In his first few weeks as FDA commissioner, Dr. Marty Makary faced a tough environment. The former Johns Hopkins University surgeon took the reins as 3,500 FDA staff were let go amid an HHS workforce reduction of 10,000 employees. In the aftermath, concerns arose about the FDA’s ability to maintain its core functions and a lack of communication from officials further scrambled the situation.
Now, Makary is finally speaking up about the Trump administration’s moves to slash federal agencies and spending. In an interview yesterday, he doubled down that “no scientists or inspectors were laid off,” and stated that the FDA was “bloated with duplicate services,” while revealing he was not involved in the job cuts. Makaray also said “the FDA will reach its PDUFA targets,” though he noted that approval dates are not actual deadlines but targets that can be moved.
The interview provides one of the first looks into Makary’s thinking as the FDA prepares to reshape itself with a smaller staff. And are more changes in store for the agency? Makary also addressed a proposed agency reorganization that was leaked earlier this month and said he “rejected” the idea. Today, we’re looking deeper into what the planned reorganization would have looked like and the pushback from pharma to changes at the FDA.
Thanks for reading.