Trump Appointed Martin Makary Targets Faster Drug Approvals With FDA Artificial Intelligence Overhaul

On Thursday, U.S. Food and Drug Administration (FDA) Commissioner Martin A. Makary announced an aggressive timeline to scale the use of artificial intelligence (AI) internally across all FDA centers by June 30, following the completion of a new generative AI pilot for scientific reviewers.

Makary has directed all FDA centers to begin deployment immediately, with the goal of full integration by the end of June. Work will continue to expand use cases, improve functionality, and adapt to the evolving needs of each center after June 30.

By that date, all centers will be operating on a common, secure generative AI system integrated with the FDA’s internal data platforms.

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Makary spoke about the need to shorten the length of the drug approval process and the use of artificial intelligence, among other topics, during the AHA Annual Membership Meeting on Tuesday.

“We at the FDA now have to ask big questions that we’ve never asked before,” Makary said. “Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things?”

Makary was also optimistic about AI helping to approve new treatments for conditions such as diabetes and certain types of cancer.

According to a media report on Wednesday, OpenAI, which is backed by Microsoft Corp MSFT, met with FDA officials to discuss the agency’s use of AI to speed up drug evaluations.

Makary didn’t say OpenAI was involved in the project, but sources familiar with it say a small team from OpenAI has met several times in recent weeks with the FDA and two associates from Elon Musk’s Department of Government Efficiency (DOGE).

They’ve been discussing a project called “cderGPT,” likely referring to the FDA’s Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs in the U.S., and “Research GPT.” Jeremy Walsh, the FDA’s newly appointed AI officer, has led the talks. No contract has been finalized yet.

According to the May 2024 McKinsey Global Institute report, AI technology could generate $60 billion—$110 billion annually in economic value for the pharmaceutical industry, as it can help speed up the process of identifying compounds, their development, and approval.

In May 2024, Researchers at Alphabet Inc.’s GOOG GOOGL Google DeepMind developed AlphaFold 3, a new artificial intelligence (AI) model.

AlphaFold 3 can predict the structure and interactions of biological molecules. This includes proteins, DNA, and RNA, and small molecules that could function as drugs.

Google DeepMind will make the model available for non-commercial use through the AlphaFold server.

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