Abstract
The mission of the Food and Drug Administration (FDA) is to protect and serve the public by regulating drugs and medical devices. The scope of the FDA's regulatory power is broad; the agency controls the clinical research, approval, and subsequent advertising language used to market drugs to physicians who ultimately prescribe to the public. Historically, the FDA has proceeded through a lengthy approval process at a slow pace to facilitate a thorough evaluation of a drug before its delivery to the public. The AIDS epidemic of the 1980s and the political influences of the 1990s forced the FDA approval process to change.' Congress, the supervising power of the FDA, instructed the FDA to develop a partnership with pharmaceutical companies to expedite the review of drugs to treat AIDS. Shortly thereafter, President Clinton issued a call for the FDA and pharmaceutical companies to act as "partners, not adversaries" and, in response, the FDA approval process changed. This Comment reviews that change and asserts the FDA's approval process, once considered the pillar of consumer safety, governed by science and fact, is now open to manipulation and pressure from political groups, views of morality, and the strong-arm tactics of pharmaceutical companies espousing corporate greed The American public is suffering as a result of the new drug-approval process: since 1997, eleven drugs have been pulled from the market by the FDA because of consumer deaths and severe side-effects.9 More than one thousand deaths are believed to stem from seven of the drugs approved through the expedited process.'°
Recommended Citation
Bean, Melissa Marie
(2003)
"Fatal Flaws in the Food and Drug Administration's Drug-Approval Formula,"
Utah Law Review: Vol. 2003:
No.
3, Article 2.
Available at:
https://dc.law.utah.edu/ulr/vol2003/iss3/2