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Fda Policies

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Submitted By jokerius
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U.S. Food and Drug Administration (FDA) drug review bears a structural similarity to many decisions made by other regulatory agencies: high uncertainty, low reversibility, avoidance of observable error, and high political stakes that induce lobbying by interested parties. This project explores the policy lessons to be learned from viewing FDA drug review as a politically shaped exercise in information processing. I argue that the incentives facing regulators induce limits on the degree to which drug review can be accelerated, that the same incentives could render privatization initiatives problematic, and that political pressures could play a useful role in identifying priority drugs. Patients, more than pharmaceutical firms, shape the political costs to the FDA of delaying drug approval. Consider two hypothetical consumers, one a pharmaceutical consumer (“patient”) who wishes to try a new drug for some ailment, the other a vitamin consumer who wishes to take zinc supplements to ward off a cold or flu. There are few institutional restrictions upon the consumption decisions of the vitamin consumer, at least in the United States. She is free to purchase vitamin products over the counter, and the vitamin manufacturer is free to sell them without prior authorization or licensing. Not so with pharmaceuticals. The marketplace for pharmaceuticals is one of the most highly regulated industries in the U.S. economy.1 To use any new pharmaceutical product, the patient must secure the approval of two agents: a licensed physician and the U.S. Food and Drug Administration (FDA).2 No discussion of the past, present, or future of the pharmaceutical industry can ignore the critical role played by the FDA in its evolution. The agency’s drug review decisions are essentially final (contesting them is extremely difficult and costly) and immensely consequential (regulators in other

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