Three Decades of Drug Regulation and Legislation - Pharmaceutical Technology

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Three Decades of Drug Regulation and Legislation
The US Food and Drug Administration has pursued many new initiatives since 1977. The agency began accepting abbreviated applications for generic versions of drugs, collected user fees to support drug review, launched the Critical Path Initiative to encourage innovation, and worked to harmonize its regulatory standards with those of Europe and Japan. New challenges such as AIDS and bioterrorism have affected regulatory policy in recent years. The author reviews FDA's changes in policy and philosophy during..

Pharmaceutical Technology

When Pharmaceutical Technology first appeared in 1977, the US Food and Drug Administration was a much smaller and less well-known government agency in the Department of Health, Education, and Welfare. Donald Kennedy, a prominent neurophysiologist from Stanford University, was the newly named commissioner. FDA was undergoing visible change as it strove to update the drug provisions in the Food, Drug, and Cosmetic Act. The act had been altered considerably by the 1962 Kefauver–Harris Amendments, which were generated in response to the thalidomide crisis that began in 1956. The amendments required drug manufacturers to submit clinical evidence of both safety and effectiveness before marketing a new medicine.

Eight commissioners have led FDA since then, presiding over a period that has witnessed the emergence of user fees, drug advertising, and drug-safety concerns. All these changes have increased the agency's oversight of drug development and market approval. They also have prompted more congressional attention to FDA and industry activities. Today FDA is struggling to assure the public and policymakers that it has the ability to ensure the quality and efficacy of medicines. It also is striving to modernize its regulatory programs and encourage pharmaceutical innovation, thereby addressing many of the challenges facing the pharmaceutical industry today.

The changing face of drug-oversight infrastructure
1970s and 1980s: Growth and innovation
During the 1970s and 1980s, FDA launched many key initiatives, including a retrospective review of over-the-counter (OTC) drugs and an increased collection of adverse drug reports, and reorganized and expanded its Bureau of Drugs (see sidebar, "FDA builds drug oversight infrastructure"). Reports of AIDS in the 1980s spurred demands from patient advocates for faster access to promising therapies, prompting a general rethinking of regulatory attitudes. The thalidomide crisis had fostered a cautious approach at the agency, encouraging staffers to move slowly in reviewing new drug applications. The AIDS epidemic, though, spurred agency officials to adopt a less risk-averse attitude, acknowledging that their job was to facilitate patient access to needed treatment as well as to guard against unsafe products. Other important developments are described below.

AIDS-influenced regulation. The first reports of AIDS expanded FDA collaboration with researchers and scientists to approve initial immunoassay tests. Several rule changes in the mid-1980s broadened access to experimental drugs for patients with serious diseases and no alternative treatment options. FDA approved AZT (azido-thymidine), the first drug to treat AIDS, in 1987, as well as treatments for opportunistic infections.

Milestone. 30 Years of Pharmaceutical Technology
Human subject protections. In 1981, FDA and other federal agencies involved in medical research revised regulations to protect individuals participating in clinical research. The revisions were inspired by the 1979 Belmont Report, a broadly acclaimed document articulating the basic need to protect human subjects participating in biomedical research. During the following decade, more government agencies adopted the "Common Rule" governing human subject research, which: requires researchers to obtain and document informed consent; provides special protections for children, women, and prisoners; and sets policies for institutional review boards.

Orphan-drug development. Congress passed the Orphan Drug Act in 1983, launching an innovative program that encourages industry to develop treatments for rare diseases, i.e., conditions affecting fewer than 200,000 people in the United States. The law provides extended market exclusivity for such drugs and medical products and awards grants to support orphan-drug clinical trials. These incentives have led to FDA approval of nearly 300 drugs and biological products under this program.


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