Generic Group Questions Guide on Guidance Meetings

Generic drug lobbying arm Association for Accessible Medicines (AAM) says FDA’s draft guidance entitled “Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA” does not implement user fee-negotiated commitments regarding teleconferences and meetings as intended, which may deter their use. In just-posted comments to the agency, the group complains that FDA seems to be reading the commitments “more narrowly than intended and imposing restrictions and limitations that will make it more difficult for applicants to request and receive timely PSG teleconferences and pre- and post-submission PSG meetings. As a result, ongoing development programs or pending ANDAs could be adversely affected, and approvals delayed, because applicants will not have clear direction on whether and if so how the new or revised PSGs will affect their ANDAs.”

AAM says that while the user fee commitment letter states that the PSG teleconferences provide an opportunity for an applicant “to obtain FDA’s feedback on the potential impact of a new or revised PSG on the applicant’s development program when the applicant has already commenced an in vivo BE [bioequivalence] study,” the draft guidance indicates that the agency will not discuss an applicant’s questions regarding an approach other than the approach recommended in the PSG and may recommend a path for future communication with FDA such as a controlled correspondence or another type of meeting.

The group contends that this limitation will negate the utility of the teleconference and likely guarantee that a further communication will be required, which could unnecessarily consume both applicant and FDA resources. “The commitment letter provides follow-up opportunities in the form of pre- or post-submission meetings to discuss in more detail an alternative proposed approach, but the PSG teleconference should be a meaningful first step in the engagement on the issue,” it says. “Furthermore, the draft guidance does not reflect a situation in which, during the teleconference, FDA could agree with the applicant that the applicant’s proposed approach is adequate. The guidance should allow sufficient discussion of the applicant’s approach to enable FDA to provide the feedback contemplated in the commitment letter, and it should include language to the effect that FDA may use the teleconference to inform the applicant that no changes are needed to their development program.”