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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.

US Food and Drug Administration Commissioner Martin Makary is considering combining all of the agency’s adverse event reporting systems into...

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