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Closing Thoughts On US FDA Advisory Committee Reforms

 
• By Michael McCaughan

One speaker at the US FDA’s day-long “listening session” on advisory committee reform captured an important truth: the problem is not necessarily how committees are run, it is that there are no alternatives for public input into agency decisions.

Window into empty store
The FDA may need a larger window into its decision-making. • Source: Shutterstock

The US Food and Drug Administration’s day-long “listening session” on ideas to reform the advisory committee process bore an uncanny resemblance to the regular open public hearing in those meetings.

Key Takeaways

  • The FDA’s advisory committee reform meeting sounded a lot like an advisory committee meeting’s open public hearing.

  • Russ Paulsen of US Against Alzheimer’s told the FDA to consider how the public can gain more access to its decision-making

Nearly 50 speakers offered five-minute perspectives to the agency, with most representing consumer or patient advocacy organizations. AbbVie Inc

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