The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.
FDA Commissioner Marty Makary wants to foster more harmony between the FDA units that regulate drug and biologic products.
Several CEOs of biotech and pharma companies attended Makary’s “listening tour” stop in New York, a private event where the commissioner met with industry leaders and got feedback on the regulatory environment the FDA is fostering. Alongside Makary was George Tidmarsh, newly appointed director of the Center for Drug Evaluation and Research and, following Vinay Prasad’s ouster earlier this week, temporarily also the head of the Center for Biologics Evaluation and Research.
Speaking to several attendees of said event, Endpoints News reported on Thursday that Makary wants both drug and biologic centers to operate more harmoniously, instead of acting as “fiefdoms.” Sources spoke on the condition of anonymity given the private nature of the event. Aside from New York, Makary will also visit North Carolina and Georgia; the commissioner has already gone to Maryland, Massachusetts and California.
“The idea is that given the fact that both ‘centers’ are under identical regulatory frameworks and fiercely compete with each other for funding and influence, they should be under the same roof,” Sean Khozin, founder and principal at New York-based Phyusion Bio, told Endpoints. Khozin, who attended the New York leg of Makary’s tour, had previously served for more than 7 years as a senior official at the FDA’s Oncology Center of Excellence.
Speaking to Endpoints, an official at the FDA denied that the agency has plans to combine the CDER and CBER into one unit.
However, Politico, citing three sources familiar with the matter, reported Wednesday that the government is considering splitting CBER into two entities: one focused on regulating vaccines and another dedicated to therapeutics.
This, according to the publication, would allow Health and Human Services Secretary Robert F. Kennedy Jr. to respond to anti-vaccine groups like Children’s Health Defense, which have voiced concerns that he has been less aggressive on the vaccine front than they had hoped.
In the lead-up to Prasad’s exit, the FDA went head-to-head with Sarepta Therapeutics, whose gene therapy portfolio has been linked with three deaths over the past months. In response to the deaths, the FDA asked the biotech to halt all shipments of its Duchenne muscular dystrophy treatment Elevidys. Sarepta pushed back initially but ultimately gave in.
Last week, media outlets reported that the FDA was considering asking Sarepta to run additional trials before allowing Elevidys back on the market, with senior officials at CBER unanimously against a commercial comeback for the therapy. Just days later, however—and shortly after the agency opened a probe into another death of a patient who had taken Elevidys—the FDA determined that the fatality was not linked to the gene therapy and recommended that the hold on Elevidys shipments for ambulatory patients be lifted.
This confusing back-and-forth gave many conservative quarters enough kindling to push President Donald Trump to fire Prasad. According to a July 30 report from Politico, Trump overrode the wishes of both Makary and Kennedy to kick Prasad out, partly influenced by his allies.
“I just texted President Trump on Monday just to make sure he was aware of the situation,” Sen. Ron Johnson (R-Wis.) said on Wednesday, according to Politico. “The Duchenne muscular dystrophy community is very concerned about some recent actions the FDA took, I just thought he ought to be aware of it.”
