And the new FDA commissioner is.... Marty Makary

Marty won over both sides of Congress

I watched Marty Makary’s commissioner hearing. He was pressed on a number of issues, which I will discuss here, and, overall, his performance has surely secured his position as the next FDA commissioner.

Forget NPR, here are my 5 take aways.

1. The FDA advisory committees are stacked with panelists who take money from Pharma, and then they vote on the most controversial drug approvals. Rand Paul asked Marty his thoughts, and it is clear: Marty will take action. I have railed about this issue for decades. To me it is completely inappropriate to bring a controversial Aztrazenica drug to the drug advisory meeting and have panelists who have past, present or future relationships with AZ vote on that. I suspect FDA will at last take action.

   

2. Marty gave a solid answer to a loaded question about an aborted FDA meeting to discuss what strains to put in the fall 2025 flu shot. The fact is: the US almost always adopts the same guidance as Europe. This guidance is largely a guessing game. Although Senator Murray wanted to press Marty to say he will reconvene the committee, he said he would make the best scientific judgement. You don’t need a committee on this topic. In fact, it might even be good if FDA issued 2 sets of guidance or 4 sets, with different strains, and then we could do what has never been done: run a randomized trial. But regardless, there is enough expertise inside FDA to make this call. The panelists add little to this question, as they are using the same magic 8 ball.

3. Senators pushed Marty to guarantee that Mifepristone will be made available, but he responded that as it is under REMS, he has to follow the safety data. I think it is unlikely we will see anything so concerning that mifepristone would be removed, but it is possible that there are some drug-drug interactions as Marty notes.

4. After DOGE fired probationary FDA workers, Senator Collins asked Marty if he will control FDA personnel going forward. He agreed. Some are upset that DOGE cut probationary workers at NIH and FDA, but this is not surprising at all. Nearly everyone running for president in the Republican party is clear that they want to reduce the size of federal government. It is not merely an issue of saving money, but because they are concerned that these employees engage in actions against the dictates of Congress and the executive. This is their guiding philosophy. Now it is challenging to fire established workers, but probationary workers are all legally able to be let go— often for no cause— hence they did it. This is an issue that people actually voted for. Candidates were clear on this message.

5. Biosimilar and generics. Marty stressed that he would maximize the speed of biosimilar and generic approvals in an effort to lower cost. Each generic lowers brand price by 10%, so we need 10 generics to really bring prices down. Marty gets this.

Marty Makary is a smart, thoughtful and disciplined physician scientist. His credentials are sterling and his answers seemed to please both sides. One of his sentences stood out, “I have never been afraid to speak my mind on scientific issues”

That’s so true, and exactly what we need at the FDA.