FDA's Draft Guidance on Postmarketing Noncompliance

Recommendation

5/6 June 2024

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The FDA may require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if the agency becomes aware of new safety information.

Postmarketing Requirements (PMRs) Noncompliance

The draft guidance provides information for marketing authorization holders (MAHs) of human prescription drugs (and biological drug products) who are required to conduct postmarketing studies or clinical trials, commonly referred to as postmarketing requirements (PMRs). An MAH required to conduct a PMR must provide certain information to the FDA, including a timetable for study or clinical trial completion and periodic reports on the status of the study or clinical trial. If an MAH fails to comply with the timetable or other PMR requirements, the MAH is in violation of the PMRs, unless demonstrating good cause for its PMR noncompliance.

The agency intends to make a finding of good cause when an MAH’s explanation for PMR noncompliance demonstrates that the noncompliance is reasonable under the circumstances. In general, FDA considers PMR noncompliance to be reasonable when it results from circumstances that meet the following criteria: 

• The circumstance is directly related to the missed milestone;
  
  AND
  
• The circumstance was out of the MAH’s control;
  
  AND
  
• The circumstance could not have been reasonably anticipated and factored in at the time the original PMR timetable was finalized.

If any one of the aforementioned conditions is not met, the FDA will consider the noncompliance to not be reasonable under the circumstances and the MAH as failing to demonstrate good cause for the noncompliance.

The MAH could then be subject to an FDA warning letter followed by enforcement action for PMR noncompliance. The agency issues warning letters to applicants to achieve voluntary compliance before taking enforcement action. An issued untitled letter cites violations that do not meet the threshold of regulatory significance for a warning letter.

More information is available in FDA's draft guidance Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance.