FDA nominee pitches AI application review

Mar 07, 2025

WASHINGTON WATCH

Martin Makary nominated to serve as Commissioner of Food and Drugs at the Department of Health and Human Services, testifies before the Senate Committee on Health, Education, Labor and Pensions on Capitol Hill Thursday, March 6, 2025, in Washington. (AP Photo/Jose Luis Magana)

FDA commissioner nominee Dr. Marty Makary has big plans for using AI at the agency. | AP

“There’s a number of opportunities with AI right now that we have that we’ve never had before,” Dr. Marty Makary, President Donald Trump’s nominee to lead the Food and Drug Administration, told a panel of lawmakers he hopes will confirm him.

In particular, AI could assist FDA staff to review drug and device applications, he told senators on the Health, Education, Labor and Pensions Committee. He was quick to add that AI would assist reviewers, not replace them.

He also said AI could be used to aid with data monitoring after a drug has been approved. “So that we don’t learn five years after Vioxx was approved that 38,000 Americans died from it,” he said.

Vioxx was a pain killer that was removed from the market after it was found to raise the risk of heart attack and stroke. Dr. David Graham, former associate director in the FDA's Office of Drug Safety, estimated that between 88,000 and 139,000 Americans had heart attacks and strokes as a result of taking the drug, some of which were fatal.

Open questions: But the Johns Hopkins surgeon also said the FDA could potentially share data with drug developers that might help them “train machine learning models, to help design AI systems that can predict toxicities, adverse events, and even cures for some conditions.”

Drug developers are also thinking about how AI can help prevent the advancements of drugs that could ultimately get pulled. It’s unclear how the FDA could play a role in that. One question is: What data could FDA provide that wouldn’t be proprietary to the companies?

Background: Former Commissioner Robert Califf also talked about using AI internally at the FDA, particularly for compliance monitoring. But those plans were dashed after Trump won the election and Califf left the FDA.

So far, the Trump administration has unwound much of the Department of Health and Human Services’ work to lay a foundation to use and regulate AI. Recently, it took down a public-facing document laying out HHS’s AI strategy.

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WORLD VIEW

Just over two dozen countries account for most of the world’s tuberculosis cases — including the Philippines — and 18 of them depend significantly on U.S. funding. Jam Sta Rosa | AFP via Getty Images

America’s sudden freezing and subsequent termination of most foreign aid funding is crippling tuberculosis services in countries with the highest number of cases and risks reversing decades of progress against one of the world’s top infectious disease killers, the World Health Organization warned Wednesday.

To date, thousands of health workers have been suspended and face layoffs, and that has impacted essential health services and drug supply chains. Laboratory testing services are “severely disrupted,” the WHO said, due to delays in sample transportation and shortages of essential laboratory materials, halting efforts to diagnose more people with the disease.

“Community engagement efforts — including active case finding, screening, and contact tracing — are deteriorating, reducing early TB detection and increasing transmission risks,” the WHO added.

The Trump administration has terminated multiyear grants, contracts or agreements on tuberculosis worth at least $820 million, according to a POLITICO analysis of a document it obtained listing all terminations. The figure doesn’t include programs focusing on both tuberculosis and HIV/AIDS or on tuberculosis and other conditions.

Research on tuberculosis has also been impacted, since the U.S. Agency for International Development, which the Trump administration has gutted, has halted all the clinical trials it was funding, the WHO said.

USAID was among the top three research funders in the world for tuberculosis, according to the WHO.

Why it matters: Tuberculosis has consistently been the world’s top infectious disease killer, besides the years where Covid-19 took its spot.

More than 10 million people globally fell ill from tuberculosis in 2023, the latest year for which data is available. Around 1.2 million people died of tuberculosis that year.

Just over two dozen countries account for most of the world’s tuberculosis cases — including India, Indonesia and the Philippines — and 18 of them depend significantly on U.S. funding.

America has provided between $200 to and $250 million yearly in bilateral funding for tuberculosis. This funding represented about one quarter of the total amount of international donor funding for tuberculosis, the WHO said.

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