FDA B A C K G R O U N D E R
HFI-40 BG 95-10 (March 30, 1995)
FDA Mission: Protect Public Health
The american poeple expect and rely on a safe and wholesome food supply, and access to safe and
effective drugs and medical devices. To meet those expectations, FDA inspects and oversees almost
95,000 establishments that produce:
• $487 billion worth of food
• $107 billion worth of drugs--prescription and over the counter--and biologics
• $350 billion worth of medical devices and radiation-emitting products
• $3 billion worth of animal drugs and medicated feed
• $39 billion worth of cosmetics and toiletries.
In addition to overseeing the production of safe foods and the manufacture of safe and effective
drugs and medical devices, FDA has responsibility for:
• protecting the rights and safety of patients in the clinical trials of investigational
medical products
• reviewing and approving in a timely manner the safety and efficacy of new drugs,
biologics, medical devices, and animal drugs
• monitoring the safety and effectiveness of new medical products after they are marketed and
acting on the information collected.
as the nation's oldest consumer protection agency, FDA is also responsible for seeing that the
public has access to truthful and non-misleading product information by:
• monitoring the promotional activities of drug and device manufacturers
• regulating the labeling of all packaged foods.
FDA's public health mission also encompasses efforts to assure:
• the safety of the nation's blood supply
• the safety of all imported FDA-regulated products.
Making New Therapies available
FDA has instituted a number of ways by which patients can receive prominsing therapies before
they receive final approval. These policies are aimed at helping patients have access to promising
therapies while not compromising the scientific integrity of formal clinical testing and the review
process. One of the most imported such policies, the treatment IND, has been used to give patients
early access to products since 1987.
• More than 75,000 patients have received access to therapies under this policy.
• Specific examples include:
- 22,000 received ddI for aIDS.
- 13,000 received d$T for aIDS.
- 2,000 received paclitaxel for ovarian cancer.
- 11,400 received colfosceril palminate for respiratory distress syndrome.
• There are other therapies that are just beginning to enroll patients under
this policy. For example, gemcitabine hydrochloride was recently approved for treatment IND
status for patients with advanced or metastatic pancreatic cancer.
Several drugs have been approved under accelerated approval, a process that is aimed at making
life-saving therapies available to patients as soon as possible in the development process
without sacrificing the rigor of a thorough review of the data. Examples include:
• Didanosine for aIDS
• Zalcitabine for aIDS
• Stavudine for aIDS
• Clarithromycin for an aIDS-related opportunistic infection
• Interferon beta-1B for multiple sclerosis
• DNase for cystic fibrosis.
Improving Performance
In 1992, the U.S. Congress passed the Prescription Drug User Fee act. This legislation provided
additional resources for FDA through user fees paid by the pharmaceutical industry, and the agency
committed to significant performance goals in the review and approval of prescription drugs. The goal
is to reduce significantly the time needed for review of new drugs: from the historic average of
about 27 months in the late 1980s to 12 months for routine drugs and six months for isgnificant new
therapies by 1997. That FDA is meeting the challenge of improved performance is shown by the most
recently compiled review and approval times in 1994:
• 10.4 months was the median time for the review and approval of new drugs with important
therapeutic uses under the user fee program.
• 13.5 months was the median time for the review and approval of all user fee drugs.
• 17.5 months was the median time for the review and approval of new drugs being
marketed in the United States for the first time--down from 23 months in 1993.
• 19 months was the median time for the review and approval of all new drugs
approved in 1994--21 percent less than in 1993.
• 12.2 months was the median time for the review and approval of vaccines and other
biological products--almost 50 percent less than in 1993.
In areas not covered by user fees, the agency is also reducing review and approval times:
• 24 months was the median time for the review and approval of generic drugs--26 percent less
time than in 1993.
• The backlog of medical device premarket notifications--510(k)'s--has been reduced by almost
80 percent--from 1,824 in January 1994 to 371 in January 1995.
• 98.5 days was the median time for the review of 510(k) devices as of January
1995, down from a median of 160.5 days as of January 1994. (The slowest 5 percent still take more
than 500 days.)
National Food Safety Educator's Network