FDA Issues First-Ever Rebuke to Sponsor for Failing to Submit ClinicalTrials.gov Info
For the first time ever, the FDA has threatened enforcement and fines against a sponsor for failing to submit trial results to ClinicalTrials.gov by required deadlines.
The FDA notified Acceleron Pharma on April 27 that it must post the trial results in the next 30 days or face fines that could total $12,316 per day. The company said it would comply with the order and will post its phase 2 trial results for its cancer drug dalantercept. Acceleron discontinued the trial in July 2017.
“It’s very clear from FDA’s enforcement efforts that it is serious about requiring companies to keep their entries in the clinical trials database up to date,” said Wayne Pines, senior director at consulting firm APCO Worldwide. “I would expect additional notices of noncompliance in situations where companies fail to post information in a timely way.”
The FDA’s action against Acceleron was taken more than eight months after the agency first warned the company that it was facing possible enforcement action in a July 20, 2020, letter. The agency also disclosed on Wednesday that it has sent more than 40 such warnings to date to other sponsors, encouraging them to comply with ClinicalTrials.gov requirements. The agency declined to elaborate on the status of those warnings.
“FDA contacted Acceleron on multiple occasions to encourage the firm to submit the required clinical trial results, agency spokesman Jeremy Kahn told CenterWatch Weekly.
The FDA put the industry on notice last August, issuing guidance on civil money penalties it could impose for failure to post results to ClinicalTrials.gov (CenterWatch Weekly, Sept. 1, 2020). Under federal regulations, the maximum penalty for violations in a single proceeding can total up to $12,316, but the agency is allowed to levy an additional fine of up to $12,316 per day if the violation is not corrected within 30 days of receiving a noncompliance notice. The amounts change yearly based on inflation.
“We can all agree that this one notice of noncompliance is going to really move up the chain to leadership at different academic medical centers,” said Sarah White, executive director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, “and will probably light a fire to really try to move to more of a commitment to transparency and at least to regulatory compliance.”
Marc Scheineson, partner with Alston & Bird, called the FDA’s move unusual. “It looks like the FDA is focusing on the accuracy of these listings. I think the agency is putting companies on notice that they have to prioritize review and keep these listings current.”
WCG Chief Compliance Officer David Forster concurred. “I’m actually glad to see them do it. There have been lots of articles out there over the years criticizing the FDA for not enforcing the requirements to post data and the results. Maybe they’re finally doing what they said they would do all along. It’s overdue, honestly.”
Read the FDA’s noncompliance letter here: https://bit.ly/3u3cud9.