[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



                  AGRICULTURE, RURAL DEVELOPMENT, FOOD

                  AND DRUG ADMINISTRATION, AND RELATED

                    AGENCIES APPROPRIATIONS FOR 2003

_______________________________________________________________________

                                HEARINGS

                                BEFORE A

                           SUBCOMMITTEE OF THE

                       COMMITTEE ON APPROPRIATIONS

                         HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS
                             SECOND SESSION
                                ________
     SUBCOMMITTEE ON AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG 
                  ADMINISTRATION, AND RELATED AGENCIES
                     HENRY BONILLA, Texas, Chairman
 JAMES T. WALSH, New York            MARCY KAPTUR, Ohio
 JACK KINGSTON, Georgia              ROSA L. DeLAURO, Connecticut
 GEORGE R. NETHERCUTT, Jr.,          MAURICE D. HINCHEY, New York
Washington                           SAM FARR, California
 TOM LATHAM, Iowa                    ALLEN BOYD, Florida         
 JO ANN EMERSON, Missouri
 VIRGIL H. GOODE, Jr., Virginia
 RAY LaHOOD, Illinois               
                         
 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, Martin P. Delgado, Maureen Holohan, and Joanne L. 
                        Perdue, Staff Assistants
                                ________
                                 PART 5

                          AGRICULTURAL PROGRAMS
                                                                   Page
 Food and Drug Administration.....................................    1
 Farm Credit Administration.......................................  809
 Commodity Futures Trading Commission............................. 1003

                              

                                ________
         Printed for the use of the Committee on Appropriations
                                ________
                     U.S. GOVERNMENT PRINTING OFFICE
 78-956                     WASHINGTON : 2002





                      COMMITTEE ON APPROPRIATIONS

                   C. W. BILL YOUNG, Florida, Chairman

 RALPH REGULA, Ohio                  DAVID R. OBEY, Wisconsin
 JERRY LEWIS, California             JOHN P. MURTHA, Pennsylvania
 HAROLD ROGERS, Kentucky             NORMAN D. DICKS, Washington
 JOE SKEEN, New Mexico               MARTIN OLAV SABO, Minnesota
 FRANK R. WOLF, Virginia             STENY H. HOYER, Maryland
 TOM DeLAY, Texas                    ALAN B. MOLLOHAN, West Virginia
 JIM KOLBE, Arizona                  MARCY KAPTUR, Ohio
 SONNY CALLAHAN, Alabama             NANCY PELOSI, California
 JAMES T. WALSH, New York            PETER J. VISCLOSKY, Indiana
 CHARLES H. TAYLOR, North Carolina   NITA M. LOWEY, New York
 DAVID L. HOBSON, Ohio               JOSE E. SERRANO, New York
 ERNEST J. ISTOOK, Jr., Oklahoma     ROSA L. DeLAURO, Connecticut
 HENRY BONILLA, Texas                JAMES P. MORAN, Virginia
 JOE KNOLLENBERG, Michigan           JOHN W. OLVER, Massachusetts
 DAN MILLER, Florida                 ED PASTOR, Arizona
 JACK KINGSTON, Georgia              CARRIE P. MEEK, Florida
 RODNEY P. FRELINGHUYSEN, New Jersey DAVID E. PRICE, North Carolina
 ROGER F. WICKER, Mississippi        CHET EDWARDS, Texas
 GEORGE R. NETHERCUTT, Jr.,          ROBERT E. ``BUD'' CRAMER, Jr., 
Washington                           Alabama
 RANDY ``DUKE'' CUNNINGHAM,          PATRICK J. KENNEDY, Rhode Island
California                           JAMES E. CLYBURN, South Carolina
 TODD TIAHRT, Kansas                 MAURICE D. HINCHEY, New York
 ZACH WAMP, Tennessee                LUCILLE ROYBAL-ALLARD, California
 TOM LATHAM, Iowa                    SAM FARR, California
 ANNE M. NORTHUP, Kentucky           JESSE L. JACKSON, Jr., Illinois
 ROBERT B. ADERHOLT, Alabama         CAROLYN C. KILPATRICK, Michigan
 JO ANN EMERSON, Missouri            ALLEN BOYD, Florida
 JOHN E. SUNUNU, New Hampshire       CHAKA FATTAH, Pennsylvania
 KAY GRANGER, Texas                  STEVEN R. ROTHMAN, New Jersey    
 JOHN E. PETERSON, Pennsylvania
 JOHN T. DOOLITTLE, California
 RAY LaHOOD, Illinois
 JOHN E. SWEENEY, New York
 DAVID VITTER, Louisiana
 DON SHERWOOD, 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 2003

                              ----------                              

                                          Thursday, March 21, 2002.

                      FOOD AND DRUG ADMINISTRATION

                               WITNESSES

LESTER CRAWFORD, D.V.M., PH.D., DEPUTY COMMISSIONER, FOOD AND DRUG 
    ADMINISTRATION
DANIEL TROY, CHIEF COUNSEL, FOOD AND DRUG ADMINISTRATION
JEFFREY WEBER, ACTING SENIOR ASSOCIATE COMMISSIONER, OFFICE OF 
    MANAGEMENT AND SYSTEMS
    Mr. Latham [presiding]. The Subcommittee will come to 
order. Good morning, everyone. Unfortunately Chairman Bonilla 
couldn't be with us today. As we speak, he is on Air Force One 
with President Bush. The President is stopping in the 
chairman's district on his way to meet with President Fox of 
Mexico. Chairman Bonilla's congressional district covers more 
than 800 miles of the Texas-Mexico border, and he serves as a 
cochairman of the Border Caucus. As part of the trip with 
President Bush, they will be reviewing the border activities 
with a number of agencies, including the FDA.
    Dr. Crawford, I understand the FDA has a number of people 
standing at attention waiting for his arrival. I am sure the 
chairman is disappointed to miss today's hearing, but rest 
assured we have a lengthy list of questions for the record. He 
is definitely here in spirit.

                       Introduction of Witnesses

    Today marks the subcommittee's last hearing on the fiscal 
year 2003 budget request. We are pleased to have before us the 
Food and Drug Administration. This agency's work affects every 
American. The vast array of FDA-regulated products includes 
devices for medical tests, medicines for humans and animals, 
blood, and food from seafood to salsa. FDA is represented today 
by its new Deputy Commissioner Lester Crawford and his 
colleagues Murray Lumpkin, deputy to Dr. Crawford, and Jeff 
Weber, the acting CFO. In the audience, we also have FDA's 
center directors who may be called upon when we get into 
certain specifics. I speak for all the subcommittee members in 
thanking you for being here today.
    Before we hear your testimony, Dr. Crawford, I would like 
to turn to my colleague, the Ranking Member of the 
subcommittee, for any opening remarks she may have.
    Ms. Kaptur. Thank you very much, Dr. Crawford. We welcome 
you and your associates. You obviously have extraordinarily 
important responsibilities. We want to hear about those and 
your budget proposal this year. Thank you so much for appearing 
here today and for your great service to our country. I look 
forward to your testimony.
    Mr. Latham. If you would go ahead with your opening 
comments. I am going to have to step out for a few minutes, and 
Mr. LaHood will assume the Chair. I will return.

                           Opening Statement

    Mr. Crawford. Mr. Chairman, members of the subcommittee, 
good morning. Allow me to introduce myself. I am Lester 
Crawford, the Deputy Commissioner of Food and Drugs, an agency 
of the Department of Health and Human Services. This is my 
fourth stint at FDA. I also served as Administrator of the Food 
Safety and Inspection Service at USDA from 1987 to 1991. I am 
joined at the table, as the Chairman stated, by Dr. Murray 
Lumpkin and also Mr. Jeff Weber.
    Mr. Chairman, members of the subcommittee, I am honored to 
be here to discuss the President's budget for the Food and Drug 
Administration for fiscal year 2003. The origins of the Food 
and Drug Administration go back to the Food and Drugs Act of 
1906, which expressed the will of Congress to protect Americans 
against misbranded and adulterated foods, drinks and drugs in 
interstate commerce. This was but the first step. Over the 
years Congress saw fit to enlarge the FDA's public health 
mandates to cover not only 80 percent of the national food 
supply, but also all human drugs, vaccines, blood for 
transfusion and blood products, tissues for transplantation, 
medical devices and devices that emit radiation, cosmetics and 
all feed and drugs for animals.
    Today our Agency is responsible for the safety, or safety 
and effectiveness, of $1 trillion worth of products on which 
Americans depend daily for their lives, nutrition and good 
health. The FDA's overall success in performing this mission is 
reflected in the traditionally well-protected public health and 
the high quality of life that are among America's most widely 
admired hallmarks. In this sense, the international reputation 
and leadership of FDA are without parallel.
    The more specific recent achievements of the Agency are 
discussed in my written testimony, which describe some of the 
Agency's actions to meet its considerable responsibilities in 
the last year. It is a record we are proud of, especially those 
accomplishments relating to FDA's rapid and effective responses 
to the terrorist attacks last September. It is a record that I 
believe measures up to the confidence that Congress has placed 
in our Agency.
    Among other subjects, my written testimony briefly outlines 
FDA's contribution to the continually improving safety and 
security of America's food, FDA's important role in the system 
of safeguards against Bovine Spongiform Encephalopathy, or mad 
cow disease, and the Agency's actions to prevent the 
development of antimicrobial resistance and to protect human 
participants in clinical trials. The document also lists some 
of the hundreds of highly complex and innovative healthcare 
products that the FDA last year approved for marketing, drugs, 
biological medications and medical devices that have tremendous 
potential to relieve human suffering as well as stimulate our 
economy.
    It is on this record of accomplishment that the President 
has based his budget request of $1.7 billion, 295 million of 
which is in user fees, for the FDA in the next fiscal year. Our 
budget seeks resources to maintain our counterterrorism 
efforts, fully fund the proposed pay increase for our 
employees, expand our efforts in patient safety and generic 
drugs, and continue funding for our new financial management 
system.
    Mr. Chairman, members of the subcommittee, as taxpayers as 
well as civil servants, we at FDA fully appreciate the 
importance of maintaining strict budgetary discipline. We are 
also conscious of the imperative of protecting the health of 
American people in an environment that is constantly evolving. 
As we look ahead, we must complete a number of significant 
projects, projects that are vital to this Nation of ours.
    We must continue to improve our counterterrorism 
preparedness. That means ensuring the security of the products 
the FDA regulates and safeguarding the availability of vaccines 
and other medications that can mitigate the potential impact of 
terrorism on America.
    We must satisfy the higher expectations of American 
consumers. They demand and deserve effective public health 
protection and ready access to health-related information even 
as their demographic and consumption patterns are becoming more 
diverse.
    We must prepare for the coming arrival of a new generation 
of efficacious medical products. These new drugs and devices 
can transform the practice of medicine and bring unprecedented 
health benefits to millions. But first their safety and 
effectiveness must be assessed by our Agency.
    We must continue on a comprehensive and open manner of 
evaluation of genetically modified food products. The 
technology is increasingly used to make American food more 
available and plentiful, but international acceptance of this 
technology is not yet complete.
    And, we must make sure that our public health activities 
are in harmony with the new world of international trade.
    These are needful goals, and I can assure you that the FDA 
will address them thoughtfully and effectively. Our most 
effective instrument, as always, will be science, which is the 
firm, factual and objective ground on which the FDA places its 
product evaluations, its regulations and its public health 
policies. And our most critical need, also as always, will be a 
steady resource commitment and continued support from the 
United States Congress.
    We are grateful for the support this committee has provided 
in recent years. The FDA looks to you, Mr. Chairman, your 
subcommittee and Congress to sustain our efforts to provide the 
American people the public health protection that is the pride 
of the world.
    In closing, let me also mention that FDA fully ascribes to 
the One HHS policy of Secretary Thompson. This ensures that our 
resources and expertise will be enhanced by a seamless system 
of cooperation with CDC, NIH and the Office of the Surgeon 
General as well as the other public health resources of the 
Department of Health and Human Services.
    My colleagues and I will be pleased to respond to your 
questions. Thanks very much.
    Mr. LaHood [presiding]. Thank you Dr. Crawford.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    
    Mr. LaHood. I would like to recognize Mrs. Emerson, who has 
to go to another meeting and would like to ask you a couple of 
questions. I thank you, Ms. Kaptur, for allowing Mrs. Emerson 
to go ahead.


                                PATENTS


    Mrs. Emerson. Dr. Crawford, thank you very much for being 
here. This is kind of an arcane issue and somewhat complex on 
the face of it, but let me see if I can sort of plow through 
it. And the issue has to do with patents and the submission of 
what could possibly be considered frivolous patents by brand-
name pharmaceutical companies. I know at least the FDA says 
that it does not have legal or statutory authority to actually 
review a patent in the same manner that the Patent Office does. 
However, the process by which a brand name company would issue 
a new patent, perhaps what some might term a frivolous patent, 
the process basically is they submit the patent to you, and you 
put it in what is called the Orange Book; is that correct?
    Dr. Crawford. That is correct.
    Mrs. Emerson. And so then immediately upon getting listed 
in that Orange Book, a pharmaceutical company can get up to 30 
months of a stay or the patent extension; is that correct?
    Dr. Crawford. Yes.
    Mrs. Emerson. So even if the patent is frivolous and 
perhaps not worthy of consideration as a patent and falls under 
what--the four categories that shouldn't be considered patents, 
like process and all of those, it still stays in the orange 
book and is--and the company still gets a 30-month delay, or a 
generic equivalent or bioequivalent would not be able to come 
onto the market; is that correct?
    Dr. Crawford. That is correct.
    Mrs. Emerson. So on this patent submission form that you 
all ask, is there not another series of questions that you 
could ask that at least would fall under the four categories 
for which a patent is not allowed so that someone on your staff 
who, while not being a patent attorney, at least has to review. 
We could add to this list of checkoffs so that we could perhaps 
prevent these patents from being listed in the Orange Book and 
delaying a process for which a generic could come on the 
market?
    Dr. Crawford. We have had discussions about this, very 
serious indeed, and as you said, it is an extremely arcane and 
legal issue. With your permission, I would like to ask our 
chief counsel, Mr. Dan Troy, to come forward and comment on 
this as well as the Director for the Center of Drugs, Dr. Janet 
Woodcock. They will flank us with more expertise than is 
presently at the table.
    Mr. Troy. Let me clarify a few things. This is a very 
serious issue. We had a 7-hour symposium recently in which we 
invited the generic industry and the innovator industry to come 
in and talk to us about this, and we are looking at the issue 
very seriously. So I think you raised some very important 
issues.
    The first thing is you need to understand that it doesn't 
automatically happen once there is a later-listed patent that 
you get the 30-month stay. First of all, the patent has to be 
one that is issued by the Patent Office. The innovator just 
can't get any patent. There is an independent intergovernmental 
check on whether or not the patent at least meets the prima 
facie test or whatever test the Patent Office applies to 
issuing a patent.


                             PATENT REVIEW


    Mrs. Emerson. How long does it take from the time of 
submission of a patent to review by someone in the Patent 
Office to make sure it is a legitimate----
    Mr. Troy. I don't know the answer to that, but I believe it 
takes a fairly long time to get a patent.
    Mrs. Emerson. So that patent has to be submitted before 
they submit it to you to put in the orange book?
    Mr. Troy. They have to have a valid patent from the Patent 
Office. Then the innovator lists this later issued patent 
provided for in the statute. The statute anticipates that that 
will happen. Then if the generic believes that it needs to 
challenge that, it files what is called a paragraph 4. We 
already can and we do on occasion go back to the innovative 
company and ask them to recertify everything that they have 
already put in their certification. That is point one.
    Point two is I have asked a number of times whether or not 
there is a problem with process patents being listed. Process 
patents are explicitly prohibited from being listed by the 
statute and our regs. and there is a sense that the generic 
industry was unable to point to any process patent. There are 
product by process patents, methods of use patents, but no true 
process patent has been applied or has been later listed.
    The reason why FDA has not--has not gotten into the 
business of assessing the validity of the patents is twofold. 
First of all, the statute says if it is listed, we shall list 
the patent. Number two, we really don't have the expertise to 
do the kinds of things that the generics would like us to do. 
And the third thing is although FDA does not have the record of 
success in the courts that some of us would like to have seen 
with respect to Hatch-Waxman, the one position that the courts 
have universally indicated is that we only serve a ministerial 
function in this regard. That is the one thing the courts have 
made very clear, and even if we tried to get into the business 
of doing this, which would be an enormous resource challenge, 
it is not clear that we have the authorization to do so, and we 
would be flying in the face of a lot of case law.


                         PATENT RECERTIFICATION


    Mrs. Emerson. Mr. Chairman, I know I am at the end of my 
time. Can I just ask a follow-up question, because I am going 
to have to leave, and I am not going to be able to finish this 
line of questioning.
    I have a letter here from Secretary Thompson to Senator 
Kennedy, and I am so sorry I don't know what date it is, but it 
is close to the end of last year, and it does say that in 
exercising its responsibility, FDA is careful to ensure that an 
orange book listing is not frivolous or tenuous on its face. 
But it seems to me--and FDA may ask for clarification to ensure 
that the patent covers the formulation of the proof product. 
That would require a fair amount of expertise, wouldn't you 
say, to make that examination?
    Mr. Troy. We do as much as we can to try and ensure that 
they are not frivolous, tenuous listings, and we do ask for 
recertification. And remember, at the end of the day, if a 
company is making false statements to the United States 
Government, that is a criminal problem. And so we do as much as 
we can, but there are resource limits and, more importantly, 
legal limits as ratified by the courts on what we can do in 
this area.
    Mrs. Emerson. But you do admit that there are many examples 
of frivolous patents.
    Mr. Troy. I am waiting for a list from the generic 
industry. I have asked them a number of times for a list of 
those cases. I don't know the answer to that. Certainly in the 
case of a number of big blockbuster drugs there have been later 
listed patents, some of which were later found by courts not to 
be valid. Whether it is as ubiquitous a problem as it is 
sometimes portrayed, and whether it was fixing that problem as 
opposed to fixing the 30-month stay problem would have an 
effect on generic drugs.
    Ms. DeLauro. Would the gentlelady yield.
    Mrs. Emerson. Let me do that right now, and then I have got 
to finish up.
    Ms. DeLauro. I think this is an incredibly important issue 
that the gentlelady has raised and one that I believe a number 
of us have some questions on. If you could, Dr. Crawford and 
Mr. Troy, and make yourselves available, and it doesn't have to 
be in the formal setting that we have here in the hearing. 
There are many, many questions attached to this issue of 
generic drugs including recent articles in the Wall Street 
Journal. If you could come up in an informal way so we would be 
able to ask the questions that the gentlelady is asking and 
other questions that this subcommittee might have.
    Dr. Crawford. May I ask if Dr. Woodcock would like to 
respond?
    Mr. LaHood. Proceed.
    Dr. Woodcock. Well, I simply echo what Mr. Troy said, that 
we do go back and ask the companies to certify, again, when 
these patents are placed in, that they are not process patents, 
that they are the correct patents, and that they pertain to the 
formulation. Since we reviewed these products, it does not 
require a tremendous amount of expertise to do that. And we 
think these patents do relate, the ones we list in the Orange 
Book, to the formulation and are correct in that regard. 
Whether they are valid patents or not for the purposes of the 
statute is something the courts decide.
    Mrs. Emerson. And I appreciate what you are saying, and I 
am sure my colleagues will be able to carry on this line of 
questioning. And I will say, though, and let me make reference 
that last year we had a discussion about this, too. In our 
conference or in our report there is language requesting that 
you all work with the Federal Trade Commission to provide a 
report on this subject to our committee, and it was to be done 
by March 1, 2002. We have not yet received it, so I would 
respectfully request that we be able to receive that report as 
soon as possible, and I thank you very much. And thank you for 
letting me go first, Mr. Chairman, and for letting me go 
longer.
    Mr. LaHood. I am told that the Senate considered this 
matter yesterday and plans to hold a hearing on this also.
    Ms. Kaptur, thank you for your indulgence.


