The Politics and Economics of FDA Drug Approval

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The Politics and Economics of FDA Drug Approval The United Sates Food and Drug Administration has been protecting American consumers for around 70 years. The FDA assures the safety drugs, medical devices, chemicals, cosmetics, foods and additives by evaluating products for approval. Controversy has recently been surrounding the FDA's drug approval process, due to a general trend to get pharmaceuticals on the market more quickly. The FDA has been under pressure from congress and the public to speed approval, but pharmaceutical companies, who benefit more than anyone form accelerated drug approval, have also been applying pressure to the FDA through congress. The speeding of the approval process helps patients with incurable illnesses receive experimental drugs, but some wonder if the FDA is weakening its safeguards in the process. Since the passing of the Modernization Act last year, people have become concerned with the safety of dietary supplements and 'off-label' uses for drugs. In the past year, drugs have been approved at an unprecedented rate, but they also have been withdrawn from the market more frequently. The recent growth in the popularity of dietary supplements has caused many to worry about their safety. Thus, there remains the question if the FDA is still adequately protecting us from dangerous drugs. The Food and Drug Administration began in the U.S. in 1927 as a separate law enforcement agency and now employs over 9,000 workers spread over 157 cities (The Food and Drug Administration: An Overview 1). Four laws dictate the power of the FDA. The Federal Food, Drug and Cosmetic Act established purity standards and introduced the requirement of factory inspection. The FDA's authority to require honest in... ... middle of paper ... ...A Modernization Act of 1997. 21 Nov. 1997. 24 Nov. 1998 . Food and Drug Administration. The Food and Drug Administration: An Overview. 30 Sept. 1998 . Hellmich, Nanci and Steve Sternberg. "Where the buck stops: Critics say known side effects were enough to stop approval." USA Today 16 Sept. 1997: 1A+. Kerr, Kathleen. "FDA knew of fen-phen woes years ago." Detroit News 19 Oct. 1997: 1A. Levy, Doug. "FDA role key in new drug direction." USA Today 24 Nov. 1998: 17A. Lewis, Charles. The Buying of Congress. New York: Avon Books, 1998. O'Donnel, Jayne. "Neither Food nor Drug." USA Today 19 June. 1997: 1A+. Pear, Robert. "FDA will require companies to test drugs on children." New York Times 28 Nov. 1998: 1A+. Rubin, Rita. "Rush to judgement? Policy speeds approvals, but some say it's risky." USA Today 10 July. 1998: 1A+.

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