The Food and Drug Administration will announce on Monday that it has sent over 2,200 letters pressing drug manufacturers, medical device makers and researchers to publish clinical trial data that they have seemingly failed to report.
Drug developers are legally required to post results from many studies on ClinicalTrials.gov, a federal database. But for years, many have not done so: Roughly 30 percent of studies examined in an internal F.D.A. analysis had not reported their results to the database.
“What I want to see is companies do the right thing and realize the moral duty they have,” the F.D.A. commissioner, Dr. Marty Makary, said. Dr. Makary added that companies sometimes suppress negative results that might look unfavorable. Without a full picture, he said, it can be difficult for physicians to best determine which medications to prescribe to patients.
“It’s a public health issue,” he said.
But some outside experts said the F.D.A. action, which asked researchers and companies to voluntarily submit their results, fails to make use of far stronger tools it has to force drugmakers to comply. The F.D.A. can make drug developers pay over $10,000 a day if they do not disclose their results within a mandated time frame. The National Institutes of Health could also cut funding to institutions that do not comply.
Christopher Morten, director of the Science, Health and Information Clinic at the New York University School of Law, said he was concerned that the effort might be “more symbolic than substantive.” Dr. Morten petitioned the F.D.A. in 2023 to ramp up enforcement of universities and companies that did not report trial results.
“This is not just some kind of paper-pushing bureaucratic requirement,” said Holly Fernandez Lynch, an associate professor of medical ethics and health policy at the University of Pennsylvania. “It’s actually a critically important scientific and ethical requirement.”
In 2007, Congress passed a law mandating clinical trial results reporting following a high-profile scandal involving the arthritis medication Vioxx. The drug’s maker, Merck, was criticized for its handling of data showing the drug was associated with an increased risk of heart attack. The company eventually withdrew the drug from the market.
Doctors and patients can be misled by existing positive data on a treatment if they aren’t able to see other, negative results, Ms. Fernandez Lynch said. And scientists use that data to determine whether they should further pursue a new treatment or drug. If a trial has already shown that a medication doesn’t work for a particular indication, companies may not need to spend money and time developing it further, and participants may not need to volunteer their time or, potentially, experience side effects.
Ms. Fernandez Lynch said she was frustrated by what she described as the F.D.A.’s “pretty please” approach.
“Just drop the hammer on this,” she said. “No more notice is needed.”
Dr. Makary said that the action was a first step and that the agency intended to send more formal warnings, known as letters of noncompliance, in the future. He added that the agency was using artificial intelligence and other technology to screen for noncompliance.
The agency has historically lacked the budget or staff to meaningfully enforce requirements for clinical trial reporting, said Dr. Reshma Ramachandran, an assistant professor at Yale Medicine who worked with Dr. Morten to petition the F.D.A.
Dr. Makary said he was confident the agency has the staffing necessary to carry out this work. The F.D.A.’s work force has undergone significant cuts over the past year.
There have been other federal efforts to push researchers and companies to publish results. In 2021, the F.D.A. formally reprimanded Acceleron Pharma for failing to report study results on time, the first time it had taken such an action against a pharmaceutical company. The National Institutes of Health has also pressed more investigators to report their results in recent years and has made some researchers prove that they had submitted their results before extending grant funding.
Dr. Makary said that to incentivize scientists to publish their negative trial data, the National Institutes of Health will also start a journal later this year that is dedicated to such results.
Dani Blum is a health reporter for The Times.
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