                           FDA BUDGET REQUEST


    Ms. Kaptur. I am not a fan of these 5-minute question 
periods. It only permits simple thoughts, and you can't explore 
what we need to explore here, particularly with the significant 
type of testimony that you present, Dr. Crawford.
    I want to ask you about your budget submission. I am a 
little bit troubled by it, and I want to make sure I understand 
it completely. According to information I have that documents 
the increased amounts of imports into our country, whether it 
is food or medical devices and other FDA-regulated products, 
all of the increasing responsibilities that you have for food 
safety, for drug approvals, et cetera, the desperate need that 
we have for trying to get cost savings from prescription drugs 
through timely approval of generic drugs, as we look at your 
budget submission, you are asking for what you call an increase 
of $122 million over last year, which would on its face appear 
to be about 8 percent. But if I subtract from that what you are 
required to take from that budget for pay increases for current 
personnel and the funds you dedicate to a unified financial 
system and then the user fees that are imposed, actual program 
increases, as I read it, are less than 1 percent over last 
year. I am having a little trouble seeing how you are going to 
be able to do your job.
    I just had a neighbor who unfortunately had to go through 
radiation treatments, and his esophagus was burned. I know you 
have major responsibilities for radiological equipment 
inspection and so forth, and I am just wondering if we are 
shortchanging here. And so my question to you is for the major 
centers that you operate are the budget requests you are making 
the same ones you submitted to the Office of Management and 
Budget?
    Dr. Crawford. I am going to ask in just a moment Jeff 
Weber, who was involved in that submission, to make some 
comments about the actual increases and also the relationship 
of the supplemental to our permanent funding. Believe me, we 
appreciate your interest in our having financial capabilities 
to do our job. We are grateful for that, and we will respond as 
completely as we possibly can.
    And let me say before Jeff speaks, we are sorry about your 
neighbor. We do have major responsibilities in examining these 
kinds of devices, and each new generation of them gets safer, 
thanks to the law that we work under and also regulations that 
we promulgated, but we still have a ways to go in that respect.
    Jeff, would you offer some comments?
    Mr. Weber. No. Our budget request does not reflect what we 
had asked OMB. However, as you know, the submission to OMB was 
done before September 11, and after September 11 a lot has 
changed. We did receive $150 million in a supplemental in 
fiscal year 2002. This budget puts that money into the base. 
The supplemental was one-time funding. So even though on the 
surface it looks like we only have a 1 percent budget increase, 
it actually is a huge increase for us when you consider the 
fact that that money was one time, and now we are making it 
permanent.
    The other thing I would like to put into perspective, we 
are only one of four agencies within HHS that has a budget 
increase this year. The majority of the agencies within HHS 
actually have budget decreases and have to offset their 
counterterrorism increases in other areas of their budget. We 
don't have to do that. So we think we are very fortunate, and 
the budget represents sufficiently what we can absorb.
    Ms. Kaptur. So you are harmed less than the rest.
    Mr. Weber. Given the priorities of the situation after 
September 11, I think we are doing very well.


                           SALMONELLA IN EGGS


    Ms. Kaptur. I may have some follow-ups on that, but I want 
to get into this issue. I have this nice little egg chart that 
the Agricultural Research Service gave us when they were here 
and it reminded me of some questions that I want to ask this 
morning; The chicken and egg question really.
    I have been on this committee a long time and it is 
difficult just trying to understand food inspection 
responsibilities between you and the FSIS. Technically you have 
responsibility--responsibility for eggs, but not processed 
eggs. There is this terrific chart that FSIS produces, which 
illustrates egg safety from production to consumption. And I 
had quite a little discussion this week with my staff trying to 
understand at what point eggs are inspected, who inspects them, 
and I am hoping you can walk us through this in just a second.
    But it gets kind of fuzzy and seems to me there might be 
the potential here, as they say, between the lip and the cup 
that may be a little slip. Maybe that is true in this egg 
arena. And there appears to be an increasing incidence of 
salmonella enteritidis which is inside the yolk itself. And one 
of my questions, Doctor, is if any of you or your associates 
could tell me the rate at which this incidence has been 
increasing or just continuing, and in which regions of the 
country.
    The CDC estimates in 1998 125,000 salmonella illnesses--SE 
illnesses, but more than 10 years have passed since the problem 
of bacterial contamination of intact shell eggs were 
discovered, and a comprehensive safety strategy still has yet 
to be implemented. For example, in 1992, the GAO reported that 
due to coordination difficulties resulting from a split 
regulatory structure for eggs, the Federal Government had not 
agreed on a unified approach to address the problem. Then in 
1999, GAO reported that the Federal Government still had not 
agreed on a unified approach. Then in 2000, FDA and FSIS 
identified a current thinking paper that would decrease the 
risks. But as of September 2001, comprehensive proposed 
regulations to implement these actions had not been published.
    What happens from an inspection standpoint between the time 
an egg is laid at a poultry farm in Ohio and the time that it 
gets to my door? Could you explain this, please?
    Dr. Crawford. I am going to ask Joe Levitt from our Center 
for Food Safety to come forward and go blow by blow. I believe 
this is correct, although I think we were using this when I was 
at FSIS, and I as Administrator did not understand it either. 
But before Joe speaks, I would say the problem of salmonella 
enteriditis, as you had indicated, is very serious indeed. It 
did not enter the overduct of chickens and insinuate itself 
into the yolk until about 20 years ago in this country.
    Ms. Kaptur. How did that happen, Doctor?
    Dr. Crawford. It was a pathogen of horses and rabbits for 
most of recorded history and somehow made a species jump, and 
how it happened is not known. This kind of thing happens all 
the time. It is a major public health problem for us because 
people will say, I have eaten raw eggs all my life and still 
alive, and am not aware that bacteria change evolved and so 
forth. And although they weren't in the eggs in the 1960s and 
even early 1970s, they are in there now, and it rapidly became 
in this country and also in England the second leading cause of 
salmonella illnesses, and also from one year to another was in 
the top five of the salmonella illnesses that resulted in 
death.
    So we do have to have a comprehensive program, and Joe is 
going to take you from conception to consumption here.


                        DEATHS DUE TO SALMONELLA


    Ms. Kaptur. I wanted to ask, while Mr. Levitt is speaking, 
I know we have 5,200 deaths annually due to food poisoning in 
this country. Do you know what subset of that is due to SE?
    Dr. Crawford. While he is speaking, I think I can come up 
with a general idea.
    [The information follows:]

                        Deaths Due to Salmonella

    The Centers for Disease Control and Prevention is responsible for 
the monitoring and collection of illness rate information. The 
proportion of domestically-acquired salmonellosis that is attributed to 
SE in eggs is difficult to estimate. The estimates have a broad range 
of uncertainty around them due to the variable nature of both foodborne 
disease outbreaks and their investigations. Although eggs remain the 
predominant identified source of SE illness, there is much uncertainty 
associated with estimates of egg-associated SE illnesses. When 1998 
domestically-acquired SE illnesses (estimated to be 192,637 when 
corrected for underreporting) are adjusted to reflect the portion that 
resulted from egg-associated SE, CDC estimates that between 100,000 (53 
percent of total) and 150,000 (79 percent of total) or a midpoint of 
125,000 (66 percent of total) egg-related SE illnesses occurred in 
1998. Similarly for 1998, CDC estimated that there was a midpoint 
estimate of 1,450 egg-associated hospitalizations and 50 deaths caused 
by SE.
    FDA has undertaken a similar estimation assuming a linear 
relationship and using this same estimating procedures for 1999 and 
2000 resulted in the following numbers of illnesses, hospitalizations, 
and deaths attributed to SE in eggs:
          1999: 112,560 illnesses, 1,300 hospitalizations, 46 deaths
          2000: 131,120 illnesses, 1,520 hospitalizations, 52 deaths

    Mr. Levitt. Pleasure to see you again. Thank you for your 
support of our budget.
    In general you are correct on a couple of important points. 
One, this problem has been going on for a period of time, and 
it does involve a number of agencies. That part is correct.
    Two, although we have made a lot of progress, we still have 
more to go. But let me mention some things that have happened. 
Number one, working together with USDA, we did develop the 
first comprehensive microbial risk assessments on salmonella 
enteritidis a couple of years ago, and that report is really 
the scientific foundation for how we need to address this 
issue. And, what it basically said was there is no single step 
in this chain that is going to fix this problem; rather, we are 
going to have to address each major step in the chain and 
together with those incremental increases achieve the public 
health goals. So that is number one.
    Number two, we did start and we issued a final rule a 
little more than a year ago on labeling. You will see in the 
eggs you purchase now safe handling instructions for consumers, 
because one step in the chain that can help is if you cook 
those eggs thoroughly, it will kill the salmonella.
    Ms. Kaptur. You recommend that people don't have eggs easy 
up.
    Mr. Levitt. That is correct.
    So that is an important step of progress. We did work with 
USDA on this jurisdictional chart and basically came to a more 
simplified agreement. Our jurisdiction does reach back to the 
farms where the eggs are laid and collected. That is within 
FDA's purview. FDA would issue standards for corrective actions 
there, and that was part of the current thinking document. When 
it gets to the packing and production level, that would be 
handled by USDA, and we issued a joint plan on how we would do 
this together.

                        USDA INSPECTION OF EGGS

    Ms. Kaptur. But there are no USDA inspectors at that point, 
are there?
    Mr. Levitt. Within the packing area there are inspectors. 
Where they do egg pasteurization they do have jurisdiction. 
Whether they have inspectors there now, I am not sure. You 
would need to ask them. But they could reach it within their 
statute. So we wanted to simplify and be sure that each step of 
that chain had, if you will, one agency to look at and have it 
more seamless that way.
    Third, at the retail level we do issue the food code 
through the FDA, and the same regulation that we issued on the 
egg labeling also addresses refrigeration at the retail level, 
because the second thing from the risk assessment was if you 
keep the eggs cool, you will stop the growth. You won't kill 
the existing growth, but you will stop the growth.
    In the current thinking document we had a set of proposals 
which we are still working on and we do apologize for the time 
it has taken, but you are correct, this is an important public 
health issue. There are additional steps that can be taken to 
reduce it further, but we also have made a lot of progress. 
There are a number of States that have developed programs. I 
think the industry deserves a lot of credit for voluntary steps 
they have taken to-date. We have what is very much a consensus 
model of how we tried to approach this. Regretfully, it does 
take longer sometimes than it feels like it ought to, but this 
is very much on my radar screen.

                  GEOGRAPHIC SALMONELLA CONTAMINATION

    Ms. Kaptur. I am going to come back to this on the second 
round, but could you tell me is there continuous inspection at 
any stage, or is it mostly random, and do you have a geographic 
mapping of incidents? If I were to ask you to describe to us 
where the situation is worse, can we isolate shipments from one 
region of the country to another? Can you prevent this from 
moving? And when you said it was a species leap, Doctor, did it 
come through feed?
    Dr. Crawford. We are not sure what made it leap from one 
species to another.

                            SPECIES LEAPING

    Ms. Kaptur. We seem to have an awful lot of leaping of 
species lately, in beef and now this, that never existed before 
in the food chain, not in my adult lifetime nor yours, I don't 
think.
    Dr. Crawford. A lot has happened in my long life, but you 
are right, it is happening more frequently now. But most 
frightening are these viruses that are leaping in some subunit 
particles like the mad cow disease. So we can provide for the 
record a resume of that, and also we need to provide for the 
record what the percentage is from salmonella enteritidis. We 
know it is high. We also know that of those 5,200 deaths, that 
a measurable number will come from salmonella enteritidis. We 
rate eggs as the second leading cause of foodborne illness. And 
we will also get a map for you of where it started and how it 
has migrated.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                            SPECIES LEAPING

    Ms. Kaptur. I think it is very important for us to 
understand the origin, and you are telling me you don't know.
    Dr. Crawford. We don't know what made it leap.
    Mr. Levitt. If I may add one additional point, the data 
that CDC does collect we will provide, and I believe what that 
data will show, to my recollection, is that in those regions 
where the States have taken a lead and industry has worked with 
them and adopted stronger prevention programs is where the most 
progress has been made. There is evidence that this is a 
problem that can and needs to be addressed and success can be 
reached. I think it will also show there have been some 
decreases over the years.
    Ms. Kaptur. And my question is is it continuous inspection 
at any point, or is it random?
    Mr. Levitt. Certainly within the area that FDA regulates it 
would be random----
    Ms. Kaptur. Thank you.
    Dr. Crawford [continuing]. Not continuous.
    Mr. Latham. Thank you. I know some Members have planes to 
catch today, so we are going to try to go to the 5-minute rule, 
as the chairman likes.
    Mr. LaHood.
    Mr. LaHood. I had some questions for the record, and I 
would like to insert them and ask that the witnesses respond to 
them.

                       COST OF PRESCRIPTION DRUGS

    Mr. LaHood. Dr. Crawford, let me tell you the most asked 
question I get any time I visit a senior citizen center, is why 
are prescription drugs so costly in the United States and more 
costly than they are in Canada? How would you respond to that?
    Dr. Crawford. Well, Canada has a cost containment 
regulation, and so they prescribe what the costs can be, 
whereas our situation is more of a free-market economy. We are 
very concerned, and as a matter of fact, the Department now has 
a task force working on this cost containment issue with 
prescription drugs.
    As you know, it costs by some estimates as much as $800 
million to develop drugs for humans, and to recover that is 
something that is mandatory for the pharmaceuticals. And how 
they recover it can be argued, but nonetheless, they have 
traditionally in the years of patent life tried to recover the 
investment. It is not possible with all drugs, and we have the 
problem with orphan drugs. We have problems with drugs that are 
never going to recover the investment.
    It is an issue that we are trying to deal with on a number 
of fronts at HHS, and I believe we are going to make some 
progress, but I have heard it explained many, many ways. I 
think the essence of it is in Canada they have cost containment 
and governmental intervention, and we do not.
    Mr. LaHood. Is the answer that it costs so much money for 
the research and development to develop these modern drugs that 
we have?
    Dr. Crawford. Yes.

                        COST OF DRUG ADVERTISING

    Mr. LaHood. And I guess the other part of that is one of 
the things that irritates seniors is why the drug companies 
have to advertise the way they do on television, and they want 
to know if that increases the costs of the prescription drugs. 
Do you think it does?
    Dr. Crawford. Actually the surveys that we have seen--we 
don't have much authority in regulating.
    Mr. LaHood. I know you don't.
    Dr. Crawford. Surveys that we have seen show that 
particular forms of advertising do not add very much to the 
cost. However, we would be glad to submit for the record some 
sources of information with respect to this, keeping in mind 
that we can't control it.
    [The information follows:]

                        Cost of Drug Advertising

    The FDA is not aware of any single study that definitively 
demonstrates the effect that drug advertising directed to consumers 
(DTC) has on prescription drug prices. DTC advertising may be effective 
in getting the attention of consumers who suffer from various 
conditions and alerting them to the fact that there is a treatment for 
their condition. DTC advertising appears to increase the use of the 
drugs being advertised, which results in an increase in the total 
spending on those products. The FDA is not aware of any evidence that 
DTC advertising affects the price of an individual drug. A Kaiser 
Family Foundation report states that the pharmaceutical industry spent 
a total of $15.7 billion in 2000 on promotional activities and $2 
billion of that total was spent on DTC advertising.

                  HHS TASK ON PRESCRIPTION DRUG COSTS

    Mr. LaHood. Tell me what your task force is doing; what is 
the goal of the task force?
    Dr. Crawford. We have, as you know, a number of agencies 
within HHS that deal with Medicare, Medicaid payments to 
patients and so forth, as well as FDA and the National 
Institutes of Health. We are heavily involved in research and 
development, both oversight and some of our own. The idea would 
be, what is the key to containing this, that is possible within 
the philosophy of the way our country works short of subsidies 
and cost containment laws, et cetera, et cetera.
    So, I would say this is a serious, comprehensive effort to 
deal with it in a public way in order to try to marshal the 
resources that we have to develop a long-range plan.
    Mr. LaHood. When do you think you will be coming up with 
it?
    Dr. Crawford. I am not in charge of that, so I could not 
say. I would think sooner than later.
    Mr. LaHood. Who is in charge of it?
    Dr. Crawford. The Deputy Secretary of HHS.
    Mr. LaHood. I am not quite sure what sooner rather than 
later means.
    Dr. Crawford. I can't speak for him, unfortunately.
    Mr. LaHood. Thank you, Mr. Chairman.
    Mr. Latham. Thank you, Mr. LaHood.
    Ms. DeLauro.

                    FDA RESOURCES FOR PATENT REVIEWS

    Ms. DeLauro. Thank you very much, Mr. Chairman, and thank 
you all for being here today and for your testimony and for 
answering our questions.
    As I mentioned before, I have a series of questions which 
have to do with the generic drugs. I am just going to ask one 
question now, and if there is a second round, I'll either ask 
the others then, or submit the questions for the record.
    Mr. Troy and Ms. Woodcock--what the Agency doesn't have, 
either the jurisdiction or the resources, if you will. In-house 
counsel that would be reviewing these patents and making a 
determination There is some discussion of whether or not they 
are frivolous or not frivolous. But to go beyond, a surface 
look at these patents before they then get passed on. And my 
point is, would it make sense to have and would it be prudent 
and cost-effective to the consumer and to the taxpayer to have 
at this juncture on the staff someone who could, in fact, make 
this kind of a review so that we don't have to deal with 30-
month extensions?
    And let me just try to reinforce the point here. Is this 
about savings to consumers? It is my understanding that--and 
these are 2000 sales numbers--that for Prilosec sales are about 
$4 billion a year. If we had a generic, the estimated annual 
consumer savings on that would be $1.3 billion. For Claritin, 
and I think probably anybody who is in Washington, D.C., and 
taking Claritin on a regular basis because of allergies, that 
the 2000 sales were $1.6 billion, and the savings to consumers 
will be $550 million. Cipro, we have all been through this 
recent experience with Cipro, $1 billion in sales, with a 
savings of $337 million. You get my point.
    Any process that would help to streamline the generic 
process. One should be thorough, one should look at all the 
properties, the formulation, and all the givens. Which is what 
we need to do to make people both safe. But we also, I believe, 
have an obligation to provide people with the opportunity after 
that patent has seen its lifetime to be able to allow the 
generic drug to come in and take over and provide some relief 
on cost to taxpayers today.
    The single biggest issue that people have today is the high 
cost of prescription drugs. Wouldn't it be cost-effective for 
the agency that deals with this issue to have on staff the 
appropriate personnel to be able to make this more consumer-
friendly?
    Dr. Crawford. Yes. As Mr. Troy is coming up, we do depend 
on the Patent and Trademark Office, but he is going to respond 
to your specific point.
    Ms. DeLauro. I am going to ask for a short response, and I 
am going to get to the pediatric rule.
    Mr. Troy. The first point, as Dr. Crawford just mentioned, 
is we are talking about a validly issued patent from the Patent 
Trademark Office. It is not just the matter of having someone 
on our staff, but we don't believe we have the legal authority 
to get into it. The third is we have to hire patent lawyers who 
are unbelievably expensive.
    Ms. DeLauro. Who gives you the legal authority to do that?
    Mr. Troy. You do. I remain to be convinced that this issue 
as opposed to, say, the success of 30-month stay issues 
something that would dramatically affect the price of drugs.
    And one last final point. Regarding Prilosec, FDA has done 
everything possible to approve that drug. The generic is not 
willing to go out on the market, even though it has FDA 
approval, because of the risks of the patent determination. So, 
to ask us to be making those determinations would be a very, 
very difficult and perilous course.
    Ms. DeLauro. What we need to do is work together on this 
effort. Let us talk about legal authority, let us talk about 
resources, let us talk about the problems that currently exist. 
On one side we have innovator drugs. I am a survivor of ovarian 
cancer, and I am here because of good biomedical research. And 
on the other hand we have generics. Already in the language, we 
prejudice a case. This is an innovation, you know. This is a 
generic. But the fact of the matter is it is about the public, 
it is about being able to get what they need in order--and to 
be able to afford it given what the high costs are today.
    I'm happy to work with you to figure out what the problems 
are in this effort.
    Can I just throw in my question about the pediatric rule?
    Mr. Latham. Certainly.

