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A Message from the Commissioner
Objective A: Maximizing the availability and clarity of information about the process for review of applications and submissions
Objective B: Maximizing the availability and clarity of information for consumers and patients concerning new products
Objective C: Implementing inspection and postmarket monitoring provisions of FDAMA
Objective D: Ensuring access to scientific and technical expertise
Objective E: Establishing mechanisms for meeting time periods for the review of all applications and submissions
Objective F: Eliminate backlogs in the review of applications and submissions by January 1, 2000
Appendix A: Application Backlogs (Overdue as of 12/31/99)
Appendix B: Sources for Additional Information
Performance on FY99 FDAMA Goals
I am pleased to transmit to Congress a report on FDA's significant accomplishments during Fiscal Year 1999. This Report satisfies provisions outlined in Section 406(b) of the FDA Modernization Act (FDAMA) of 1997, which charged FDA to develop a plan for meeting its statutory requirements, and to report on planned vs. actual performance. The Plan was published in November of 1998. This report identifies accomplishments against that Plan.
Although major challenges loom for FDA in the next decade and beyond, we can take great pride in the successes we have realized during the past year, and which you will read about in this document. To cite just a few examples:
I would like to thank our collaborators in other federal and state agencies, the health professional community, industry, academia and U.S. consumers for all of their insights in formulating a plan of action, and for their support in making these ideas work. I am also grateful to our many employees for all their tireless efforts to meet the needs of those we serve. We welcome the opportunity to continue working with the Congress and our stakeholders in improving our performance and working to meet our statutory obligations under FDAMA.
The Food and Drug Administration's Plan for Statutory Compliance was submitted to Congress in November 1998, as required under Section 406 of the FDA Modernization Act of 1997 (FDAMA).
The Plan outlined FDA's strategies for achieving six objectives that were stipulated by FDAMA as preconditions for FDA's ability to meet complex public health challenges in the 21st Century. The six objectives addressed by the Plan are to:
As this report shows, FDA achieved in 1999 significant gains in all six areas by combining the Agency's traditional principles and practices with innovating approaches.
In keeping with its traditional values, FDA continued to concentrate on providing a broad spectrum of consumer protections based on rigorous science-based standards. The Agency also continued to carry out timely new product reviews and effective risk-based inspections of the regulated industry.
To strengthen its performance, FDA developed partnerships with stakeholders who share its goals of consumer protection, developed novel regulatory processes, disseminated consumer-friendly health and safety information, and made greater use of information technology to increase the Agency's efficiency. FDA stimulated cooperation and participation by making its activities more understandable and accessible to stakeholders.
The success of FDA's efforts was reflected in last year's survey by the PEW Research Center in cooperation with Princeton Survey Research that explored the standing of five government agencies in the eyes of their constituents. The results placed FDA at the top of the charts with an overall favorable rating of over 80 percent, more than twice the approval rate of the entire government. The pollsters' report noted that
[t]he FDA is unique among the agencies we studied for how similarly-- and highly-- its very different customers rate its performance. Regulated industry as well as medical professionals, advocates and the chronically ill all credit the FDA for making a positive contribution to the safety of the Nation's food, drugs and other medical products.
The Agency, despite these advances, continues to be unable to fulfill its mandated responsibilities in two areas: the timely review of new regulated products (except for the user-fee supported reviews of prescription drugs and biologics); and inspections of drug and medical device establishments. Rigorous and punctual product reviews, and postmarket inspections at reasonable intervals of the production facilities, are the backbone of FDA's system of public health protections.
During the past year FDA has:
Provided helpful and timely information about the new product review process. In a survey by the University of California and PricewaterhouseCoopers, almost two-thirds of 4,000 manufacturers of drugs, biological agents, and medical devices last year reported that FDA's guidances on submission requirements made the approval process faster and easier than it was in 1997.
Given patients easy access to information about ongoing clinical trials that may pertain to their condition. The new source, accessible on the Internet, is a user-friendly database with the results of clinical trials of new medications.
Helped reduce injuries and other adverse events caused by improper use of medicines, vaccines, medical devices, and foods. Thanks to the cooperation of 20,000 drug stores and scores of organizations, six million consumers received an FDA-developed, easy-to-follow brochure on drug safety. Another 20 million people learned about the safety tips from the media. In an opinion sample, virtually all recipients of the drug-use information said they found it useful.
Improved the safety of seafood by installing a highly dependable quality control system in all domestic seafood plants. The system, which was originally developed to ensure safe food for orbiting U.S. astronauts, identifies and eliminates contaminants and other hazards while the food is being processed.
Cooperated in the establishment of a nationwide food safety surveillance network. The joint project of FDA, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, and state health departments uses state-of-the-art rapid analysis of bacterial DNA fingerprints to pinpoint the source of foodborne illnesses that affect up to 76 million people a year.
Made important progress toward internationally harmonized drug, medical device, and veterinary product standards. Minimizing unnecessary, duplicative tests and creating consistency will speed up the introduction of new medical products for American consumers and patients worldwide.
Advanced the development of a state-of-the-art diagnostic technique based on genetic mapping. The innovating process will allow faster and much more accurate identification of people who are at high risk for cancer and certain adverse drug reactions.
Approved new drugs and biologics in record time. The most significant new drugs are now being approved in just six months. Last year, FDA approved important new drugs to treat (among others) osteoarthritis, influenza, obesity, HIV, and diabetes.
This report highlights FDA's key accomplishments in fiscal year (FY) 1999 toward each of the six objectives outlined in the FDAMA Statutory Compliance Plan. Appendices have been added to identify FDA's specific progress in each performance category. The text also includes hyperlinks to other Agency documents that provide more detailed descriptions of FY 1999 accomplishments within specific program areas, such as foods and drugs. A detailed tabulation of FDA's performance on the FY 1999 goals specified in the Plan can be found in "Performance on FY 1999 FDAMA Goals."
Table of Contents | Objectives (Part 1) | Objectives (Part 2) | Appendices