.
    Secondly, drugs marketed and sold from rogue Internet 
pharmacy sites present real risk for the American consumers. 
These have been made a priority for FY 2001. Again, we have 
addressed the most serious risks first as a part of the food 
safety initiative, provided funding, we will be able to inspect 
high risk food firms at least once a year. We would continue to 
do the work supported by Congress in the past which focuses our 
efforts in the important arena by targeting imported produce 
that contain microbiological pathogens.
    Collaboration and leveraging opportunities. Working with 
FDA's assets alone is not sufficient to address the complex 
risk management challenges that we face. Many of our 
initiatives in this budget require our agency to work in 
concert with a broad spectrum of stakeholders to rein in the 
safety net for the U.S. consumer. A prime illustration of this 
approach is in food safety.
    Because we regulate in a global marketplace, our 
collaborative efforts must extend beyond our domestic borders. 
In this regard we collaborate with our foreign regulatory 
counterparts in joint efforts that include setting standards to 
reduce the risk of products to the consumer. Whether it is 
within our domestic borders or beyond, FDA undertakes 
collaborative initiatives because all parties can unify behind 
goals that are in the best interest of public health and 
safety. With such collective efforts we will be able to move 
our world to better health outcomes.
    Open, transparent, predictable regulatory processes. 
Another key provision of the FDA Modernization Act of 1997 
directed our agency to consult with our many stakeholders on an 
ongoing basis to keep them apprised of our strategies and new 
product decisions and to generally make them an informed 
participant in the regulatory process. The relevant principle 
here is that a confident and well-informed individual or 
industry also becomes a partner in shouldering the management 
of risk. We intend to keep these communication channels alive 
and humming. And in addition to our ongoing dialog with 
industry and consumers that take place in a variety of 
settings, this spring we will listen at two formal additional 
stakeholder forums, the first at Stanford University in March 
and the second at Duke University in April. At both of these 
sessions we will no doubt receive suggestions on how to improve 
our programs by leveraging our resources and further 
strengthening our working relationships with our constituents.
    These 21st century ways of doing business, strengthening 
science, addressing high risk priorities, collaborating 
effectively with our partners and leveraging our resources and 
using open, transparent regulatory processes must be applied 
across the entire spectrum of product development review and 
post-market monitoring. When we are able to do this, bolstered 
by science and augmented by partners who share our goals, 
American citizens can be confident an effective safety 
assurance system is in place. FDA's budget proposal for FY 2001 
moves us toward that desirable state of affairs.
    Before I close my remarks, I would like to briefly 
highlight for you the key elements of our budget request. This 
proposal will enable FDA to implement the priorities I have 
outlined for you today. The request is for $1,390,831,000 which 
is $176 million increase over the FY 2000 enacted level. The 
request includes $42 million to enhance the science basedreview 
of new health giving products so they can more rapidly enter the 
marketplace.
    $30 million to enhance the safety of the food supply 
through strengthening key elements of the President's food 
safety initiatives. These elements include increasing 
inspection frequency for high risk food firms, implementation 
of an egg safety action plan, developing nationwide standards 
for food safety, and expanding the research activities 
necessary to support the entire initiative.
    $20 million to replace FDA's obsolete Los Angeles 
laboratory facility. I would contrast the picture before you 
that is down here, our L.A. lab, with a new modern facility of 
Cincinnati that you provided the funding for us for a few years 
ago. We need this kind of facility in Los Angeles because it is 
a critical linchpin in assuring the safety of a major portion 
of U.S. imports, particularly food, to this country.
    [Additional information follows:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Dr. Henney. $15.9 million to strengthen our systems which 
report on and correct medical errors and adverse event 
reporting. This is the interagency cooperative effort designed 
to reduce the estimated 100,000 annual deaths that occur 
because of medical misadventures or mistakes.
    $13.5 million to focus on domestic inspections of our firms 
in order to target high risk violators and to come closer to 
meeting the agency's statutory inspection requirements.
    $10 million to help stop the illegal sale of drugs over the 
Internet. And finally $11.5 million as part of the President's 
comprehensive response to possible bioterrorist attacks. And $5 
million to further the administration's effort to reduce 
smoking by the youth of our nation.
    In summary, Mr. Chairman, fiscal year 2001 is the year in 
which FDA must cope with the maturation of two of the most 
massive and significant forces the agency has ever faced. In 
2001 the increasing impact of molecular science, genomics in 
particular, and the information revolution, especially the 
Internet, and its linkage to an array of real time data and as 
a new vehicle for commerce that was unimaginable only a few 
years ago will combine their forces to change how FDA regulated 
products are discovered, researched, manufactured, distributed, 
marketed and advertised. When the world around us changes this 
much, we must be prepared to respond in order to assure that 
products are still safe for American consumers. Our credibility 
to provide valid assurance is a risk without strong science, 
effective collaborations and consultation and even greater 
openness and transparency in our processes.
    I wish to thank the members of this committee, its staff 
and the staff of the individual subcommittee members for your 
support this past year. This subcommittee has many legacies 
from improved agriculture production to safer consumer products 
to protection of the American farmer. I ask that you add 
another critically important one to the list, bringing forth 
the technological promise of the 21st century. If you will 
provide FDA the resources to do the job, I will commit to you 
that those funds will be used wisely.
    I look forward to the discussions, our discussing this 
committee to ensure that we are able to fullfil our mission in 
this challenging environment. Thank you very much.
    [The prepared statement of Jane E. Henney, MD, and 
biographies follow:]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                             medical errors

    Mr. Skeen. Thank you, Dr. Henney. We want to welcome you 
back to the committee. We would like to congratulate you on the 
completion of your first year as Commissioner of the Food and 
Drug Administration. I can see from the information that you 
submitted that you are already developing the building blocks 
for real improvement at the agency and that management issues 
are as important to you as they are to the members of this 
committee.
    Let me ask a couple of questions about challenges that you 
face every day. Starting with medical errors, the Institute of 
Medicine issued a study on medical errors stating up to 100,000 
people per year died due to preventable medical mistakes. What 
types medical errors could FDA help prevent? What will be FDA's 
role in this national effort? I think it has been the spear 
point that we are dealing with today. Go ahead.
    Dr. Henney. Thank you, Mr. Chairman. The medical errors and 
the medical risks that are inherent in them were highlighted in 
a task force report that the agency issued last May. They were 
again highlighted, as you have noted, in the Institute of 
Medicine study, where it is estimated that up to 100,000 people 
are affected in very serious ways as a result of mistakes or 
misadventures that happen within the context of our health care 
delivery system. As those mistakes might be related to products 
that we regulate in the device, drug,blood or vaccine area, we 
know that our role is really with respect to having the proper kind of 
information systems in place. This is necessary so that as things 
happen in the post market arena that have to do with adverse events, we 
have the capability not only to receive through appropriate technology 
those reports, but the capability of analyzing their meaning. If we 
need to notify the greater health care community about risks to be 
avoided or even up to and through removing products from the 
marketplace, we do that from a basis of strong knowledge.
    We also will be cooperating in this effort to see that the 
kind of information that we provide to health providers is as 
accurate and clear as it can be. One example that has been 
pointed out on many occasions is issues that may be related to 
labeling and so-called sound alike drugs. We need to be 
prepared as drugs move on to the marketplace that we have the 
means to put these names through the scrutiny of both how they 
sound, how they look when they are written so that preventive 
steps can be put in place to avoid mistakes that might occur.

                               leveraging

    Mr. Skeen. Before I ask this next question I want to remind 
everybody that we are going to hold this to 5 minutes starting 
with me. You have been working with partners in the state and 
academia and industry. And this has been stretching the FDA's 
resources through this leveraging. Can you explain a little bit 
more about the leveraging concept and to what FDA functions it 
may be applied and highlight some of the successes that the 
agency has had in the leveraging process?
    Dr. Henney. Mr. Chairman, the issue of leveraging is not 
new to the agency, but it has never been used as a primary 
strategy where we can really extend our critical resources; not 
just our financial budgetary resources but our ability to 
really tap into the intellectual capital--the time and energy 
of many important individuals and institutions around this 
country. This will allow us to do our job better; which is 
protecting and promoting the public health.
    A few examples of where this has been very successful in 
the past, was the establishment of such a cooperative 
initiative with the Illinois Institute of Technology, an 
academic institution just outside of Chicago, regulated 
industry, and FDA. This has been on-going for nearly 10 years. 
We clearly monitor issues related to conflicts quite closely, 
but together I think we are able to look at issues that relate 
to food, particularly food packaging and safety, in an 
environment where not only the institutions engaged benefit but 
the outcome of that effort really benefits the consumer.
    We have recently entered into an arrangement, called the 
PQRI, in which the groups will be able to look at issues 
related to drug and drug manufacturers. We, I think very 
successfully, have collaborative efforts with our partners at 
the CDC and the Department of Agriculture in many of our food 
safety initiatives. It is really by those collaborative or 
leveraged activities that we are able not only to stretch our 
fiscal resources, but also to build up the protection that we 
provide to consumers.
    Mr. Skeen. Thank you. Ms. Kaptur.

                       budget request priorities

    Ms. Kaptur. Thank you, Mr. Chairman, Commissioner Henney, 
for your very thorough testimony. I have noted that the 
increase you are asking for is rather substantial. It is at 
least a 10 to 15 percent increase over your currently 
appropriated level. And I know you have indicated how some of 
that increase is going to be spent. Could you summarize perhaps 
for me the highest priority increases that would be 
accommodated by your request?
    Dr. Henney. Thank you, Ms. Kaptur. Even though the increase 
is substantial, our needs are also substantial. The items that 
I would list as the highest priority are the ones in the 
premarket arena that really would help us to maintain our 
scientific strength. They are vital to how strong we will be 
now and in the future as an agency.
    In the area of the post-marketing arena, those things that 
are of critical importance in terms of safety are those related 
to the medical errors initiative and the Internet initiative. 
Right now, we are having to devote some precious resources that 
we would use for other things because of what we see as a real 
risk from rogue operators in the Internet environment. We need 
to have the resources needed in that area.
    I think, we desperately need to get back to a position 
where we are able to complete our statutory obligations with 
respect to inspections of the industry. The statutory 
requirements of most of our products and industry call for a 
biennial inspection. These resources would get us close to that 
in two areas in biologics and in veterinary medicine but they 
would not be totally comprehensive.
    The food safety initiative, is again a high priority of 
this committee, this Congress, and this administration. Again, 
it invests in our inspection capabilities, and it also advances 
our research mission.
    And finally, our most critical need is in the replacement 
of the Los Angeles lab, a lab that's over 40 years old and is 
unsafe. I think the chairman has actually visited this 
laboratory and the pictures are before you. We cannot keep pace 
with the kind of work that is required that we do in the L.A. 
lab. This lab is one of our most important port sites and the 
work that they do is largely on food imports. And as we all are 
concerned about food safety, getting a replacement lab close to 
the port is of prime importance to the agency. Those would be 
the ones I would stress.