                             PEDIATRIC RULE

    Ms. DeLauro. Let me just say that I am very, very 
disappointed with FDA's announcement that it is going to 
suspend the requirement that drug makers test their products to 
ensure that they are safe and they are effective for children. 
Essentially what the FDA is going to rely on is companies 
voluntarily conducting clinical trials on children. This has 
vast implications, in my view, for the health of America's 
kids.
    Children are not little adults. They require different 
dosage levels than adults, and there are different reactions. 
Long-term effects can potentially come from the medications, 
and that is why I believe it has been critical that companies 
conduct careful clinical trials to ensure that children will 
not suffer adverse effects.
    I would like to take some quotes from the January 2001 FDA 
Report on Pediatric Exclusivity. Regarding FDA's pediatric plan 
of 1994, the report states that, quote, these voluntary 
activities did not substantially increase the number of drugs 
with adequate pediatric labeling. The report also noted, and I 
quote, although the incentive provided by the pediatric 
exclusivity provision was expected to result in the submission 
of pediatric studies for many drugs, the Agency issued the 
final pediatric rule to address some of the gaps left by the 
pediatric exclusivity provision. Your report concluded that, 
quote, the cost impact on consumers will be substantially due 
to the additional 6 months of time that innovator drugs will be 
marketed without competition from lower-priced generic drugs, 
and that the increased outlays are estimated to total about 
$13.9 billion over a 20-year period.
    Given what your report stated, that past voluntary efforts 
were not adequate, that the pediatric rule was implemented to 
fill the gaps in pediatric exclusivity, and that relying on 
exclusivity will result in higher bills for consumers, why are 
you suspending the rule, and why isn't it mandatory for drugs 
that will most likely be used in children to be used in 
clinical trials to establish a correct dosage level and other 
information on kids?
    Dr. Crawford. We want to remove any doubt that we possibly 
can about HHS's determination to make sure that children's 
medications are safe and used properly. The health of America's 
children is a top priority of this administration, and having 
drugs that are properly studied for use in children is an 
integral part of assuring that our children receive the safe 
medical care they deserve. The Department reiterates its 
commitment to implementing all provisions of the Best 
Pharmaceuticals for Children Act, which was signed into law by 
the President in January, and that, you know, is one factor.
    Another factor is the fact that we were sued by three 
different organizations over the pediatric rule. Now, the 
pediatric rule has done a great deal of good, and so what our 
charge is to make sure that the rule itself, the good parts of 
it and the parts that can be legally enforced that are not 
subject to this challenge, be retained. So, we asked the court 
for 8 weeks to see what this new law does and what is left out 
from the regulation, and we will do whatever it takes to make 
sure that nothing is lost from the pediatric rule.
    We think that the law just passed will do most of it. If it 
doesn't do all the good things that the pediatric rule was 
designed to do, then we will take whatever steps we need 
through the regulatory process to ensure that it happens.

                       PEDIATRIC RULE SUSPENSION

    Ms. DeLauro. Let me just understand, you suspended the rule 
because you were sued. Who sued?
    Dr. Crawford. The organizations that sued were the--do we 
have it handy?
    Ms. DeLauro. And did you regard them as frivolous suits?
    Dr. Crawford. The court gave them standing. Consumer Alert, 
Citizens for a Sound Economy, and the American Academy of 
Physicians and Surgeons, and the Competitive Enterprise 
Institute.
    The rule has not been suspended, Madam Congresswoman. It is 
still in effect.
    Ms. DeLauro. Is the rule suspended?
    Dr. Crawford. No.
    Mr. Lumpkin. It was a proposal to the court, but it has not 
been suspended. We have not issued a statement in the Federal 
Register suspending it to this point. As of today the rule is 
still in effect. But this was a proposal to the court.
    Ms. DeLauro. Your proposal to the court? Whose proposal to 
the court?
    Dr. Crawford. Let me explain. We asked for 8 weeks to 
consider the suspension of the rule and replacing it with some 
other rule or whatever it takes to do it because--just because 
we are sued in court doesn't mean we are going to give up on 
children.
    Ms. DeLauro. But what do you have to test that against if 
we are going to get sued on something else, and then we begin 
to cave on something else? You have a rule--you have a rule 
that was presumably--by your own words you felt that this was 
the direction in which to go. And you are on the right track, 
and you wanted to do this and wanted to safeguard our kids. You 
are on the right track.
    I don't know all the backgrounds of some of those groups. I 
do know some of the background of some of those groups that you 
are talking about, and to have that kind of really tampering 
with the health of our kids really flies in the face of the 
mission that you are charged with.
    So we are going to suspend for 8 weeks to figure how we can 
water down the rule. We just did pediatric exclusivity. We gave 
these pharmaceutical companies another 6 months of the dollars 
and cents of the kinds that I talked about before to do what 
they are doing. You believe there are gaps in that proposal.
    I would just say to you, I don't know what the process is 
in these next several days, and I say to my colleagues that 
whatever role we can play in making sure that that rule does 
not get suspended and that we hold firm that these companies do 
proper clinical trials in order that our kids are safeguarded. 
We look like we are rolling back every opportunity to put into 
place the protections that we have there, and everything 
becomes voluntary. Well, we have found over and over again that 
voluntary just doesn't work and that we shouldn't be using--
going in that direction, particularly for our kids.
    Thank you for your indulgence.
    Dr. Crawford. The rule has not been suspended, and we will 
work with you to maintain whatever is good about that rule.

                        COUNTERTERRORISM FUNDING

    Mr. Latham. Thank you for that brief additional question.
    This year our concerns about bioterrorism and intentional 
contamination of the food supply are paramount. FDA received 
$151 million in the homeland security supplemental, and the 
entire amount was annualized in the fiscal year 2003 budget. 
That truly is a significant amount--$151 million--a 13 percent 
increase from the 2002 appropriation. The fiscal year 2003 
budget requests includes $159 million for counterterrorism 
activities, including 894 full-time equivalents, nearly 10 
percent of the FDA personnel.
    We do not have the opportunity to hold any hearings on the 
homeland security supplemental, so I would like to ask some 
questions about that today. In what areas was the $151 million 
funneled, and what is the money funding?
    Dr. Crawford. I am going to ask Mr. Weber to give you a 
rundown, and we will submit for the record exact dollars and 
cents in that category.
    [The information follows:]

              [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Weber. Approximately two-thirds of that funding is for 
food safety. Over 600 staff are being hired for import 
operations and inspections in 2002 and in 2003, and 
approximately one-third of the funds are for medical device, 
vaccine review, drug review, and a small amount of resources 
are for security of FDA facilities.
    As Dr. Crawford mentioned, we can give you a complete 
detail of how the funds are being spent.
    Mr. Latham. Are these all unique FDA functions?
    Mr. Weber. Actually, no. There are functions that FDA 
should be performing in any case, and in the past we haven't 
had sufficient resources. So this will put additional import 
inspectors at the borders. We will be inspecting additional 
food facilities within the U.S., and just to give you an 
example, between 2001 and 2003, we anticipate increasing the 
number of import field exams from 12,000 to 48,000 with the 
staffing. We also anticipate increasing the number of food 
inspections from 18,000 to 29,000 in fiscal year 2003.
    So that is just two examples of what we will be able to do 
with the additional staff.
    Mr. Latham. Were there any new initiatives, or were these 
activities being pursued prior to September 11?
    Mr. Weber. In the food area the initiatives are pretty much 
the same. There are additional surveillance activities that are 
being performed. We are enhancing our work with the States in 
eLexnet, which is a system where we can identify microbes that 
are in the food supply quicker. We are doing some additional 
work in the biologics area and the drug area to work with 
industry for approval of drugs similar to Cipro that was done 
even before September 11. We are working with the biologics 
industry to approve new vaccines. We are involved--we were 
involved in the approval of an anthrax vaccine supplement. We 
are working with industry to make sure the smallpox vaccine 
that the Department just contracted for comes to market, things 
like that.
    Mr. Latham. The supplemental funding really wasn't 
designated for any particular fiscal year. How much of a 
carryover are you going to have for the fiscal year 2003 from 
those funds?
    Mr. Weber. We are not anticipating any carryover from the 
funds right now. There will be some payroll lapse because 
obviously we will not be able to hire all of the 800 staff for 
the full year. But we have put together a strategic plan that 
is being finalized for our counterterrorism efforts, and some 
of the payroll lapse money will be used to enhance our OASIS 
system, put additional resources to eLexnet, convert some of 
our laboratories to BL3, et cetera.

                          GENERIC DRUG REVIEW

    Mr. Latham. As you are aware, this body has been very 
interested in improving performance in the generic drug 
program. In fact, Congress has provided increases even when the 
executive branch hasn't asked for them in the past 5 years. The 
FDA budget request asks for an additional $4,582 million. If 
the Agency received the full request for the generic program, 
would it be able to meet the statutory time frame for 
application and review?
    Dr. Crawford. Could I ask Dr. Woodcock who is in charge of 
that program to come forward?
    Dr. Woodcock.  Thank you. We expect to move closer to that 
goal. With the increase that we would hope to get, we do not 
expect to get 100 percent of reviews done within 180 days.
    Mr. Latham. What percentage?
    Dr. Woodcock. 68?
    Mr. Weber. 75.
    Dr. Woodcock. 75 percent, three quarters.
    Mr. Latham. I am going to actually try to follow the rules 
here on 5 minutes; so I will recognize Mr. Hinchey.

                       PEDIATRIC RULE ENFORCEMENT

    Mr. Hinchey. Thank you very much, Mr. Chairman. I was 
fascinated by the question that was asked by Ms. DeLauro just a 
few minutes ago, and I would like to try to understand the 
situation with regard to the pediatric rule and the need to 
examine drugs that are given to children for their specific 
impact on small bodies.
    We have testimony from pediatricians, and even from the 
National Association of Pediatrics, that the use of some drugs 
in the past probably has caused the death of children because 
not enough was known about their use. FDA wrote this rule and 
then was sued by these politically conservative organizations, 
and then seems to have stopped enforcing the rule. Is it being 
enforced?
    Dr. Crawford. Yes, it is. There is a part of the rule which 
basically seems to give us the authority, without being based 
in the law, to force companies to do certain things. The new 
law that was signed into law in January attempts to give a 
legal basis for making sure that pediatricians and others have 
the drugs they need that are safe and properly labeled. You are 
right, when the rule went into effect, only 20 percent of the 
pharmaceuticals on the market had indications for children. So 
physicians had to extrapolate to get the dose, and what we are 
trying to do, and have been since that time--and we are 
grateful for the law, we are grateful for Congress, but it may 
not go all the way.
    We may still need the rule or some form of the rule in 
order to have a seamless approach. I can assure you that we are 
going to continue with the initiative that was started some 5 
years ago in some shape, form or fashion. We may need to come 
back to the Congress to ask for both funding and perhaps an 
amendment to the law. But while that is going on, and while 
this court case is proceeding--they have given us 8 weeks to 
get our pleadings together which we asked for and was granted. 
While that is going on the rule will stay in effect.
    We will continue doing what we are doing, and we will not 
abandon children in any sense.

                  PEDIATRIC RULE AND COURT PROCEEDINGS

    Mr. Hinchey. Well, it is comforting to hear that, and I 
think everyone would be very grateful to you for continuing in 
that vein. We have statements from doctors who say that in many 
cases they are just flying blind. They don't know the impact of 
these drugs on children and the results are all too frequently 
adverse. Will you defend the rule in court against these suits?
    Dr. Crawford. Well, we are trying. The court proceeding has 
been going on now for 2 years and we have made Herculean 
efforts to defends the rule and I can't say----
    Mr. Hinchey. Have you been in court?
    Dr. Crawford. Yes. I have not, but our attorneys have.
    Mr. Hinchey. Your attorneys have. Who is defending it for 
you?
    Dr. Crawford. The lawyer----
    Mr. Hinchey. Counsel apparently was on the other side----
    Dr. Crawford. He is recused from these proceedings. We have 
another attorney by the name of Mike Blanda who is the lead 
attorney.
    Mr. Hinchey. You will continue to defend the rule in these 
court actions, and pending that, you are still enforcing the 
rule?
    Dr. Crawford. That is correct.

                         REIMPORTATION OF DRUGS

    Mr. Hinchey. Thank you very much. I want to ask you a 
couple of questions about prescription drugs as well. As you 
know the appropriations bill that passed in the House of 
Representatives two years go contained a provision which would 
permit the reimportation of drugs manufactured in the United 
States from other countries like Canada and Mexico. The 
purpose, of course, was to allow those drugs to be reimported 
at the reduced prices for which they are available in other 
countries.
    However, when that bill finally made its way through the 
process here, it was so butchered that it was rendered 
ineffective. Secretary Donna Shalala, as she was leaving 
office, said that there was nothing that could be done. 
Secretary Thompson said essentially the same thing, there is no 
way to write a meaningful rule consistent with the provisions 
of that law. I would like to have your staff review the 
situation and make some recommendations as to how the Congress 
might proceed in order to present you with a law that you would 
feel comfortable within attempting to provide for the 
reimportation of those drugs back into the country?
    Dr. Crawford. We will submit that for the record, if we 
may. We have been looking at it very seriously, as you probably 
know and we will give you a report on that.
    [The information follows:]

                           Drug Reimportation

    FDA has been examining the issue of prescription drug importation 
or reimportation for some time. We have not been able to devise a 
mechanism that would assure the same level of protections provided to 
US consumers under the existing system, where all prescription drugs 
are manufactured by FDA approved facilities and distributed by entities 
regulated by FDA or by state agencies. The ``gold standard'' of drug 
safety and efficacy that prevails in the United States is due in large 
part to the ``closed system'' of drug distribution. Drugs are 
manufactured in registered facilities subject to FDA inspections and 
intermediate and finished products move through a distribution network 
regulated by federal and state law before reaching the consumer. The 
foreign distribution network operates without any FDA oversight. Even 
with FDA oversight of an expensive testing system for imported products 
from non-State or FDA registered sources, no assurances could be made 
that such products would meet the same standard of safety and efficacy 
required of domestic products.
    FDA remains willing to explore this issue further with the 
Committee.

                      FASTER DRUG REVIEW BENEFITS

    Mr. Hinchey. I would appreciate that. I think that one of 
your major accomplishments, and I think you touched upon this 
in your testimony, has been the product review and development 
issue where you have managed to speed that up quite 
effectively. I am pleased to see that the premarket approval 
process is going forward very effectively, and much more 
speedily than in the past.
    I am wondering if there is any evidence that the 
pharmaceutical companies are passing on the financial benefits 
of the speeded-up process to consumers in the cost of the drugs 
they bring to the market. This is obviously of great benefit to 
have this process carried out much more expeditiously than it 
has previously.
    Dr. Crawford. I am going to ask Dr. Lumpkin to respond to 
that, but before he does, I would caution him and also--I mean 
this is one of the few things we don't have responsibility for. 
So Dr. Lumpkin, you are on your own.
    Dr. Lumpkin. Having been cautioned, I think the point is 
well taken. We do not have data to answer your question 
directly, whether they are passing this on or not. We don't 
receive financial information from the companies along those 
lines, and I know you are aware that is something we don't have 
jurisdiction over. I think your point is well taken, and we 
appreciate your comments on what we have done as far as 
speeding up the process. We think by doing so, people get a 
public health benefit of having earlier access to effective and 
safe products. Whether they get an economic benefit that is 
something we simply don't have the information or the expertise 
to comment on.
    Mr. Hinchey. Is there any way we can develop that 
information effectively?
    Dr. Crawford. We don't have the authority to do that. If 
you are asking if it could be done somewhere else in the 
government? Or are you asking could FDA do it?
    Mr. Hinchey. Could FDA do it? I think your answer to that 
is no. Are there any other places that you are aware of where 
it could be done effectively?
    Dr. Crawford. No, I don't think there is a designated site 
within the Federal framework that does that kind of----
    Mr. Hinchey. This is something we would have to do. Thank 
you very much.
    Mr. Latham. Thank you, Mr. Hinchey. I recognize Mr. 
Nethercutt.

                                OBESITY

    Mr. Nethercutt. Thank you, Mr. Chairman. Gentlemen, 
welcome. I am glad to have you here. I think one of the great 
problems in our country healthwise is directly related to 
obesity. I have a profound interest in diabetes and have 
questioned witnesses here from FDA before about diabetes and 
glucose monitoring device, and drugs and so forth, as it 
relates to diabetes. And if you really look at the health 
conditions in our country, they stem in large measure from 
obesity, with all due respect, to people who have a genetic 
conditions that perhaps make them more obese than less.
    But I think we need to, as a Nation, focus a lot of 
attention on this whole issue, and that touches your work in 
FDA. Perhaps you could present for the subcommittee's 
consideration, your concern about this, issue, what the agency 
sees as the directions it ought to take to address the issue of 
obesity and the attendant health consequences from heart 
disease, hypertension, and diabetes. We are seeing in the 
Agriculture Department, I think, a need to change the commodity 
programs to not have so much cheese and fat distributed to our 
populations who are most needy, Indian tribes and others, 
because it perpetuates this condition that then leads to 
tremendous expense for you and me as taxpayers and us as a 
Congress trying to address the issues of health care. So I 
would be interested in your thoughts, gentlemen, or anybody in 
your team to address this issue.
    Dr. Crawford. We recognize and are very concerned about 
what has been called the obesity epidemic in America and I 
believe, and my colleagues here believe, that this is going to 
be a disease entity, or a collection of entities, that we are 
going to have to deal with within our mandate, probably for as 
long as any of us now serving will serve.
    It is very serious and the statistics on the number of 
people in the U.S. who are obese, and particularly children 
that are obese just means that it is going to be a tremendous 
burden on our health care system and on the health and well-
being of our people.
    We are doing several things on several fronts as you would 
know. One thing is that we have a new publication called Take 
Time to Care, which Secretary Thompson is inaugurating. It 
deals with this problem, and it deals with women's health 
issues also. We will be doing, through the FDA consumer, a 
publication and through public meetings of various sorts and 
different things through a number of different centers. The 
Center for Food Safety and Applied Nutrition is our parallel to 
the entities at Agriculture that you mentioned. They will be 
working with Agriculture and also with the Centers for Disease 
Control, the National Institutes of Health, to start a major 
initiative in this area.
    But various other centers within FDA also have a 
responsibility to do something about that. I think it is a 
typical FDA issue. Obviously, a lot of it is related to intake, 
as you mentioned, of fat and other substances and probably 
overall caloric intake, but the exact cause of why it hit us so 
hard at this particular time is probably complex. I think it 
relates to portion sizes of foods, when we order a hamburger or 
when we order fried chicken, it seems to be four times larger 
than it used to be.
    And then one of the things that happens, even when you 
order fish in our society, it is laid in a casserole-type way 
over a lot of food, more food than some of us used to consume 
in three meals, and our mothers and fathers taught us to clean 
the plate, and that, I think, is also a part of it.
    So I think it is part societal, part medical, but it is 
going to get very medical if we don't do something about it. We 
are doing everything within our mandate to deal with it. 
Coordinated programs like Take Time to Care are going to help.
    Mr. Nethercutt. I appreciate your views and think we need 
to make it sort of a national effort and a political campaign, 
in some respects, to change the mentality of consumers around 
the country, and others who don't realize probably that we are 
all paying for it literally, the cost of it in taxes and health 
care costs and low productivity and so forth. I think we need 
to address that issue straight on and firmly and aggressively.
    Mr. Chairman, I will have other questions, if I may, later.
    Mr. Latham. Very good.
    Mr. Farr.

