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FDA Reform: It’s Time to Act, But Not as an Independent Agency

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Summary

As former federal officials, Dan Troy, David Beier, and I share our perspectives on the call by former FDA officials representing both political parties to make the FDA an independent agency separate from its parent, HHS.

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 rulemaking, as well as less bureaucratic meddling by its parent agency, the Department of Health and Human Services (HHS), 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.

In a recent Health Affairs blog post, we discuss 3 risks to separating FDA from the HHS structure.

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