Vinay Prasad returns to FDA
In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of the Center for Biologics Evaluation and Research (CBER), just over a week after he left the role.
The word from the FDA is that Prasad has come back at the request of the regulator's Commissioner, Marty Makary, who appointed Prasad to the CBER position in May. Endpoints first reported his return on Saturday, and that was confirmed by the FDA shortly thereafter.
Prasad stepped down from the CBER role at the end of July, a move reportedly stemming from discontent over some of his recent regulatory decisions, difficulties in winning over senior staffers at the unit, a campaign by right-wing activists for his removal, and – according to sources including Politico – pressure from President Trump himself.
Prominent right-wing influencer, Laura Loomer, accused Prasad of "defying" Trump administration objectives by allowing remote working for CBER employees, blocking efforts led by FDA Commissioner Marty Makary to deregulate the agency, and allowing various missed Prescription Drug User Fee Act (PDUFA) deadlines that have undermined Trump's push for faster drug approvals.
Loomer was quick to comment on Prasad's return, saying it was "another egregious personnel decision under the Trump administration" and criticising Makary for the decision to welcome back a "longtime progressive Marxist Vinay Prasad who referred to President Trump's supporters as criminals and compared them to drug addicts after saying he stabbed a Trump voodoo doll to 'curse Trump'."
Loomer recently posted a video claiming to show Prasad making the statement, although, it has been claimed the clip has been edited and Prasad had, in fact, been referring to the kind of thing an imaginary liberal Trump hater would do. She also threatened to expose other officials within HHS and the FDA so "the American people can see more of the pay for play rot themselves."
While acknowledging Prasad's return, the Department of Health and Human Services (HHS) would not comment further, saying in a statement that "neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration."
For now, it is not clear whether Prasad will also regain his position as the FDA's chief medical and scientific officer.
Regardless, the flip-flop adds to the sense of chaos at the FDA as the regulator grapples with the impact of mass firings, the loss of scientific expertise, and the restructuring of specialist centres within the agency – which some consumer organisations claim have compromised its ability to regulate effectively.