                                CAFFEINE

    Mr. Farr. Thank you very much, Mr. Chairman, and thank you 
for all being here today. My question kind of relates to a very 
personal issue. My daughter recently told me that she was 
expecting a baby, our first grandchild, in October next year, 
and I was drinking coffee and she asked me how many cups of 
coffee, and I was embarrassed to tell her many, many a day, as 
supposedly most Members of Congress do, and she was telling me 
that her physician had recommended against her having a high 
intake of caffeine.
    So we started it talking about caffeine, and then I found 
out about 5 years the American Medical Association called on 
the FDA to require the amount of caffeine in foods and 
beverages to be declared on food labels, as you do, as it does 
for NoDoz, and then in July of 1997 the Center for Science and 
Public Interest petitioned the FDA to require the disclosure of 
caffeine content in food beverages.
    I think I have learned we have caffeine in coffee but it is 
in teas, colas, soft drinks, caffeinated water, ice cream, 
frozen yogurt, chocolate milk and chocolate candies. Caffeine 
is a big issue in America. My question, I guess, is when is the 
FDA going to take action on the Center for Science and Public 
Interest petition and begin a rulemaking on this important 
issue?
    Dr. Crawford. I am going to ask the recipient of that 
petition, Mr. Joe Levitt, to come forward, but as he is 
lumbering towards the table, let me say that caffeine is a big 
issue, and it is in places that we don't expect it to be. There 
are contradictory studies on what population may be at some 
risk for it. As you know, it is a chemical that is rapidly 
dissipated from the body, but it is not without its risk and 
Joe is going to address what we are dealing with.
    Mr. Levitt. Thank you. As the committee has pointed out, we 
have a lot of issues we try to deal with. What we have tried to 
do in our Center for Food Safety and Applied Nutrition is to 
have an annual priority setting process for which we start with 
an external request for comment and where our stakeholders feel 
we should apply our efforts, and we then develop that into what 
I call the Yellow Book because that is the cover of it. It is 
also available on the Web page.
    And we go through and prioritize what can we try to 
accomplish this year, what can we try to make a lot of progress 
on, what is still kind of there in the wings that we will get 
to if time permits. It is a hard process to go through because 
we have so many competing demands. At the end of the year, we 
report out what we have accomplished. We have been very 
successful in accomplishing most of what we set out to do in 
that year. Regretfully we can't do everything. We have our so-
called A list, B list and the caffeine petition has not really 
risen yet to a level given all the other priorities. We have 
talked about food safety, imports, and so we don't really have 
that right now as something that is going to be looked at and 
certainly not this year.
    Mr. Farr. It is not even on your list.
    Dr. Crawford. But what we can do in response to this 
question is give you a recitation of what we have done in the 
past, where we think it is and give you some projection about 
our dealing with it, and having raised the question means that 
it is on Mr. Levitt's list, and also puts it on my list. So we 
will respond.
    [The information follows:]

                                Caffeine

    Following receipt of two Citizen petitions in 1997, FDA, reviewed 
the literature submitted by the petitioners as well as other available 
data. In particular, the Agency has reviewed the effects of caffeine on 
reproduction (including birth defects, fetal growth, fertility, and 
miscarriage), bone-mineral metabolism, and behavior. As part of this 
evaluation FDA contacted scientific an advocacy organizations that had 
an interest in the effect of caffeine including the March of Dimes, 
American College of Obstetricians and Gynecologists, American Academy 
of Pediatrics, National Osteoporosis Foundation, and the various arms 
of the National Institutes of Health. FDA tentatively concluded that, 
at this time, there was inadequate scientific evidence to establish a 
quantitative level of intake of caffeine relative to avoiding adverse 
pregnancy-related outcomes. However, psychological and physiological 
effects of caffeine and effects of caffeine withdrawal are well known. 
Therefore, the agency is exploring various options for informing 
consumers, within its statutory authority, about the presence of 
caffeine in food products. FDA is also planning to undertake efforts to 
explore the amounts of caffeine in products across the food supply and 
to use the agency's Food Advisory Committee to consider issues related 
to caffeine. Pending the outcome of these activities we will respond to 
the citizen petitions on caffeine.

                                EPHEDRA

    Mr. Farr. Mr. Chairman, we ought to have all committees 
respond like that. I am glad somebody in this town thinks our 
questions are important. Let me ask you kind of an opposite 
issue, because I think I have the capital of dietary 
supplements in my district. Santa Cruz, California is the home 
of these and I have been sort of drawn into this ephedrine 
alkaloids debate, and I am just finding myself confused. There 
have been some appropriations put together to try to convene a 
scientific panel, and in the meantime, you withdrew portions of 
the 97 proposed rule because you are setting this and there is 
still part of that rule out there. My question is are you going 
to withdraw the final portion of the pending 97 rule in order 
to allow the agency to consider the full range of sound science 
available as well as the findings of the NIH?
    Dr. Crawford. We are evaluating that now. As you know, the 
FDA food advisory committee was asked to comment around 1995 on 
some adverse reactions that were allegedly due to consumption 
of ephedra-containing substances, and it made a recommendation 
that FDA take some regulatory actions and that was the genesis 
of this 1997 proposal.
    Since I have been on board which is now about 3\1/2\ weeks, 
we have looked again at the ephedra situation. I believe that 
certain of the ephedra products are separable. There are 
synthetic ephedrine products which are obviously not 
supplements in the truest sense. They tend to be more like 
drugs, and I think they need more careful evaluation than those 
that are truly herbal products that come from not only this 
country, but other countries, and I think you could probably 
separate the herbals from the synthetics and that is the 
approach we are taking.
    Mr. Farr. Just in closing, I think it is really important 
that you have credibility in this process and the road leading 
to that has been rather rocky. I think the separation is 
probably a step in the right direction.

                                BSE ROLE

    Mr. Latham. Thank you, Mr. Farr. We are going to start a 
second round. I would very much appreciate it if we stay to the 
5-minute rule for fairness to everybody in this round. At last 
year's hearing, we discussed the threat of BSE, mad cow 
disease. The committee understands that FDA has a significant 
role in protecting this country from the threat of BSE, and it 
provided a $15 million increase for BSE prevention in the 
current year.
    Dr. Crawford, would you describe your role with regard to 
BSE and what the FDA has accomplished with those dollars?
    Dr. Crawford. Yes. I am going to ask Steve Sundlof, our 
director for Center of Veterinary Medicine to come forward. Our 
piece of this regulatory puzzle is a regulation of both animal 
drugs and animal feed, and as you probably know, the epidemic 
that occurred in England, and now in certain other countries, 
is believed to have occurred entirely from consumption of 
contaminated feed. So the FDA has perhaps the major role in 
controlling BSE and Dr. Sundlof has put together a plan for 
inspecting feed mills and other sources of animal feed and can 
report on his success rate with respect to that. Steve.
    Dr. Sundlof. Thank you, Mr. Chairman. With the help of this 
committee, last year in our appropriations $15 million was 
appropriated specifically to deal with the issue of BSE. Most 
of that has gone to the animal and drugs and feeds area, and it 
is to increase the inspections of all the establishments that 
handle the materials that are potentially capable of 
transmitting BSE, both to cattle and then from cattle obviously 
to humans. We have done a number of things to improve that 
situation. First of all, we are doubling the number of 
inspectors on the border and ports of entry, so that any 
materials that are coming into the United States that are 
potentially infectious can be detected and turned back. So we 
have increased border inspection.
    The second thing we have done is we have increased 
dramatically the number of inspections that are going on in the 
field domestically. We are now inspecting 100 percent of all 
establishments that handle these potentially infectious 
materials every year. So every year they get inspected. We 
prioritize the process such that anybody who is found to be out 
of compliance in their last inspection are the first people to 
get inspected. We also have a number of other criteria that we 
use to prioritize who gets inspected first, like everybody who 
handles the material, except the individual farmers, because 
there are about a million of them, and it would be impossible 
to get to them.
    We have significantly improved our database in reporting 
system. On April 16 we will be switching over to a new database 
system which will give us much more rapid information about 
which firms are not in compliance so that we can get back to 
them very quickly. We have increased our State contracts. The 
officials in the States actually do about 80 percent of our 
inspections. They are located in places that are remote from 
our district offices. So it is very important we have people 
who can get out to these remote areas of the State and inspect 
their facilities. We are doing a lot more training of 
individuals so that they are better prepared to do the 
inspections. We are actually sampling feed and testing it with 
some test methods that we developed so that we can detect the 
presence of these materials. So we have done a lot of things 
and we think that with the funding provided that this program 
is on very solid footing.

                          BSE STATE INSPECTION

    Mr. Latham. Who at the State level is doing the inspecting?
    Dr. Sundlof. It falls to various departments within various 
States. Generally it is within the State Departments of 
Agriculture, the Commissioners of Agriculture, and they have 
feed inspectors that go out and inspect these establishments 
for various reasons pertaining to taxes and other things. There 
are also the American Association of Feed Control Officials 
that has members in every State that are State employees, and 
we work through those individuals. There are a lot of issues 
other than BSE that involve feed. So that has been an 
established organization for 100 years, and so we work through 
those people.

                            BSE REGULATIONS

    Mr. Latham. Do you anticipate any additional regulations? 
Do you think there is any legislation needed or does the FDA 
have a position on banning any kind of bonemeal?
    Dr. Sundlof. We will be coming out later this spring with 
what is called an advanced notice of proposed rulemaking that 
basically, here are some of the exceptions to the rule that we 
have allowed. And we are going to be asking, based on a lot of 
things that we have learned since the Harvard risk assessment, 
are current regulations adequate? So we will be asking that 
question.
    There are certain practices that we were not as confident 
of right now as we were back in 1997 when the rule passed, 
things like allowing plate wastes from restaurants to be fed to 
ruminants. So we will be looking at those. The Harvard risk 
assessment said that our rule is pretty effective in preventing 
BSE from becoming established in the United States, but there 
are things that can be done to improve that safety even more. 
So we are going to be looking for that kind of balance.
    Mr. Latham. That is a huge issue in agriculture. Livestock 
is over a $100 billion dollar industry and BSE could wipe us 
out overnight.
    Ms. Kaptur. Yes, and I am equally interested in the people 
that will be wiped out by these foods. Dr. Crawford, I have to 
say I am really impressed with you and with your associates, 
but with your background in particular, starting out in the 
veterinary sciences, and going on for a Ph.D. in pharmacy. You 
really are the right man for the job and we thank you for your 
service.
    Dr. Crawford. Thank you very much.

                              BSE ORIGINS

    Ms. Kaptur. I have a lot of questions. I want to say this 
on the record, I hate the way we are doing hearings in this 
subcommittee now. We are so limited by time, maybe 3 hours with 
such an important agency. There is no afternoon scheduled. I 
have so many questions here and I can't get into them being 
restricted to a 5-minute rule. This is happening in many of our 
subcommittees with few exceptions, and it really dumbs down the 
process.
    So it is hard to know what to ask in order to make the best 
use of our time. I want to ask you on BSE and also on 
salmonella, help me understand what we know and what we don't 
know from a scientific standpoint. What types of longitudinal 
studies have been done in terms of the actual cause of the 
species leap or of the original provocation of the 
microbiologics that caused all this to happen.
    I am trying to understand that and then to ask myself the 
question, do we need more money in research? Do we know enough 
now? Where did this start? First with the BSE and then the 
salmonella, where did it start? Did it start in feed lots with 
BSE and did it start in egg production facilities in some 
certain town? Can you take us back on both of them and then 
tell me are we devoting the proper resources we need to figure 
out what is going on here with the science of it?
    Dr. Crawford. Well, first, with BSE as you mentioned, it 
seems to have stemmed--as you know, it started first in England 
and then has spread elsewhere. What happened in England is in 
1948 right after World War II there was a shortage of protein 
for animal feed, cattle feed in particular in England and also 
in other countries. So they began feeding meat and bonemeal in 
the overall ration to cattle in this particular case.
    Ms. Kaptur. As opposed to what had they eaten----
    Dr. Crawford. Previously they had either been on pasture or 
they had been fed grains and nonanimal byproduct substances. 
Initially in England they took very careful pains to render 
that product, which means, as you know, to heat it to 700 
degrees and even more for a long period of time in order to 
kill whatever was in it.
    As time went on and the demand for cheaper meat and 
bonemeal preparation and cheaper animal feed occurred, they 
relaxed some of those requirements in England. They stopped 
heating it to the same temperature and they also abandoned in 
England, but not in Scotland, a process called solvent 
stripping, which essentially adds chemicals that further 
denature the meat and bonemeal and might have prevented 
something like BSE.
    Then sometime around 1980, the first cases of BSE began 
incubating. The incubation period from the time of infection is 
4 to 7 years in cattle. So since the first cases were found in 
late 1985 and early 1986, they would have been incubating for a 
long time. They didn't know what the disease was, but the 
British government and its research establishment did a good 
job of identifying and characterizing it.
    So by December of 1988, they were able to brief the U.S. 
Government, which I was in also at that time, on what they had 
and also to give us an indication that this could be 
transmissible to humans. So what happened to us in the United 
States is we put in, as fail-safe a system as we could, for 
keeping all things British out until we could evaluate it 
further.
    Later on I served on an advisory committee, as it turned 
out, for FDA on BSE, and we were concerned with the blood 
products and various other things. Where did it come from is a 
million dollar question.
    There was a report of a similar kind of disease in cattle 
in England during World War I. So it may have been there at a 
low level for a long time and it got amplified by this 
rendering process or lack of it. There also is the theory it 
might have come from sheep, a similar condition occurs in sheep 
called scrapie. But where it came from and how it got there is 
certainly not clear. What is clear is that animal feed is the 
source. Those other countries like Japan recently got animal 
feed from England which was very expensive and that is what 
happened to them. The other specifics----

                          RESEARCH AND FUNDING

    Ms. Kaptur. My question is in terms of the research. 
Longitudinal studies, are we properly funding within USDA? You 
are not really the research agency for this, are you? It would 
really be over at the USDA.
    Dr. Crawford. It would be the Ag Research Service. 
Actually, though, this family of diseases was first discovered 
in the National Institutes of Health, and one of my colleagues 
there actually got the Nobel Prize for describing a similar 
condition that occurs in humans. So NIH provided scientific 
backup, but the actual agricultural research, as you know, was 
done by the Agriculture Research Service or the Cooperative 
States Research Service.
    Ms. Kaptur. I know I am over my time, but I think this is 
important, and I have served here for 20 years, and I am going 
to ask my questions. I want your opinion. If we were to look at 
the dollars that are appropriated now for research at USDA and 
at FDA in this particular arena of BSE, TSE, also salmonella, 
where you have these species leaps, I want to know, do we have 
the proper research regimen in place or do we need more money 
to understand what is going on here on the biological side? How 
do I find an answer to that question?
    Dr. Crawford. If you can give me 10 days to evaluate it, I 
will add it to the record.
    [The information follows:]

                          Research and Funding

    Predicting and controlling the emergence of new disease-causing 
microorganisms or their reemergence due to their gaining the ability to 
affect new hosts has been one of the major challenges of the scientific 
and medical communities for over a century. Being able to proactively 
predict and thus prevent the ability of a pathogenic microorganism to 
jump from one species to another can reap tremendous public health 
benefits when one considers some of the historical examples such as the 
1918 influenza pandemic which killed tens of millions of people 
worldwide. During the past decade research through agencies such as the 
NIH have provided the scientific tools that are allowing the challenges 
of emergence to be addressed in an entirely new manner. Continued basic 
research of this type is critical. Basic research alone is insufficient 
to translate this into active prevention of disease. It must be coupled 
with applied research performed cooperatively by FDA and its academic 
research partners targeted to examining how the technologies and 
practices in the production, processing, and marketing of food affect 
the genetic stability of pathogenic microorganism. While this would be 
a major new research initiative ($5,000,000), this type of mechanistic 
approach would be inherently more cost effective than attempting to 
examine each microorganism and each food for potential. The acquisition 
of such knowledge would allow for the first time the development of a 
realistic plan for identifying the current and future steps in the 
production, processing, and marketing of food that may foster emergence 
and developing rationale programs for more rigorous surveillance.

                        DRUGS FOR MENTAL ILLNESS

    Ms. Kaptur. All right. I thank you very much for that, and 
I also am going to ask a question which you don't have to 
answer, but I would like it for the record. How many new drugs 
were approved in fiscal year 2001 for the treatment of serious 
mental illness, and how many are in the pipeline for approval 
in fiscal 2002, 2003? This set of illnesses are terribly 
complicated and are devastating to our families. I have asked 
this question in preceding years and have been extremely 
disappointed with the small number of drugs in the pipeline. I 
have additional questions, but I am going to save those until 
the next round. Thank you.
    Dr. Crawford. We will add that to the record.
    [The information follows:]

                        Drugs for Mental Illness

    Due to our disclosure rules, I cannot specifically name the drugs 
that are currently under review. However, I can tell you that we 
currently have 17 new drug applications (NDAs) under review for the 
treatment of mental illness. These mental illnesses include treatment 
of:
     Depression (8 NDAs)
     Panic disorder (1 NDA)
     Schizophrenia (3 NDAs)
     Acute agitation in psychotic patients (1 NDA)
     Attention deficit hyperactivity disorder (4 NDAs)

    Mr. Latham. There is no limitation on time today.
    Ms. Kaptur. Fantastic, thank you.
    Mr. Latham. I am just trying to get around as much as we 
can to all the members.
    Mr. Goode.
    Mr. Goode. I am going to do a good thing so we can get out 
early and not ask any questions, Mr. Latham.
    Mr. Latham. Then would you yield to Mr. Nethercutt.
    Mr. Goode. I will.
    Mr. Latham. Thank you.

                              REGISTRATION

    Mr. Nethercutt. Thank you, Mr. Chairman, Mr. Goode. I want 
to follow up on Ms. Kaptur's comments about the issue of 
scrapie, and I am informed that Washington State University, my 
alma mater, and the animal disease biotechnology facility there 
has developed a test for scrapie where you don't have in sheep, 
where you don't have to kill the animal. I don't know if you 
have heard of it, but there is some great research going on 
there that seeks to address this whole issue.
    Let me ask you gentlemen about the subject of terrorism and 
bioterrorism. In the bioterrorism bill, there is a provision 
that requires registration and facilities engaged in 
manufacturing, processing or handling food to register with the 
FDA for the first time. I am troubled by that, not because I 
don't want us to be safe, but by the paperwork and the 
administrative cost and burden that it puts on all parties, not 
the least of which is you. Could you handle the probably 
million registrations that might come in for grocery stores or 
other convenience stores or quick stops or whatever it is? It 
seems like it is overkill here and I am wondering if you have 
looked at it that way or if you care to comment.
    Dr. Crawford. I haven't personally evaluated it. As I 
mentioned, I have only been on the job for a short time and I 
understand that is in conference committee and I also 
understand we normally don't comment at this point, but I have 
not researched it.

                   REIMPORTATION OF DRUGS FROM CANADA

    Mr. Nethercutt. All right. Just for your consideration it 
may come cascading onto you here one of these days if that 
provision is maintained in conference. I think the way to 
handling it is just to have a different definition of facility 
that would be required to register. My information is that most 
States require these kind of registrations, and why should the 
Feds replicate the infoormation? It is something to be 
concerned about, it seems to me.
    The other question I had would relate to security also, and 
bioterrorism and terrorism in general, regarding prescription 
drugs or the reimportation of drugs from Canada. My State 
borders Canada. My district borders Canada. People go up there 
and get drugs from time to time. Given the challenge we face in 
the world of terrorism today, do you have opinions officially 
for the agency as to whether reimportation now raises greater 
challenges than it did previously? What is your view on this 
reimportation issue as it relates to safety of drugs for the 
consuming Americans?
    Dr. Crawford. Reimportation has always been worrying to FDA 
because we are charged with protecting the safety and ensuring 
the effectiveness of these kinds of drugs and obviously if it 
is approved, packaged and manufactured somewhere else we have 
less of a chance to do that. Now, the argument has been made 
that the Canadian regulatory system is good and I would agree 
with that. The problem would be--and I just throw this as a 
cautionary flag, if I might. The problem would be if it becomes 
apparent to the rest of the world, including the world of 
terrorists that we are not interdicting shipments of drugs that 
come from Canada or Mexico, the contiguous States, either one 
or both, then I think this is a signal to a would-be terrorist 
that this might be a way to enter the United States.
    It also would be a signal to a community that is not as 
dangerous as terrorists obviously, but to the transshippers and 
these would be people in various countries that may not have a 
regulatory system or may not have a regulatory system for 
exported drugs, which would probably include the majority of 
Nations within the United Nations.
    Mr. Nethercutt. Canada in particular, to my understanding, 
does have a provision in law that says we are not responsible 
for anything that is not used and consumed in Canada.
    Dr. Crawford. That is transshiped. So I think that would 
also open that up. So FDA also has to exercise its authority in 
this regard. We won't want to disadvantage citizens 
unnecessarily, but to answer your question, we are concerned 
about that.
    Mr. Nethercutt. Thank you. Thank you, Mr. Chairman.
    Mr. Latham. Thank you, Mr. Nethercutt.
    Mr. Hinchey.

                     FEEDING OF ANIMAL BY-PRODUCTS

    Mr. Hinchey. Thank you, Mr. Chairman. Dr. Crawford, I want 
to thank you and your colleagues for the straightforward and 
thorough answers to the questions that have been put to you 
this morning. I think you have been very responsive and very 
helpful. I appreciate it. Are we aware of any animal by-
products that are being fed to animals in feed lots in the 
United States?
    Dr. Crawford. We have a regulation that covers that, and we 
also police it to make sure that products that are suspected of 
carrying the prion that causes BSE are not allowed in animal 
feed and, Dr. Sundlof has testified about what his center does 
in order to police that.
    In order to explain the details of the rule of what can be 
put in and what cannot be put in, I would like to call him back 
if I may for a brief response.
    Mr. Hinchey. Thank you.
    Dr. Sundlof. Yes. Animal by-products are allowed in animal 
feeds, but the rules we put in place restrict certain animal 
proteins from going into the feed of ruminants which include 
cattle, sheep, and goats. This is because certain mammalian 
proteins are known to be able to support the prion protein that 
cause mad cow disease.
    So we don't allow cattle to consume any proteins that come 
from other cattle or sheep or goats because that potentially 
would be a source of BSE, if it were to be introduced into the 
country. To the best of our knowledge, and we always caveat 
this by the fact that as Dr. Crawford also said, the disease 
has a 4 to 7 year incubation period. So if it were to get into 
this country, it would be difficult for us to know that for 
that long a period. So to the best of our knowledge, we don't 
believe the disease has gotten into this country. As a strong 
precautionary measure against that, and it was already 
referenced as to the damage that would do to the United States, 
if the disease were to get into the country, as a strong 
preventative measure, we have said that producers of sheep, 
cattle and goats cannot feed certain mammalian-derived proteins 
to those animals, so even if the disease were to enter the 
United States, it couldn't spread to the national herd.
    The reason Harvard Risk Assessment looked at this and 
basically said that the real safeguard in here was making sure 
the disease doesn't get into the country and should it get into 
the country, having these strict feed laws in place will 
prevent it from becoming a problem.
    Mr. Hinchey. Ms. Kaptur.