                             mental illness

    Ms. Kaptur. Thank you for that clarification. On page 13 of 
your testimony you talk a great deal about advances in 
medications that have been approved by FDA in different areas 
over the last few years for HIV, AIDS, for the elderly, for 
people with diabetes. One area you did not address in your 
testimony are the advances in medication for those confronting 
mental illness. I know I have asked for some additional 
information from your staff and they have provided it. But I 
wonder if you could just discuss in my remaining time here how 
FDA is regarding this set of illnesses, what can be done in 
terms of your own staffing levels, the rate at which 
medications are being approved versus applied for, compared to 
other illnesses that you approve medications and treatments 
for. The fact that it is absent from your testimony is 
troubling to me.
    Dr. Henney. Let me give you our 5-year track record in 
terms of products that deal with mental illness. We are meeting 
all of our user fee goals with respect to the time frames that 
are expected to be accomplished for these products. We have 
seen four new molecular entities reach themarketplace in that 
time period. Ten new formulations of former drugs that were available. 
We clearly act from applications received and the readiness to meet us 
at the time of the review. I think we have staff on board right now 
that is adequate to meet the needs of the application load that we 
have. However, I would put in one plug, that not only in this area but 
across the board in the agency, in order to keep our scientists current 
with the most cutting edge science, it really requires that we start 
thinking about them as 110 percent FTE. They simply cannot be thought 
of as a sweat shop worker that continue to grind out reviews. They must 
have the ability to go to professional meetings, to take additional 
training, to interact with the academic community, to keep at the top 
of their game so that as they review these kinds of applications they 
will make right and timely decisions. So if there is any need that we 
have, it is in that area.
    Ms. Kaptur. Mr. Chairman, I know the time has expired. I 
would only ask the Commissioner for the record. She made the 
statement that the staff is adequate to approve or review the 
drugs that are coming in the area of mental illness. I would be 
very interested in terms of the representation of that set of 
illnesses in our population, at what rate applications are 
coming to you compared to the presence of individuals affected 
with AIDS and the rate at which those applications are coming 
to you, diabetes and the rate at which those applications are 
coming to you and so forth. I would be very interested why we 
aren't getting answers to this set of illnesses in our country.
    [The information follows:]

    FDA's Center for Drug Evaluation and Research--CDER--
allocates resources based on the number of applications 
received for products to treat illnesses, rather than on the 
prevalence of illnesses in the population. This allows us to 
respond to breakthroughs in scientific knowledge about 
treatments that may generate many new products for particular 
diseases in a relatively short period to time. Our Division of 
Neuropharmacological Drug Products currently is the largest of 
any review division under CDER. Applications focused on drug 
treatments for psychiatric disorders are reviewed in this 
Division by the Psychiatric Drug Products Group, staffed by 
psychiatrists whose special knowledge and training is critical 
because of an increasing interest in exploring mental health 
needs in pediatric patients. In addition, a separate team of 
neurologists have been assigned to assess conditions of 
cognitive impairment including Alzheimer's disease. The 
Division of Neuropharmacological Drug Products has met all of 
their user fee goals by approving new drug applications and 
supplements within the prescribed time frames. Drugs for the 
treatment of all of the major psychiatric illnesses are the 
subject of very active drug development programs by the 
pharmaceutical industry.

    Mr. Skeen. We will give you another 5 minutes after Mr. 
Bonilla.

                             food additives

    Mr. Bonilla. Thank you, Mr. Chairman. I want to start out 
with concentrating on the requests for $8.4 million in users 
fees for the direct food additive reviews. Last year, we 
earmarked for the first time a $5.4 million increase for the 
premarket reviews of direct food additives. My questions are in 
this area. Why should we provide additional funds without first 
determining how the FY 2000 funds have been used? Another part 
of that is, is the FDA having any difficulty hiring additional 
reviewers with that money, and what assurances do we have that 
the FY 2000 funding we provided will result in a noticeable 
reduction in review times and in the backlog of pending food 
additive petitions?
    Dr. Henney. Well, we are very appreciative of the funding 
that you did provide last year and we are moving quite rapidly 
to try to hire the kind of scientific staff that we need to do 
those reviews. Hiring does take time to advertise and recruit, 
so in the meantime we are also issuing some contracts so that 
on an even more timely basis we will have the access to the 
human resources we need to do those reviews.
    We believe that we have made positive movement in this 
direction. We believe that we will be able to feature this as 
one of our major accomplishments of the next year. And we 
believe that a further investment in this program would allow 
us to essentially buy out the program. But the proof will be in 
the pudding. We think that we have really come out of the 
blocks early and will be able to do what we said we would. As a 
result, we believe that this is an area where we could take on 
more resources.
    Mr. Bonilla. But if you have had trouble getting it started 
already and are still looking to hire people, how can you 
project that you are going to need all this additional money if 
you really haven't gotten your feet squarely planted yet with 
the first round of money that you got?
    Dr. Henney. I did not mean to imply, Mr. Bonilla, that we 
are having trouble. I was just pointing out the realities that 
once you appropriate the funds it does take time for us to hire 
and get people on board. So we have made a provision to make up 
for that. We are out of the block on this one.
    Mr. Bonilla. So you started interviewing people then at the 
beginning of the fiscal year when you got the money approved 
and that was, what, a few months ago?
    Dr. Henney. We couldn't interview people until we actually 
had notices out that we were recruiting. So that is the first 
thing that we have to do.
    Mr. Bonilla. Okay. Do you see where I am coming from 
though? We want to know exactly what you have done with the 
2000 money before anybody ever considers looking at adding 
awhole ton of money in the 2001 budget.
    Dr. Henney. I appreciate your point.

                               egg safety

    Mr. Bonilla. I want to move now to proposed warning labels 
for eggs which many producers feel are somewhat alarmist. The 
FDA has not published a final rule implementing this label, and 
the label was proposed well before the President's egg safety 
action plan was issued. In light of the action plan don't you 
think you should take another look at the warning label? After 
all, if producers are going to be required to implement quality 
assurance programs and take other proactive steps your agency 
may find it appropriate to propose a label that is more 
educational and would be less alarmist, at least according to 
the views of some.
    Dr. Henney. Mr. Bonilla, I believe we did come out with the 
proposed rule in July of last year. Some of the rule dealt with 
the storage temperature of eggs issue, to make FDA's rule 
compatible with a rule that was in play by the Department of 
Agriculture. We did ask for additional labeling for eggs to 
make sure that consumers knew the risks that were inherent with 
eggs and to inform them that they needed to be quite adherent 
to food preparation rules. I believe that rule was issued, as a 
proposed rule. We are clearly receiving comment and will take 
all of those comments.
    Mr. Bonilla. How does that tie into the President's egg 
safety action plan. Wouldn't you want to make sure that you are 
on the same page?
    Dr. Henney. We have had public meetings around the issue of 
the egg safety plan in August, and we intend to have two more. 
I am sure that at those sessions that will be held in Columbus, 
Ohio on March 30th, and in Sacramento, California on April 6th 
we will hear comments on that point and of course we will take 
those comments into consideration.
    Mr. Bonilla. Commissioner, thank you. I have a couple of 
questions I will submit for the record. Thank you.
    Mr. Skeen. Mr. Boyd.

                                Ephedra

    Mr. Boyd. Thank you, Mr. Chairman. And Commissioner Henney, 
welcome. First of all, I want to start off by saying that I had 
a meeting earlier this month with Mr. Levitt and Ms. Plaisier 
and I want to commend you and them for the way they handled 
themselves in that meeting. They were very helpful to helping 
me understand the issue that I want to talk about.
    We met to discuss the proposed rule on Ephedra. And 
basically I asked them two questions, number one, why had the 
law not been met in the FOIA, Freedom of Information Act, in 
releasing the information that you had on AERs. And secondly, I 
asked them why would they not consider, you would not consider 
withdrawing the proposed rule since they seemed to think that 
the proposed rule was not going to come to conclusion in its 
current form. The answers were, number one, is the FOIA, you 
did not have the resources to redact, to prepare the 
information for release to the public, and, secondly, that you 
would take under consideration the issue of withdrawing the 
rule.
    I got a letter as to some other Members of Congress on the 
25th of September in which you outlined basically three points. 
Number one is that the AERs would be released by March 31st, 
that it also would be released with an analysis, your analysis 
of those AERs and, thirdly, that a portion of the rule would be 
withdrawn. My questions revolve around this issue in this 
letter. Number one, what are the implications of withdrawing a 
portion of the rule in terms of dialogue with the public and 
with the industry? That would be my first question.
    Dr. Henney. Thank you, Mr. Boyd. Let me respond to the many 
questions that you have raised within the context of this one. 
Clearly the issue of the rule on Ephedra has received much 
public comment. We received literally thousands of comments to 
that proposed rule. We also had a GAO analysis of the work that 
was done with the context of that rule that was supportive of 
the agency's position regarding the safety and concerns of 
these products but was highly critical of the kind of analysis 
that had gone into the review of adverse reactions.
    I think what we intend to do with the time line that has 
been set out, is to display our review of what we have seen 
with respect to adverse reactions related to Ephedra that will 
come out coupled with our analysis. We will open that up to 
public comment of the widest kind, anywhere from the comments 
from a lay person to health professionals to scientists. We 
will let the science see where that takes us. I think that 
clearly there are particular parts of the rule that will come 
under analysis for change but we intend to do that as a 
package. But will there be a public process? Absolutely, yes.
    Mr. Boyd. My question is what are the implications of 
withdrawing a portion of the rule in terms of your dialogue 
with the industry? Obviously there is a lot of information that 
you could glean or gather from the industry which you are not 
getting now because you are basically, is the way I understand 
it, forbidden from having a dialog with the industry while you 
got a proposed rule out there. Will that continue to be the 
case since you have only withdrawn a portion of the rule?
    Dr. Henney. The rule is proposed, it is not final. I expect 
and assume that industry will be part of the public 
conversation that we will have around the adverse event 
reports, and we will take those all into consideration before 
we move to a final rule.
    Mr. Boyd. Okay. So what I hear you saying that will 
become--they will be involved in the public hearing process at 
which time you release the AERs and you have released also your 
analysis of the AERs.
    Dr. Henney. Yes.

                                  FOIA

    Mr. Boyd. Mr. Chairman, I have one additional question I 
really want to pursue, the FOIA issue. Mr. Levitt, again I want 
to be very commending of him and the way he handled himself in 
the information he provided me, but basically told me that the 
Department was unable to provide the informationpublic, to the 
public, because of its inability or lack of resources to redact and 
prepare for public. I noticed that in your letter on the 25th you say 
that you are going to release an analysis of the information. Now that 
must be a very detailed process that takes a lot of resources. So I 
assume that you had the resources to do the analysis but not had the 
resources to prepare it for public consumption over the last 2 years. 
Is that--I don't want to be unfair here but that seems, struck me as a 
little bit strange.
    Dr. Henney. Mr. Boyd, I think it is fair to point out when 
Congress passed and the President signed the Dietary Supplement 
Health Education Act it clearly authorized us to do the work. 
However, there were no appropriations that followed that 
authorization. So as we work on issues in terms of implementing 
that important law, we have to draw on resources that were 
either already within the agency or were doing other work. So 
we have to spend our time quite judicially and wisely as we do 
this. We have used our resources to look at an analysis, to 
make sure that it would be scientifically sound and that we 
could stand behind it, and I think that was a judicious use of 
the limited resources that we have in this area.
    In this area of our budget that you have before you, we 
have asked for additional resources to undergird the kind of 
adverse reporting system for dietary supplements that may make 
this an easier process in the future.
    Mr. Boyd. Thank you. And, Mr. Chairman, I will withhold my 
other questions until the next round.
    Mr. Skeen. All right. Mrs. Emerson.

