The Unheralded Legacy of Marty Makary’s FDA Tenure

Marty Makary’s resignation as FDA commissioner in May 2026 was met with a mix of relief and disappointment. While his departure was precipitated by disagreements over e-cigarette regulation, it would be a mistake to dismiss the significant reforms he implemented during his tenure as mere controversy.

Beneath the headlines lies a remarkable story of regulatory modernization and innovation. Makary’s team introduced sweeping changes to the FDA’s approach, reducing unnecessary mandates related to drug clinical trials and cutting risks and costs associated with pharmaceutical innovation.

One of the key aspects of Makary’s reforms was his focus on lowering drug prices. The number of generic approvals increased by 20 percent, promoting price competition in the market. He also eliminated burdensome clinical-trial requirements for biosimilars, which are “generic” versions of biologics, cutting approximately $200 million and years off development time.

The FDA made interchangeability easier, allowing patients and pharmacists to swap expensive biologics for their cheaper biosimilar equivalents with less red tape. Affordability became a qualifying criterion for the accelerated national priority review program, and an initiative was launched to move more drugs over-the-counter, where they are cheaper and easier to obtain.

Makary’s push to bring the FDA into the AI era was significant. The agency developed a new tool that uses AI to speed up the filing check process, allowing for approvals two months sooner in principle. This is just one example of how AI transformed the FDA’s traditional 60-day filing check.

The FDA also consolidated its databases, collapsing seven adverse-event systems and three drug-safety systems into one, resulting in a reported $120 million annual savings. It built a new tool to improve public access to adverse event information, demonstrating a commitment to transparency.

Makary’s FDA overhauled drug review times by introducing the National Priority Review Program. This program cut review times for some drugs from around a year to one or two months. The results have been promising, with 23 drugs receiving expedited reviews and clearance being granted in as little as two days.

The agency also found ways to reduce animal testing by replacing older requirements with computational modeling and organ-testing technology that can predict toxicity better than animals. This not only cuts time off the drug R&D timeline but also reduces animal use.

To modernize its operations, Makary’s team launched the first real-time clinical trial. This innovative approach allows regulators to watch what is happening in trials live on a dashboard as it happens, reducing dead time and cutting years out of the process.

Makary’s legacy at the FDA should not be defined solely by the noise surrounding his departure. His tenure represents a significant turning point for the agency, marking its entry into the AI era and paving the way for faster approval times and lower drug prices.

The question now is what happens next? Will these reforms continue under new leadership, or will they falter due to bureaucratic resistance? One thing is certain: the pharmaceutical industry and patients stand to benefit from the momentum generated by Makary’s efforts.