Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business, in “Vaccines Face Uncertain Approval, Reviews with New FDA Official,” by Nyah Phengsitthy.
Following is an excerpt:
The appointment of a vocal critic of expedited approvals of vaccines, Vinay Prasad, to run the FDA’s office responsible for those drugs presents a challenge for the pharmaceutical industry.
Prasad on May 6 was named the new director of the FDA’s Center for Biologics Evaluation and Research, taking the reins of a high-profile position that oversees the safety and efficacy of vaccines, complex gene therapies, blood supply, and other cutting-edge treatments.
The hematologist-oncologist, frequent YouTuber, and podcast host brings a public record of opinions with him that signals how he could run the center. He’s criticized mRNA and Covid-19 vaccines, questioned current clinical trial practices, and repeatedly attacked the decisions of his predecessor, Peter Marks, who resigned from his post in March after holding opposing viewpoints from US Health Secretary Robert F. Kennedy Jr., a vaccine skeptic.
The pharmaceutical industry and medical leaders expect changes at CBER after his appointment, including how the agency interacts with the industry and influences business decisions. Those changes could start to take shape as soon as this week, as the center prepares a framework to guide industry on the FDA’s thinking about vaccines.
“He is a fairly polarizing figure, and I think it really signals a change in direction at CBER,” said Richard H. Hughes IV, a member at Epstein Becker & Green PC, who represents some vaccine makers. “This is going to be a huge obstacle and a huge change in direction for the agency with respect to vaccines and clinical trials.”
Shares of manufacturers for vaccines and immunotherapies plunged shortly after Prasad’s appointment on concerns he would crack down on approvals. Vaccine development, which is known to be less attractive for investors, is likely to be influenced by his assessments and could lead to less incentives to take risks and develop new products.
