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With Release of New Guidance, FDA Signals It’s Serious About Enforcing Clinical Trial Data Requirements

Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding clinical trial registration and results reporting.

In a new guidance it released on August 12, 2020, FDA outlines how it intends to identify parties who have failed to register a clinical trial on, or submit results to, the ClinicalTrials.gov databank, as required by the FDA Amendments Act of 2007 and final regulations promulgated in 2016 by the National Institutes of Health (NIH).  According to the guidance, enforcement will also focus on responsible parties who have submitted false or misleading information to the databank, or who have failed to submit a certification (or who knowingly submitted a false certification) to FDA regarding the submitter’s compliance with the requirements set out in the law.  The agency will generally rely on evidence collected during inspections conducted as part of FDA’s Bioresearch Monitoring Program, whose mission is to ensure good clinical practices are adhered to by all stakeholders in the clinical research enterprise, along with complaints received by the agency.

The guidance also clarifies the circumstances under which the agency’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), or Center for Devices and Radiological Health (CDRH) may seek civil monetary penalties for noncompliance.  If a Center believes a responsible party – i.e., the clinical trial’s sponsor or principal investigator – has failed to comply with its registration, results submission, or certification obligations, the Center will send a Preliminary Notice of Noncompliance (Pre-Notice) Letter to that party. The Pre-Notice Letter will give notice that the recipient has 30 days to correct the potential violation. After the 30 day period, FDA will conduct a follow up review and assessment to determine if the potential violation has indeed been remedied.  If it remains unaddressed, FDA may proceed to issue a Notice of Noncompliance, levy civil monetary penalties, issue an injunction, or even pursue criminal prosecution.

Monetary penalties imposed by a Center can run up to $10,000 for all violations adjudicated in a single proceeding.  If a violation is not corrected within 30 days from the noncompliant party’s receipt of notification of the violation, FDA may impose an additional civil monetary penalty of up to $10,000 for each day that the violation continues until it is corrected.  The guidance identifies various factors that will weigh in a Center’s decision to pursue monetary penalties and explains the procedures that apply when a Center chooses to impose such penalties.

FDA’s new guidance follows a decision out of the Southern District of New York earlier this year setting aside a Department of Health and Human Services final rule implementing the clinical trial reporting requirements at issue in the new guidance (read more about that decision here). That decision eliminated a loophole which had previously allowed clinical trial sponsors and principal investigators to not report certain clinical trial results.  FDA and NIH also recently posted an open letter to responsible parties on the ClinicalTrials.gov website informing them of the court decision and directing them to:

"Review your clinical trial(s) to determine whether it is affected by the Court’s decision because it is an [applicable clinical trial or ACT] that: (1) was initiated after September 27, 2007, or was ongoing as of December 26, 2007; (2) reached its primary completion date before January 18, 2017; and (3) studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date…If the product studied in the ACT is currently approved, licensed, or cleared by FDA, then you must submit the results information…to the ClinicalTrials.gov data bank for such ACT as soon as possible." (emphasis added)

The letter also reminds readers of the available penalties for non-compliance. In addition to posting the letter, NIH has also updated its online FAQs for the clinical trials registry to account for the recent court decision.

Impacted parties that have been sifting through clinical trial results data and working to comply with their reporting obligations in light of that ruling should take note of this guidance and know: both NIH and FDA are watching, and FDA finally appears to be ready to levy financial penalties for noncompliance.

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Authors

Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.
Michelle L. Caton is a Mintz attorney who focuses her practice on life sciences and health care transactions as well as a variety of health care regulatory and compliance matters.