                    prescription drug marketing act

    Mrs. Emerson. Thank you, Mr. Chairman. Dr. Henney, as you 
know, when we have talked about this before I expressed concern 
about the regulations issued by FDA implementing a statute 
enacted back in 1988 called the Prescription Drug Marketing 
Act. And as I understand FDA's interpretation of this statute, 
drug wholesalers who don't buy directly from manufacturers are 
required to provide their customers with a detailed and 
complete sales history of all prior sales of drugs back to the 
original manufacturers and the wholesalers who buy directly 
from them are not required to provide this detailed sales 
information to the secondary wholesalers, is that correct?
    Dr. Henney. Mrs. Emerson, I believe that the origins of the 
bill that you refer to really tried to make sure that consumers 
would receive a product where there was an appropriate pedigree 
for that product all the way through the system. This would 
mean anywhere from the obtaining of the bulk material all the 
way through receiving the finished product. And it was with 
that intent that these regulations were drafted.
    Mrs. Emerson. So your answer is yes.
    Dr. Henney. Yes, it is really the pedigree tracking of a 
drug.
    Mrs. Emerson. And so consequently part of the sales history 
that is required by the FDA's final rule going all the way back 
to the original manufacturer includes the actual date of the 
sale of every shipment of the drugs and the number of 
containers in each shipment, the dosage, and the allotment, is 
that correct.
    Dr. Henney. Yes.
    Mrs. Emerson. Let me follow that up with more detail about 
that. Therefore then large national wholesalers may buy a 
shipment of a given drug twice a week and each shipment may 
contain four to six lot numbers or more. Then several of the 
lot numbers in the first purchase will more than likely be the 
same as some of the lot numbers in the second purchase, and 
each shipment of the drug will be placed in the same spot in 
the warehouse where shipments purchased in previous weeks are 
stored and each of these previous shipments will probably 
contain lot numbers that are the same as the most recent 
purchases separating each shipment of drugs by lot number. And 
date of sale in a vast warehouse and keeping track of those for 
resale purposes would be rather complex, don't you agree, even 
for large wholesalers?
    Dr. Henney. It is a very complex system, but I think that 
Congress wanted us to go back and be able to track the pedigree 
again of a product, and that is the way in which these 
regulations were drafted.
    Mrs. Emerson. Well, then, if wholesalers who don't buy 
directly from the manufacturer can't obtain detailed prior 
sales history, required information that your rule requires, 
then they are not going to be able to resell any product, is 
that correct?
    Dr. Henney. That may be the case. I might ask Dr. Woodcock, 
who is lead of the Center for Drugs, to comment on this fairly 
intricate matter of the tracking of drugs and why that is so 
important.
    Dr. Woodcock. Thank you. Yes, the issue is when the statute 
was written, people were concerned about counterfeit drugs, 
substitution of actually fraudulent products for the real drugs 
that were being sold. For that reason it was required when we 
implemented these regulations that we have the pedigree of a 
product, including the lot numbers and other identifiers 
through the chain. What you are pointing out I believe are 
perhaps some consequences of requiring this pedigree that 
really were not commented on when we published the proposed 
rule. So we will certainly take this into account now as we 
look at the consequences of this rule.

                    prescription drug marketing rule

    Mrs. Emerson. Particularly because of the fact that 
thousands of small businesses who are presently licensed to 
sell pharmaceuticals to rural areas like nursing--like my 
district to nursing homes and the like will be forced out of 
business. And I want to tell you all that by the end of the 
week you are going to receive a letter signed by me and several 
other members of the subcommittee and other colleagues to ask 
you to reopen the rule and suspend its effective date until the 
FDA and Congress can work together and determine how to best 
ensure that we are going to have safe drugs on the one hand but 
we are not going to put thousands of businesses out of 
business, particularly when so many of our constituents and 
others depend on the distribution of drugs in a very efficient 
manner. And it seems to me also that by allowing only the 
manufacturers to distribute the drugs we are perhaps 
encouraging a monopoly situation, which I don't think is your 
intent and certainly I don't believe--well, I know it is not 
the intent of Congress. But it is very, very critical that we 
get this done.
    So can I ask if you would agree at this time to reopen the 
rule as it applies to wholesalers and at least suspend its 
effective date until we can get together to make corrections 
necessary so that we cannot effectively disrupt a very good 
wholesale distribution system for drugs and perhaps having the 
unintended consequence of course of driving up prices for drugs 
which are outrageous as it is.
    Dr. Woodcock. We certainly will work with you on this 
issue. There is no intent to put small businesses out of 
business. The intent was to make sure that people arereceiving 
wholesome and proper drugs and so we will certainly work with you on 
this.
    Mrs. Emerson. So the answer is yes and that you would be 
willing to suspend the final rule until such time that we can 
work together to come up with a solution to this.
    Dr. Henney. Why don't I respond to that, Janet. I think 
that we have time here, because as I understand it, the full 
implementation of this rule isn't until next December. I think 
we have a lot of time to have conversations with both you and 
the affected parties to see if we need to make a change here.
    Mrs. Emerson. Let me just, I know, Mr. Chairman, I am sorry 
I am going over my time but just to make one more statement 
here before we conclude. Unfortunately, I think in anticipation 
of this rule being promulgated or finalized by the end of the 
year, unfortunately, some of our small distributors are already 
being impacted and I have here and I would like to submit for 
the record lots of letters from some of these small groups who 
have been told by the primary distributors that they don't want 
to do business with them anymore, that it is too complex and in 
anticipation of this rule that they are afraid they are not 
going to be able to give them any business.
    So it is being felt today in spite of the fact that the 
rule has not been finalized.
    Dr. Henney. Thank you, fair enough.
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    Mr. Skeen. Mr. Farr.

                             generic drugs

    Mr. Farr. Thank you, Mr. Chairman, and thank you, Dr. 
Henney. I would like to also echo the compliments of having Joe 
Levitt come by and visit, of the very candid and 
straightforward comments. I appreciate that. I think it gets us 
prepared for hearings like this. You have a tough job. And I 
was thinking last night as I was flying here probably the two 
Federal agencies that we put our lives in the hands of are FAA 
and FDA. And because you have to do such a good job, and the 
world is getting so tough at doing that with the Internet, and 
I commend you on wanting to crack down on drug sales on the 
Internet. The discussions we have had in our community 
particularly from pharmacists and doctors, this is a really big 
concern that people are buying prescription drugs off the 
Internet and being able to get permission to do that from these 
doctors that are essentially renegade operations. I hope you 
will crack down on it.
    The big question here in Congress this year is bringing 
down the cost of drugs for people in the United States, 
particularly for our elderly population. And last year we 
appropriated some money for your Office of Generic Drugs for 
the purpose of trying to bring more patents. It is estimated 
about $22 billion worth of brand name drugs will expire in the 
next few years, and the only blockade of getting those drugs 
into generic compounds and the opportunity to get them 
distributed is the opportunity to review them. That is why this 
committee put a $1.9 million increase in the Office of Generic 
Drugs.
    My question is are you on track to hire enough people to do 
that? How much was spent on hiring of staff this past year?
    Dr. Henney. Well, Mr. Farr, thank you. At times it does 
seem like a tough job but it is worth doing. It takes a lot of 
hard work on the part of all of those people who are 
surrounding me today as well as a lot other people back in the 
agency, and it also requires your support too, for which I am 
appreciative.
    I think to the issue of generic drugs and how we are doing, 
we did note that you wanted another million dollars put in this 
program this past year. Most of that was eaten up in our 
inflationary costs that we have within the agency. So we are 
pretty much at an even keel in terms of the number of people 
that are doing the work. But are they doing good work? Are they 
keeping up with the pace of their workload? Yes. But they are 
stressed. Let me give you just a couple of examples.
    Mr. Farr. The question, the bottom line here with time 
being limited, are we going to get there? Are we going to have 
this huge backlog of brands names coming off their patent and 
then not being able to be generic?
    Dr. Henney. We have requested in this year's budget some 
$2.3 million that would directly go to the Human Drugs Program 
that would improve scientific knowledge across the board. It is 
not targeted to the Office of Generics because I think we have 
challenges in more than just that area.
    We do see a workload coming. We have been able to meet it. 
Last year we approved 198 generics, 40 of them were first time 
generics. So we are keeping pace at this point. We do think 
that we have a strong request, however, for you to keep 
supporting the kind of science we need both in the generic 
arena as well as in the new product lines. In terms of how fast 
these cycles are coming through, in 1997 it took approximately 
2.9 cycles in terms of an approval process. We are down to 2.4. 
So we are keeping pace. It is of concern, but we have many 
concerns across the agency in terms of what is coming through 
the technology pipeline, and then what will come through the 
generic pipeline.
    Mr. Farr. I appreciate that response. Time is running out. 
I think I also want to get into your highest priority risk. You 
have also indicated there are four priorities: Strengthening 
science, high priority risk, effective collaboratives and more 
predictable, timely, transparent regulatory process. Those are 
great priorities. I commend you for them. I would like to ask 
some questions in the next go round on the others. My time is 
up, Mr. Chairman, beforethe bell.
    Mr. Skeen. That is exemplary behavior. Mr. Latham.

                              irradiation

    Mr. Latham. Thank you, Mr. Chairman, and welcome you back, 
in the last year you were getting your feet on the ground, and 
compliment you for the job that you are doing.
    Just recently on February 22, after years of regulatory 
decision-making, consumers were finally able to obtain 
irradiated red meat. It has taken a long time to get to this 
point but it appears there is still regulatory problems and it 
has to do with packaging. The FDA rule basically says that 
irradiation is irradiation regardless of the technology. And 
the FDA approved packaging for gamma but not energy beam source 
irradiation. It seems inconsistent with your agency's own 
definition of irradiation. I've got a plant in my district that 
is the first state-of-the-art red meat energy beam irradiation 
facility in the country, and the lack of approved packaging has 
left the industry in the horrible position that it is unable to 
properly package their products. And irradiation is probably 
the single biggest advantage in food safety in decades. And it 
appears again the FDA is a bottleneck as far as allowing them 
to function.
    Can you give me an idea how soon you will be able to review 
and approve packaging for the red meat?
    Dr. Henney. Mr. Latham, I thank you for your interest in 
this issue. We have this proposal under active consideration. 
Actually I think there was some misunderstanding or 
miscommunication from industry about what they would need in 
terms of review, but we are giving it our prompt consideration. 
I do want to ask our best ambassador from the FDA, Joe Levitt, 
who is also the head of the Center for Food Safety and Applied 
Nutrition, to explain to you exactly what went on there.

                       food irradiation packaging

    Mr. Levitt. Thank you. On the subject of the food 
irradiation packaging, we actually have had a very close 
working relationship with the Department of Agriculture and we 
have recently exchanged correspondence, which I would be happy 
to submit for the record, which would allow the packaging that 
you mentioned to be allowed, if you will, on a trial basis 
while we review the petition. The petition does fall under our 
expedited review. But even while it is under review, we have 
provision for limited use where the safety issues are generally 
known. In this case, we have worked out a system with the 
Department of Agriculture.
    I have a letter that we just signed yesterday by Alan 
Rulis, who is the Director of our Office of Premarket Approval, 
and I believe that will fully address the issue--at least in 
the short term--that you raise.
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    Mr. Latham. Okay. That is good news. So you are saying they 
can go ahead and function and operate.
    Mr. Levitt. That is right. We also, in conjunction with the 
issue of food irradiation, have published a brochure, which we 
will submit for the record, to try and educate the public on 
food irradiation. As irradiation is an important tool in the 
safety of food, we really want to be sure that the public is 
fully understanding of the fact that it has been properly 
tested and so forth; and we have done that, again, in 
collaboration with a number of other organizations.
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                       food irradiation labeling

    Mr. Latham. I guess on that very subject, and I am 
concerned about labeling and how it may cause some problems in 
the marketplace as far as people assuming it is some kind of a 
warning that the product may be tainted or is not safe, and I 
think back in the conference report of the FDA Modernization 
Act of '97. It required the FDA to make changes in the labeling 
by the end of '98. As long as the labels are truthful and not 
misleading, why don't you prescribe other labeling disclosures, 
say, you know, cold pasteurization or electronically 
pasteurized or something like that. You were apparently, back 
from '97, you were supposed to have a different label 
available.
    Mr. Levitt. On the subject of food irradiation labeling, we 
did put out last year--in conjunction with the direction we got 
from the Congress--an advance notice of proposed rule making to 
take the pulse of public interest and knowledge and desires on 
the subject. I am afraid to report that what we got back really 
showed a wide disparity of views on exactly how to address 
that. And so what we have tried to do is an interim measure, 
while we work through that, is number one, put our best talents 
on food irradiation on the scientific review petitions, 
expedited review process that we put in place last year. That 
process has indeed served as providing an incentive for new 
technologies to come to the FDA for food safety.
    Second, we put out this brochure, which I would mention was 
in conjunction with the American Meat Institute, the Food 
Marketing Institute, the Grocery Manufacturers of America, as 
well as several others, including the American Dietetic 
Association, as a way of trying to educate consumers that this 
is a technology that they can take comfort in. And we are 
trying to address that in education while we work through the 
regulation on exact labeling.
    Mr. Latham. I would like to see the brochure. I also would 
like to know, you know, are any consumers actually going to see 
it? I mean it is nice to have a nice brochure but if no one 
knows what is in it.
    Mr. Levitt. I would hope that by having the Food Marketing 
Institute, which you know covers all the major food marketing 
outlets in the country as a co-sponsor to this, that they will 
be strong partners in our broad leveraging effort to get 
information out to consumers.
    Mr. Latham. Thank you, Mr. Chairman.
    Mr. Skeen. Ms. DeLauro.

                             food allergens

    Ms. DeLauro. Thank you, Mr. Chairman. Commissioner Henney, 
welcome and thank you for the good job that you do. In 1996 the 
FDA's Center for Food Safety and Applied New Distribution 
notified manufacturers of its concerns regarding the labeling 
of foods that contain allergenic substances, inparticular 
peanuts. We have a district meeting at Stop and Shop or Walgreens. It 
is not a town meeting but it is office hours. I have several families 
come to see me concerned about this issue of allergenic substances, 
including peanuts, and are scared for their kids. Some manufacturers at 
that time had incorrectly interpreted what constitutes an insignificant 
level of such foods, resulting in dangerous allergenic reactions to 
their products. Since that date what has the FDA done to ensure that 
manufacturers have sufficiently addressed the problem and what are we 
going to try to do so it doesn't happen again. Are we moving along in 
trying to get products labeled so that parents know what is in them if 
their child happens to be deathly allergic to a particular item?
    Dr. Henney. Ms. DeLauro, the issue of food allergens, are 
those things that represent high risk for individuals, things 
like peanuts, eggs, and the like. And I would again ask Mr. 
Levitt to describe the individual steps that we have taken and 
initiatives in that regard. We share your concern and the 
concerns of those consumers affected by these allergies.
    Mr. Levitt. Thank you. As Dr. Henney said, food allergens 
is an issue in which we have a lot of interest. Actually if you 
look at our class one recalls, the number one reason would be 
for undeclared allergens. So it is something for which we have 
a constant monitoring. In addition, in our priorities document 
for this coming year for 2000, we have added as a new area to 
focus specifically on food allergens. In particular, we said we 
would work to raise consumer and industry awareness to the 
presence of allergens in foods, and conduct meetings on 
labeling approaches to identify the presence of allergens. So 
we are trying to raise the visibility of this issue.
    On the one hand, there are clear rules that certain things 
have to be labeled because they are known allergens. However, 
we realize we have to work more with the industry--on how did 
these mistakes happen, i.e. how does a food product that is not 
supposed to have peanuts get peanuts into it? We are always 
playing catch up. So we are looking at approaches we can take 
to be sure that we hit it from the front end of it, the 
manufacturing end, as well as from the consumer end, and to 
make sure there is a greater awareness and understanding of how 
to look for the information on the label. We try to approach it 
both ways. So we thank you for raising this. We think it is an 
important public health issue.

                                tobacco

    Ms. DeLauro. Let me just talk about an issue that has two 
or three parts. Smoking. Children are able to buy tobacco 
products 25 percent of the times they try. The varying rate is 
Georgia 53 percent, Maine 9 percent. FDA has conducted over a 
hundred thousand compliance checks to track the issue. What can 
we do. I think last time you asked for money which this 
committee did not get to you to be able to deal with this issue 
of compliance and preventing youngsters from smoking. In 
another committee that I serve on, Labor-HHS, Dr. Klaus said 
that one-third of cancer mortality had dropped specifically 
because of prevention of smoking. Now if we have that kind of 
cause, and we have that kind of an effect, what are we doing at 
this end of it to make sure that these kids don't start to 
smoke so we don't have to spend the money that we are spending 
on research for the future and spending money on the research 
that we are now at the same time providing the substance to 
youngsters to start to smoke? So what more could you do in that 
area, how can we be helpful in that effort? Second, bidis, what 
are you doing about bidis, the cigarette from India which has 
at least 7 or 8 times more nicotine in it than regular 
cigarettes? Also, Phillip Morris, I understand from today's 
papers, is indicating that they would be willing to listen to 
some sort of regulations. Can you tell us a little bit about 
that or when can you tell us something about that and what 
direction is that going in?
    Thank you.
    Dr. Henney. Thank you for your questions regarding tobacco. 
Clearly a very important issue as it relates to our overall 
public health, but, particularly as it relates to the youth of 
this country. The data which you cite actually comes from a web 
site that we make available, the results of our own compliance 
checks. When somebody has a high rate it may mean that they are 
doing a good thing in terms of the checking that they are doing 
in their state.
    We have applied the dollars that you have appropriated to 
us in two ways: One, to enforce that part of the rule that we 
can and that has to do with access. So we are doing compliance 
checks. This is a partnership that we have largely with the 
states which gives us coverage of most of the U.S. and in many 
territories. Those checks are going on on a regular basis and 
the over 100,000 checks that you cite actually were done under 
the aegis of this program. Two, this year some of that money 
was used for an award winning media campaign to again make the 
point clear that tobacco, particularly when used by youth, can 
be addictive and very dangerous to one's health.
    With respect to bidis, that has not been the focus of this 
effort to date. We were quite concerned particularly about what 
we hear from youth in their thinking that these are safe or 
safer, because they are, quote, not cigarettes. CDC has 
recently completed a survey in that regard. It may clearly lead 
us in a direction that we might encompass them within our 
compliance program. I think we also have to be aware that where 
these kinds of products are sold often times helps us focus our 
efforts.
    With respect to the recent announcement that you saw, and I 
did in the paper this morning, I think that we will have to 
wait to see what is proposed and see where we go from there.
    Ms. DeLauro. Thank you, Mr. Chairman.
    Mr. Skeen. Mr. Dickey.
    Mr. Dickey. Commissioner, thank you for coming to Pine 
Bluff. I do see that we have a picture of Cincinnati and Los 
Angeles and not of our lab in Arkansas. Is it outside 
somewhere, the picture?
    Dr. Henney. It is being blown up as we speak, the picture I 
mean.

                      arkansas regional laboratory

    Mr. Dickey. The Arkansas Regional Laboratory that you were 
nice enough to come and dedicate will provide the FDA with a 
good deal of vital research. It is my understanding that this 
is not complete and I would like to know if you can tell me 
what additional programs we will hope to get once we bring 
other labs into this facility.
    Dr. Henney. Mr. Dickey, it was a real joy to be able to 
have you dedicate that facility, which is I think one not just 
the bricks and mortar, but what it represents, and that is 
really the blending of both our research and regulatory 
mission. I think the Congress has been very wise over the last 
number of years to see our facilities needs asimportant. And 
that is why we raise the critical need in our L.A. district, which is 
quite desperate.
    We have requested in this year's budget $3 million for some 
of the next phase of the Arkansas regional lab. We do, 
according to the consolidation plan, intend to move some of the 
work that has been going on in the Denver district and Kansas 
City to this facility. And I think that it will really take on 
great meaning as we are able to do that. As you are aware some 
of the kinds of projects we already have going on there relate 
to dioxin and the like are very important to our mission. So we 
are very happy to have that presence there.
    Mr. Dickey. I am impressed, Commissioner Henney, with the 
cooperation that we have at that laboratory with the University 
of Arkansas medical sciences facility in Little Rock. And Dr. 
Harry Ward is very complimentary of the cooperation that is 
going on and I think it is a wonderful thing. Will there be any 
increase in that relationship as we consolidate?
    Dr. Henney. Mr. Dickey, I am always ready to take Dr. 
Ward's compliments. Every once in a while he throws me a 
criticism too and I accept both. We have enjoyed a fine 
relationship not only with the University of Arkansas Medical 
Center but other academic institutions in the area that have 
engaged with us in training opportunities. We do see that 
relationship growing, particularly as it relates to some of the 
work that we do in the area of toxicology at the center. And so 
we intend to not only continue that relationship, but let it 
nourish.

                              bioterrorism

    Mr. Dickey. Thank you. Next subject chemical or biological 
weapons of mass destruction. You have asked for $11.5 million 
to address this segment of your concern. How does the FDA 
intend to use these funds and what unique ability does the FDA 
feel that it has that it can add to this serious problem?
    Dr. Henney. Well, the bioterrorism effort in this country 
is really multi-agency. For the FDA, the work is really 
concentrated in three areas: One, within our Center for 
Biologics. As new vaccines might be developed we need to be 
prepared to readily and appropriately review those kinds of 
applications and also engage in doing work in terms of some 
vaccine development with our colleagues from other Federal 
agencies. That is a long term process. That is not overnight. 
But we need to begin to invest in that arena.
    Our Center for Drugs would also be engaged in looking at 
some of the stockpiling issues. And at NCTR much of the work, 
as you know, is also looking from a research perspective at 
some of the products as they would be related to either 
neurotoxins or products that could be used and end up in the 
food supply. So those three parts of the agency would be most 
heavily engaged in the bioterrorism effort.
    Last year, as you know, our appropriation was linked and 
carried with the Department's request to Labor-HHS. 
Unfortunately, they saw an FDA request as not theirs. We have 
made some accommodations to still stay in the game this year, 
but to have an ongoing effort in this we really need your 
support.
    Mr. Dickey. Thank you, ma'am.
    Mr. Skeen. Mr. Nethercutt.

                            bioport facility

    Mr. Nethercutt. Thank you, Mr. Chairman. Commissioner, 
welcome, gentlemen, glad you are here. A couple of areas of 
inquiry, one involving anthrax, the other involving the issue 
of insulin for diabetics. In November last year the Food and 
Drug Administration Office of Compliance and Biologics filed a 
Form 483 following an inspection of the Bioport Corporation, 
which manufactures the anthrax vaccine, and a number of serious 
problems were observed during the inspection: Documentation and 
reporting was inadequate, the manufacturing process was not 
validated, lots and sublots of the vaccine failed 
specifications and were contaminated and lots failed potency 
testing. And numerous aseptic failings were observed and 
temperature limits were not established. It is a nine-page 
report. The Commissioner raises serious questions about the 
ability of Bioport to manufacture safely this vaccine, which is 
an important vaccine. I am wondering if you could advise the 
subcommittee of the status of the FDA approval for the 
facility, the Bioport facility.
    Dr. Henney. Mr. Nethercutt, we share your concerns. We 
don't take lightly the need to assure safety by making sure 
that the conditions under which any products are made follow 
good manufacturing practices. It is through that mechanism that 
we can ultimately assure safety of a finished product. I 
believe that the Center for Biologics has been engaged with the 
BioPort about what needs to be done in terms of an actual 
progress report. I would appreciate providing you an update for 
the record.
    [The information follows:]

    The BioPort facility in Lansing, Michigan is continuing to 
implement a strategic plan for compliance submitted to Center 
for Biologics Evaluation and Research--CBER. The most recent 
inspection of the Anthrax Vaccine Adsorbed--AVA--manufacturing 
facility was conducted in November, 1999. This inspection 
resulted in an extensive list of inspectional observations. 
Following FDA's inspection and review of the BioPort supplement 
for the renovated inspectional facility, FDA sent BioPort a 
complete response letter in December, 1999.
    We have met with BioPort and the Department of Defense 
several times since that letter was issued, and BioPort has 
presented various portions of their response, including a time 
line for validation of the manufacture of AVA. When the firm 
has completed all submissions to respond to the inspectional 
observations and complete response letter, we will review these 
submissions, conduct an additional pre-approval inspection, of 
needed, and respond to the submission with either an approval 
or an additional complete response letter. Until the supplement 
for this facility is approved, newly manufactured vaccine 
cannot be distributed for the lot for sale.

