FDA reform: it’s time to act, but not as an independent agency

Health Affairs Blog

19 March 2019 - In a rare exercise in bipartisan leadership, former FDA commissioners of both political parties called, in the January 2019 issue of Health Affairs, for the FDA to become an independent agency. 

As former federal officials, we support a strong, vibrant, and well-funded FDA, but we depart from this consensus recommendation that the FDA become an independent agency. We understand the need for more trust in FDA decision making and rule making, as well as less bureaucratic meddling by its parent agency, the Department of Health and Human Services, and the White House Office of Management and Budget. 

However, we believe the negative consequences of hiving off the FDA into a separate agency are too risky and likely to outweigh any benefits.

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Michael Wonder

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Michael Wonder

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Medicine , US , Regulation , Review