A PSA on PSGs: PSG Meetings Are Now Available

FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug.  As the Office of Generic Drugs (“OGD”)  has stated, “[t]he clarity and transparency provided by PSGs help streamline generic drug product development, promote timely approval of Abbreviated New Drug Application (ANDA) submissions and increased drug competition, improving patient access to high quality and affordable medicines.”  Indeed, PSGs help facilitate generic competition, and to date, OGD has published more than 2,000 PSGs.

As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.  Specifically, FDA agreed to issue PSGs for 90 percent of new, non-complex New Chemical Entities within 2 years of reference product approval and 75 percent of complex New Chemical Entities within 3 years of approval.  FDA also agreed, for the first time, to host PSG teleconferences and meetings with applicants to provide feedback on the potential impact of a new or revised PSG on an applicant’s development program.  Pre- and post-submission meetings to discuss alternative approaches than that recommended in PSGs may also be available.

While PSGs are not new—OGD has published them for many years—a new Draft Guidance was released earlier this month covering “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.”  This new Guidance outlines procedures for requesting and conducting PSG meetings with OGD, including PSG-specific teleconferences, as well as pre- and post-submission PSG meetings.

According to the Guidance, the PSG-specific teleconference—also categorized as pre- or post-submission—is a prerequisite to a pre- or post-submission PSG meeting, and such teleconferences and meetings are available only after the publication of a PSG.  Like the name implies, the pre-submission teleconference or meeting would be held prior to submission of the ANDA while the post-submission teleconference or meeting occurs after submission.  A post-submission PSG teleconference and meeting should occur before responding to a possible bioequivalence deficiency identified during review or in a Complete Response Letter.

The Guidance distinguishes between the PSG teleconference and the PSG meeting.  A PSG teleconference is a forum for applicants to obtain feedback on the impact of a new or revised PSG on an in-progress development program for which in vivo bioequivalence studies have either commenced or completed.  Discussions during these teleconferences are limited to feedback on the potential impact of the PSG recommendations on an existing development program; FDA will not discuss the applicant’s questions regarding an approach other than the approach recommended in the PSG.  Applicants should submit a request for a PSG teleconference within 60 days after publication of the new or revised PSG so that FDA can provide timely feedback to applicants.  FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

If OGD indicates in the PSG teleconference that the PSG would impact an applicant’s development program, the Guidance explains that this indicates that the ongoing or completed study alone is unlikely to be sufficient to establish bioequivalence.  Any subsequent changes to the development plan resulting from the recommended PSG can be discussed with FDA in a pre- or post-submission meeting during which the Agency will discuss with the applicant the scientific rationale for an approach other than that recommended in the new or revised PSG.  These pre- or post-submissions meetings (as opposed to teleconferences) are intended to discuss scientific rationale for an alternative to the PSG and address applicant’s questions related to their own proposed bioequivalence approaches.  OGD will deny a pre-submission PSG meeting request if the applicant did not have a pre-submission PSG teleconference or if the applicant has already submitted the ANDA after the pre-submission teleconference.  Similarly, OGD intends to deny a post-submission PSG meeting request if the ANDA applicant did not have a post-submission PSG teleconference or if the ANDA applicant had a pre-submission PSG teleconference and then submitted the ANDA.  OGD may also deny the request if it determines that the questions in the meeting package have been addressed during the ANDA assessment or the ANDA applicant has already responded to the possible deficiencies to be discussed.

Specific timing goals, as well as procedures for requests, apply to each type of PSG meeting.  Meeting package content, timing of submission, and directions for submission are also covered by this Guidance.

And, of course, the Controlled Correspondence process remains an option as an alternative to a pre- or post-submission PSG meeting.