FDA Still Weighing Potential CBER Director Candidates

FDA is still weighing candidates to lead CBER as controversial director Vinay Prasad prepares to leave the agency at the end of the month. FDA commissioner Marty Makary says a decision is expected “in the coming weeks,” according to reporting from Reuters. Makary had previously indicated a successor would be named by that time but acknowledged Tuesday that no final decision has yet been made.

Earlier this month, various media outlets indicated that prominent ophthalmologist and biotech executive Houman Hemmati was being considered as CBER’s next director. The potential appointment comes at a pivotal moment for FDA, as the agency navigates evolving vaccine policy, public scrutiny, and leadership transitions within its biologics center. The role in question is central to overseeing approvals and regulatory decisions for vaccines, cell therapies, and other advanced biologics.

Hemmati’s background spans clinical medicine, biotechnology entrepreneurship, and media engagement. While supporters may view his cross-sector experience as an asset, his frequent appearances on cable news could draw scrutiny from critics concerned about the politicization of scientific roles.

The reported consideration also reflects broader shifts in federal health leadership under the current administration, which has signaled interest in reshaping regulatory priorities and accelerating innovation in areas such as vaccines and gene therapies.

Prasad’s tenure at the agency has been marked by a series of high-profile regulatory disputes and controversial product decisions. Most recently, CBER has been engaged in a public dispute with uniQure over its experimental gene therapy for Huntington’s disease. Regulators asked the company to conduct an additional study to support approval, a request uniQure and some patient advocates argued would take too long and place additional burdens on patients with the rare neurological condition. Another incident involved his overruling staff to issue a "refusal-to-file" letter for a Moderna influenza vaccine, which was later reversed. Prasad also faced internal and external scrutiny for an internal memo in which he claimed Covid vaccines were responsible for the deaths of at least 10 children, a claim that critics said relied on unverified and “incomplete information.”

The CBER director position is expected to be closely watched by industry stakeholders, public health experts, and policymakers given its influence over vaccine oversight and broader biologics regulation in the U.S.