Dr. Houman Hemmati, an ophthalmologist and vocal critic of the federal government's Covid vaccine strategy, has emerged as the leading candidate to take over as director of the FDA's vaccine and gene therapy division, according to sources with knowledge of the deliberations.
Hemmati would helm the Center for Biologics Evaluation and Research, or CBER, replacing Dr. Vinay Prasad, who is departing the agency this month. The position carries enormous weight, overseeing the safety and effectiveness assessments for all U.S. vaccines and gene therapies.
FDA Commissioner Marty Makary is backing Hemmati for the role, one source said, though a final decision has not been made. The White House, the Department of Health and Human Services, and the FDA are all involved in the selection process. HHS officials view Hemmati as the top choice, though officials cautioned that other candidates remain under consideration.
"No decision has been made on the selection of the next CBER director," Andrew Nixon, an HHS spokesperson, said in a statement. "We continue to vet highly qualified candidates." The White House declined to confirm reports about the search, with spokesman Kush Desai calling such reporting "baseless speculation" unless officially announced.
Hemmati is co-founder and chief medical officer of Optigo Biotherapeutics, a Canada-based biotech firm focused on vision loss treatments. He has held senior positions at other eye care biotech companies and makes periodic appearances on Fox News.
His track record mirrors Makary's own pre-FDA skepticism of the government's pandemic response. In a 2023 Fox News segment, Hemmati criticized the Biden administration for purchasing additional Covid vaccine doses, arguing the government was essentially subsidizing pharmaceutical companies to recoup their investments. Last May, he praised the decision by Makary and Prasad to end sweeping vaccine recommendations for healthy children and pregnant women.
Prasad's departure follows mounting criticism over the agency's handling of several high-profile medical decisions. The FDA delayed or rejected treatments and vaccines under his watch, including a gene therapy for Duchenne muscular dystrophy, a rare blood cancer treatment, and Moderna's mRNA flu vaccine. Prasad also authored a controversial internal memo asserting that Covid vaccines killed at least 10 children, a claim for which he never publicly released supporting evidence.
The vaccine division faces leadership challenges. Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children's Hospital, said the office needs stability and clear direction. "I think we can all agree that there's been some degree of instability at the FDA and CBER," Levy said. "Academic centers, and importantly industry, need a clear signal about what the rules of the game are and what are the priorities."
Hemmati did not respond to requests for comment about his candidacy.
Author Sarah Mitchell: "Putting a vaccine skeptic in charge of the FDA's vaccine division signals a sharp ideological shift, and the industry's concerns about clarity and consistency are completely justified."
Comments