Fda Policies

5132 Words Dec 12th, 2013 21 Pages
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 …show more content…
The organizational structure today of the FDA can be seen in the chart below. The president of the United States, with the advice and consent of the senate, appoint the Commissioner of Food and Drug Administration. The commissioner himself reports to the Secretary of Health and Human Services. Throughout history the commissioner has been a physician, it is however, not required for the position. Protecting Reputation The FDA behaves in ways that enhance its reputation for protecting consumer safety and public health. As gauged by public opinion polls, the FDA remains one of the most popular agencies in government, regularly securing 70 percent or greater “approval” of its performance among sampled respondents.5 Buttressing this popularity are powerful symbolic lessons of history: The FDA is widely credited with saving thousands of American lives in its response to the sulfanilamide tragedy of 1937 and the thalidomide scandal of 1959–1961.6 Congress dramatically strengthened pharmaceutical regulations after each of these events. Thereby whether or not the agency deserves it, the FDA clearly possesses a reputation for protecting public health and consumer safety. This reputation did not arise by accident but is the result of refined bureaucratic
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