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Advisory Committees: US FDA Should Explain Divergent Decisions But Keep The Vote

 
• By Sue Sutter

Agency should be more proactive in issuing communications after advisory committee meetings, stakeholders advised; public interest group and industry representatives said the voting process is important for transparency and accountability.

Diverging paths
FDA should publicly explain why it made a regulatory decision that diverged from adcomm advice, stakeholders said. • Source: Shutterstock

The US Food and Drug Administration should issue summaries immediately after advisory committee meetings and proactively explain the discordance when its final regulatory decisions differ from advice provided by the external experts, according to stakeholders.

Key Takeaways

  • FDA should be more proactive in its communications to clear up misperceptions about the role expert panels play.

  • The agency should issue meeting summaries...

Such measures could help build public confidence in the advisory committee process and the agency’s own decision-making, explained participants at a 13 June FDA listening session on advisory committee reforms.

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