Although I was unable to appear today before this Subcommittee on the Food and Drug
Administration's (FDA or Agency) Fiscal Year
2000 budget request, I would like to submit this statement for the record.
As you know, Mr. Chairman, the FDA is the most important consumer protection agency in
the world, and is responsible for insuring the safety of an enormous variety of products
our citizens use every day of their lives. FDA has carried out that mission with great
care for the public health. But we and the public have asked much of the Agency in recent
years. Indeed, FDA's workload has soared--in
such major areas as product marketing applications, reports of injuries from approved
drugs and medical devices, and imported foods and drugs. Complex new technologies such as
gene therapy, tissue transplantation, anti-viral drugs and human cloning have come to the
Agency, as have new challenges that were unforeseen in the past--such as AIDS, BSE, lethal
new food pathogens, drug counterfeiting, and bioterrorism.
This necessary attention to new areas, along with passage of more than 10 major new
statutory responsibilities given the Agency since 1990, has put virtually every program in
FDA under great stress. For example, FDA's food
inspections are down from 21,000 in 1981 to 5,000 today; drug and device firms are not
inspected in the timeframes directed by Congress; fewer than 1% of imported foods are
examined by FDA inspectors; adverse event reports that tell us of hidden dangers in
marketed products go unread; and many products go virtually unregulated (such as dietary
supplements, cosmetics, and medical products purchased from foreign countries).
The President's budget request for FY 2000 is
intended to begin a fundamental rebuilding of an agency, and it's science base, that is so important to the health
and well being of our citizens. We are requesting an 18% increase over FY 1999 that can
achieve very substantial accomplishments in protecting public health. Let me highlight a
o Food safety is a compelling public health issue and is a critical
responsibility of my department. The thousands of annual deaths and millions of illnesses
that our citizens now suffer from contaminated food should be intolerable to us, and the
requested new funds will reduce a persistent hazard and save the public billions of
dollars in preventable health care costs.
o Errors in the use of drugs and medical devices cause thousands of deaths and injuries
that could be prevented if those incidents are properly recognized and acted upon. The new
funds requested will allow us to begin developing an effective injury reporting
system that will save lives and lower the estimated $26 billion annual cost of these
o Commercially important and life-saving new products are being delayed by FDA=s inability to apply the necessary scientists to premarket
review. FDA proved that getting sufficient resources for product review can result in
great success, as the new funding you provided for drug review has resulted in new drugs
entering the market here faster than anywhere in the world, with the same high standards
the public expects.
o The public expects, and Congress has directed, that manufacturers of foods, drugs,
and medical devices be inspected periodically to insure that safety standards are being
met. But the funds have not been provided for this product safety assurance, and
our budget begins the process of meeting those expectations.
o Lastly, I do not need to remind you that 3,000 young Americans begin smoking each and
every day, and that one-third of them will die prematurely as a result. I urge you to
increase funding for our program of state grants to enforce the ban on the sale of tobacco
to our children.
I know that in recent years the presence of deficit reduction user fees has been a
deterrent to increased funding for FDA. There are no such fees in this budget. The budget
is targetted toward critical public health needs, and if the funds are appropriated, they
will return the investment many times over.
There is certainly some good news to report. I am sure the Subcommittee will agree with
me that Dr. Jane Henney's appointment as the new
Commissioner of Food and Drugs gives us all great encouragement about the prospects for
FDA's success in the future. I believe that she
is the right person at the right time to strengthen FDA's
scientific capabilities and move it into the next century. And our FY 2000 request will
support the priorities for the agency that she intends to you about when she testifies
before you. I urge you to give her the tools she needs to get this important job done.