Personnel is policy. The leadership team of Marty Makary and Vinay Prasad at the Food and Drug Administration (FDA) has made dysfunction and unpredictability the agency’s top policy to such an extent that people may be excused if they believe that FDA now stands for “Frequently Delays Action.”
Like many other federal agencies, the FDA has suffered headcount losses since the start of 2025. Its workforce is down over 1300 net employees from the start of 2025. Morale among the remaining employees is reportedly incredibly low, which may be influencing the slow pace of drug approvals. The top drug regulator, Dr. Richard Pazdur, openly disagrees with White House policy on expediting approvals. Consequently, the FDA approved a mere 46 drugs in 2025, a drop from 2024, on par with the lowest year of Trump’s first term, and lower than every year in the last decade except 2022.
Part of the internal difficulty has been catalyzed by the instability surrounding Vinay Prasad. Biotech companies do not like or trust Prasad, viewing him as anti-innovation. Biotech stocks soared in response to his initial ouster in mid-summer 2025,. But when he returned to the agency after a brief absence, biotech stocks tumbled again. Prasad also has been accused of pushing at least seven top scientists out of the agency and causing others to self-censor to avoid the same fate.
Prasad’s presence appears to be causing significant harm to the FDA’s ability to do its job. The FDA’s turmoil is threatening America’s longstanding poll position in biotech, as it becomes harder to navigate the confused, erratic regulatory environment. Biotech companies will only tolerate chaos for so long before moving their regulatory approvals and funding requests to a competitor, like China. If that happens, the FDA’s inability to get its house in order will be a major contributing factor.
One way the FDA has contributed to the ongoing confusion is through its use of complete response letters (CRLs). These are industry-standard letters informing a company its drug cannot be released in its current form. There are different types of CRLs that denote different levels of severity. While the FDA does not list how many CRLs it sends out per year, recent data dumps from the agency reveal at least 291 were sent between 2020 and 2024, or approximately six per month. The most common reasons for rejection have to do with the manufacturing process, not the drug itself. While rejecting drugs based on manufacturing issues is not a new practice, it would appear to run counter to the rapid innovation being pushed by the White House and probably should be subject to review.
The chaos has resulted in high-profile delays, like that associated with the rejection of KalVista’s Sebetralsta. The FDA missed its deadline to complete its review of the drug, citing resource constraints. This is the first time a missed review deadline has been explicitly acknowledged as resulting from resource constraints.
That should have been a flashing red light, alerting the Administration to entrenched agency dysfunction. However, somehow, it got worse. There were, however, rumors that Makary wanted to use a CRL to reject the drug, despite it having a good review, but was told doing so would be foolish. While these reports were denied, they are not exactly inspiring faith that the FDA has its act together.
FDA leadership and FDA staff do not appear to be on the same page. Staff cuts both demotivated existing employees and reduced the agency's ability to get work done. Further, leadership has done little to address the issue, either by rebuilding morale or by bringing in new staff. Alternatively, they could have simplified and streamlined the review process to reduce burdens on companies and complexity for FDA reviewers. They did none of those things, instead appearing to rely on reputational inertia.
The medical world does not run on inertia, however. It requires innovation and outside-the-box thinking to solve new problems and help cure diseases. The FDA seems beholden to a failed regulatory paradigm that prioritizes stasis, not innovation. That certainly is no way to ensure progress in medicine and definitely not what President Trump promised during his campaign. The FDA needs an overhaul, but its current crop of leaders do not seem up to that task.
Gerard Scimeca is chairman and general counsel for CASE (Consumer Action for a Strong Economy), a free-market-oriented consumer advocacy organization he co-founded.
