A responsible party, typically a clinical trial sponsor or sponsor investigator, of an applicable clinical trial (any clinical trial (other than a device feasibility trial or a phase I drug trial) to collect data to support an FDA premarket submission) is required to submit to ClinicalTrials.gov certain information about the results of such a clinical trial; this information generally must be submitted no later than one year after the primary completion date of the applicable clinical trial unless an exception applies. See section 402(j)(3)(E) of the Public Health Service Act (PHS Act) (42 U.S.C. § 282(j)(3)(E)). The responsible party can submit a certification of delay, a request for an extension of good cause, or a request for a waiver of the requirements for submission of results information. See 42 C.F.R. § 11.44, and section 402(j)(3)(H) of the PHS Act (42 U.S.C. § 282(j)(3)(H)). The responsible party is also required to register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled in the applicable clinical trial.

In the letter sent in April, FDA stated it acted after warning Acceleron in July 2020 that the company had failed to properly report the study results of the completed clinical trial. In the same April letter, FDA threatened Acceleron with a $10,000 fine or criminal prosecution if the company did not post these results on ClinicalTrials.gov within 30 days. Furthermore, FDA stated that if Acceleron fails to submit the required information within the 30-day period, it will seek additional monetary penalties and consider criminal prosecution. After the 30-day window, financial penalties for failure to comply with FDA’s request can be up to $10,000 for each day of the violation until the violation is corrected. See section 303(f)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 U.S.C. § 301-392). As reported by trade press, Acceleron stated that lack of compliance was the result of a clerical oversight and that the results will be posted within the 30-day remediation period set by FDA.

FDA’s action is thought to be the first notice of noncompliance sent to a pharmaceutical company that threatens prosecution and threatens imposing fines for not posting a summary of clinical trial results on ClinicalTrials.gov. In August 2020, FDA described its approach regarding how it identifies responsible parties that had failed to submit required registration and or summary results to ClinicalTrials.gov. Until now, FDA has only sent notices of noncompliance to encourage voluntary compliance with the information submission requirements, which have served primarily as verbal warnings.

According to a recent statement by FDA, the legal requirements applicable to Clinicaltrials.gov reporting are intended to provide greater transparency about the results of completed clinical trials to allow for the scientific community to build on submitted information. FDA stated that it “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.” The Agency further stated it will take appropriate actions when necessary to ensure that required information is available on ClinicalTrials.gov as required by the law. This recent turn of events may signal a new wave of enforcement actions against companies who fail to comply with these statutory and regulatory requirements related to ClinicalTrials.gov.