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New FDA Guidance on Penalties Relating to ClinicalTrials.gov

By Carrie Mitchell and Jason Buck

Recently, the FDA issued a guidance concerning the penalties for noncompliance with ClinicalTrials.gov requirements. Sponsors conducting clinical trials should understand and follow the requirements for registering trials and reporting the results on ClinicalTrials.gov.

The requirements have been in force since 2007 and were part of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 402(j) of the Public Health Services Act, and the Final Rule for Clinical Trials Registration and Results Information Submission. With the recent Federal Court decision in Seife et al. v. HHS et al., 18-cv-11462 (NRB) (S.D.N.Y. Feb. 24, 2020), clinical trial records that were previously compliant can now be marked as noncompliant.

The August 2020 FDA guidance addressed civil money penalties that FDA could pursue in cases of noncompliance against sponsors, responsible parties, and submitters of certain applications and submissions. Moreover, the guidance details the series of actions, and associated deadlines, the FDA can take to allow the responsible party to remedy noncompliance before imposition of monetary penalties is considered. If a sponsor fails to comply with the requirements, FDA will send a Preliminary Notice of Noncompliance (Pre-Notice) as a first step to rectify the noncompliance. Failure to comply within 30 days may result in further regulatory action, including the issuance of a Notice of Noncompliance, civil money penalties, injunction, and/or criminal prosecution (Link). The statutory maximum penalties do not exceed $10,000 for all violations adjudicated in a single proceeding. If a violation is not corrected within 30 days following notification, an additional civil penalty is imposed of not more than $10,000 for each day that the violation continues until it is corrected.

When evaluating potential violations, the FDA is focusing enforcement and attention on applicable clinical trials of products that may pose a higher risk to subjects or applicable clinical trials of products intended to address significant public health need. Trials that may fall under this focused enforcement of compliance are trials of products not previously approved, licensed, or cleared by the FDA and intended to treat a serious and/or life-threatening disease or condition and trials involving vulnerable populations (pediatrics), rare diseases, or emergency research conducted without informed consent.

ClinicalTrials.gov is already notifying sponsors concerning potential compliance issues for postings or certification. However, notifications are for only those trials that have been registered with the database. Sponsors may have submissions that were not registered and could still fall under the regulations to post results. If you are running clinical trials, take a proactive approach to compliance and review submissions and remedy compliance issues as quickly as possible.

Unsure of your compliance or need help to meet compliance requirements? Synchrogenix, a Certara company can help. Using a proven methodology, we have supported sponsors with thousands of trial postings to global disclosure databases. Contact us today to avoid compliance issues or penalties.


Carrie Mitchell

Carrie Mitchell is a Regulatory Services Manager at Synchrogenix, a Certara Company. She is responsible for the clinical trial disclosure and transparency team, which includes clinical trial registrations and results postings for Clinicaltrials.gov and other registries and databases as well as the redaction and advanced anonymization services. She has over 18 years of experience in the clinical research industry with 10+ years of experience in medical writing with a concentration in Clinical Trial Disclosure.

Jason Buck

Jason Buck is a Senior Regulatory Writer at Synchrogenix, a Certara Company. He is responsible for clinical trial registrations and results postings and has prepared numerous postings for Clinicaltrials.gov and other registries and databases. In addition to clinical trial disclosure, Jason also supports clients with redaction of regulatory submissions to various health authorities.

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By: Carrie Mitchell and Jason Buck

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