                          diabetes and insulin

    Mr. Nethercutt. I appreciate that. With respect to the 
issue of diabetes and insulin supplies, you may know I have 
been involved with other Members of the House in trying to meet 
the needs of diabetics in this country and cure this disease 
and it is a condition that needs a cure. About a year ago we 
discussed this issue of beef-pork insulin. I appreciate your 
easing the importation process so that people with diabetes who 
feel their body has stabilized better with beef-pork insulin 
can import it from abroad. That is positive. The U.S. 
Department of Agriculture has also simplified the forms that 
USDA requires for personal importation. But there is a problem, 
it does remain costly and burdensome and for some users. It is 
a life line for many people who have been accustomed to beef-
pork insulin and feel as though it is their only way to feel 
good and live well. There is a problem of supply in this 
country.
    I am wondering if you have taken or are considering any 
steps to ease that process, make it simpler for people who are 
dependent on beef-pork insulin.
    Dr. Henney. Mr. Nethercutt, yes, we are well aware of this 
issue of diabetics who feel their disease is better controlled 
on beef insulin rather than relying on the alternative of pork 
insulin or the human derivatives types of products. We have had 
a staff member working quiteclosely with this group to keep 
them informed about what we have going in this area. Really the 
situation, as you know, arose when a company in this country decided to 
stop manufacturing this product because they saw a shrinking market 
share as many diabetics convert to other products and also because of 
the concern about BSE in the source supply of beef insulin. There are 
really no domestic manufacturers at this time. We are trying to work 
with any foreign manufacturers that might be willing to provide a 
source. We have allowed enforcement discretion up to a 6-month supply 
for the personal importation of this product. But we have to work on 
what comes to us and we are trying to do that.
    Mr. Nethercutt. If I might just close by stating that I 
have an extraordinary number of people communicating with me on 
this issue. There are people here today who are very concerned. 
I would request that perhaps you would be able to take a few 
minutes at some point to meet with these folks at least to get 
a better sense of the problem, or give some thought to the idea 
that an emergency could be declared perhaps by the Secretary of 
Health and Human Services to allow this importation. It is of 
serious personal consequence to a lot of people. I think they 
want to be sure that the diabetic community wants to be sure 
that you have a sensitivity to this issue and that the agencies 
of government who have jurisdiction over this also do and 
should have, in my judgment. I would appreciate that you would 
be willing to consider the dependable supply issue.
    Dr. Henney. Thank you.
    An unidentified member of the audience. Mr. Chairman, can I 
address or say something just for a moment please about the BSE 
issue? There is no BSE in insulin that comes from the U.K. 
Because those pancreases, that beef comes from the United 
States.
    Mr. Skeen. Would the lady please take a seat. We will get 
to you later.
    An unidentified member of the audience. I am sorry.
    Mr. Skeen. That is quite all right. Ms. Kaptur.

                         foreign drug purchases

    Ms. Kaptur. Thank you, Mr. Chairman. Commissioner Henney, 
last evening I was with several doctors in my home community 
who told me that they refer many of their patients to Canada to 
purchase medications, which cost far less than most medications 
do here in the United States. I don't know from my colleagues 
that serve at the U.S.-Mexico border whether their doctors do 
the same thing. When you and I met several weeks ago, I asked 
the question about the safety of drugs purchased in other 
countries by U.S. citizens and you indicated some skepticism as 
to the safety of those drugs. Here I have doctors from my 
community referring people to Canada and I repeated what you 
had said to me about ingredients and the possible differences 
in the constitution of those drugs, and the physicians 
basically said to me but, Congresswoman, they have an FDA up 
there in Canada too.
    So my question really goes to the heart of how many 
complaints has FDA received in a given year relative to 
medications that have been taken by U.S. citizens where they 
have had very bad effects from those and to what extent do you 
measure where those drugs were purchased, whether they were 
purchased in Canada or Mexico or Cuba or wherever they might 
be. I was very surprised at the referrals being provided by 
physicians back home quite frankly.
    Dr. Henney. Ms. Kaptur, I would love to be able to provide 
you with that information but that is not necessarily the kind 
of information we collect. We do collect adverse reactions but 
being able to know precisely where a product was purchased or 
whether it was purchased in this country or elsewhere is not 
necessarily within our data scope right now. Canada certainly 
does have a very active FDA and we interact regularly with that 
regulatory body. However, there are drugs that are manufactured 
in Canada that have a different biological activity, than drugs 
that are manufactured here. So you may be getting a more or 
less potent drug. From other countries we might have greater 
concerns about whether you would be getting a counterfeit or a 
contaminated product. The issues are real. How many adverse 
reactions we have actually seen from that I just do not know.
    Ms. Kaptur. Who would keep such data?
    Dr. Henney. Who would keep?
    Ms. Kaptur. Within the government of the United States who 
would track if a consumer goes to Mexico or goes to Canada and 
purchases a drug and something goes haywire; where does one go?
    Dr. Henney. I am not sure that there is a government body 
that does that. I could ask Dr. Woodcock if that information 
sometimes appears on our adverse reaction reports but I 
believe, it would not.
    Dr. Woodcock. That is correct. Consumers and pharmacists 
and physicians will report adverse events to the FDA. They 
could have in their written material that it was purchased in 
some other country but actually they are probably unlikely to 
do that. And we do not have data that analyzes the adverse 
events in that manner.
    Ms. Kaptur. I find this omission somewhat striking. If we 
are having trouble with imported food, we are very concerned 
about people purchasing items that may be harmful. We have 
bodies of this government that worry about the safety of 
children's toys, and yet if we have citizens purchasing drugs 
and they may not be warned, if nobody is collecting data that 
means nobody is being warned either. And if doctors are 
referring people all over the place, as I was very surprised to 
learn--I am going to submit some additional questions to the 
FDA as a part of the record. Perhaps there is something that 
could be done somewhere to provide a greater level of 
sophistication here and reporting if people are actually being 
encouraged to purchase elsewhere and what those effects are. 
Perhaps FDA is not the agency to do that, but I am very 
surprised that this isn't somehow monitored.
    Dr. Henney. There are two issues coupled here I think, Ms. 
Kaptur. One is the issue of the kind of data that we would 
request or require when an adverse report would come in and 
whether we would be able to validate that or not. It is also 
linked a bit to this issue that was raised before about the 
ability to truly track a pedigree of a drug. And so I think 
there are two issues that are coupled here and we will be glad 
to respond to your question.
    [The information follows:]

    There currently is no mechanism to track these personal 
purchases. If an adverse event occurred due to a drug purchased 
in the foreign country, it can be reported and monitored by FDA 
through our MedWatch program. If it can be determined that the 
product originated in a foreign country, FDA can communicate 
serious events regarding a foreign drug with FDA's counterpart 
in the foreign country.

    Ms. Kaptur. Thank you, Mr. Chairman.
    Mr. Skeen. Thank you. Mr. Kingston.

                                 pdufa

    Mr. Kingston. Thank you, Mr. Chairman. Ms. Henney, it is 
good to have you back at the committee again. I regret we had 
another committee that started at 10:00 that Mr. Nethercutt and 
I had to go to so we were late. First of all, give you an 
opportunity to brag, this may have been brought out but I 
understand that on the prescription drug approval process that 
you have cut that to me down to 12.9 months. And I think that 
is great. In the past I think it has been longer. I have heard 
up to 8 years. I am not sure what it was, but I just, you know, 
open with a friendly comment on that. If you want to say 
anything that would be up to you.
    Dr. Henney. Well, Mr. Kingston, I appreciate being back 
before the committee. I also appreciate being able to provide 
you with a report card on our effort to meet the requirements 
of the Prescription Drug User Fee Act. It is a lesson that 
demonstrates when the agency is properly resourced we are more 
than able to do our job and do it well. I think prior to the 
Congress' passage of that act in the early 1990's average 
review times were 30 months, sometimes 36 months. We have cut 
that down for both drugs and biologics to a little under a 
year. We are not only proud of the track record in terms of 
timeliness, but the kind of products that we are reviewing, I 
think are providing real benefit for the population and it is 
good to do that for the public health.

                         cochlear impant device

    Mr. Kingston. I think all Members of Congress commend you 
for that. They are using this drug in Canada, we hear that so 
often, or it is safe elsewhere. So I think 12.9 months is 
really great. So a question that I have which I believe you are 
familiar with has to do with this cochlear implant device for 
hearing impaired and has to do with a constituent of mine who 
is working with FDA on it. And I was wondering if you could 
give me an update. I can read some background on it but if you 
just want to.
    Dr. Henney. Mr. Kingston, at this point in that particular 
application, most of the information is still seen as 
confidential trade secret. So we are not permitted under those 
rules, unless the company gives us permission, to talk in a 
public session about the application. If the committee would 
desire to go into executive session we could or we would be 
glad to come down and brief you individually about what the 
issues are there.
    Mr. Kingston. That might be good. I do understand that your 
staff has been working with my staff on it and I believe that 
they are making progress and things are going well. The people 
involved with all that here have been very frustrated, as you 
know, and so--but I also know there is always two sides to a 
story. But it is something we are interested in because I think 
it would help lots of people. And I have among other things a 
mother who is hard of hearing. I know as many items as we get 
out there on the market for hearing impaired people to choose 
from I believe it is in the interest of all of our constituents 
and everything that we are trying to do. So I would like to 
continue this dialog with you in the appropriate forum.
    Dr. Henney. We would be delighted to do that.
    [The information follows:]

    Your constituent appears to be interested in trials of 
experimental cochlear implants. The design of trials to 
demonstrate safety and effectiveness of new implants and 
provide new options to otolaryngologists and their patients is 
a high priority for the Agency. We would encourage your 
constituent to work through the manufacturer with FDA.

    Mr. Kingston. Am I out of time, Mr. Chairman.
    Mr. Skeen. No, not yet.
    Mr. Kingston. On the food safety initiative, I don't know 
which one of you wanted me to run out the fastest.
    Mr. Skeen. Are you taking bets?

                         food safety initiative

    Mr. Kingston. No, I have learned, Mr. Chairman. But the 
President's Food Safety Initiative, FDA got 79 million increase 
last year asking for 30 million this year. In terms of 
quantitative measure, which I know is very hard, but have we 
seen a corresponding reduction in food borne illnesses or what 
kind of reductions have we seen? What have we gotten for our 
money? That is all I am asking.
    Dr. Henney. Mr. Kingston, I think what this country and the 
American people have received from the food safety initiative 
has been a tremendous amount in terms of our capacity to deal 
with several issues as they relate to food safety. Perhaps 
those issues that create the highest risk are microbiological 
contaminants. I believe that we are able to track issues 
related to food safety better than ever before. We have put a 
tremendous amount of effort through the President's Foods 
Safety Initiative into research, the PulseNet, and the FoodNet 
programs that have been jointly sponsored by the Agriculture 
Department, the Centers for Disease Control and ourselves. I 
think the list is very long and I would love to supply that for 
the record for you.
    [The information follows:]

    The President's Food Safety Initiative has sought to 
establish preventive systems such as the Hazard Analysis 
Critical Control Point--HACCP--in domestic seafood processors, 
Good Agriculture Practices, and intervention technologies such 
as sprout producer guidance. It has established educational 
messages such as egg safety campaigns for food handlers and 
consumers, and food safety campaigns for senior citizens, who 
are a higher risk of developing foodborne illnesses. Research 
and risk assessment has improved to better understand and 
target foodborne hazards such as Listeria monoctogenes, 
especially for pregnant women, development of methods to detect 
Cyclospora, Campylobacter, Vibrio parahaemolyticus and a rapid 
screen that identifies twelve common foodborne pathogens. 
Surveillance systems, such as the National Antimicrobial 
Resistance Monitoring System--NARMS--which monitors for 
resistance to antimicrobials, are used to combat foodborne 
bacteria that cause disease in humans. The Food and Drug 
Administration has also collaborated with Mexico to help them 
develop the first international human and animal monitoring 
system for foodborne antimicrobial drug susceptibility 
surveillance in the Americas. Based on CDC's estimates of 5,000 
deaths and 76 million illnesses per year, foodborne illness 
remains a major public health problem. In dealing with these 
significant public health issues, the Food Safety Initiative 
funds have contributed significantly to the federal 
government's ability and capacity to move on multiple fronts 
and afforded resources to build prevention systems, enhance 
current system capabilities while responding promptly to 
outbreaks from foods produced domestically and abroad.
    The overall picture of trends for food safety knowledge and 
practices that emerges from research is quite encouraging. 
Between 1993 and 1998, the public's food safety practices, both 
the consumption of risky foods and food handling behaviors in 
home kitchens, show dramatic improvement. For example, for the 
population as a whole, the incidence of eating pink hamburger 
is down 33 percent and the incidence of eating raw oysters or 
clams is down 39 percent. The safety of reported hand-washing 
and cutting boards practices has also improved markedly. The 
improvement is particularly strong for handling meat or 
chicken, which improved 74 percent compared to a 27 percent 
improvement for fish. Knowledge levels about microbia food 
pathogens increased, along with rising perceptions of the 
possible risk of getting foodborne illness.
    That is not to say that there are no consumer education 
issues to be addressed. There are obvious gaps in consumer 
knowledge, attitudes and practices related to food safety. For 
example, most consumers still do not handle eggs very carefully 
and they are more likely to consume undercooked eggs or foods 
containing raw eggs than any other risky food. Most consumers 
have never heard of Listeria or Campylobacter, which are at 
least as prevalent in the food supply as the more well known 
pathogens, Salmonella or E. Coli.
    The Food Safety Initiative has provided necessary resources 
for FDA to undertake the enormous challenge of foodborne 
illness. However, even more is expected of this Agency.

