Makary Defends Approval Standards and Prasad’s Role
FDA commissioner Marty Makary is defending the agency’s scientific standards and personnel, particularly CBER director Vinay Prasad, amid mounting political and investor criticism. In a 2/26 CNBC interview about recent FDA review policy changes (e.g., not requiring two pivotal trials for approval, and this week’s release of the plausible mechanism pathway), Makary addressed criticism surrounding Prasad, who has drawn scrutiny from some investors and opinion writers over recent complete response letters issued for certain rare disease therapies.
Makary characterized criticism of Prasad as politically motivated, describing him as a prolific scientist “on loan” from the University of California, San Francisco, and a key architect of the agency’s regulatory reforms. “There has been this effort to put a fatwa on Vinay Prasad by one or two media outlets as if he’s the one who’s making these decisions,” Makary said. “Vinay Prasad is a genius.” Makary also rejected claims that the agency is quietly raising evidentiary standards or undermining rare disease development. For the first time, he said, FDA is publishing detailed rejection letters in real time to explain why applications fail — including when sponsors do not follow agency guidance or when randomized trials show no clinical benefit.
“If your drug works, it’s going to get approved,” Makary said. “If the clinical trial shows no benefit and harm, we’re not going to approve it.” He emphasized that all approval or rejection decisions under his tenure have followed the recommendations of career scientists and that the biologics center recently posted a record number of approvals.
Makary said the FDA is now meeting 100% of its Prescription Drug User Fee Act target dates and, under a new “national priority review” initiative, is cutting review timelines from roughly a year to a matter of weeks for certain high-impact therapies. He said one oncology decision expected this week was completed 44 days after the filing period — far faster than historical norms — and predicted 2026 would be a record year for approvals, already exceeding five- and 20-year averages.
The interview underscored an FDA leadership team attempting to balance faster approvals and regulatory flexibility — particularly for rare and ultra-rare diseases — with public transparency and scientific rigor amid heightened political and financial scrutiny. “You’re going to see some amazing announcements from the FDA in the next couple of weeks,” Makary said. “The FDA is strong and is going to continue to be strong.”