As reported on NBC News, an ophthalmologist with a history of criticizing the U.S. government’s Covid-19 vaccine strategy is emerging as a leading contender to oversee the Food and Drug Administration’s vaccine and gene therapy programs, according to individuals familiar with the deliberations.
Dr. Houman Hemmati is reportedly at the top of a short list of candidates being considered to lead the FDA’s Center for Biologics Evaluation and Research (CBER), the division responsible for regulating vaccines, gene therapies, and certain blood products. The leadership change comes as the current CBER director, Dr. Vinay Prasad, prepares to depart the agency later this month.
CBER plays a central role in evaluating the safety, effectiveness, and approval of vaccines and advanced biologic therapies. A final decision on its next director is expected soon, though officials involved in the process say no selection has been finalized. Discussions are being closely coordinated among the FDA, the Department of Health and Human Services (HHS), and the White House.
Hemmati is believed to be favored by FDA Commissioner Dr. Marty Makary, according to one source, though several candidates remain under review. Federal officials emphasized that the administration is continuing its vetting process. An HHS spokesperson said the agency is still evaluating qualified applicants, while the White House cautioned against drawing conclusions from unconfirmed personnel reports.
Prasad’s tenure at CBER was marked by controversy, including criticism of the agency’s handling of several high-profile applications. These included decisions affecting a gene therapy for Duchenne muscular dystrophy, a treatment for a rare blood cancer, and Moderna’s mRNA-based influenza vaccine. Prasad also drew attention for authoring a memo alleging fatal outcomes linked to Covid-19 vaccination in children, though supporting data were not publicly released.
Hemmati currently serves as co-founder and chief medical officer of Optigo Biotherapeutics, a Canada-based company focused on treatments for vision loss. His professional background includes leadership roles at multiple ophthalmology-focused biotech firms, and he has made periodic appearances on cable news programs.
Like Makary prior to becoming FDA commissioner, Hemmati has been openly critical of aspects of the federal pandemic response. During a 2023 television appearance, he questioned the Biden administration’s procurement of additional Covid-19 vaccine doses, suggesting the move benefited manufacturers financially. On social media, he has publicly supported recent decisions to limit routine Covid-19 vaccination recommendations for healthy children and pregnant individuals.
Experts say the FDA’s biologics division is in need of steady leadership. Dr. Ofer Levy of Boston Children’s Hospital noted that recent disruptions have created uncertainty for academic researchers and industry partners alike. He emphasized the importance of clear regulatory priorities and consistency for the vaccine and biotechnology sectors moving forward.