                            food inspection

    Mr. Kingston. Okay, Mr. Chairman, I yield back. I do want 
to say one of the things that we on this committee, and on both 
sides of the aisle, we are very concerned about food safety but 
we really want government agencies to work as partners in 
technical assistance with food processors rather than kind of 
an ``I gotcha'' approach, which we do see from time to time in 
certain agencies with certain food inspectors and people on the 
line. And I just bring that out.
    Thank you, Mr. Chairman.
    Mr. Skeen. Thank you. Mr. Boyd.
    Mr. Boyd. Thank you, Mr. Chairman. And Commissioner, 
sitting here listening to all the questions, that myriad of 
issues, you really do have a tough job. And I commend you for 
the way you conduct yourself.
    Dr. Henney. You want to tell the President that I need a 
raise?

                                ephedra

    Mr. Boyd. I am not sure I would go that far. Commissioner, 
in your testimony you state, and I quote, the FDA--I want to go 
back to the Ephedra issue here because I didn't have time 
enough to finish it. ``The FDA Modernization Act directed the 
agency to consult with stakeholders on an ongoing basis and to 
keep them apprised of our strategies in new product decisions 
and to generally make them informed participants in our 
regulatory process.'' and I assume that stakeholders means the 
consuming public in the industry probably would be the----
    Dr. Henney. Yes.
    Mr. Boyd. Now, certainly as I told you before, I applaud 
the decision of the agency to withdraw portions of the proposed 
rule on the Ephedra. I am not sure I understand exactly what 
that means at this point in time. But I am sure at some point 
in time Mr. Levitt is going to tell me. And I would ask you 
this. In light of that statement, that quote out of your 
statement, wouldn't it make sense to try to gather all of the 
information that you can before you present publicly an 
analysis of the AERs, wouldn't it make sense to listen to the 
public in that public forum, all the stakeholders, including 
the consuming public and the industry, any information that 
they might have that might help you make a more thorough and 
appropriate analysis?
    Dr. Henney. Mr. Boyd, I can assure you that we will be 
receptive to receiving that kind of information in the public 
meeting. We are always open. I think our mailboxes are full of 
people who want to provide us with information that they have 
with respect to any issue that we deal with. We have to pace 
ourselves in terms of how we respond, that is why we have 
designated this particular time period in which we will share 
the analysis and look for reactions or additional information.
    Mr. Boyd. But my question was, wouldn't it make more sense 
to withhold the analysis until you have benefit of that 
information?
    Dr. Henney. I don't know, Mr. Boyd, if there is some 
information that we do not have in hand at this point. I think 
Mr. Levitt and his staff have met numerous times with industry, 
and has encouraged them to bring forward any information that 
they might think is relevant. But if they still have some out 
there, we of course are glad to receive it.

                           food safety audits

    Mr. Boyd. Okay. I will shift gears. Go to another subject. 
I note from time to time that your agency has visited foreign 
countries to audit the safety of food produced in those 
countries that are being exported to the United States. Now, we 
go to great lengths in this country to ensure that our 
consumers have access to a safe and healthy food supply. We 
have standards for poultry and beef and we often ban the use of 
certain pesticides in the name of food safety, not only in the 
name but practically to provide a safe food supply. That makes 
it more costly for our U.S. producers and consumers obviously, 
but we think it is well worth it.
    Now, would you elaborate to us about your efforts to audit 
other countries, other ag producing food producing countries 
which are exporting to the U.S.? And I will ask a series of 
questions here: Which countries have been audited; which 
particular food product was the subject of that audit; are 
written reports prepared on the results of those audits; are 
they available to the public? If not, why not? Has the FDA ever 
been denied access to a foreign country in which we want to 
conduct an audit?
    If you can't answer all the those in the time remaining I 
will submit those for the record, Mr. Chairman.
    Dr. Henney. I will try to put myself on fast forward but I 
am not sure I have time to answer them all. Within the limits 
of our resources which we have to use wisely, we do look at the 
whole issue of an increased amount of food that we regulate 
coming into this country. We have tried to do this judiciously 
by setting up mutual recognition agreements with some countries 
that we know are large exporters to make sure that our 
regulatory capacity may be similar or equivalent. Those kinds 
of understandings are in their earliest phases of negotiations 
because they have to be sure of us and we have to be sure of 
them. We have made a commitment to inspect some of our highest 
risk areas of production. We have also tried to increase what 
we do in terms of inspections at the border and be smarter by 
looking at products that are of particular high risk or 
importers that have been problems in the past.
    We have undertaken this past year a tremendous outreach 
effort of technical assistance to countries so they will know 
what our expectations are of and for them. This has gone on in 
Mexico, Latin America and some countries in South America.
    So it is that kind of outreach, so that people know what 
your standards are so that you can educate them about those 
standards and then you can inspect against the standards that 
really keep a program strong. Do we have the kind of resources 
where we could be in every country at every plant? No. There is 
no way. That is why we have got to target and limit and be 
smart about what we do.
    Mr. Boyd. Thank you, Commissioner. What I would like to do, 
Mr. Chairman, is submit some of these specific questions to 
which Commissioner Henney didn't have the time to answer and 
submit them for the record.
    Mr. Skeen. Thank you. It will be done. And let's have Mr. 
Latham.

                            irradiated foods

    Mr. Latham. Thank you again, Mr. Chairman. I don't know if 
I really got an answer to my earlier question about labeling on 
irradiated foods. Is there any plan or proposal or thought at 
FDA about allowing different labels such as electronically 
pasteurized or cold pasteurized or anything; is there any plan 
thought of that?
    Dr. Henney. Taking those specific words into account, I 
don't know of a specific plan. However, in educating the 
consumers about irradiation, I think we need a much more 
extensive and comprehensive plan, particularly as we deal in 
this public-private partnership to educate consumers about what 
irradiation does and what it can mean for food safety. Quite 
frankly, when I was down in the Miami district knowing what 
some of their initiatives had been in terms of trying to 
educate consumers about irradiation and its beneficial effects, 
I saw as quite positive. I hope we can emulate those kind of 
things.

                             food additives

    Mr. Latham. But I guess the answer then is no, there is no 
effort to approve of any other label. Okay. Last year they 
announced an intent to go to give priority reviews to food 
additive petitions having to do with say hot dogs or luncheon 
meats, ready to eat. How quickly does FDA intend to act on the 
pending petitions as far as irradiation petitions and can we be 
assured that it won't take 5 years like it was on red meat.
    Dr. Henney. Mr. Latham, Mr. Levitt has a very intense 
effort in terms of strategic planning and having people keep to 
time in terms of performance and I will let him describe some 
of his priority setting for those specific issues that you 
raise.
    Mr. Levitt. What we have put in place is a series of goals, 
actually in all of our programs, but, in particular for food 
additives. In the expedited review that you mentioned, our goal 
for this year, is quite ambitious but I believe appropriate. 
For the petitions that we got in fiscal year 1999, our goal is 
to complete, within 360 days of filing the safety evaluation, 
80 to 90 percent of food and color additive petitions that 
qualify for expedited review. So we are saying, within a year 
of filing, we will try to do nearly all of these--i.e., 80 to 
90 percent. We are getting an increasing number of these 
petitions, but, we believe it is important, as I said before, 
both to create the incentive for companies to bring those 
technologies to the FDA, and for us to position ourselves so 
that we can review those rapidly. We also have put out our 
report card from last year, which shows I believe that it is 
important that we not only say what we are going to do, but be 
willing to report on what we actually did or didn't do. Last 
year, we were able to complete nearly 90 percent of all the 
priorities across CFSAN.

                           food biotechnology

    Mr. Latham. As far as GMO's and biotech, do you plan to 
initiate any revisions or proposed changes to your existing 
review process, and I think very importantly, labeling policy 
as far as biotech foods? If so, what are your next timetables 
and what are your next steps and have you made any preliminary 
decisions as to what changes would be made and also what 
additional funds you would need to do it?
    Dr. Henney. Mr. Latham, with respect to the issue of foods 
that have been developed using the tools of biotechnology, we 
have had in place a policy since the early 90's that spells out 
how the agency deals with issues related to these products 
anywhere from their review--to how we interact with the 
industry in terms of the consultative process before they come 
to market, to which ones of these products we require labeling 
on. A piece of that policy also spells out that the industry 
can choose to voluntarily label if they so desire.
    Recently we have had cause to really listen again to the 
public about where we are on that policy. I think it started 
really because of what was happening in Europe and a lot of the 
surrounding trade issues. It was clear that there was a cause 
of concern or at least expression of concern in this country as 
well. We had been lulled into doing our business in a very 
quiet way. We felt like we had very strong compliance from 
industry in terms of the consultative process. The things that 
were on the market we saw as being appropriately there, but 
that very few outside of the agency were aware of what we were 
doing. So we were certainly not as transparent as we would like 
to have been.
    We also heard concerns from industry and stakeholders. As a 
result, we decided to revisit the policy. We held three open 
meetings over the course of this fall, public meetings, and 
they were held in Chicago, Washington, and Berkeley, 
California. We listened to all of the concerns expressed there. 
We have also had an open docket to which we have received over 
25,000 comments about the issue of bioengineered foods. We 
looked and we sought answers to questions in two areas. One is: 
are there safety issues that should cause us to rethink or 
revisit this policy, and two: how do we provide information to 
consumers about bioengineered foods, anywhere from the labeling 
which is popularly raised, to other means of communicating this 
information to the public.
    It is fair to say with that amount of input we are still 
deliberating on this matter. I think I would hasten to say that 
we heard very little about those products that are on the 
market in this country in terms of their safety. And that was 
reassuring.
    There may be issues related to the science of future or 
developing products, issues related to how we provide 
information to consumers who want to make a choice about what 
they eat for whatever reason, issues related to environmental 
concerns, issues related to food safety, and the issue of 
individuals who just want to know if the product has been 
changed or modified in any way. Clearly we hear this more as we 
go into the European nations. From developing countries we hear 
do not do anything to disturb this technology, we need it for 
our health and we need it to feed our nation's people.
    So those are the gamut of issues that we are dealing with 
right now and we will be glad to keep you involved as we would 
go forward with any changes in current policy.
    Mr. Levitt. If I might add one footnote, you will find in 
the budget a request for an additional one and a half million 
dollars for food biotechnology that will be shared by my 
Center, the Center for Veterinary Medicine and the National 
Center for Toxicological Research down in Arkansas.
    Mr. Dickey. Say that again.
    Mr. Levitt. National Center for Toxicological Research down 
in Arkansas.
    Mr. Latham. He just wanted you to say Arkansas.
    Mr. Levitt. We really feel that we need to have resources 
as in all areas, not only to maintain our expertise and enhance 
it, but be on the cutting edge of this particular area. We want 
to be sure that we are viewed as world leaders in the science 
of biotechnology.
    Mr. Latham. It is an important issue and this is going to 
affect a lot of areas, including trade and everything else.
    Mr. Skeen. Put a label on that ``to be continued.'' Mr. 
Farr.

