Why sudden Vinay Prasad departure from FDA is about more than Sarepta missteps

Vinay Prasad is out at the FDA after less than three months. It may be the shortest tenure as CBER Director in FDA history.

This is an ominous sign for the agency, but probably not just for the reasons you might first think.

Vinay Prasad’s departure and gaps in FDA leadership

Prasad had three key roles.

He was CBER Director and both Chief Medical Officer and Scientific Officer of the FDA.

At a simple, practical level, these are just more troublesome gaps for an agency that’s already hurting for personnel and top leaders,  Even prior to this I wondered how the FDA can function with so few people.

This sudden exit puts even more on the shoulders of Commissioner Marty Makary and his inner circle. Biologics oversight is particularly susceptible to dysfunction moving forward.

Given that the FDA already seemed to be on the edge in terms of leaders and other personnel, why the Prasad exit now?

Why is Vinay Prasad out? The official word

There is a sense that Prasad’s mishandling of Sarepta’s Duchenne gene therapy (Elevidys) was the key factor.

Things were herky-jerky on this front over the last week.

First, the FDA/CBER were saying one thing on this, then another. The agency finally reversed to essentially say Sarepta would be okay marketing Elevidys for a subset of Duchenne patients.

What was going on behind the scenes?

Trouble of some kind for sure.

The official line on Prasad’s exit is that he “did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family.” That’s the typical cliché after departures. What really happened?

Data over politics for Prasad?

I was no fan of his and never saw Prasad as a logical choice to lead CBER. He lacked experience and had some extreme views.

Then he was given those other top FDA roles. Everything seemed so insular around Makary including bringing in all these folks he already knew. Another key criteria to be a leader under him seemed to be a past stance critical of Covid vaccination policies.

One thing that always puzzled me about the choice of Prasad was that he had also been critical of the FDA for decisions such as on Elevidys that he felt didn’t have enough data. Or the data weren’t good enough. Was Makary going to be okay with someone like that in the long haul?

I wonder if the zigzagging on Elevidys reflected tensions between Prasad and Makary over what is enough and good enough data. It might be simpler than that and Prasad just made big mistakes here, but I feel like there’s probably much more to it.

Politics wins out

Makary seems to have done some zigzagging too. Per STAT, last week Makary was still Prasad’s biggest supporter: “There’s not a political bone to his body,” Makary said. “He’s an impeccable scientist. I think one of the greatest scientific minds of our generation.”

Could the lack of political savvy, just touted by Makary as a good thing, have flipped to become a key factor in Prasad’s departure?

Notably, a recent WSJ opinion piece attacked Prasad, calling him “a Bernie Sanders acolyte in MAHA Drag” and “a top FDA appointee who doesn’t think patients can be trusted to make their own healthcare decisions.” That may have signaled the beginning of the end for the former CBER director. From Christina Jewett over at the NYT, right-wing extremist Laura Loomer led the charge against Prasad.

The choices for new CBER director, CSO, and CMO may tell us more about how things will play out. Will someone else be more willing to play ball on politics more than Prasad? Will they keep folks like columnists at the WSJ happier? Update: it was just announced that George Tidmarsh, the new CDER will act as CBER director.

What does all of this mean moving forward?

Together it’s a recipe for more trouble and erratic behavior by the agency, often driven by politics at a level not previously seen before.