Will FDA chief’s embrace of anecdotal evidence extend beyond COVID?

Recent public comments by FDA Commissioner Marty Makary have endorsed a broader role for anecdotal evidence in shaping regulatory decisions. While the statements pertained to COVID-19 vaccines and food additives, they raise questions about how the agency will weigh traditional clinical data against personal stories across therapeutic areas.

Providing insights into the agency’s recent decisions to restrict the labels of COVID vaccines, and more broadly into his regulatory philosophy, Makary stated in a July 17 interview with Epoch TV that he is aware of instances of injury and death caused by mRNA vaccines. ...