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Makary Suggests Combining All FDA Adverse Event Reporting Systems

 
• By Sarah Karlin-Smith

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

Martin Makary Senate Confirmation Hearing
FDA Commissioner nominee Martin Makary faced questions about a cancelled vaccines advisory committee meeting at his confirmation hearing. (Screenshot of Senate Broadcast)
Key Takeaways
  • FDA Commissioner Martin Makary suggested combining all of FDA's adverse event reporting systems, currently divided by product area into separate systems, into one.
  • While many FDA experts have called for improvements to the agency's post-market surveillance capabilities, this particular change called for by Makary was not seen as adding much value to FDA and could cause some problems, experts said.
  • Makary also falsely argued in the 17 April interview with The Megyn Kelly Show that FDA did not properly investigate certain adverse events tied to COVID vaccines.

US Food and Drug Administration Commissioner Martin Makary is considering combining all of the agency’s

While he framed the change as a way to create better coordination among the agency, but other experts say it could create problems given the diversity of the type of products – drugs,

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