                     genetically modified organisms

    Mr. Farr. Thank you, Mr. Chairman. I want to ask a 
question. Before that I want to echo Mr. Latham's concern. I 
just had a meeting with industry folks and the university folks 
on GMO's and I tell you if we don't make this more transparent 
than we are, this is going to be regulated from the streets. 
And it is going to be regulated by state initiatives. And 
California is very famous for being able to be successful for 
those initiatives. And that is the biggest market in the United 
States or the world that is going to be regulated and it is all 
going to be because people have lost confidence in government.
    So my point is that you have got to make this transparent. 
You have to get people that are in the scientific fields out in 
the streets talking with consumers. My question really goes to 
the issue of how you prioritize. You talk about we must address 
the highest priority risks. You also point out the FDA is a 
regulatory gateway through which an estimated $50 billion in 
biomedical research must pass and be judged and you also state 
you don't have enough FDA assets alone to address the complex 
risk management challenges. So in this, how do you determine 
priorities. I have concerns with this because we have some, 
dietary supplemental manufacturers in our district and a lot of 
them in my district and they are concerned about regulations 
putting them out of business. On the same hand you have those 
that--Congresswoman DeLauro's concerns about if it is not 
properly labeled adverse. So how do you prioritize? And make 
sure. Why, for example, is Ephedra one when we don't even know 
or do we know, how many Americans consume Ephedra?
    Dr. Henney. Mr. Farr, I think your question goes to the 
heart of how do we set priorities. Also in my testimony what I 
tried to express is that our priorities are set on looking at 
what threatens the public health and that is the whole issue of 
risk based analysis. We also set priorities on what scientific 
assessments tell us to do.
    Mr. Farr. Is that a marketplace determination? We are in 
this dilemma. Here we are in the Agriculture Committee. What is 
happening in agriculture is called fresh to market. They 
harvest it right in the field, put it in a bag in the field and 
tomorrow it is delivered anywhere in the world because we can 
do that. I represent all these speciality crops, strawberries 
and lettuce and all that stuff. And all things as you go down 
in the market here in Washington you look at it, it is all from 
the Salinas Valley. How does it get here from the day after its 
harvested in the fields? Because everything is done there. So 
on the other hand you are having risk capital go in, we want to 
be in this business. But the worst thing that could happen to 
businesses like that is all of a sudden say, oh, this fresh to 
market is unsafe. Then they are out. Government is still 
around. So how is it--we don't depend more on marketplace 
reactions?
    It seems to me there is a cause and effect here. If there 
is thousands of people, millions of people doing something and 
there is very little adverse effect, that it wouldn't have much 
of a health risk.
    Dr. Henney. Oftentimes there is very little effect because 
we have put in good preventive control measures to make sure 
that those bad things won't happen in the first place. We need 
to also have a capacity to intervene when we do see risk in the 
marketplace to move rapidly. But one of the reasons----
    Mr. Farr. Let me give you an example where government has 
done both. On the science side we told everybody to use 
reclaimed water. We said the tests show you can use reclaimed 
water on agriculture. If you clean it up to a certain level, 
almost drinkable level--we don't allow that yet but that level, 
you appropriately apply it to these crops, that they will be 
fine. On the marketplace because competitors don't like that 
because you are growing a crop that they want to sell too, they 
are going to try scare tactics. Government doesn't seem to come 
in and defend those people that are using reclaimed water. They 
have led them down the path in saying this is okay to do it but 
now that there is an alarm in the field, that we don't defend 
them. And that is the kind of balance that we need to look at, 
is more appropriate applied enforcement. I guess my time is up, 
Mr. Chairman.
    Mr. Skeen. I believe it is. Mr. Dickey.

                                 Ru-486

    Mr. Dickey. Commissioner Henney, you have given a 
conditioned approval to the drug RU-486. And there is further 
study being made. Is there any being made on the psychological 
effects of the drug on women or the long term medical 
consequences by your Department?
    Dr. Henney. There is--let me ask. Mr. Dickey, you asked me 
specifically if there were any research like that going on in 
my Department. The answer to that, is no. What I was consulting 
Dr. Woodcock about was did she know of any research like that 
going on anywhere. I think what we would have to do is go back 
to our European colleagues and see. Neither of us know if that 
kind of research is ongoing or not.
    [The information follows:]

    The primary clinical trials conducted by the sponsor to 
support the safety and efficacy of mifepristone--RU-486--were 
discussed before the Reproductive Health Advisory Committee in 
July 1996. These clinical studies did not include an evaluation 
of the psychological effects of the drug in women or an 
evaluation of the long-term medical consequences of the drug in 
women. FDA is unaware of any published studies on the 
psychological effects or the long-term medical consequences of 
mifepristone in women.

                           cecure application

    Mr. Dickey. Could you do that. Could I ask you to do that? 
There is no rush on it but just some report in that respect. I 
would like to mention something to you that I have mentioned 
before and that is Cecure, there is an application before your 
Department about that. Can you tell me the status of that?
    Dr. Henney. Mr. Dickey, I think, as I mentioned to Mr. 
Kingston, much of the material that we receive from a company 
must remain confidential in terms of trade secrets kind of 
status. I think that if the committee wants a briefing on that 
matter we would have to go into executive session or we would 
be glad to keep you apprised on what the issues are, Mr. 
Dickey, individually.
    Mr. Dickey. I appreciate what you are saying. The thing I 
need is just the time as to when you project that we might get 
some response or my constituent might get some response. We can 
do that apart from here.
    Dr. Henney. We are working actively on that and I will get 
back to you in terms of when we might have a response on it.
    [The information follows:]

    One firm has submitted a generally recognized as safe--
GRAS--notice to inform FDA of its view that the product Cecure 
is exempt from premarket approval for use as an antimicrobial 
because that use is GRAS. We provided a response to this firm 
today, February 29, and have scheduled a meeting with the firm 
on March 31, to further discuss issues related to this GRAS 
notification.

    Mr. Dickey. Thank you. That is all the questions I have.
    Mr. Skeen. Ms. DeLauro.

                                Tobacco

    Ms. DeLauro. Thank you, Mr. Chairman. Commissioner, what I 
will do and I don't want you to have to go through this again, 
is just have my question submitted to you, if you wouldn't mind 
to lay out with the additional funds that you are requesting 
for the tobacco prevention efforts what would that allow you to 
do, how much stronger, or weaker we might be in this process. 
But I want to know what would this in your estimation allow us 
to do in terms of preventing youngsters from starting to smoke?
    Let me ask a couple questions if I might. A constituent of 
mine, Mark Mushin, is the father of a child with Canavan's 
disease, a hereditary brain disease that affects very young 
children. The average life-span of Canavan's child is 5 to 10 
years. Just in terms of these kinds of illnesses what is the 
time span for reviewing potentially life saving drugs 
especially for such rare diseases? How do you prioritize which 
therapies to review?

                                 PDUFA

    Dr. Henney. Ms. DeLauro, in this kind of situation, the FDA 
Modernization Act and the Prescription Drug User Fee Act speak 
to this issue of serious and life threatening illness. We have 
very tight performance standards to meet and in this area the 
review time is on average less than 6 months from the time we 
begin application review.

                      medical device reprocessing

    Ms. DeLauro. On February 11th, the Hartford Courant 
reported that the FDA is considering raising the safety 
standards for the reuse of medical devices. One of the concerns 
I have is about the need to balance quality patient care with 
cost savings. Do you know of any data that indicates that 
people have actually been injured or put at increased risk by 
the means of single used devices?
    Second, does the FDA have all the authority that it needs 
to effectively regulate the reprocessing of medical devices 
labeled for single use. And, third, have the FDA's quality 
system regulations that regulate third party reprocessors been 
working to protect the public sufficiently to ensure that 
safety of these reprocessed medical devices that have 
originally been labeled for single use?
    Dr. Henney. Ms. DeLauro, I would ask the Center Director 
David Feigal to come and elaborate on your three questions. I 
think that we do have authority in this area with respect to 
reprocessors that are spoken to in our basic food, drug and 
cosmetic law. We are in the process of--and very active process 
of looking at this issue again with risk-base analysis, that is 
where people are at most risk--and we make sure we devise an 
appropriate regulatory scheme. But I will let Dr. Feigal 
explain that.
    Dr. Feigal. The question often comes up whether or not 
there have been injuries and, in fact, there have been some 
reports, but in general they are the same types of injuries 
that occur when the devices are used new. Part of the problem 
is it is difficult to tell when a device has been reused. But 
even if there weren't injuries we would still be concerned that 
devices would perform satisfactorily, that they would be well 
manufactured devices, and that they would meet the quality 
systems requirements that you alluded to.
    We do inspect the third party reprocessors. Some of them 
actually haven't recognized that we have jurisdiction over them 
and we are in the process of finding some of them in order to 
begin this process. The warning letters that have been issued 
for that are public. There have been 11 of them in the last 
year and we are working with that segment of the industry to 
make sure what they reprocess will result in devices that are 
safe.
    Ms. DeLauro. Thank you very much. Thank you, Commissioner. 
Thank you, Mr. Chairman.

                            Los Angeles Lab

    Mr. Skeen. I think this just about gets us to the final 
stages of this thing. I will close it by making some comment. 
We had a discussion about the laboratory in California. It is 
really a disappointment to me in the travels that I have made 
throughout the country and overseas and so forth that the 
laboratories that we are getting the sizes are not adequate for 
the work that we are getting done today and the requirements 
done today. I don't know why we haven't kept up with the 
modifications to make us, to give us the tools to work with. 
And the laboratories I think are very important. Well, there 
goes another deal, we can make a big investment in it. But I 
think the science that you are dealing with today has to have a 
better laboratory base from which to work on it. They are not 
getting equipped with better equipment and state-of-the-art. 
But I just want to tell you that people in these laboratories 
are top notch. Plus given the stuff to work with, I know it is 
expensive, but it can be done. We have--we are just not giving 
our folks the tools to work with. So thank you for what you do 
and how well you do it, and your Department and the rest of it. 
We appreciate that.
    So without any further ado, thank you very much.
    Mr. Farr. We can submit questions for the record.
    Mr. Skeen. Absolutely. Thank you.

                    prescription drug marketing act

    Clerk's Note.--FDA has delayed the effective date of some 
provisions of the Prescription Drug Marketing Act. The Federal 
Register notice regarding this matter, published May 3, 2000, 
is on page 1362 of this volume.

                          Tobacco Jurisdiction

    [Clerk's Note.--The following statement explains the March 
21, 2000, Supreme Court decision on FDA's authority over 
regulation of tobacco.]

