CDER director Patrizia Cavazzoni, FDA commissioner Robert Califf and OPDP acting director Catherine Gray

Drug pro­mo­tion en­force­ment so far sim­i­lar un­der new FDA chief, with just 4 let­ters in first half of 2022

Will a trio of new boss­es at the FDA lead to an in­crease in drug ad­ver­tis­ing en­force­ment? It’s a good ques­tion, but with few let­ters sent out so far, there’s just not enough in­for­ma­tion to tell, says one long­time FDA reg­u­la­to­ry watch­dog.

“I don’t think there is any­thing to in­di­cate the Ad­min­is­tra­tion is lean­ing one way or an­oth­er,” Mark Senak, a lawyer at Fleish­man­Hillard who tracks FDA ac­tions on his Eye on FDA blog, said in an email. “It is worth not­ing that we have a new FDA Com­mis­sion­er, new head of CDER and a new head of OPDP which opens up the pos­si­bil­i­ty of change, but there has not yet been enough en­force­ment ac­tiv­i­ty to iden­ti­fy re­al change.”

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