Congress demands that FDA and NIH sanction sponsors that fail to report clinical trial results

A Congressional committee has slammed two federal agencies for failing to ensure that clinical trial results are made public, raising the pressure on FDA and the National Institutes of Health (NIH) to finally impose sanctions on companies and institutions that have violated a key medical research transparency law and left thousands of clinical trial results hidden from public view.

The letter, sent by the ranking member of the Congressional Committee on Energy and Commerce, Frank Pallone, rakes both agencies over the coals for turning a blind eye to violations of the FDA Amendments Act. The 2007 law requires sponsors to make results public on the American trial registry ClinicalTrials.gov within one year of completing a clinical trial.

What does the letter say?

According to the letter:

“The law requires that certain clinical trial sponsors report results to ClinicalTrials.gov to expand the knowledge base, support additional research, and provide important safety and efficacy information to health care providers and researchers.”

“Sponsors of several thousand trials have been in violation of ClinicalTrials.gov reporting requirements, and yet it appears FDA and NIH have taken only modest compliance actions since reporting requirements first went into effect in 2007.”

“FDA has also not yet imposed any civil money penalties on any trial sponsors. The collection of these penalties would provide a stronger incentive for trial sponsors to comply.”

The letter asks the FDA Commissioner, Robert Califf, and the acting director of NIH, Lawrence Tabak, to explain what steps they are taking to enforce the law.

Patients exposed to dangerous treatments

In the past, some pharma and medical device companies deliberately concealed clinical trial results that reflected badly on their products, exposing patients to treatments that were dangerous or ineffective.

Meanwhile, the results of thousands of publicly funded academic trials were also left unpublished, leading to the unnecessary duplication of studies and waste of taxpayers’ money.

The 2007 law set out to fix that problem by requiring companies, universities and hospitals to make the results of many (but not all) clinical trials public. However, FDA and NIH long failed to enforce the law, leaving the problem unresolved. President Biden has yet to honour his 2016 promise to fix the problem.

Teddy Malpass, a member of Universities Allied for Essential Medicines (UAEM), a student group that has long advocated for greater clinical trial transparency, said:

"This letter highlights the minimal amount of enforcement FDA has done. Over the past two years, FDA has only sent three Notices of Noncompliance to a drug company that had failed to submit results to ClinicalTrials.gov, while thousands of trials remain noncompliant.”

Over 10,000 trial results remain hidden

Today, over 10,000 trial results are likely to be missing from the ClinicalTrials.gov registry in violation the law.

The results of over 3,000 clinical trials completed since 2017 verifiably remain unreported. The precise number of missing results from the preceding decade is unknown because they are not captured by a website that tracks recent violations. Such older trials are equally subject to the law.

While the largest pharma companies and academic institutions have significantly improved their reporting in recent years, many players continue to break the law with impunity. For example, the company Cutera has simply ignored repeated calls to make its 16 missing trial results public.

Hope for American patients?

Till Bruckner, founder of TranspariMED, said:

"It is wonderful to see that Congress is finally waking up to the immense human and financial costs of persistent inaction by the FDA and NIH on missing clinical trial results.”

“Hopefully these agencies will now stop dragging their feet, start imposing sanctions, and ensure that the thousands of results that are still missing in violation of the law are made public as rapidly as possible, going back all the way to 2007.”

What happens next?

The letter sent by Congress asks the FDA and NIH to provide answers to a long list of questions about their past enforcement efforts and future enforcement plans by 17 February 2023.

In the meantime, TranspariMED and other health groups will keep up the pressure on FDA and NIH to finally do the right thing. Revisit this blog next week to find out how…

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