For the first time ever, an American pharma company has been threatened with a fine for failing to make the results of a clinical trial public.
On Tuesday, the US Food and Drug Administration warned Acceleron Pharma that:
“If your company does not submit the required clinical trial results information [to the public registry ClinicalTrials.gov]… within 30 calendar days after receiving this Notice, FDA may also seek additional civil monetary penalties against your company… In addition to civil monetary penalties, violations… could result in other regulatory action, such as injunction and/ or criminal prosecution.”
In a public statement issued the following day, the FDA explained that:
“Today, the FDA issued its first Notice of Noncompliance to Acceleron… for failing to submit required summary results information to ClinicalTrials.gov."
“The Notice of Noncompliance gives Acceleron 30 days to submit the required summary results information. The FDA is authorized to seek civil money penalties for Acceleron’s violation, including additional civil money penalties if Acceleron fails to submit the required information within the 30-day period.”
A company spokesperson told Science that Acceleron now plans to make the results of the trial public.
The United States adopted a law requiring many clinical trial results to be made public in 2007, and sponsors who violate the law face fines of over $10,000 for every day a trial result is not reported.
The FDA could by now have collected over $19 billion in fines for such violations, but until this week had failed to take action. One observer noted that $19 billion is "pretty much the same amount Operation Warp Speed spent for Covid vaccine R&D".
As the article in Science points out:
“Congress created the reporting law after pharma companies suppressed data revealing lucrative drugs to be unsafe or ineffective… FDA has yet to collect a single dollar. NIH can also withhold violators’ grant funds but has never done so. Instead both agencies have encouraged voluntary compliance – until now.”
“As vice president, Joe Biden pledged in 2016 to enforce the clinical trials law after learning it was being ignored. Wednesday’s action is the first sign that his administration would reverse years of passive acceptance that the law is widely ignored.”
Universities Allied for Essential Medicines (UAEM), which has long campaigned for for the FDA to take effective action on missing clinical trial results, called the FDA's action "a huge win in the battle for transparency". TranspariMED shares this view.
However, 2,772 clinical trials are currently in violation of U.S. transparency laws, making it imperative for the FDA to cast the net wider. As former ClinicalTrials.gov head Deborah Zarin told Science, “it will be important for FDA and NIH to follow this up with a program of systematic monitoring and enforcement” to ensure full compliance.
Image Source: FDAAA Trials Tracker, University of Oxford
The FDA’s statement signals that the agency intends to take action more frequently in future:
“Although many responsible parties comply with the law without FDA action, the agency has sent Pre-Notices of Noncompliance (more than 40 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements.”
“The FDA takes its role in enforcing the ClinicalTrials.gov registration and results information submission requirements extremely seriously and we will continue to encourage voluntary compliance with these requirements. When necessary, the FDA will take appropriate actions to help ensure that required information is available on ClinicalTrials.gov as required by law and for the benefit of clinical trial participants and public health.”
Aaron Kesselheim, director of the Program on Regulation, Therapeutics and Law at Brigham and Women’s Hospital, told RAPS Focus that FDA’s action is a step in the right direction:
“Public reporting of clinical trials is extremely important for public health reasons and ethically because it recognizes the sacrifices of the patients who volunteered in the trial. It’s great to see the FDA taking steps to make sure current rules are enforced.”
From January 2022 onwards, national regulators across the European Union will also gain the power to issue fines to companies, universities and hospitals that fail to make the results of drug trials public. Denmark's regulator has already announced that it intends to impose strong sanctions.
TranspariMED will continue to closely monitor regulators' actions worldwide. Stay tuned to this blog for regular updates.