Fourteen Years Later, FDA Flexes Its Clinicaltrials.gov Enforcement Authority

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Morgan Lewis - As Prescribed

FDA recently issued its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health (NIH) databank. Despite having authority to issues such notices since the 2007 passage of the Food and Drug Administration Amendments Act (FDAAA), FDA has not previously exercised its clinicaltrials.gov enforcement authority.

Under federal law, sponsors of clinical trials must register certain studies on clinicaltrials.gov within 21 days of first subject enrollment and must submit certain study results within a year after the study’s completion date. Sponsors may, however, delay results submissions under certain circumstances (e.g., by submission of a certification to NIH that the clinical trial studies an FDA regulated drug or device product that was not previously approved, licensed, or cleared by FDA for any use or is being studied for a new use, and that the sponsor intends to seek FDA approval, licensure, or clearance).

In August 2020, FDA outlined its approach to enforcement of the clinicaltrials.gov posting requirements in its guidance, Civil Monetary Penalties Relating to the ClinicalTrials.gov Data Bank. Under this guidance, FDA states that, before pursuing enforcement action, it will send sponsors a preliminary notice of noncompliance describing potential violations (Pre-Notice Letters). These Pre-Notice Letters describe the potential violation and request that the sponsor take corrective actions within 30 days. (According to a statement made by Acting Commissioner Dr. Janet Woodcock, the agency has sent more than 40 Pre-Notice Letters to date.) Following this 30-day period, FDA states that it will conduct a further review and that continued failure to comply with posting requirements may result in the issuance of notice of noncompliance letters, civil money penalties, injunctions, and/or criminal prosecution. Notice of noncompliance letters are publicly posted on FDA’s website and information about notices of noncompliance are also posted to the clinicaltrials.gov study record.

In light of FDA’s latest action, clinical study sponsors in the biopharmaceutical industry and academic and medical institutions should review their current clinicaltrials.gov postings and ongoing clinical studies to determine whether all posting responsibilities have been met. It would also be prudent for sponsors to review their clinicaltrials.gov posting policies and remind employees of their posting obligations.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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