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                           W I T N E S S E S

                              ----------                              
                                                                   Page
Byrd, R.J........................................................     1
Feigal, David....................................................     1
Henney, Dr. Jane.................................................     1
Levitt, J.A......................................................     1
Rainer, W.J......................................................  1051
Reyna, Michael...................................................   886
Schwetz, Dr. Bernard.............................................     1
Williams, D.P....................................................     1
Woodcock, Dr. Janet..............................................     1


                               I N D E X

                              ----------                              

                      Food and Drug Administration

                                                                   Page
Animal Drugs:
    Electronic Submissions.......................................    92
    Inspections..................................................    90
    Premarket Review.............................................    91
    State Contracting............................................    91
Antimicrobial/Antibiotic Resistance:
    FDA Action..............................................93, 496-498
    NARMS..................................................93, 497, 555
    Product Approval.............................................   555
Application Review:
    Animal Drugs.................................................    91
    Devices.....................................................112-117
    Foods.......................................................228-236
    Generic Drugs.....................................293-297, 404, 553
    Human Drugs............................................129-132, 345
    Performance..................................................   550
    Statutory Requirements and Funding...........................   553
Biographical Sketches:
    Dr. Bernard Schwetz..........................................    33
    Dr. David Feigal.............................................    36
    Dr. Jane Henney..............................................    32
    Dr. Janet Woodcock...........................................    38
    Mr. Dennis Williams..........................................    35
    Mr. Joseph Levitt............................................    37
    Mr. Robert Byrd..............................................    34
Budget:
    Advance Appropriations.......................................   109
    Contingency Fund.............................................   112
    Current Services.............................................   112
    Enacted vs. Actual..........................................101-103
    Initiatives by Program.......................................   104
    PDUFA Resources..............................................   348
    Reprogramming................................................   351
    Rescission and Current Service Table.........................   108
    Rescission Distribution......................................   109
    User Fee Table...............................................   106
Buildings and Facilities:
    Arkansas Regional Laboratory.................................69, 94
    College Park.................................................   138
    Consolidation Plan...........................................   133
    Field Consolidation.........................................134-138
    Los Angeles Laboratory..................................84, 317-319
    Renovation...................................................   133
    Rent.......................................................350, 351
    White Oak Consolidation....................................390, 391
Congressional Justification......................................   564
Devices and Radiological Products:
    510(k) Application Review...................................112-115
    Application Review.........................................116, 117
    Breast Implants............................................392, 559
    Classification...............................................   118
    Cochlear Implant Device.....................................74, 546
    Grants and Contracts.........................................   118
    Inspections..................................................   115
    Laser Eye Surgery............................................   548
    Mammography................................................320, 321
    Regulatory Actions...........................................   115
    Reprocessing Single Use Devices...............83, 405-407, 412, 549
    Reprocessing Devices, List..................................407-411
    Resources....................................................   117
    User Fees..................................................388, 389
Explanatory Notes................................................   564
Food Safety Initiative:
    Accomplishments.............................................75, 287
    Annual Report...............................................240-282
    Components............................................236, 504, 505
    Goals.......................................................237-239
    Research....................................................283-286
    Resources.............................................236, 286, 505
    Surveillance................................................288-292
Foods:
    Accomplishments Summary.....................................507-528
    Additives....................................................42, 78
    Agricultural Biotechnology...................................   558
    Allergens....................................................    67
    Annual Summary..............................................148-151
    Application Review.....................................228-235, 236
    Biotechnology................................................    79
    Bottled Water..............................................391, 392
    Codex Alimentarius Commission..............................110, 412
    Dietary Supplements..........................................   120
    Egg Safety........................................43, 132, 393, 550
    Ephedra.......................................43, 76, 132, 562, 563
    Equivalency Audits......................................77, 142-144
    Food Contact Notification....................................   140
    Gentically Modified or Engineered.......................80, 400-402
    Imports.....................................................144-146
    Imports, Rejection Rates....................................413-490
    Inspection--Domestic....................................76, 146-148
    Inspection--Foreign.........................................140-142
    Interagency Cooperation......................................   560
    International Food Safety...................................412-490
    Irradiation--Policy and Labeling......................55-60, 67, 78
    Irradiation--Brochure........................................ 60-66
    Labeling..............................................148, 545, 553
    Priorities for FY2000.......................................529-544
    Recalls and Seizures........................................151-153
    Recalls, FY 1999 List.......................................153-227
    Seafood Equivalency Agreements..............................373-375
    Seafood HACCP Inspection....................................376-384
    Seafood Proposed Transfer.............................375, 384, 385
    Seafood Safety.............................................375, 376
Human Drugs and Biologics:
    AIDS/HIV..................................................... 87-90
    Application Review..........................................129-132
    Blood Safety............................................98-101, 503
    Foreign Drug Purchases.......................................    72
    Generic Drugs............................54, 293-297, 404, 405, 553
    Inspections................................................128, 129
    Insulin.....................................................71, 300
    Internet Drug Sales..........................313-317, 402, 403, 561
    Intravenous Gamma Globulin...................................   551
    Orphan Drug Program.....................341-343, 403, 404, 546, 561
    Prescription Drug Marketing Act..45-53, 84, 344, 345, 556-558, 1362
    Prescription Drug User Fee Act......................74, 83, 345-348
    Product Quality Research Initiative..........................   371
    RU-486......................................................82, 547
    Terbutaline..................................................   545
    Vaccines.....................................................   561
Imports, Volume and Funding..........................298, 299, 498, 503
Inspections:
    Animal Drugs.................................................    90
    Devices......................................................   115
    Foods...................................................76, 144-148
    Human Drugs................................................128, 129
    Inventory of Firms...........................................   300
    Statutory Requirements............................301, 302, 498-503
International Activities:
    Foreign Inspection.....................................140-142, 313
    MRAs and MOUs...............................................302-306
    U.S.-EU MRA.................................................306-313
Medical Errors:
    Medical Errors.................................39, 335-339, 493-496
    MedWatch.....................................................   491
    Relation to Rick Management Needs..........................370, 371
    Risk Management Program Goals................................   369
    Risk Management Report......................................352-368
National Center for Toxicological Research.......................   339
Opening Statement by Dr. Henney..................................     2
Other Activities:
    Advisory Committees..........................................    86
    Bioport Facility.............................................    71
    Bioterrorism..............................................70, 94-98
    Cecure Application...........................................    82
    Clinical Pharmacology........................................   110
    Congressional Directives, Status of.........................120-128
    FOIA.........................................................    45
    Health Fraud.................................................   297
    Legislative Proposals......................................389, 390
    Leveraging and State Partnering...................39, 371, 372, 385
    Management Reorganization...................................321-334
    Mental Health...........................................41, 397-399
    Office of Criminal Investigations............................   340
    Organizational Chart.........................................   333
    Personnel.............................................339, 349, 350
    Priorities..............................................40, 491-493
    Risk Management.............................................352-371
    Science and Research..............................138-140, 371, 373
    Supreme Court Decision on Tobacco............................84, 85
    Tampering....................................................   386
    U.S. Code Citations..........................................   387
    User Fees..................................................388, 389
    Watson Pharmaceutical Company...............................394-397
Performance Plan.................................................   724
Prescription Drug Marketing Act (PDMA):
    Delay of Provisions, Notice................................84, 1362
    Effect on Wholesalers..................45, 46-53, 344, 345, 556-558
Questions Submitted for the Record:
    Mr. Bonilla..................................................   550
    Mr. Farr.....................................................   562
    Mr. Kingston.................................................   505
    Mr. Nethercutt...............................................   548
    Mr. Skeen....................................................    86
    Mrs. Emerson.................................................   556
    Ms. DeLauro..................................................   560
    Ms. Kaptur...................................................   397
Statement by FDA Commissioner....................................    11
Tobacco:
    Bidi Cigarettes..............................................   560
    Funding......................................................   386
    Jurisdiction............................................84, 85, 387
    Prevention and Compliance..........................68, 83, 386, 387
    Supreme Court Decision on Jurisdiction.......................    85

                       Farm Credit Administration

Accountability Report Fiscal Year 1999...........................   921
Annual Performance Plan..........................................  1029
Audit............................................................   901
Biography--Michael M. Reyna......................................   919
Biography--Ann Jorgensen.........................................   920
Condition of the Farm Credit System..............................   892
Examination Issues...............................................   900
Farm Credit Leasing Services Corporation.........................   916
Farm Credit System Insurance Corporation.........................   912
Farm Credit System Senior Officer Compensation...................   911
Farm Credit System Structure.....................................   897
Farmer Mac.......................................................   914
FCA Operations...................................................   895
FCA Staffing.....................................................   895
FCS Building Association.......................................905, 988
FCS Market Share.................................................   917
Federal Agricultural Mortgage Corporation........................   893
Fiscal Year 1999 Accomplishments.................................   887
Fiscal Year 2001 Budget Request..................................   893
Fiscal Year 2001 Proposed Budget.................................   999
Litigation Involving FCA.........................................   910
Mission of the Farm Credit Administration........................   887
National Consumer Cooperative Bank...............................   899
Office of Inspector General......................................   916
Questions Submitted by Chairman Skeen............................   895
Regulatory Issues................................................   904
Risk Assessment..................................................   901
Sole Source Contracts and Consulting Services Contracts..........   906
Testimony--Michael M. Reyna......................................   886
Year 2000 Technology Issues......................................   918
Young, Beginning, and Small Farmers..............................   917

                  Commodity Futures Trading Commission

Advisory Committees..............................................  1351
Agricultural Advisory Committee..................................  1361
Agriculture Trade Options........................................  1327
Agricultural Trade Options Rule Modifications....................  1328
Agricultural Trading Volume......................................  1328
Annual Performance Plan:
    Goal 1.......................................................  1197
    Goal 2.......................................................  1223
    Goal 3.......................................................  1270
Appropriations and Authorized FTEs...............................  1351
Budget:
    Executive Summary............................................  1074
    Mission Statement............................................  1082
    Significant Developments.....................................  1086
    Market Surveillance Analysis and Research....................  1102
    Trading and Markets..........................................  1109
    Enforcement..................................................  1117
    Proceedings..................................................  1126
    General Counsel..............................................  1131
    Executive Direction and Support..............................  1139
    Improving Efficiency and Effectiveness.......................  1145
    Working Relationships........................................  1157
Carryover Funds..................................................  1323
Changes from OMB Request.........................................  1323
Charge Card Usage................................................  1323
Civil and Administrative Proceedings.............................  1346
Civil Monetary Penalties.........................................  1338
Civil Monetary Penalties (FY 1990-1999)..........................  1339
Civil Monetary Penalities from Administrative Proceedings........  1347
Civil Monetary Penalitie Imposed and Collected...................  1339
Contract Market Designations/Rule Reviews/Fast-track.............  1356
Commodity Futures Trading Commission and National Futures 
  Association....................................................  1329
Cooperative Enforcement and Regulation...........................  1342
Derivatives Policy Group.........................................  1324
Dual Trading Fraud...............................................  1336
Dual Trading Investigations/Exchange Database System.............  1336
Electronic Filing of Financial Reports...........................  1359
Enforcement Investigations.......................................  1342
FY 1999 Activities of the Office of International Affairs........  1352
Firm Failures....................................................  1337
Foreign Assistance...............................................  1339
Global Market Advisory Committee.................................  1360
Inspector General Investigations and Audits......................  1325
New Contracts Approved...........................................  1348
NFA Disciplinary Actions.........................................  1330
Non-Electronic Oversight.........................................  1335
Pending Designation Applications.................................  1348
Percentage of Foreign Exchanges' Budgets Financed from 
  Transaction Fees...............................................  1332
President's Working Group on Financial Markets...................  1337
Questions for the Record:
    Mr. Skeen....................................................  1323
Rainer:
    Testimony....................................................  1051
    Biography....................................................  1066
Regional Offices.................................................  1331
Registered Introducing Brokers...................................  1352
Reparations Program..............................................  1354
Risk Management Education........................................  1355
Self-Policing Activities.........................................  1337
Service Fees.....................................................  1330
Surveillance System..............................................  1354
Trade Practice Matters...........................................  1341
Transaction Fees Charged by Foreign Exchanges....................  1333
Travel Budget....................................................  1339
Volume for Foreign Exchanges.....................................  1331
Working Relationship between the CFTC and the SEC................  1334
Y2K Compliance...................................................  1326

                                
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