FDA Announces New Process for Requesting Release from Postmarketing Requirements (PMRs)

As surveyed in detail by our colleagues in an earlier blog post, FDA’s PDUFA VII goals letter, for fiscal years 2023-2027, is full of announcements and new agency initiatives.  One of those announcements is a commitment to create a new process for reviewing sponsor-initiated requests for release from postmarketing requirements (PMRs).

The process outlined in the goals letter begins when a sponsor submits a request to FDA summarizing its rationale for why an existing PMR is no longer needed, including all necessary supporting data and information.

The relevant FDA review division or office will initiate review of the request, and will notify the sponsor of any additional information considered necessary to evaluate the request within 45 days of receipt.  FDA will then respond to the sponsor with a decision on the PMR release request within 60 days of receipt of the original request, or within 60 days of receipt of the additional information requested by FDA, whichever is later.

FDA’s decision will take the form of an “agreement letter” or a “non-agreement letter.”  In the case of a non-agreement letter, FDA will provide its rationale for the decision.

If FDA’s response is a non-agreement letter, the sponsor has the option of submitting a request for reconsideration with justification, and any additional information and/or data if appropriate.  The process as outlined in the goals letter does not include a deadline for when such a request for reconsideration must be submitted.

Upon receiving a reconsideration request, the review division/office will discuss with the appropriate internal committee that includes senior agency leadership (e.g., Medical Policy and Program Review Committee, Medical Policy Coordinating Committee, and Pediatric Review Committee).  The review division/office will issue a written response to the reconsideration request within 45 days of receipt.  As with the original request for release from the PMR, FDA’s decision will be an agreement letter or a non-agreement letter, and if a non-agreement letter, will include FDA’s rationale for the decision.

Today, sponsors are able to submit requests for release from PMRs.  FDA may respond to these requests by arranging a teleconference to discuss and/or providing a decision in the form of a General Advice Letter.  However, there is currently no formalized timeline or review process.  There is also no guarantee that FDA will provide any rationale for its decision to deny a request for PMR release.

The new review process announced in the PDUFA VII commitment letter will bring much-needed consistency and predictability to requesting release from PMRs.  Additionally, the commitment to include FDA’s rationale in a non-agreement letter will provide sponsors another opportunity to address FDA’s concerns in the form of a reconsideration request.

We look forward to the roll-out of this new process, but it will be some time until we see it in action.  This new process will be incorporated into relevant agency procedures and guidances beginning FY 2023, and will be finalized by the end of FY 2027 and are not subject to PDUFA performance goals.  So, FDA may not begin implementing this new process immediately, but it may be a potential avenue for sponsors starting in late 2022 or early 2023.