This Week at FDA: Makary names Vinay Prasad to lead CBER, more high-level hirings and departures

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, Vinay Prasad has been named the new leader of CBER, replacing Peter Marks, who was forced out over disagreements with HHS Secretary Robert J. Kennedy Jr. over vaccine safety.

Prasad, a hematologist/oncologist and professor of epidemiology at the University of California, San Francisco, has been a vocal critic of the FDA and the use of the COVID-19 vaccines but also a “rigorous and professional” cancer research methodology expert with hundreds of peer-reviewed publications to his credit, according to reporting from Stat and MedPage Today. Prasad addressed new colleagues on the FDA’s Silver Spring, MD, campus this week and gave a “perfectly reasonable and, apparently, quite successful” speech, MedPage Today Editor in Chief Jeremy Faust reported, based on a recording that he said was shared with him.

“One FDA scientist who acknowledged deep concerns about his tone in recent years described the presentation as 'charming' and even 'self-deprecating,’” Faust noted. He added that, “at times, Prasad demonstrated his unusual command of under-the-hood problems of the medical literature -- the kind that earned him enormous respect last decade from many physicians and scientists, myself included.”

The day after his speech, Prasad announced that CBER would return to its pre-pandemic, two-days-per-week telework policy, according to a report in Politico.

The FDA is actively recruiting talent to help implement AI-driven scientific reviews throughout the agency. This week, Commissioner Martin Makary announced that the agency has completed its first AI-assisted scientific review for a product, with plans to expand the program agency-wide by June. Jeremy Walsh has been appointed to lead the agency’s Office of Artificial Intelligence and Information Technology. Makary stated that Walsh's appointment aligns with his goal of accelerating the scientific review process. Before joining the FDA, Walsh spent 14 years at Booz Allen, where he served as chief technologist.

In other news, Michael Rogers, FDA associate commissioner for inspections and investigations, announced his decision to retire this week, after 34 years with the agency. According to FDA colleagues granted anonymity by CBS News, Rogers’ departure comes amid frustrations among inspectors directed at the FDA's new commissioner. Two FDA officials said that Rogers privately expressed unhappiness in recent days, as the agency's inspections office has been struggling following significant staff reductions.

According to Reuters, the FDA has asked some recently dismissed employees, who handled funding negotiations with pharmaceutical companies, to come back. These individuals are responsible for renewing agreements in which drug manufacturers pay user fees that help fund the agency's drug review system.

Reuters also reported that Secretary Kennedy is scheduled to testify before the Senate's Health, Education, Labor, and Pensions Committee on 14 May. This announcement follows on a request to appear from the committee's Republican chairman. Kennedy was originally expected to attend an April hearing to discuss significant changes at the HHS, including the termination of 10,000 employees and other structural modifications at its regulatory agencies.

Drugs & Biologics

Reuters reported that FDA has accepted Novo Nordisk's marketing application for an oral version of its weight-loss drug Wegovy. The agency is expected to decide in the fourth quarter. If approved, this once-daily oral formulation will be the first oral GLP-1 medication for chronic weight management.

KFF Health News reported that the Trump administration's unprecedented $500 million grant to develop a broadly protective flu shot has puzzled vaccine and pandemic preparedness experts. They have pointed out that the project is still in its early stages, relies on outdated technology, and is just one of over 200 similar efforts. Secretary Kennedy reallocated funds from a pandemic preparedness program to support a vaccine development initiative led by two scientists who were recently appointed to senior positions at the National Institutes of Health.

NPR reported that the Trump administration sought to have a judge dismiss a lawsuit aimed at eliminating telehealth access to mifepristone. Attorneys from the Justice Department supported the legal position established by the Biden administration, but they did not directly address the issue of access to the drug, which is commonly used in abortions. Instead, the government argued that the states lacked the legal standing to bring the lawsuit.

According to a report from Reuters, Kennedy aide William “Reyn” Archer III is seeking more information about three vaccines recently recommended by the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. Archer, a physician and former Texas health commissioner in the late 1990s, made inquiries about vaccines against RSV, meningitis, and chikungunya.

Medical Devices

FDA on Friday published Federal Register notices reclassifying nine types of medical devices from Class III to Class II, including qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays, a breast milk macronutrients test system, quantitative assays that detect anti-HBs, and quantitative assays based on HBV nucleic acids.

Food

The FDA has announced the approval of three new color additive petitions, allowing manufacturers to use a wider range of colors derived from natural sources for food products. This decision supports the HHS goal of phasing out petroleum-based dyes from the nation's food supply as part of the administration's broader initiative to Make America Healthy Again.

FDA and the National Institutes of Health (NIH) announced the creation of the Nutrition Regulatory Science Program to undertake research to support effective food and nutrition policy actions to help make Americans’ food and diets healthier. The initiative will aim to answer questions such as how and why ultra-processed foods harm people’s health.

This Week at FDA: Makary names Vinay Prasad to lead CBER, more high-level hirings and departures

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