                    SPENT CHICKENS IN THE FOOD CHAIN

    Ms. Kaptur. I wanted to ask Dr. Sundlof, while you are up 
here, what about spent chickens in the food chain? And you 
referenced other meat products. Could you address the 
relationship between salmonella and the use of spent chickens 
in pet food and so forth? I am just asking the question about 
poultry.
    Dr. Sundlof. Yes. Well, spent chickens can be used to 
reduce poultry meal which would then be used in pet foods but 
in order to produce poultry meal it has to go through this 
rendering process, and that is a very destructive process, as 
Dr. Crawford already indicated. It is heated to a high 
temperature, high pressure in many cases, for a sufficient 
period of time to kill anything bacterial. Now, the problem 
with BSE is it is not a bacterial, not a living organism, and 
that is why it is not destroyed by the rendering process.
    Ms. Kaptur. What is it?

                          BSE A PRION PROTEIN

    Dr. Sundlof. It is a prion protein. It has been referred to 
as a rogue protein. Your question of how does this happen, this 
is one of the great mysteries of science, how this protein 
became infective.

                  BENEFIT OF ANIMAL BY-PRODUCT IN FEED

    Mr. Hinchey. Given the super abundance of grains in our 
country, is it prudent for us to allow animal by-products to be 
used in ruminent feed? There doesn't seem to be any economic 
necessity for it? What is the point?
    Dr. Crawford. The point is that it does raise the energy 
level of the feed and makes the feed more effective----
    Mr. Hinchey. But these animals are not meat eaters 
normally. These ruminents do not eat meat products, they eat 
grass. That is their natural diet. Isn't it dangerous to be 
messing with mother nature in this way?
    Dr. Crawford. We have learned from this particular 
procedure that in fact it is, yes. I believe that the use of 
these products, Dr. Sundlof may disagree, by the agricultural 
community, particularly livestock agriculture is being 
reevaluated all the time because there are hidden risks in 
these kinds of things and some very horrible risks like BSE.

                        EXPANSION OF FOOD SAFETY

    Mr. Hinchey. I think my time is up, but I am happy to 
proceed if that is not the case. Let me ask just one quick 
question. The importance of your agency to national security 
was recognized by this committee, and you were given a 
substantial increase in funding, and that has allowed you to 
hire, 673 new investigators, laboratory analysts, compliance 
officers and support staff, to improve surveillance and 
inspections of foods. These new positions will allow you to 
quadruple the number of inspections of imported food products.
    Nevertheless even with that increase, you will only be able 
to inspect about 2 percent of the food products that are 
entering the country. I know that many of our trading partners 
that import food products into the United States do not adhere 
to the same high environmental standards that are required in 
our country with regard to the use of pesticides, for example. 
Many of these countries, for example, haven't even banned DDT. 
They continue to use pesticides that are not permitted in the 
United States.

                               PESTICIDES

    Last year, Doctor, we were told that the FDA would like to 
broaden the agency's food safety initiatives to include testing 
for chemical and pesticide contamination as well as microbial 
contamination. Can you tell us what kind of progress you are 
making on that and what we can do to help you?
    Dr. Crawford. We have made that switch in emphasis. The two 
main things you worry about in the food supply, whether it is 
domestic or international, can be categorized as chemical 
contaminants, like the DDT you mentioned, and microbial 
contaminants like the salmonella that was mentioned. And we 
have been involved in some unfortunate cycles at FDA and at 
other agencies in the government.
    Following the development of antibiotics in the 1940's and 
on into the 1950s, we sort of assumed in the public health 
establishment of this country that we weren't going to have to 
worry about bacterial diseases anymore, and so we deemphasized 
the microbial contamination in favor of chemical contamination. 
And you may recall that in the 1970's, FDA was primarily 
concerned almost exclusively with dioxins and PCBs and PBBs and 
chlorinated hydrocarbons and all these things, and, in fact, 
many of the officials in FDA had toxicology backgrounds as a 
result.
    Then in the 1980's, we had the advent of the salmonella 
enteritidis, and vibrio vulnificus that came in oysters that 
hadn't been there before. We had BSE happening. So we switched 
again this time almost entirely to antimicrobial claims, and we 
got out of balance one more time. My goal in the agency is to 
see if we can't effectuate a proper balance. It already had 
taken place before I got here to be frank, and so we are now 
reemphasizing chemical contamination particularly overseas, and 
although there is never enough money to do--for someone like 
me, you always would ask for more and we appreciate that, but 
what we can do for the record is to show you what we are 
spending in each category and also what the historical cycles 
have been going back a reasonable amount of time, and then 
answer your specific question about are we funding it at the 
right level.
    [The information follows:]

                               Pesticides

    FDA estimates that recent spending on resources for pesticide and 
chemical contamination was approximately $5.45 million for fiscal year 
2001. It is expected that this spending level will continue throughout 
fiscal year 2002.

    Mr. Hinchey. Thank you very much.
    Mr. Latham. Mr. Nethercutt.

                              JUICE HACCP

    Mr. Nethercutt. Thank you, Mr. Chairman. Let me ask you a 
question about the juice HACCP issue. I know there are 
regulations that are being forced on processors to repasturize 
their product. I think there are 900 or so processors of juice 
and vegetable juices who pasteurize their product, and I am 
informed that over 98 percent of all juices are already 
pasteurized, and therefore, not a source of food-borne illness. 
I am wondering what is going to be expected of the industry as 
it relates to the implementation of HACCP for juice? Can you 
tell us the status.
    Dr. Crawford. Yes. The concept of going to HACCP for juices 
came about, as you know, when we had several incidents 
involving this terrible bacteria, ecoli 015787, which is so 
dangerous to children and also to the elderly, and some of 
these were traced to juices or juice products. So the agency 
evaluated this for a reasonable amount of time and then 
concluded that HACCP was the proper way to go. As you know, 
this government has done that for meat and poultry and for 
seafood and will look at other risk categories like dairy 
products, for example and in concluding that HACCP was the 
proper way to go, the industry was prepared to the extent we 
could work with them.
    Now, one of the hitches, as we understand it, is that some 
juices are having to be repasteurized or reheat treated, and 
the log reduction, which is the number of bacteria they have to 
reduce it by raises questions of juice quality if you do it 
twice. So what we have done is to try to be flexible about 
that. If a company can show us if the juices are imported or if 
they are produced domestically at another location at another 
plant, that there is a valid authenticated paper trail to show 
that this product was already heat treated at the proper level, 
then we waive that requirement.
    So the key to dealing with it in this break in period is to 
have good communications between FDA and the industry and it 
will work well. When we did it in meat and poultry there was a 
break-in period during which we had to become more flexible. 
The same thing was true with fish and fish products, and so we 
are committed to doing the same thing here.
    Mr. Nethercutt. Are the people that are in place to perform 
the functions safely and timely? Are you satisfied.
    Dr. Crawford. Yes, I am.

                    LABELING OF BIOENGINEERED FOODS

    Mr. Nethercutt. Let me ask you about bioengineered foods. 
Over a year ago there was a draft guidance on the voluntary 
labeling of foods indicating whether or not they have been 
developed using bioengineering. There still hasn't been, I 
guess, a finalization of that guidance. What is your 
expectation when that is going to be forthcoming and what will 
it do?
    Dr. Crawford. That proposed regulation is still pending. 
The idea would be that producers would be allowed to place on 
the label whether the product was bioengineered or not. As you 
know, we take the label seriously because of the law. Our 
concept or their concept was that we ought to produce a 
regulation that would allow people to label the product 
bioengineered or not bioengineered. The scientific and 
technical issues that this raises are considerable, though, and 
I think that is what is holding up the rule.
    FDA has to commit resources to inspect, to be sure that if 
they say it is not bioengineered that they are within the 
tolerance, which would be something like 1 percent. So you 
can't know that unless you actually are doing testing. Some 
countries have estimated that the cost of that testing would be 
in the billions of dollars like Australia. The other thing that 
happens is how valid is the test, and what do you do about 
products like soft drinks that might contain bioengineered 
products, that have been destroyed through heat processing? So 
there are a great number of issues, and in this country, unlike 
most countries, if it is on the label, it has to be true, you 
know and it is up to us to be sure that it is.
    Mr. Nethercutt. Any idea on timing, when that might be 
forthcoming?
    Dr. Crawford. That is one of the things I haven't focused 
on yet.
    Mr. Nethercutt. Uncertain at this point?
    Dr. Crawford. Yes.
    Mr. Nethercutt. Thank you. Thank you, Mr. Chairman.
    Mr. Latham. Thank you Mr. Nethercutt.
    Ms. DeLauro.

                           SINGLE FOOD AGENCY

    Ms. DeLauro.  Thank you very much, Mr. Chairman. I want to 
move to the food safety issue if I could for a moment. This is 
around the issue of a single food agency. I introduced 
legislation in May of 2001, the Safe Food Act, which would 
consolidate all the food safety activities into one agency. 
There appears to be some interest in moving in this direction, 
by the administration. Homeland Security Director Ridge, and I 
want to quote him, said ``one of the questions we need to 
answer is whether or not we need multiple agencies dealing with 
food responsibilities.'' Is that the way we want to do it, 
multiple agencies, or is there a better architecture? There is 
also, on October 2001 GAO report, that talked about a group of 
former food safety officials who support legislative reform and 
the consolidation of food safety activities. Two or three 
questions. What do you think is needed to create a food safety 
system that will protect consumers? Would you support efforts 
to modernize food safety statutes and what recommendations do 
you have? Do you support the creation of a single food agency 
and will you push for that in your time at the FDA? And what is 
the current level of discussions at the moment with Director 
Ridge on this topic?
    Dr. Crawford. As you know, when we--what almost everybody 
says is that if you had to start out de novo with the food 
safety system, you would have it in one agency. Well, we did 
start out de novo at one point and all of it was in 
Agriculture. And over time, for various reasons, virtually all 
of those areas have been spun off. The FDA was spun off in 
1941, first as an independent agency, and then finally into 
what became the HEW, now HHS. EPA didn't leave until the early 
1970s, and then a separate agency entirely.
    So in one sense, we have been there and done that. But in 
another sense, there is this tension and also these ambiguities 
in regulation that are occasioned by having food safety in 
about eight different agencies. And it was a problem to me when 
I was administrator of FSIS in terms of communication. I have 
been around here long enough to know what the problem would be 
here, so I can say that based on the experience.
    When we thought seriously about seafood inspection--and 
there was a congressional bill that passed the Senate and 
failed in the House some 12 years ago--the problem we ran into, 
quite frankly, was the overlapping legislative authorities that 
was this mass of laws that had been passed for good reasons. 
And how to reconcile them, even just for fish, so that we could 
consolidate all fish inspection into one agency was formidable 
indeed. I believe the record will show we had nine 
congressional hearings on the subject and there were nine 
subcommittees or committees that believed that fish inspection 
was theirs. And I remember having to agree that it was theirs 
about nine times. But I think that is the issue. So that is the 
way I feel about it.
    Ms. DeLauro. So that we could enlist your efforts and 
support to talk about the efficacy and the cost efficiency of 
trying to do something with regard to this area in a 
consolidated fashion. And I also think that Ms. Kaptur's 
comments early on and the chart reinforce that issue.
    If I could just--I just want to say thank you for FDA's 
work with NCI on ovarian cancer research, an issue that is 
important to me. I noted in your testimony here it says, 
scientists from FDA and NCI reported research findings that may 
lead to a new way to determine the presence of ovarian cancer 
through a simple finger-stick blood screening. Can you talk to 
us about that and the research, and can we look to something 
that is a simple diagnostic?

                     BLOOD TEST FOR OVARIAN CANCER

    Dr. Crawford. The person in our organization closest to 
that is Dr. Katherine Zoon. And I am going to ask her to come 
forward, if I may. She is the director of the Center for 
Biologics.
    Dr. Zoon. Thank you very much for your interest in this 
very important program that I think has been an important 
collaboration between two public health agencies such as the 
National Institutes of Health and the FDA to look at new ways 
of exploring medicines and their use to best serve the public. 
And in doing this, I can tell you that the project started 
several years ago as a collaboration in a very new field called 
proteomics.
    And this new field, which is the ability to look at 
proteins and how they function on very small single cells and 
surrounding tissue, has led to our ability to look at patterns 
of proteins that look different based on a set of cells. As a 
result of this technology we can now recognize patterns that 
have been able to be translated, to look at serum samples or 
blood samples to detect these patterns of proteins to diagnose 
a variety of cancers. The one that has recently been reported 
in Lancet, which is very exciting, is a way to diagnose ovarian 
cancer earlier at stage I, where the opportunity to have a 
higher cure rate is very important.
    We are also looking at breast cancer and prostate cancer 
and other forms of cancer to look at this technology as an 
application. Not only is this technology exciting from the 
aspect of diagnosis, but it is also important in the future for 
looking at new therapies. The ability to look at a single cell 
or type of tumor, to coordinate what the effectiveness of a 
particular drug or agent is on a particular cell type may lead 
to much better care and treatment of patients overall and help 
the FDA do a better job in looking for ways at surrogate end 
points to treat these diseases as well as toxicities of these 
products.
    Ms. DeLauro. Thank you very much. And I appreciate so much 
what you are doing. And I know it is hard to put time frames. 
You know, as best you can, how close are we? Just as a general 
question. I had ovarian cancer 16 years ago, and for 16 years 
we haven't had a test.
    Ms. Kaptur. Would the gentlelady yield? While I am sitting 
here today, my Aunt Esther who is 76 years old, is going 
through her fifth chemotherapy treatment at the Medical College 
of Ohio. She has ovarian cancer.
    Dr. Zoon. I can't give you an exact date. We are working 
very hard with our colleagues at the NIH. We have supported 
this activity. FDA, with the support of our colleagues from 
NIH, have really focused on this area and we will be happy 
sometime to come down and give you a full briefing.
    Ms. DeLauro. Thank you very much. We will take you up on 
it.

                                 PDUFA

    Mr. Latham. Thank you.
    On prescription drug user fees, the FDA's major user fee 
legislation supporting the review of new drugs is in effect 
only for the current year and reauthorization is in the works 
for the budget year. Could you clarify for the committee what 
assumptions are made in the budget relating to that 
reauthorization?
    Dr. Crawford. Yes. As you know, we just had hearings in the 
House on this subject. And Mr. Weber prepared an analysis for 
that and I am going to ask him to respond, if I may.
    Mr. Weber. The budget assumes a $103 million increase for 
prescription drug user fees. However, as the result of recent 
discussions with industry, the eventual fees will be slightly 
less than that, probably about $40 million less than the $103 
million will be required in 2003.

                           IRRADIATION LABEL

    Mr. Latham. On a different subject, as you know, last year 
irradiated ground beef became eligible for sale to the public. 
Since then, other irradiated foods have been approved and 
hopefully more will be approved in the future. Yet the current 
FDA and USDA label statement for irradiated foods treated by 
irradiation may be interpreted by some consumers as a warning. 
Members of our committee in both the House and Senate have 
questioned why the FDA can't identify other labeling statements 
so long as they are truthful and not misleading. What can be 
used on irradiated food instead of the word ``irradiation''? 
Are there other things that you have come up with? Apparently 
there is a deadline in 2002 for labeling.
    Dr. Crawford. That is correct. We have a history of trying 
to deal with that issue. We had a Secretary of Health and Human 
Services, sometime Agriculture, who believed that the term 
``picowaving'' would--p-i-c-o waving, which sounded like 
microwaving. And it is in the pico wavelength. But consumer 
organizations and scientists thought that was kind of a leap 
and it didn't really work. And then shortly after that, there 
was interest in the term ``cold pasteurization.'' And so the 
scientific world was very, I think, accepting of that; thought 
it was a good idea because those of us who work in food safety 
believe that irradiation is a means to control foodborne 
disease at a level that would be cost effective and also human 
health effective.
    However, when we did focus groups at FDA on cold 
pasteurization, the general feeling of the average citizen was 
that this was kind of a ruse or a means to conceal the fact 
that the food had been irradiated. And so we are kind of back 
to square one. We don't have a good synonym for irradiation and 
would like to have one. We don't want to mislead the public. 
The public needs to know that it is irradiated. It also needs 
to know that irradiation is safe. But that term and also the 
radura symbol that is on there is threatening to the public. We 
don't have solutions at this point, but we are continuing to 
look. But I would say, with some pessimism, that we have been 
looking for a quarter of a century and we don't have anything 
yet.
    Mr. Latham. So you don't see making the deadline this year?
    Dr. Crawford. I would be skeptical of it as the 
administrator, yes.

                       DIETARY SUPPLEMENT FUNDING

    Mr. Latham. A significant number of people rely on dietary 
supplements and want to be free to make health-related choices 
without restrictions. The FDA has warned the public that there 
are risks involved that consumers are not able to discern, 
including problems in manufacturing that could lead to 
variations in the potency or contamination. I am wondering what 
is your progress on issuing good manufacturing practices, and 
is there money in your budget request to do the job?
    Dr. Crawford. I am going to ask Mr. Weber in a moment to 
comment on the money and the budget. We are moving forward 
towards good manufacturing practices. The consumer 
organizations and individual consumers and the industry have 
indicated that that particular exercise, which is provided for 
by the law, the Dietary Supplement and Health Education Act 
should be consummated. And so we are moving forward with it.
    As to the budget, Jeff.
    Mr. Weber. There are no additional resources requested in 
our budget for dietary supplements, primarily because of the 
need to fund the counterterrorism supplemental this year in 
this year's budget.
    Mr. Latham. Thank you. Mr. Farr.

                 REGULATED ESTABLISHMENTS IN CALIFORNIA

    Mr. Farr. Thank you Mr. Chairman, I appreciate the length 
of this hearing and the ability to ask these questions, but I 
just have one California question. I notice that the amount of 
increase in your budget, if you take away the fee increases, is 
about 1 percent. And I also noticed that NIH increase in their 
budget--their increase this year is more than your entire 
budget. So you have very little new money to work with. And yet 
in California, I noticed that--to other States it might seem 
like a lot, but you have a presence of about 416 FDA employees 
in the State. Three of the regions report to the district 
office in Oakland, the Pacific regional office. And yet in the 
southern part of the State down by the border, Otay Mesa and 
Calexico, which is just east of San Diego, report to Texas. And 
that is confusing to me, why almost all the State would go to 
one spot and a little part of the State would report to another 
State.
    That is not the question. The question is, there are about 
16,268 FDA-regulated establishments in the State of California. 
And you have got a State with the greatest number of medical 
device and biotechnology firms in the United States. You have 
the major producer of tree--fruits and nuts, and the only State 
that produces almonds.
    California receives 25 percent of all FDA-regulated 
commodities into the United States. We have the largest harbor 
complex in the country. Additionally, the international cargo 
from Los Angeles International Airport, courier hubs at 
regional airports and a central mail processing facility are 
all in southern California. The district serves as the gateway 
to the Orient, with both exports and imports, and a total of 
about 70 percent of all incoming cargo is believed to stay 
within the State boundaries. You really think that 416 people 
can really service those 12,688 regulated establishments?
    Dr. Crawford. I am going to call to the stand now the man 
who is responsible for that, Dennis Baker. Mr. Baker is the 
Associate Commissioner for Regulatory Affairs, and field 
operations are under his jurisdiction.
    Mr. Baker. I will attempt to address your question. First 
of all, the Southwest Import District was created as a pilot, 
and we are evaluating that pilot right now, and that was to 
cover entries coming across the Mexican border.
    Mr. Farr. So everything that relates to border issues.
    Mr. Baker. The reason for that being that way is because 
the person that actually developed the pilot was our regional 
director in Texas. So we felt, since he had the greatest 
knowledge at the time, to put it in there on a pilot basis. We 
haven't determined yet where the final location of the district 
headquarters will be. It may wind up somewhere other than in 
Dallas.
    From the standpoint of staffing, the industry dynamics are 
such that we are constantly shifting resources to cover 
different areas. We are stretched all across the country, as 
you are well aware, with our staffing and our staffing needs, 
so we do shift slowly. But when you hire people and you got 
them located in a given area, shifting those resources as the 
industry shifts is a slow process.

