Medical drugs of limited commercial interest frequently are unavailable to the public even though their therapeutic efficacy is well established. At present, availability of a particular drug is unpredictable, and determined largely by pharmaceutical industry willingness to produce the drug potentially at no profit. Anticipated profitability also profoundly guides drug development decisions by industry. Federal efforts by both the executive and legislative branches to develop policy aimed at facilitating development and distribution of medical drugs of limited commercial interest have intensified. Thorough analysis of the problems and of proposed plans for their amelioration is necessary to effect a policy which takes into account the social, political, and scientific factors, as well as the profit motive.
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