On April 27, 2021, the Food and Drug Administration issued its first Notice of Noncompliance to a pharmaceutical company for failure to submit required information to the ClinicalTrials.gov databank operated by the National Library of Medicine (which is a part of the National Institutes of Health).1  The agency has sent more than forty Pre-Notices of Noncompliance, but this is the first Notice of Noncompliance for a company’s failure to submit required summary results information.

In accordance with section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), including its implementing regulations in 42 C.F.R. part 11, sponsors are required to submit results information for certain applicable clinical trials to ClinicalTrials.gov generally no later than one year after the primary completion date, unless there is a certification of delay or a request for an extension of good cause or waiver of the submission requirements.2  In addition, responsible parties are required to register applicable clinical trials on the ClinicalTrials.gov website within twenty-one days after the first human subject is enrolled.3  The FDA reviews and makes determinations regarding whether responsible parties are in compliance with these requirements.4

According to the Notice of Noncompliance, the pharmaceutical company received a previous letter in July 2020 for potential noncompliance with requirements to submit clinical trial results to the ClinicalTrials.gov data bank. At the time, the company was directed to review its records and submit all required results promptly or face potential regulatory action. Due to its failure to subsequently comply with the ClinicalTrials.gov submission requirements, the company received the first Notice of Noncompliance. The company was given 30 days from the date of receiving the Notice of Noncompliance to remedy its noncompliance by submitting the required clinical trial results information in the required manner and format.

FDA is also authorized to seek civil money penalties for the company’s violations, including additional penalties if the 30-day deadline is not met. The letter also makes clear that violations could result in the company being subject to other regulatory action, such as an injunction and/or criminal prosecution.

AGG Observations

  • Companies should review ClinicalTrials.gov submission and registration requirements and take measures to ensure compliance.
  • If a company has received a Pre-Notice of Noncompliance, the company should promptly respond to correct the violation.
  • The Notice of Noncompliance signifies FDA’s review and vigilance in ensuring the transparency of clinical trials information and ensuring timely submission of such information. Companies should consider reviewing or implementing policies to confirm that required information is submitted in a timely manner.
  • If a company determines early in the process that it will not be able to comply with the applicable requirements, it should evaluate next steps and determine if a meeting with FDA is appropriate. Simply ignoring the requirement is not a viable option.

[1] The Notice of Noncompliance is available here.

[2] See, generally, 42 U.S.C. 282O)(3)(E) and (H) and 42 C.F.R. part 11 subpart C for the results submission requirements.

[3] 42 C.F.R. § 11.24.

[4] FDA also issued guidance regarding the submission obligations to the ClinicalTrials.gov data bank for applicable clinical trials studying drugs, biological products, and devices. The guidance is available here.

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