In an effort to improve adherence with postmarketing requirements (PMR), the FDA has laid out the circumstances under which noncompliance with PMRs is justified in a new draft guidance.

The 14-page guidance explains that the agency considers it reasonable for sponsors to miss PMR milestones when the circumstance:

• Is not within their control;
• Is directly related to the missed milestone; and
• Could not be “reasonably anticipated and factored in” when the original PMR timetable was agreed upon.

All these conditions must be met for PMR noncompliance to be deemed acceptable in the eyes of the FDA. Should any not be met, the agency will consider the sponsor as having failed to demonstrate good cause for noncompliance, and warning letters and enforcement actions may ensue, including civil monetary penalties and misbranding charges.

The agency will take sponsors’ efforts to mitigate or correct the reasons for PMR noncompliance into account when considering advisory or enforcement action, the guidance says, expanding on this in its own section.

Additionally, the guidance offers examples of reasonable and unreasonable situations of PMR noncompliance, as well as a procedural section that details how sponsors should submit explanations for PMR noncompliance or expected noncompliance.

The FDA has been criticized for being too lenient on dealing with sponsors that fail to meet their PMR commitments, and sponsors have generally not performed well in this area, according to FDA data (CenterWatch Weekly, Feb. 6).

Comments are due by Sept. 12. 

Read the full draft guidance here.