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US FDA Commissioner Makary Wants To Combine 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.

packages of pills surround a paper reading "adverse events"
FDA Commissioner Martin Makary expressed interest in overhauling FDA's adverse event reporting systems in a 17 April interview. (Shutterstock)
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 adverse event reporting systems into one, a move he framed as a way to create...

Makary brought up FDA’s multiple AE systems in a lengthy 17 April interview with The Megyn Kelly Show as an example of his push to create...

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