FDA prods more than 2,200 companies and universities over missing clinical trial results

America’s medicines regulator has chased up thousands of missing clinical trial results.

This is big news. For most of these institutions, it will be the first time they have ever heard from the FDA about their legal obligations.

In a press release, the FDA announced that:

“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community.”

“On March 30, 2026, the agency sent messages to more than 2,200 companies and researchers (associated with more than 3,000 registered clinical trials, including some that were publicly funded) that do not appear to have submitted required results information to ClinicalTrials.gov...”

“The messages issued on March 30, 2026, represent an extra step the agency is taking to provide the relevant responsible parties with the opportunity to comply with federal law before the agency considers whether to take further regulatory action.”

FDA adopts approach suggested by TranspariMED

In an earlier submission made to the FDA, TranspariMED had suggested exactly this approach.

TranspariMED had recommended that the FDA should push drug and medical device companies as well as universities to “self-assess compliance”. The campaign argued that:

“Taking this step would, at marginal cost, strongly incentivise Responsible Parties to step up their compliance efforts [and] rapidly and significantly reduce the population of noncompliant trials.”

Why has FDA not enforced the law?

Under a 2007 law, the FDA can levy a fine of $15,107 for every day a clinical trial result remains missing.

Over the years, numerous lawmakers and health groups have urging the FDA to finally take action. Notably, the campaign group Universities Allied for Essential Medicines filed a lengthy Citizen Petition asking the FDA to impose fines.

Nonetheless, to date, the FDA has sent out only eight warning letters and not imposed a single fine. 

A key barrier to comprehensive enforcement is that the law itself is badly written. The FDA has to dig deep into the files for each individual trial to assess whether that trial is subject to the law.

This makes it very complex and time-consuming to monitor compliance. For example, the recent FDA press release noted that an internal FDA analysis had estimated that 29.6% of applicable clinical trials had not reported results. In contrast, a widely used independent tracking tool estimates that only 21.5% of due trial results are missing.

Regulatory innovation

Instead of trying to precisely identify all applicable trials, FDA appears to have adopted TranspariMED’s suggestion to contact all parties responsible for unreported trials that seem highly likely to fall under the law, and send all of them boilerplate letters prompting them to review their own legal compliance.

Till Bruckner, founder of TranspariMED, said:

“We have seen repeatedly across Europe that these kinds of simple nudges from medicines regulators can be highly effective at increasing clinical trial reporting rates.”

“We expect that this simple move by the FDA will cause sponsors to make hundreds of missing clinical trial results public.”

“This is also a big step forward towards future enforcement, because it is likely to greatly reduce the number of potentially delinquent trials requiring manual review by FDA staff.”

Dissenting voices

Other transparency advocates are more skeptical.

The driving force behind the Citizen Petition, Christopher Morten from the New York University School of Law, told the New York Times that he was concerned that the FDA’s effort might be “more symbolic than substantive.”

Holly Fernandez Lynch of the University of Pennsylvania told the newspaper that the FDA should “just drop the hammer on this” and impose fines.

Why do some drug companies hide clinical trial data?

Announcing the FDA’s recent move, FDA Commissioner Marty Makary explained that:

“Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data’s influence on the company’s share price.”

“Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers."

"If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”

What happens next?

As a next step, TranspariMED will file a Freedom of Information request to obtain the list of companies and universities contacted by the FDA.

TranspariMED will then check how many of the missing trial results those sponsors have made public, and publish the names of companies and universities that have failed to clean up their acts. 

Click on the image below to read the full FDA press release.