                              FDA'S BUDGET

    Mr. Farr. Why haven't you asked the administration, OMB, 
for more in your budget for staffing purposes, rather than just 
getting them to increasing your fees and covering your 
additional costs that way? I mean, the Agency wasn't set up 
just to be a fee-supported agency.
    Mr. Baker. No.
    Dr. Crawford. I think probably Jeff would be able to 
respond to that.
    Mr. Weber. Yes. Thank you. First of all, the fees only make 
up about $270 million of our $1.6 billion budget, so it is not 
that large a proportion.
    The second thing, and I alluded to this earlier, we are 
only one of four agencies within HHS to have a budget increase 
this year. If you take NIH out of the equation, who is getting 
a $2.4 billion increase, HHS is actually reducing their budget 
by $1.3 billion, while FDA's budget is still growing. The 
challenge within the administration was to find enough 
resources to be able to annualize the $150 million that we 
received in the supplemental and they also funded our full pay 
raise. So we have substantial new resources compared to last 
year's 2002 appropriation before the supplemental.

                         STATUTORY REQUIREMENTS

    Mr. Farr. And do you have enough to do the job? I mean, the 
FDA reported--and this was in the year 2000--that you fell far 
short of statutory requirements given your funding levels. I 
mean, you only inspected about 1 in 4 of the human drugs and 
only 1 in 10 of the medical device statutory establishments. 
And yet you are supposed to be about 50 percent of--the 
statutory establishments should be inspected annually. So you 
are not meeting your workload requirements and you did get an 
increase, but is it enough to cover your responsibility?
    Dr. Crawford. We believe it is. Over the last few years, we 
have had great difficulty finding the money for the pay raise, 
which we had to get out of our own budget. Now that has changed 
and that helps us a great deal. And we have goals to narrow all 
those inspection times so we do meet the statutory 
requirements, and we are committed to do that. There was a 
time, though, when we fell far behind and, you know, we have 
not been able to correct those inequities overnight, but we are 
on target to make the statutory requirements.
    Mr. Farr. We will keep an eye on it. Thank you very much, 
Mr. Chairman.
    Mr. Latham. Ms. Kaptur, would you like to go again?

                          PEDIATRIC RULE DELAY

    Ms. Kaptur. Thank you, Mr. Chairman. I wanted to go back 
for just a second to the issue on the delay of the pediatric 
safety and dosing rule for children. And just so I understand, 
Doctor, for the record now, are you saying that you are 
implementing the rule but there is an 8-week suspension at the 
moment where you are talking to other departments, and that the 
department is not suspending the rule for 2 years?
    Dr. Crawford. What is happening is that we asked the court 
for 8 weeks to consider our options. With respect to the 
several weeks that we are reviewing, what we are to do with 
respect to this new law, the pediatric rule and also the 
lawsuit, we are giving ourselves 2 months. In that 2 months the 
pediatric rule remains in effect. That we are committing to 
here. All that is good about the pediatric rule, we will retain 
in some form or another. We have to evaluate whether the new 
law, which was effective in the month of January is--you know, 
what it subsumes about what we were doing and what we need. 
There is a chance that we need a new regulation, but we are not 
going to suspend that pediatric rule during the time that we 
are considering this.

                           PEDIATRIC DRUG USE

    Ms. Kaptur. As I understand the new law, there is an 
emphasis on drugs that are more commonly used as opposed to 
those that are not as commonly used for children. Is this going 
to sway your thinking one way or another, or are you going to 
accommodate need?
    Dr. Crawford. Our first responsibility is to the children, 
and also to good and proper labeling, and to continue to chip 
away at the fact that when we started this initiative 5 years 
ago, only 20 percent of drugs were labeled for children. So we 
are going to keep down that path. Our evaluation of the new 
law--you know--I will enter it for the record, but I am not 
prepared to say what it might leave out that we have to capture 
in some other way.
    Ms. Kaptur. It is just being pointed out to me that the 
administration, perhaps prior to your tenure, did play an 
extensive role in providing technical assistance in drafting 
the law, the Pharmaceuticals Act. So my question is why do you 
need the time, the 8 weeks?
    Dr. Crawford. That is what we asked the court to give us to 
consider our options. And so we basically are using that time 
to respond to the inquiries in the court proceedings.
    Ms. Kaptur. At any time during those extensive hearings, 
did the FDA suggest that the act would have any impact on the 
pediatric rule?

               LONGITUDINAL STUDIES IN RESEARCH PROGRAMS

    Dr. Crawford. I can search the record and provide the 
answer. That was before my time.
    Ms. Kaptur. We will provide some follow-up questions on 
this issue. I am glad to hear your priority is children, 
however. I wanted to reinforce what I had asked for in the way 
of additional submissions--you thought you could get it to us 
in a couple of weeks--in terms of longitudinal studies that may 
be needed to deal with this issue of BSE, TSE, perhaps 
Salmonella enterititis, where we have these bacteria and other 
microbiologics skipping from one host to another. And I noted, 
as I said in my opening, you don't have very much of a budget 
increase and certainly not adequate to increase what needs to 
be increased in your Agency to get to the bottom of some of 
these questions we have all been discussing this morning.
    But the NIH did receive an increase of $3.7 billion in 
their 2003 budget submission, more than twice your entire 
budget. And what I was going to suggest as you come back to us 
with recommendations on the research front, I would hope that 
you would look at that as a possible source of research dollars 
to complement what we may be able to do at USDA. I guess I need 
a special briefing on the science of it, and perhaps some of 
your excellent people could come up and talk a little bit about 
the proteins. The latency period bothers me.
    I am looking at a memo I got from USDA about spent 
chickens. And I heard what you say about the procedure where 
England got a little bit lax on cooking the stuff to a high 
enough temperature, to put it in layperson's terms. And I keep 
thinking about all this pressure that is on us to change the 
manner in which spent chickens are used. And I know a lot of it 
is used in pet foods right now.
    But if there is this latency and this skipping between 
hosts, how do I know that the attempt to use spent chickens in 
other products, including animal feed, is the right thing to 
do? I don't feel comfortable, based on the science, to promote 
that kind of activity. So I am asking you to look at the NIH 
budget as well as the source of dollars to give us the kind of 
research program that we need to understand this.
    Dr. Crawford. We will certainly be happy to provide the 
briefing. We will contact your staff and see when that can be 
arranged.
    Ms. Kaptur. I thank you very much. And I wanted to go on to 
irradiation safety, but I will do that in the next round.

                 PATIENT SAFETY MEDICAL ERRORS FUNDING

    Mr. Latham. Thank you very much.
    The committee provided a $10 million increase in the 
current year to help the FDA reduce adverse effects from 
approved medications or devices. The budget request asks for an 
additional 5 million for these activities. Can you give us an 
idea in the current year how much is being spent in this area 
and what you accomplished in your surveillance activities?
    Dr. Crawford. I am going to ask colleagues to come to the 
table. But before they do, if I could ask Mr. Weber to comment 
on how much was spent.
    Mr. Weber. During fiscal year 2002, we are spending 
approximately $58 million on patient safety/medical errors. And 
as you said, in fiscal year 2003 we are asking for another $5 
million.
    Dr. Crawford. We need Dr. Woodcock to come forward, 
Director for the Center for Drug Evaluation and Research.
    Dr. Woodcock. We have made considerable progress with the 
money that we got this year. We have improved our adverse 
reaction reporting system for drugs. And we are now at the 
state where the manufacturers can actually file these reports 
electronically into our database. We receive about 250,000 
reports every year, so it has been crucial to improve our 
analytical abilities.
    We also have links to outside databases as well as the 
Center for Biologics, so that the health care systems data can 
be reported to us. This is extremely important in interpreting 
what is going on out there in the health care system as far as 
errors and adverse events.
    The Center for Medical Devices has implemented the pilot 
for MedSun, which is a very innovative program where hospital 
personnel are trained to report to the FDA over the computer, 
and they receive feedback from the system on how they are doing 
and what is being found around the country. And we hope next 
year we will be able to expand that program.
    Mr. Latham. Would you expect the user fees to provide 
funding for adverse event monitoring in the budget year? Is 
that where the funding is?
    Mr. Weber. In addition to the $5 million in appropriated 
funds, some of the user fees will be provided for risk 
management activities.
    Mr. Latham. Is it going to be adequate?
    Mr. Weber. We are doing an assessment right now of what the 
total buyout cost of the program would be, as I am sure there 
are some additional needs. But for now, that is what can be 
absorbed in 2003.

                  EFFORTS TO MITIGATE VACCINE SHORTAGE

    Mr. Latham. Recently there has been a shortage of vaccines 
for children, including Diptheria, Tetanus, & Pertusis, and 
Pneumococca. Some of the shortages seem to be manufacturing or 
production problems over which you have jurisdiction. Could you 
tell us about your efforts to mitigate the shortage, and will 
parents be able to vaccinate their children according to their 
recommendations rather than being rationed?
    Dr. Crawford. I am going to ask Dr. Zoon to come to the 
table and comment on the program that we have effectuated 
there.
    Dr. Zoon. Yes. This is a very important area and one that 
requires, I believe, a lot of attention. There are many 
agencies and organizations as well as manufacturers that have a 
role in this that requires us all to put our heads together to 
find the best way to deal with this. There have been vaccine 
shortages, as you have mentioned, in a number of areas and 
several in the pediatric disease area as well, and in some of 
the cases with influenza vaccines. And we have been working 
with the National Vaccine Program Office as well as the new 
Assistant Secretary for Health in HHS to look at the issues 
surrounding what are the parameters impacting on vaccines and 
their shortages.
    There is no one easy answer. We have a limited number of 
vaccine manufacturers. There are issues with respect to this--
having issues with respect to financial incentives for people 
to go into this area. There are issues with respect to these 
very old production facilities that need to be brought up into 
compliance with current GNPs that we are working very closely 
with them on. There are also issues with respect to products, 
and sometimes they will be in their own production, changes in 
their production cycles that need to be managed and worked 
through.
    So there are a number of issues as well as changes and 
recommendations for use of vaccines. Sometimes we will modify 
the formulation of the vaccine because there are issues such 
as, most recently, with thimerosol which is a mercurial 
preservative, and the concerns of parents looking at removing 
mercury from vaccines and having single dose with no 
preservative or different kinds of preservatives.
    We work with the Center for Disease Control and the NIH, 
the manufacturers, and with the Department to try to effect 
this in a way that makes a smooth transition. But, 
unfortunately, sometimes there are pockets and lapses where 
there are products that do not meet all the demands of the 
time, in which case then we work with our colleagues at the CDC 
to try to make sure that the folks that need these vaccines the 
most get them. But this is a big problem. We are very in tune 
to this, and we are working very hard on this and we hope to 
have some options to be able to proceed and eliminate or at 
least reduce some of these problems.
    Mr. Latham. Thank you. And I know I have a special interest 
here with a new mother. Mr. Hinchey.

                     SECTIONS OF THE PEDIATRIC RULE

    Mr. Hinchey. Thank you very much, Mr. Chairman. I am 
confused about the pediatric rule, and I want to return to it 
for a moment. There were press reports that the rule was being 
suspended for 2 years. You told us that is not the case and the 
rule is still in force and you are enforcing that rule. Are you 
enforcing that rule actively and aggressively?
    Dr. Crawford. Yes.
    Mr. Hinchey. Can you give us any indication of the kinds of 
mechanisms or enforcement action that has been taken within the 
last several months?
    Dr. Crawford. I will ask my colleague to my right, Doctor 
Lumpkin to comment on that. He has been involved with the rule 
since its inception.
    Dr. Lumpkin. I think it is important for people to realize 
that there are different sections to this rule. It tried to 
address a series of different kinds of needs. Since it became 
effective in 1999, the parts that deal with working with 
companies during the development of products, requiring 
companies that are coming in with new formulations to think 
about the impact that it will have on children, we are 
developing new drugs to think about the impact it will have on 
children, and if it looks as though the product might be used 
in a substantial number of children or if it looks as though 
the product has a substantial role within pediatric medicine, 
then they have to look at ways to address that. That has been 
ongoing and has been a routine part of our interactions with 
companies since 1999.
    There is another part of the rule that talks about FDA 
going out de novo to a company and saying it appears to us you 
need to develop this kind of a product or you need to do this 
kind of a study, not when the company is coming to us 
developing new products--that piece of the rule. That part of 
the rule has been one that since 1999, we have never gone out 
and done that. We have said, looking at the whole world of 
pediatric development during this last period, we have wanted 
to let the exclusivity provisions work for those products for 
which it works, and we think it has been a successful program 
and Congress attested to the success of that program for those 
products that benefitted from it.
    And then you look at products that are coming along. That 
part of the pediatric rule we think has been successful also, 
because we can look at the kinds of products that have come in 
and the development that we see and the fact that people are 
building the thought process into drug development that, yes, 
children are important and we need to think about the impact of 
products on children.
    Mr. Hinchey. Are those products being tested for their 
impact on children?
    Dr. Lumpkin. Yes, sir, they are. And I think what we are 
looking at in this new legislation, as has been alluded to 
here, that piece of the legislation that talks about the new 
fund--or going out and funding studies in old products, generic 
products, products that the industry doesn't have a financial 
interest in looking at, setting up an alternate tool to get us 
to the goal of having these products studied in children. That 
is now what we are beginning to implement to see if we can 
address that piece over there.
    So your question is, has the rule been enforced? I hope I 
answered it by talking about the piece of the products that are 
being developed and working with them. Indeed it has been an 
ongoing part of what we do, and it still is an ongoing part. 
The piece about us going out and saying to a company, you must 
do this, you must do that, we have never done that throughout 
the history of this rule yet.
    Mr. Hinchey. The law indicates that this is something in 
which you should be interested.
    Dr. Lumpkin. The new law?
    Mr. Hinchey. The rule.
    Dr. Lumpkin. Exactly. And I think what Congress has done 
now is, given us another tool also to go out--and that is this 
fund--to go out and ask the companies as the law says, are you 
interested? And if they say no, then bidding it out to other 
entities to do the appropriate studies in those products that 
people don't have interest in.
    Mr. Hinchey. So it is self-enforcing at the moment, 
largely.
    Dr. Lumpkin. I don't understand.
    Mr. Hinchey. Self-enforcing. You are not aggressively 
enforcing it.
    Dr. Lumpkin. They come in and work with us on development 
as they submit their applications. We are indeed requiring that 
and we work with them on that; absolutely.
    On the other piece where we go out on de novo products, 
that the industry has not come into us, we have not done that 
in the past because we have been concentrating on the other 
part and the exclusivity piece. And Congress has given us the 
new tool to address that other part and we will be working in 
setting up that procedure. Does it make it any clearer?

                      FOODS AND BANNED PESTICIDES

    Mr. Hinchey. It makes it a little clearer but not as 
crystal clear as I like. But we will pursue it after the 
hearing.
    I want to ask another question about the inspection 
program. We talked a little bit earlier about the fact that we 
are implementing this inspection program for chemical and 
biological elements that may be coming into the country on 
imported produce. Do you have the authority to prevent food 
grown in other countries that use banned pesticides from coming 
into the United States?
    Dr. Crawford. Yes, we do.
    Mr. Hinchey. How do you enforce that?
    Dr. Crawford. Well, we do it in a variety of ways. The most 
visible way is at the border, where we do take samples and we 
also inspect food, and if we have any reason to be suspicious 
of its origin or its contamination level, we can interdict the 
food at that point. More and more, though, what is required is 
for us to work with the country of origin, to go to that 
country and be sure that they are capable of producing safe 
food.
    And in that sense, we are following to the extent we can 
the FSIS model; you know, if you want to ship meat or poultry 
products to the United States, you have to be approved as a 
country to be eligible. And the main thing that is looked for 
there is the presence of a food law. In other words, does the 
country have that capability legally to enforce food safety 
standards? And the second thing is do they have a laboratory 
system so they can verify that enforcement, particularly for 
exported items. And then the final thing in the model that we 
are approaching is that individual plants or shipment points or 
companies doing business also can be inspected, and we can work 
with them through the government to those individual companies. 
So our international presence is gradually increasing and will 
increase some more.

                          HIRING OF INSPECTORS

    Mr. Hinchey. What kind of progress have you made in hiring 
the additional inspectors that are authorized?
    Dr. Crawford. We have made offers to about half of the 
number that we have; in other words, well over 300. Some of 
them are on board, and this half that I mentioned will all be 
on board in a very short time. Some of them needed a month or 
so to finish their business before they started. This hiring 
process is a very intense one, because the increases that we 
are getting in this area amount to about 10 percent, of the 
FDA's staff.
    And so in a very real sense, this is the future of FDA. 
These are young people and they are consumer safety officers, 
which means that they have college degrees, they have great 
versatility within the Agency, and there is no better place for 
them to start their careers at FDA than in inspection 
activities; you know, the journey man profession of FDA, for 
time immemorial, has been as chemists, and that is because they 
do these things. These people will be following that tradition. 
So we have been very careful in hiring them and also very 
careful in getting them on board and vetting them, if you will, 
for their backgrounds and so forth. But we are halfway there 
and we expect to get there in a reasonable amount of time.

                   NUMBER OF SEIZED ADULTERATED ITEMS

    Mr. Hinchey. And finally, have you seen any increase in the 
numbers of adulterated items that have been seized at the 
border as a result of this increase?
    Dr. Crawford. Dennis, would you respond to that?
    Mr. Baker. As you are aware, we are just now putting the 
people on board, so those numbers are coming up slowly. We 
would anticipate seeing an increased examination. How much of 
that will translate into increased violations that we detect is 
hard to project at this time.
    Part of our putting these people at the border and doing 
more physical examinations also serves as a deterrence by 
virtue of the fact we are looking at more--we are certainly 
going to have more violations that we will uncover. Whether 
that is going to be in line with the percentage increase is 
hard to project, but we do anticipate more.
    Mr. Hinchey. Thank you very much. Thank you, Mr. Chairman.
    Mr. Latham. Thank you Mr. Hinchey. Ms. Kaptur.

                        SPENT CHICKENS IN FOODS

    Ms. Kaptur. Should I have any concerns about spent chickens 
being used in the animal or human food chain?
    Dr. Crawford. These spent chickens are old laying hens that 
have finished their productive careers. When they are added, 
they are subjected to prescribed treatments--that is, rendering 
high heat, high temperature with pressure, and they are in 
effect sterilized. So I don't believe there is any real risk 
from spent chickens.
    Now, the levels in these chickens at that particular point 
in their lives of Salmonella and some of these other things 
have been shown in the past to be higher than when they were 
younger and also, in effect, the diseases of old age, albeit in 
chickens, like arthritis and tumors and so forth, is certainly 
higher.
    If you would like, we could give like a little report on 
what is--kind of like your diagram of the eggs--the steps that 
are taken in order to be sure that this product when it enters 
the food chain is safe. Because you are right; we have to be as 
concerned about pet food as we are about human food in a real 
sense, because it is in the home, it is put out.
    [The information follows:]

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    Ms. Kaptur. Would the gentleman yield? Some of our senior 
citizens eat it.
    Dr. Crawford. That has certainly been the case from time to 
time.
    Ms. Kaptur. And as I listen to you I heard you say that the 
rendering of animal meat doesn't destroy certain proteins, 
apparently the prion protein important in BSE and I am asking 
myself the question in poultry: Do we really know enough? And 
my question as a nonscientist: Should I be concerned?
    I didn't have the concern that I have now about beef 7 
years ago. Now I have it. And so I am trying to understand--
just trying to understand and protect human health here. So any 
enlightenment you could offer would be appreciated.
    And, by the way, some of that is used in chicken soup and a 
lot of products that are consumed by humans. I think there are 
more--what, two or three times many pets in the United States 
as human beings. If you are talking about species leaping, 
there are a lot more chances for those critters to infect us if 
they get something. So we have to understand the science of 
this.

                  SAFETY INSPECTION PROCEDURE FOR EGGS

    Also on the egg chart, I am trying to think how to ask a 
question so I can get the answer I want. Can you design for me 
a seamless design safety inspection procedure? If you could 
dream of the best one, what would it be? Any suggestions? Could 
you offer anything like that?
    Dr. Crawford. We will do that as best we can. But we don't 
have all of the authorities wrapped up into one agency. But 
that doesn't matter; I mean, we will give you what we can give 
you.
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                            RADIATION SAFETY

    Ms. Kaptur. Dream. Dream. Let me just turn to radiation 
safety if I could, Doctor. According to the numbers I have been 
given, in 1978 there were 400 full-time staff equivalencies at 
FDA in the radiological health arena. Today there are 50. And 
according to FDA's own performance review which predated your 
appointment, the irradiation system is not working well, and we 
have evidence, that equipment is not being inspected, and many 
times injuries, including burns, are experienced by patients. 
My question to you is: What resources does FDA need to put an 
end to the resurgence of problems in equipment that we are 
experiencing and effectively regulate radiation safety?
    Dr. Crawford. I would like to call--Dr. Feigal. As you 
said, it did precede me. He has been back here for some time, 
and now I would like him to respond to your question. He is the 
Director of our Center for Medical Devices and Radiological 
Health.
    Dr. Feigal. Thank you very much for that question. Let me 
just begin by saying the burns are actually coming from the use 
of equipment that is functioning properly. There are burns that 
are occurring after long cardiology procedures and from use of 
fluoroscopy. And one of the efforts that we have undertaken is 
to really begin an educational campaign with the physicians 
that use fluoroscopy for things like cardiac catheterization 
and stint placement. These procedures are becoming more and 
more common. And the training, the clinical training, which 
isn't our direct responsibility--ours is equipment--but the 
clinical training doesn't seem to be emphasizing keeping track 
of how much exposure the patient has had.
    We will be looking at proposals to acquire new machines 
which essentially have speedometers that will tell you how much 
you have exposed the patient, and we look forward to that 
equipment being put into place. Right now, that has been an 
effort that has been led by Tom Schope of our staff to really 
have outreach.
    One of the things to remember about the radiation health 
program when it began, at one time it had 1,600 staff. It was 
at the time when we had responsibility not just for devices 
that emit radiation but also nuclear, and monitoring fallout. 
And our staff were actually split off at various times to be 
part of the Nuclear Regulatory Commission staff and 
Environmental Protection Agency. And there is now a complex 
government-wide program.
    But the program is also a little bit of a victim of its own 
success. It set up training programs that trained a cadre of 
radiation health physicists that staffed the States, that 
staffed the Center. And that group became very stable. The 
training programs began closing down. And now it is actually 
very hard now to find people that are trained in this area and 
have the proper background.
    And the States and the EPA and the NRC are having the same 
problem. We have been dealing with the efforts after September 
11 to actually work with organizations such as USIS, the 
military school, that have a particular interest in radiation 
from nuclear sources, to actually look at new training programs 
and ways we can rebuild the cadre. It is a program that assures 
the safety of products in two ways: one, by setting standards; 
and the other, by having an adequate inspectional force to 
assure that the standards are being met, either in this country 
or from products being imported abroad.
    And so some of the things that have been part of the 
strengthening of the field after September 11 will strengthen 
that program because that will have that focus. There is much 
work to be done. We are in the process, actually, of developing 
a strategic long-range plan of what it takes to put together a 
program that doesn't need to meet the needs that we were 
meeting back during the Cold War, but will meet the needs with 
all the innovations that are coming in the future.
    We have not yet finished that process, and actually put a 
request for the size of that program--the long-term needs--on 
the table, but we are anticipating completing that in the next 
year.

                       RADIATION SAFETY PLANNING

    Ms. Kaptur. Doctor, with all of the additional funds we are 
being asked to appropriate here for the war on terrorism, this 
is the time. I mean, these bills are going to be moving through 
here. So I would just encourage you, if you have some 
conclusions that have already been reached, to bring those 
forward; because this area of radiation and just general public 
safety in this regard and how we deal with the potential dirty 
bomb or whatever--though that isn't directly related to your 
job description, some of the technologies are. And so I think 
that you could get the support of the administration, rather 
than wait an entire another year to bring some of these needs 
forward now.
    Dr. Feigal. Thank you for the comment. There actually has 
been multiagency planning for things relating to dirty bombs, 
or a scenario if two warring parties around the world got into 
a nuclear dispute, what would be the FDA's response to making 
sure that the food imported would not in fact be contaminated 
by radiation. There are many different issues, and we have been 
technical consultants on issues ranging from the way to kill 
anthrax spores in mail through irradiation, looking at new 
security devices such as the people scanners and new 
technologies, provide the expertise of these kinds of 
technologies used in airports to screen baggage and cargo. So I 
wouldn't want you to think it is an area that has dwindled to 
the point that we don't have capability. But we do have some 
rebuilding to do and we will bring those requests forward.
    Ms. Kaptur. Does that rebuilding include personnel and the 
training of personnel?
    Dr. Feigal. Yes, it does. And we have actually had regular 
scenarios and exercises and radiation emergency exercises that 
include not just FDA, but have also included the other--Public 
Health Service, the military, Department of Energy, all of the 
different players.
    Ms. Kaptur. Was FEMA involved in that discussion?
    Dr. Feigal. Yes.
    Ms. Kaptur. We are increasing their budget substantially.
    Thank you very much.
    Mr. Latham. Mr. Hinchey.

            LABELING GUIDANCE ON GENETICALLY MODIFIED FOODS

    Mr. Hinchey. Thank you for your stamina. I just wanted to 
ask a question about, genetically modified organisms. There has 
been considerable public support and I think a lot of confusion 
on this issue, particularly about the labeling of genetically 
modified food. FDA proposed a rule about a year ago. I am 
wondering what is the status of the rule. Has it been sent to 
OMB? Will we see enforcement of it? Can you bring us up to date 
on where that is?
    Dr. Crawford. It came out before I did, so I am going to 
ask Joe Levitt to comment on where it is and if there is any 
time line.
    Mr. Levitt. It is being worked on at FDA. There are 
actually two pieces. One was a proposed regulation for a 
premarket notification program for new products that involve 
biotechnology. The second, which I think was what you were 
asking about, was a draft labeling guidance dealing with the 
labeling of these foods. Both of these proposals generated 
thousands and thousands of comments, and so we actually needed 
to send them out to a contractor to organize and synthesize 
those comments for us. And that is one reason why it has taken 
some time, but it is back at the FDA and is a priority on our 
work plan, but it will still take some time to work through.
    Mr. Hinchey. Any idea how long?
    Mr. Levitt. No.
    Mr. Hinchey. Is it months or years?
    Mr. Levitt. I suspect in the middle.
    Mr. Hinchey. I am sorry? Both?
    Mr. Levitt. I said in the middle.
    Mr. Hinchey. Between months and years.
    Dr. Crawford. He never was good on the calendar.

                              CELL PHONES

    Mr. Hinchey. And one question about cell phones. In June, 
almost 2 years ago, the FDA entered into a collaborative 
research agreement with the cellular telephone industry to look 
into the health consequence of radio frequency emissions from 
cell telephones. Can you bring us up to date on where that is?
    Dr. Feigal. As I put my cell phone on the table--that is a 
project that is still underway. The goal of that cooperative 
agreement was to find a way to get some independent 
recommendations and assessment of needed research products on 
cell phones that--where the funds would come from industry, and 
by having the government input on the design of the studies and 
the nature of the studies, would add more credibility than if 
they had been funded by industry directly. That was the intent 
of that.
    And that process continues. The studies are typically 
multiyear studies. I think the goals are to identify the kinds 
of preliminary findings that have been reported in other 
studies but have been difficult to verify, and see if we can 
address if these are methodologic issues and those were false 
alarms or these are signals that need further follow-up. At 
this point, most of the information about cell phones, 
particularly the human epidemiological studies, have been 
reassuring. But it is something we need to follow up because 
the advent of very widespread cell phones is a new phenomenon.
    Mr. Hinchey. I assume that in the course of your work here, 
you are looking at previous studies done in other countries. 
For example, there was one in Great Britain that was done a few 
years ago.
    Dr. Feigal. We have looked worldwide. Many of the studies 
that raise the hypothesis, for example, the suggestion that 
brain tumors were more likely on the side of the head that you 
might use your cell phone, was the Swedish study. It actually 
wasn't a cell phone study. It was a study of handedness and 
location of brain tumors. But that was the suggestion. And 
there have been other studies like that.
    So I think this is an area we will continue to follow. And 
our approach, in an area where there is potential risk, is to 
tell people who are concerned about those risks what is known. 
In this case, we don't see any evidence or the definitive 
evidence for the kinds of threats that are suggested. But we 
tell people how they can decrease their exposure, and that is 
one of the ways we can help manage risk. People who want to 
take extra precautions for the risk, like using hands-free 
operations and keeping the antennas further away from their 
head or body, that is a way to do that; and, of course, remind 
people that driving and using cell phones is far more dangerous 
than the other risks that have been talked about.

                       NIH AND FDA ON CELL PHONES

    Mr. Hinchey. There was one other aspect of this which just 
left me. So maybe it is just as well. Are you involving the 
National Institutes of Health in this study at all?
    Dr. Feigal. I would have to check, I think not, but I can 
check and verify that. But we are involved with the NIH, which 
had epidemiologic studies, because they have large population-
based epidemiology studies of cancer in the United States. And 
they have actually released reports that studied primarily the 
effects of short-term use, 3- to 5-year use, that do not see an 
increased risk. But those--you know, as I say, we are just 
beginning on this.
    I think this is a fairly common problem for FDA, is that we 
often get a signal and some of them don't pan out. And when we 
are in that middle stage, we need to continue to follow them, 
because some of them are real risks. And that is the situation 
with cell phones.
    [The information follows:]

                       NIH and FDA on Cell Phones

    FDA is collaborating with the Cellular Telecommunications Industry 
Association (CTIA) on research into mobile phone safety. Under a 
Cooperation Research and Development Agreement (CRADA), FDA will 
provide research recommendations and research oversight and CTIA will 
fund research into the health effects of radio frequency (RF) emissions 
from wireless phones. The research will be conducted over the next 
three to five years by third parties. NIH was not involved in setting 
up the CRADA on Cell Phones. However they will be involved in some of 
the research.
    The CRADA had three goals, one of which involved the National 
Cancer Institute (NCI), NIH:
    1. To develop epidemiological studies; NCI did participate in this 
activity;
    2. To conduct the micronuclease assay for assessment of effects of 
cell phones. NIH was invited to contribute in the development of 
experimental protocols and to select participants, but they declined to 
participate; and
    3. To determine what other activities are needed; NIH did not 
participate.

                            RECALL AUTHORITY

    Mr. Hinchey. Thank you, Mr. Feigal.
    Dr. Crawford, one of the ways in which you try to inform 
the public and to promote health and safety is when you 
discover there a problem, you issue a press release to try to 
get it out into the media so people can be informed about it. 
One of the examples was a recent statement about a nationwide 
and international alert of potentially dangerous Ob-Gyn 
surgical devices. These are Ob-Gyn surgical devices which are 
supposed to be sterilized but are found often not to be so, and 
can cause infection, miscarriage, and infertility. It is a 
pretty serious matter. And you put out what is a very good and 
clear statement about it, and you were warning people and 
urging the company to recall these products. You don't have 
recall authority, do you?
    Dr. Crawford. We do not have mandatory recall--except in 
devices.
    Mr. Hinchey. In this particular case, you do have it. That 
has been a very interesting case.
    Dr. Feigal. We had an insider in the company who told us 
that this company ships about 10,000 items per month and has 
about 1,600 customers and sort of a middle man repackaging. 
They buy unsterilized equipment. They put them into packaging 
and then sell them either directly to hospitals or to other 
middlemen.
    The companies--we were informed that they weren't 
sterilizing all of the equipment. And no one from the company 
is actually left in the country, except for a shipping clerk 
and another employee. And so we have been communicating with 
the principals in the company, out of the country and--but 
there is actually no one from the company available--who can 
actually do the recall.
    So we do have the authority to do mandatory recalls. They 
are very unusual because the companies are usually very 
willing, for business reasons, to do prompt recalls when they 
have a problem. But in this case--in fact, this may be either 
the first or second time in 27 years we have done the recall 
ourselves. And we are in the process of doing that.
    Mr. Hinchey. This company is operating out of a Georgia 
community and--but they are actually foreign owned?
    Dr. Feigal. You know, I don't know the details.
    Mr. Hinchey. They just skipped?
    Mr. Baker. The owners of this company were from another 
country, but they actually owned the company. It is a U.S. 
Firm.
    Mr. Hinchey. Where are they from?
    Mr. Baker. Lebanon. I think our first clue was when we went 
in to investigate. They left the country, so we pretty much 
knew we were going to have a problem.
    Mr. Hinchey. How many of these devices are out there?
    Mr. Baker. Tens of thousands.
    Mr. Hinchey. And you are actively considering a recall?
    Mr. Baker. It is in the works right now.
    Mr. Hinchey. Thank you very much.
    Mr. Latham. Ms. Kaptur.

                     PRODUCTS RECOVERED IN A RECALL

    Ms. Kaptur. Once you do the recall, based on past record, 
what percent of items are actually recovered?
    Dr. Feigal. One of the things that isn't clear to us is how 
long the practice has been going on of not sterilizing them. It 
could have been going on for as long as 3 years. So it is--and 
these are disposable devices. These are single-use devices. And 
so we anticipate that we will find a lot of the material that 
has been shipped and used has been disposed of.
    And so what we are trying to do now is to get the material 
that is still in warehouses, still in hospitals, and get it off 
the shelves so it isn't used. In these settings we often 
collaborate with the Centers for Disease Control to see if they 
can give us any insight as to whether there is any observable 
increase in infections or other kinds of problems.
    It really depends on the details of what the nature of the 
problem was. The devices may have been cleaned, but not 
sterile, which is better than devices which are often being 
recleaned in hospitals, where they begin as being contaminated 
with biological materials and they need to be cleaned and 
sterilized.
    So it is not clear to us even what the magnitude of what 
the public health problems have been. But at this point, our 
emphasis is to get the products off the shelves.
    Ms. Kaptur. If I could ask you to give us a list in the 
last year or two of items that were recalled, and then ask you 
to indicate how much was actually recovered, do you have the 
ability to do that?
    Mr. Feigal. Well, we have different types of effectiveness 
checks for different types of recalls. We do the most 
rigorous--looking at recovery in the setting of the Class I 
recalls, the ones that are the highest public health risk. The 
recalls often occur after the products have been used. And so 
what you really--it is often hard to figure out how much you 
are actually trying to recover.

                            CIVIL PENALTIES

    Ms. Kaptur. The reason I am asking this question is because 
on the USDA side, if we look at recalled hamburger where E. 
coli was present, the vast majority is never recovered, even 
though it has been recalled. So there is a distinction in the 
meanings between ``recall'' and ``recover.'' to the general 
public, ``recall'' sounds like it was made better. We drew it 
to public attention that it wasn't made better. And I am asking 
myself the question, well, if we don't recover, then what 
additional actions can we take if we can find those 
responsible? Do you have civil penalty authority under current 
law?
    Dr. Feigal. The Center for Devices has several penalties, 
and we have exercised those and the fines are often in the 
millions of dollars.
    Ms. Kaptur. I would be very interested in submitting a 
question for the record, if you could review the various types 
of recalls that you have issued and the items recovered and 
then any civil action taken against the responsible parties.
    Dr. Feigal. We would be happy to do that.
    [The information follows:]

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                                SEAFOOD

    Ms. Kaptur. Dr. Crawford, I want to move to seafood. We 
have records that show us that the majority of seafood eaten in 
this country comes from somewhere else--over 159 countries. And 
FDA's recent evaluation of the HACCP program operating in these 
other places indicates that even though FDA gave advanced 
notice of their coming to examine and inspect, only 33 percent 
of foreign firms had a satisfactory HACCP system in place. What 
is FDA doing to increase compliance in this area?
    Dr. Crawford. Mr. Levitt, please.
    Mr. Levitt. In short--and I will try to respect the time 
this time--we have tried to focus on what is most important and 
really emphasize that. We issued about a year ago what we call 
the mid-course correction on our seafood HACCP program. The 
focus is on those firms that make products that are subject to 
problems with pathogens, with histamines that cause allergic 
type of reactions, and with firms at that point who did not 
have a HACCP plan. We focused both our domestic inspection 
program, and our foreign inspections and border sampling in 
those areas. And so by focusing our attention to what matters 
the most to the consumer, we feel we will make more progress 
quicker.
    Ms. Kaptur. Are certain countries more prominent than 
others in sending a tainted product?
    Mr. Levitt. I don't have the information in my head that 
could answer that.
    Dr. Crawford. We could give you a rank ordering.
    Ms. Kaptur. That would be very helpful for the record, the 
countries and also the products. I got really sick on sea bass 
from South America, and so I know what that feels like. So I 
will appreciate that very much.
    [The information follows:]

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                          GENDER-BASED TRIALS

    Ms. Kaptur. My time is up, and I have two more questions 
remaining. Let me just turn to the question of drug development 
and the inclusion of gender-based trials. In July 2001, a GAO 
report found that women were only 22 percent of the 
participants in the initial small-scale safety trials used to 
set dosing levels for larger-scale trials. And, in fact, I 
won't read the entire GAO conclusion, but I have to say they 
say something like, FDA has not effectively overseen the 
presentation and analysis of data related to sex differences in 
drug development.
    I am interested in what the Agency is doing to remedy the 
deficiencies that were discussed in the GAO report.
    Dr. Crawford. Dr. Woodcock.
    Dr. Woodcock. Thank you. Well, I think we have some good 
news in this regard. First of all, our recent look at clinical 
trials shows that, especially for many chronic diseases, women 
are the majority of participants in the large-scale trials, 
which reflects their utilization of health care, actually.
    As far as the analysis of the results and enforcing the 
requirements on companies about presentation of the analysis, 
what we did last year was to implement a strict format for 
medical reviewers, which has a section--which we will submit 
this to you--where they must discuss the industry's analysis by 
gender, they must discuss the adequacy of that analysis, and 
they must discuss their conclusions and how it reflects on the 
label both for safety and effectiveness of the drugs.
    We are currently evaluating the effect of that program that 
we have had in effect for 1 year, and we should have 
information very soon on that. But that is the essential step, 
which is to draw the attention of our medical reviewers, make 
sure they assess the adequacy and make sure they write that 
down. We will be able to take steps based on that one year of 
information.
    [The information follows:]

                          Gender-Based Trials

    We have developed and launched a web-based educational program for 
reviewers on the collection and evaluation of demographic information. 
In addition, we have implemented a ``Clinical Review Template'' which 
reviewers must follow and complete a part of the review of new drug 
applications. A ``demographic worksheet'' that will be appended to the 
Clinical Review Template has been developed and will soon be 
implemented. These tools provide the guidance necessary for drug 
reviewers to evaluate gender-based data in clinical trials.

