FDA Signals Reporting Requirements for Clinical Trials Enforcement with First-ever Notice of Noncompliance to Drug Maker
On April 28, 2021, the US Food and Drug Administration (FDA) issued the first-ever Notice of Noncompliance after the drug maker did not comply with its legal reporting obligations for clinical trials upon earlier receipt of a Pre-Notice of Noncompliance from the agency. FDA notified the company that it has 30 days to correct the issue or face up to $10,000 per day in civil monetary penalties or other regulatory action including injunction or criminal prosecution.
Registration and results reporting requirements for applicable clinical trials were established under section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and clarified in FDA’s regulations in 42 CFR part 11. In a press statement posted to FDA’s website, Dr. Janet Woodcock, Acting Commissioner of FDA, says, “Federal law requires that responsible parties, typically trial sponsors, register applicable clinical trials on ClinicalTrials.gov within 21 days after the first human subject is enrolled1 and submit certain summary results information for those trials, generally no later than one year after the study’s completion date unless a deadline extension is obtained.” ClinicalTrials.gov, a web-based registry and results database of federally and privately supported clinical trials conducted in the US and around the world, was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA) and managed by the National Institutes of Health (NIH)/National Library of Medicine (NLM).
In August 2020, FDA finalized its guidance regarding the agency’s authority to assess civil money penalties against responsible parties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Per the policy described in the guidance, entities that fail to comply with requirements related to clinical trial registration, results reporting or certification submission will be issued a pre-notice of noncompliance from the agency, which allows 30 calendar days for responsible parties to voluntarily correct any potential violations before sending a final notice allowing another 30 calendar days to remedy the situation before the agency levies any penalties.
Woodcock notes that “many responsible parties comply with the law without FDA action,” and “the agency has sent Pre-Notices of Noncompliance (more than 40 to date) to encourage voluntary compliance with the ClinicalTrials.gov requirements.” The agency’s action this week marks the first time a Notice of Noncompliance has been issued to a drug maker for failing to submit required summary results information to ClinicalTrials.gov for its Phase 2 clinical trial, despite having published results for the study that did not achieve its primary endpoint.
In describing the greater transparency that the statutory and regulatory requirements provide for applicable clinical trials, Woodcock explains, “The submission to and posting of clinical trial information on ClinicalTrials.gov honors volunteers who participate in research to advance medical science and enhances public trust by creating a transparent and robust public record of clinical trials and information about their results.”
After more than a decade, the FDA is exercising its authority over the disclosure of clinical trial information to ensure that all clinical studies are publicly available. The issuance of this first notice of noncompliance is a clear signal that the FDA is taking steps to enforce the current rules.
1 The International Committee of Medical Journal Editors (ICMJE) requires registration of clinical trials prior to enrollment of the first participant (http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html).