The news: FDA commissioner Marty Makary resigned this week after 13 months leading the agency.. Kyle Diamantas, the FDA’s deputy commissioner for food, will serve as acting commissioner.

Why it matters: Makary’s departure leaves a medical leadership gap at the FDA and raises questions about whether the policies and priorities he introduced will continue.

Below, we break down 4 key pharma initiatives Makary instituted and the likely outcome for each under new FDA administration:

1. AI Drug and Clinical Trial Review

The FDA introduced agentic AI for drug reviewers, scientists, and investigators in December after piloting genAI to speed up reviews. It also launched a proof-of-concept program for real-time AI in clinical trial reviews.

Likely to continue: AI will remain central to FDA reviews—especially after the 2025 layoffs that cut reviewers and investigators—but specific programs could shift under a new commissioner.

2. One-Trial Drug Reviews

Makary formalized the policy in February, allowing drugmakers to submit new drug applications with one pivotal trial instead of two. The FDA already uses a single-trial approach when two aren’t feasible—66% of drugs approved in 2024 relied on one trial. Now the default, Makary framed the shift as a practical timesaver and evolution of existing practices, but some experts warn it could lower scientific expectations.

Likely to continue: The policy probably won’t be reversed, though a new commissioner could set stricter guidelines for when two trials are required.

3. Increased Pharma Drug Ad Enforcement

The crackdown on drug ads began in September with a Makary letter sent to thousands of drugmakers, noting its intent to begin aggressive enforcement of misleading disclosures, risks, and content. The agency followed with hundreds of formal warning letters, with enforcement continuing this year.

Likely to continue: The push for greater drug ad transparency goes beyond Makary, reflecting a broader Trump administration priority—and signaling continued crackdowns on ads.

4. Commissioner’s National Priority Review Voucher (CNPRV)

The pilot program awards drugmakers accelerated reviews, cutting timelines from 10–12 months to 1-2 months. Since June, the FDA has awarded 18 vouchers, leading to seven approvals, including Eli Lilly’s weight loss pill Foundayo. CNPRV, which Congress did not authorize, has drawn criticism from industry watchdogs and Democratic leaders alleging political interference, favoritism, and safety risks.

Likely to be modified: Its survival depends on the next commissioner who either aligns with a more aggressive push for new drugs or pulls back on controversial deal approaches.

Implications for pharma marketers: Makary’s tenure brought trade-offs for drugmakers, who welcomed faster reviews and one-trial clinicals but faced stricter ad enforcement. Little is likely to change until a new commissioner is appointed, but that process could take time as other leading health roles, including CDC director and surgeon general, also remain unfilled. In the meantime, pharma companies should maintain rigor in one-trial drug reviews, adopt AI tools that can integrate with the FDA’s system, and stay vigilant on ads as AI-enabled monitoring remains in place.

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