    Ms. Kaptur. So when GAO says there is no management system 
in place to record and track the inclusion of women in clinical 
drug trials or to monitor compliance with the relevant 
regulations, that is no longer a true statement?
    Dr. Woodcock. That is correct. In addition, we received 
$500,000 in the Office of Women's Health at the FDA for setting 
up a clinical trial database that will actually enter data on 
inclusion of women in clinical trials. That is under 
development but not done yet. That will take some time to 
complete.
    Ms. Kaptur. And where the GAO says the Agency also does not 
routinely review the required tabulation of demographic data by 
sex in the annual reports for drugs and development, that is no 
longer true?
    Dr. Woodcock. I can't say that. The template I was 
referring to is not for annual reports. That is the next step 
we will have to take.
    Ms. Kaptur. I also listened to you carefully when you said 
that women were 50 percent of the large-scale trials. What 
about the small-scale initial trials.
    Dr. Woodcock. The very initial trials, are what we call 
Phase I trials, look at the pharmacokinetics of the drug. 
Traditionally, they included only young men. So they didn't 
include older people and they didn't include women or people 
who had any disease. This is gradually changing. But it has 
taken some time to change those early safety pharmacokinetics 
trials. It has definitely improved, but it isn't up to 50 
percent by any means.
    Ms. Kaptur. The GAO report says here, even though about 
one-third of new drug applications specify that the 
concentrations of the drug in the bloodstream were greater in 
people who weighed less, as most women do, FDA reviewers did 
not comment in their summaries on the lack of dose adjustments 
based on sex. I like to cut my vitamin pills in half. I think 
they give us too much compared to these guys.
    Dr. Woodcock. That deficiency is taken care of by this 
template.
    Ms. Kaptur. We are going to ask you some questions on which 
of FDA's recommendations you have acted on, which you haven't, 
and what is the estimated time of implementation and at what 
cost? Thank you.
    My final question--and I thank the witnesses very, very 
much and I thank the chairman also--deals with FDA's regulatory 
responsibility in the area of animal drug residue levels in 
food-producing animals. And even working in conjunction with 
the State, FDA has only investigated, according to the numbers 
we have, 43 percent to 50 percent of each year's USDA animal 
drug residue referrals made in the last 10 years.
    The GAO report indicated--actually cited FDA officials who 
stated that the Agency lacks the resources to conduct prompt 
follow-up investigations and does not have an adequate referral 
assignment and tracking system to ensure that investigations 
are made in a timely manner.
    GAO cited also that FDA only has resources to cite repeat 
violators and investigate repeat violators. As a result, animal 
producers who are not investigated may continue to use animal 
drugs improperly, putting consumer health at risk. What 
resources are required here for FDA to do 100 percent of the 
job?
    Dr. Sundlof. I can't tell you what the numbers are, but let 
me talk about the relationship between our BSE enforcement and 
our tissue residue enforcement. When the BSE rule passed, or 
when it went into effect, there were no additional resources 
that came with that, and we had something on the order of 
10,000 more firms to inspect.
    As a result of that, we put more of our priority emphasis 
on getting through those feedmills and those renderers that 
were regulated under the rule, and some of those resources had 
to come from somewhere, and the place where a lot of them came 
was from the tissue residue program. Last year, this committee 
appropriated sufficient funds so we can put those resources 
back into the tissue residue program.
    Even though we have not been following up on every 
violation--and I will have to check on the figures, but I 
assume that the ones that you read were fairly accurate--we get 
out to a lot of those firms and we take more regulatory 
enforcement actions against residue violations than anything 
else. And every month we are taking strong enforcement actions, 
levying large fines against individual farmers who send animals 
to slaughter that have violative residues.
    Ms. Kaptur. Could you explain for the record, why this is 
important?
    Dr. Sundlof. The reason it is important is because that is 
the only way we can ensure that the food supply is safe. If we 
want to have drugs that are approved for use in animals, which 
we think is absolutely necessary--animals do need drugs on 
occasion--but in order to make sure that the food is safe, 
those drug residue levels have to be below some set standard 
that we consider to be absolutely safe for public health. If 
they are above that, then those foods are no longer considered 
to be safe.
    If you look at the total residue violation, they are far 
less than 1 percent. Far less than 1 percent of the animals 
that go to slaughter have residues that are in excess of the 
Federal standard. So it is a very, very low number of residues.
    But when you consider the number of animals that are 
slaughtered every year, 8\1/2\ billion chickens, you know, the 
number is actually bigger than what the percentage indicates. 
Again, we are shifting resources back into our tissue residue 
program now that we have sufficient funding to enforce the BSE 
rule.
    Ms. Kaptur. So you are saying you have adequate resources 
to properly enforce in this area?
    Dr. Sundlof. Yes, we believe so.
    Ms. Kaptur. Let me say, Dr. Crawford, thank you very much. 
As I have been listening to you, I also have been thinking 
about the substantial increases that we have provided to the 
National Science Foundation over the years and the importance 
of understanding the science of what has happened in the 
species leaping. Frankly, I find it frightening because I don't 
understand it. I don't understand what is going on, and the 
biology has changed in my lifetime and there appears to be 
latency periods going on. This was never taught in school when 
I went to school. So this is an area I feel we need some kind 
of an initiative.
    And I serve on the National Science Foundation committee as 
well. I want to impress upon you our seriousness on this. And 
we do want to help you help the world understand what is going 
on, so I hope you give us a chance and win some Nobel Prizes. 
Maybe you can get one. I would certainly like that.
    Let me just ask this. I did think of one thing that I 
hadn't asked before, and that is if you have any plans to 
reevaluate Ritalin. Anybody have comments?
    Dr. Crawford. We can submit that for the record if you 
like.
    [The information follows:]

                           Ritalin

    We are aware of a grant provided to Dr. Lawrence L. Greenhill by 
the National Institutes of Health to conduct clinical trials regarding 
the use of Ritalin (methylphenidate hydrochloride) in 
children 3 to 6 years of age. We have been consulting with Dr. 
Greenhill regarding the design of the clinical trial. Once the trial 
has been completed and the data has been submitted to us, we will 
evaluate that data for the safe and effective use of methylphenidate in 
children in this age.

    Ms. Kaptur. Thank you. Thank you very much, Mr. Chairman.
    Mr. Hinchey. Thank you very much.
    Mr. Latham. I join in thanking you.
    Members and I have a considerable number of questions for 
the record. We would appreciate your prompt response. Also 
thank you for the extraordinarily important work that you do on 
behalf of all the people who rely on your ability. Thank you. 
The subcommittee stands ajourned.

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                           W I T N E S S E S

                              ----------                              
                                                                   Page
Crawford, Lester.................................................     1
Newsome, J. E....................................................  1003
Reyna, M. M......................................................   809
Troy, Daniel.....................................................     1
Weber, Jeffrey...................................................     1


                               I N D E X
                              ----------                              

                      Food and Drug Administration
                                                                   Page
Advisory Committees..............................................   133
AIDS Activities................................................135, 369
Animal Drugs and Feeds:
    Animal Drug Review...........................................   139
    Benefit of Animal By-Product in Feed.........................    93
    BSE-Accomplishments..........................................    86
    BSE-Imported Foods...........................................   153
    BSE-Origins..................................................    88
    BSE-Prevention Activities....................................   149
    BSE-Protection of Blood Supply...............................   150
    BSE-State Inspections........................................    87
    BSE-Regulations..............................................    87
    BSE-Research.................................................    89
    BSE-Resources..............................................150, 154
    BSE-Vaccine Safety...........................................   151
    Feeding of Animal By-Products................................    92
    Spent Chickens in Animal Food................................    93
Antibiotic/Antimicrobial Resistance:
    Antimicrobial Resistance Activities..........................   140
    Antimicrobial Resistance.....................................   139
    Guidance for Industry........................................   142
    National Antimicrobial Resistance Monitoring System (NARMS)314, 316
    Withdrawal of Product Approval...............................   141
    Application Reviews-Statutory Requirements............186, 251, 342
Biographical Sketches:
    Dr. Lester M. Crawford.......................................    45
    Mr. Daniel Troy..............................................    46
    Mr. Jeffrey M. Weber.........................................    47
    Dr. Janet Woodcock...........................................    48
    Mr. Joseph A. Levitt.........................................    49
    Dr. Murray Lumpkin...........................................    50
    Dr. Stephen Sundlof..........................................    51
    Dr. Kathryn Zoon.............................................    52
    Mr. Dennis Baker.............................................    53
    Dr. David Feigal.............................................    54
Biologics:
    AIDS Vaccine.................................................   369
    Blood Safety.................................................   145
    Blood Safety-Guidance........................................   146
    Blood Safety Resources.......................................   147
    Blood Test for Ovarian Cancer................................    97
    Bovine Spongiform Encephalopathy (BSE).....................150, 151
    Diabetes Vaccine.............................................   369
    Efforts to Mitigate Vaccine Shortage.........................   104
    Enzyme Potentiated Desensitization...........................   389
    PDUFA..................................................98, 273, 360
    PDUFA Financial Report.......................................   276
    PDUFA Performance Goals....................................275, 351
    PDUFA Resources.......................................273, 309, 361
    Vaccine Shortages..........................................104, 384
Bovine Spongiform Encephalopathy (BSE):
    Accomplishments..............................................    86
    Benefit of Animal By-Product in Feed.........................    93
    BSE State Inspections........................................    87
    Feeding of Animal By-Products................................    92
    Imported Foods...............................................   153
    Origins......................................................    88
    Prevention Activities........................................   149
    Protection of Blood Supply...................................   150
    State Inspections............................................    87
    Regulations..................................................    87
    Research.....................................................    89
    Resources..................................................150, 154
    Vaccine Safety...............................................   151
Budget:
    Congressional Justification..................................   395
        Foods....................................................   449
        Human Drugs..............................................   464
        Biologics................................................   486
        Animal Drugs and Feeds...................................   503
        Devices and Radiological Health..........................   515
        National Center for Toxicological Research...............   460
        Office of Regulatory Affairs.............................   539
        Other Activities.........................................   562
        Rent.....................................................   579
        Buildings and Facilities.................................   584
    Contingency Fund.............................................   159
    Crosswalk from Current Estimate to Actuals...................   154
    Counter Terrorism Funding...................................70, 318
        FY 2002 Supplemental Request............................71, 317
        FY 2003 Budget Request..................................76, 325
    Current Services.............................................   159
    Expiring Authorizations......................................   313
    FY 2003 Budget Request.................................58, 100, 353
    FY 2003 Budget Initiatives by Program........................   157
    Funding to Meet Statutory Requirements.......................   101
    Research.....................................................   310
    Transfer of Funds..........................................317, 359
    Unauthorized Appropriations..................................   313
Buildings and Facilities:
    Arkansas Regional Lab Construction...........................   316
    Consolidation Plan and Status.........................189, 312, 316
    Los Angeles Laboratory.....................................270, 310
    Rent.........................................................   309
Congressional Directives:
    Biotechnology................................................   171
    Biotechnology Labeling.......................................   172
    Blood Product Safety.........................................   172
    Breast Implants..............................................   169
    Catfish......................................................   177
    Codex........................................................   177
    Current Good Manufacturing Practice (CGMP) Regulations.......   178
    Devise Reprocessing..........................................   174
    Dietary Supplement Adverse Event Reports.....................   166
    Dietary Supplements..........................................   176
    Food Safety..................................................   167
    Financial Management System..................................   179
    Free Health Care Clinics.....................................   179
    Generic Drugs................................................   177
    Import inspections...........................................   170
    Interstate Shellfish Sanitary Commission.....................   176
    Labeling of Irradiated Foods.................................   167
    Medical Device Application Review............................   175
    Reused Medical Devices.......................................   173
    Secondary Wholesale Pharmaceutical Industry..................   169
    Shellfish Safety.............................................   168
    Shellfish Safety Goals.......................................   168
    Tissue Processing............................................   172
    Tissue Processor Inspections.................................   173
    Waste Management Education and Research Consortium...........   171
Congressional Reports-Status.....................................   180
Counter Terrorism:
    Activities and Accomplishments...............................   325
    Bioterrorism Legislation-Food Firm Registration..............   346
    Counter Terrorism Funding...................................70, 318
        FY 2002 Supplemental Request............................71, 317
        FY 2003 Budget Request..................................76, 325
Food Safety......................................................   354
    Inspections and Imports......................................    79
    New Iniatives................................................    79
Foods/Food Safety:
    Allergens....................................................   388
    Bioengineered Foods.........................................95, 115
    Caffeine....................................................84, 391
    Codex Alimentarius Commission..............................159, 373
    Dietary Supplements..............................165, 364, 374, 390
    Dietary Supplements-New Funding..............................    99
    Egg Safety Action Plan.......................................   188
    Equivalency Agreements.......................................   370
    Ephedra......................................................    85
    Export Certificates........................................115, 349
    Food Safety Action Plan......................................   376
    Food Safety Definition.......................................    93
    Food Safety Initiative.....................................247, 249
    HAACP-Juice/Seafood................94, 121, 122, 310, 366, 374, 376
    High Risk Food Inspections-Domestic..........................   193
    Imported Meat................................................   355
    Imports-Amount of Coverage............................254, 353, 354
    Labeling....................................................98, 195
    Pesticides..................................................94, 106
    Petitions for Rulemaking...................................385, 393
    Recalls......................................................   195
    Registration of Food Manufacturers, Handlers, and Processors.    90
    Regulated Establishments in California.......................    99
    Salmonella Geographical Contamination........................    64
    Salmonella in Eggs-Inspections...........................59, 60, 61
    Single Food Agency..........................................96, 356
    Species Leaping..........................................62, 63, 65
    Spent Chickens in Human Foods..............................108, 109
    USDA Inspection of Eggs......................................    61
Human Drugs:
    Adverse Events-Recalls.......................................   144
    Adverse Medical Event Activity Funding.......................   144
    AIDS Drug Approval Times.....................................   136
    Application Review Statutory Requirement and Performance 
      Level......................................................   186
    Cost of Drug Advertising.....................................    66
    Cost of Prescription Drugs...................................    65
    Drug Application Review Status...............................   183
    Emergency Contraception Over-The-Counter.....................   387
    Environmental Policy Act of 1969.............................   365
    Financial Benefits of Faster Drug Review.....................    82
    Gender Based Trials...................................129, 366, 385
    Generic Drugs............................67, 79, 251, 254, 359, 383
    HHS Task Force on Prescription Drug Costs....................    66
    Internet Drug Sales..........................................   269
    Medical Gas...........................................347, 348, 350
    Mental Illness...............................................    90
    Orange Book................................................344, 381
    Patient Safety/Medical Errors Funding.................103, 367, 368
    PDUFA..................................................98, 273, 360
    PDUFA Financial Report.......................................   276
    PDUFA Performance Goals....................................275, 351
    PDUFA Resources.......................................273, 309, 361
    Pediatric Drug Use...........................................   102
    Pediatric Studies............................................   357
    Reimportation of Drugs.......................................81, 91
    Review Times for Priority and Standard NMEs..................   185
    Ritalin......................................................   131
    Shortages....................................................   384
    Virginiamycin................................................   387
Imports and Inspections:
    Adulterated Items............................................   107
    BSE and Imported Foods.......................................   153
    Civil Penalties............................................118, 120
    Device Inspections--Domestic.................................   362
    Device Inspections--Foreign..................................   363
    Food Inspections--Domestic............................194, 378, 379
    Food Inspections--High Risk..................................   193
    Funding to Meet Statutory Requirements.......................   101
    Hiring of Inspectors.........................................   107
    Imported Food Inspections....................................   378
    Imports--Amount of Coverage...........................254, 353, 354
    Import Resources...........................................354, 355
    Inspections--Food Safety Resources...........................   379
    Inventory of Firms...........................................   254
    Inspections--Medical Gas.....................................   347
    Operational and Administrative System for Import Support 
      (OASIS)..................................................341, 353
    Products Recovered in a Recall...............................   118
    Recall Authority...........................................117, 380
    Regulated Establishments in California.......................    99
    Reimportation of Drugs.......................................81, 91
    Safety Inspection Procedure for Eggs.........................   111
    Seafood Detention............................................   122
    Statutory Inspection Requirements............................   364
    Tampering....................................................   311
    USDA Inspection of Eggs......................................    61
International Activities:
    Implementation of the US-EU Mutual Recognition Agreement.....   268
    International Cooperative Agreements.......................256, 265
    International Harmonization of Drug Regulations..............   369
    International Health Regulations.............................   372
Justification of Estimates for Appropriations Committee:
    Organization Chart...........................................   397
    Budget in Brief..............................................   398
    Performance Plan Summary.....................................   426
    Appropriations Language and Analysis.........................   430
    Summary of Change............................................   435
    Crosswalk for Summary of Change to Budget Authority by 
      Activity...................................................   436
    Budget Authority by Activity (All Purpose Tables)............   439
    Program Justifications.......................................   449
    Exhibits.....................................................   587
    Longitudinal Studies in Research Programs....................   102
Medical Devices and Radiological Products:
    510(k) Applications Definition........................159, 160, 161
    Approval Times...............................................   391
    Cell Phones................................................115, 116
    Device Application Reviews--Combination Products...........313, 342
    Devices--Establishment Types.................................   163
    Devices--Extramural Projects.................................   163
    Devices--Inspections.........................................   363
    Devices Resources............................................   162
    Mammography Quality Standards Act (MQSA)...................270, 271
    Radiation Safety......................................113, 114, 362
    Regulatory Actions...........................................   161
    Obesity......................................................    82
Office of Criminal Investigations................................   273
Opening Remarks by Dr. Crawford, Deputy FDA Commissioner.........     2
Patent Certification:
    Orange Book................................................344, 381
    Patent Review................................................56, 67
    Patent Recertification.......................................    55
Pediatric Rule:
    Court Proceedings............................................    80
    Delay........................................................   101
    Enforcement..................................................    80
    Pediatric Drug Use...........................................   102
    Pediatric Studies............................................   357
    Proposed Suspension..........................................68, 69
    Sections of the Rule..................................105, 356, 357
Performance Plan:
    Performance Plan and Summary.................................   635
    Performance Plan Report by Programs/Areas....................   672
Personnel:
    Hiring of Inspectors.........................................   107
    Hiring Rate..................................................   272
    Workforce-Future Shortages...................................   364
Questions Submitted for the Record:
    Mr. Bonilla..................................................   133
    Mr. Nethercutt...............................................   341
    Ms. Emerson..................................................   344
    Mr. Goode....................................................   349
    Mr. LaHood...................................................   350
    Ms. Kaptur...................................................   353
    Ms. DeLauro..................................................   378
    Mr. Farr.....................................................   389
    Mr. Boyd.....................................................   391
Recalls:
    Civil Penalties............................................118, 120
    Products Recovered in a Recall...............................   118
    Recall Authority...........................................117, 380
Statement by Dr. Crawford, Deputy FDA Commissioner...............     5
Tobacco..........................................................   312
United Financial Management System (UFMS).................337, 338, 339
US Code Citations................................................   312
Witness List.....................................................     1

                       Farm Credit Administration

Annual Performance Plan..........................................   985
Audit............................................................   830
Budget Trends....................................................   959
Condition of the Farm Credit System..............................   819
Examination Issues...............................................   829
Farm Credit System Financial Condition...........................   827
Farm Credit System Insurance Corporation.........................   940
Farm Credit System Senior Officer Compensation...................   828
Farm Credit System Structure.....................................   826
Farmer Mac.......................................................   944
FCA Operations...................................................   823
FCA Staffing.....................................................   823
FCS Annual Report................................................   952
FCS Market Share.................................................   950
Federal Agricultural Mortgage Corporation........................   821
Financial Condition of the Farm Credit System....................   976
Fiscal Year 2001 Accomplishments.................................   815
Fiscal Year 2003 Budget Request..................................   810
Fiscal Year 2003 Proposed Budget.................................
954, 957
Litigation Involving FCA.........................................   940
Loans for Designated Parties.....................................   952
Major Accomplishments and Projects During FY 2001................   965
Performance and Accountability Report Fiscal Year 2001...........   831
Questions Submitted by Chairman Bonilla..........................   823
Risk Assessment..................................................   936
Role and Responsibility of the Farm Credit Administration........   809
Sole Source Contracts and Consulting Services Contracts..........   938
Status of Regulations............................................   951
Testimony--Michael M. Reyna......................................   809
Young, Beginning, and Small Farmers..............................   949
                  Commodity Futures Trading Commission
Advisory Committees..............................................  1083
Agricultural Trade Options Rules.................................  1068
Agricultural Trading Volume......................................  1069
Appropriations and Authorized FTEs...............................  1083
Carryover Funds..................................................  1066
CFMA Implementations, Regulations Necessary......................  1089
Civil and Administrative Proceedings.............................  1081
Civil Monetary Penalties.........................................  1074
Contract Designation Applications, Pending.......................  1082
Contract Market Designations and Rules Reviews Under Fast Track 
  Review.........................................................  1086
Contracts Approved, New..........................................  1082
Cooperative Enforcement and Regulations..........................  1076
Dual Trading.....................................................  1071
    Dual Trading Fraud...........................................  1072
    Dual Trading Investigations/Exchange Database System.........  1072
Firm Failures....................................................  1073
Foreign Assistance...............................................  1075
Electronic Trading...............................................  1090
Electronic Trading Implications for CFTC Surveillance............  1091
Enforcement Investigations.......................................  1076
Inspector General Audits.........................................  1066
International Affairs, Activities of the Office of...............  1084
Introducing Brokers, Registered..................................  1083
NFA Disciplinary Actions.........................................  1069
New York Regional Office Space, Status of........................  1091
Non-Personnel Services...........................................  1095
OMB Request......................................................  1066
Opt Out of Segregation...........................................  1090
President's Working Group on Financial Markets...................  1072
Retention Bonuses................................................  1096
Regulatory Relief After September 11, 2001 Attacks...............  1091
Reparations Programs.............................................  1085
Rule Enforcement Program.........................................  1071
SEC and CFTC Cooperative Actions.................................  1070
Self-Policing Activities.........................................  1073
Service Fees.....................................................  1069
Single-Stock Futures Regulations.................................  1089
Space Rental Costs...............................................  1095
Supplemental Funds, Homeland Security............................
1093, 1095, 1096
Staff, Impact of Additional Staff Requested......................  1093
Travel Budget....................................................  1074
Unauthorized Appropriations......................................  1089

                                

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