ON AUG 18, 1982, a nationally televised morning news program featured a segment discussing the issue, "When the Food and Drug Administration approves a drug, does that mean it is safe?" Some three weeks later, the Commissioner of the FDA, Arthur Hull Hayes, MD, debated Sidney Wolfe, MD, of Ralph Nader's Health Research Group, on another nationally televised morning news program. Their debate concerned Dr Hayes' recent efforts to simplify and expedite some of the FDA's regulations concerning the investigation and approval of new drugs. Dr Wolfe wanted regulations tightened rather than relaxed, particularly in view of the necessity to recall such recently approved "unsafe drugs" such as benoxaprofen (Oraflex) and ticrynafen (Selacryn).
Dr Wolfe's attack on the FDA's recent efforts to simplify some of its procedures is also an attack on the recent report of the Congressional Commission on the Federal Drug Approval Process. Twenty-six knowledgeable members representing academia,
McMahon FG. How Safe Should Drugs Be? JAMA. 1983;249(4):481–482. doi:10.1001/jama.1983.03330280027023
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