United States: FDA Issues Draft Guidance On Pre-Submission Facility Correspondence - A Way To Reduce FDA Action Times For Priority ANDAs

The U.S. Food and Drug Administration (FDA) has released a draft guidance 1, entitled "ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions," that provides recommendations regarding use of a pre-submission facility correspondence process (PFC) to help prospective generic drug applicants reduce approval time for priority abbreviated new drug applications (ANDAs), including priority original ANDAs, priority major ANDA amendments and priority ANDA prior approval supplements (PAS). 

What Is PFC?

PFC is a mechanism that a prospective generic drug applicant can use to expedite approval of its priority ANDAs by providing FDA with information regarding its manufacturing and bioequivalence facilities. This information will allow FDA to determine whether it needs to inspect the generic drug applicant's facilities and, if needed, will enable FDA to initiate early inspection planning.

FDA Goals for Standard and Priority ANDAs

FDA has set a goal to review and act on priority ANDAs two months faster if the submission meets all PFC requirements. The table2 below compares timelines for FDA's goals regarding various types of submissions with or without PFC.

Submission Type

Goal for FDA to Review and Act on Submission (from Submission Date)

Standard Original ANDAs

90 percent within 10 months

Priority Original ANDAs

90 percent within eight months if the applicant is successful3 in PFC process

90 percent within 10 months if the applicant does not use PFC process or is unsuccessful in meeting its requirements

Standard Major ANDA Amendments

90 percent within eight months if preapproval inspection is not required

90 percent within 10 months if preapproval inspection is required

Priority Major ANDA Amendments

90 percent within six months if preapproval inspection is not required

90 percent within eight months if preapproval inspection is required and applicant is successful in PFC process

90 percent within 10 months if preapproval inspection is required and applicant is unsuccessful in PFC process

Standard and Priority Minor ANDA Amendments

90 percent within three months

Standard PAS and Standard PAS Major Amendments

90 percent within six months if preapproval inspection is not required

90 percent within 10 months if preapproval inspection is required

Priority PAS and Priority PAS Major Amendments

90 percent within four months if preapproval inspection is not required

90 percent within eight months if preapproval inspection is required and applicant is successful in PFC process

90 percent within 10 months if preapproval inspection is required and applicant is unsuccessful in PFC process

Standard and Priority Minor PAS

90 percent within three months of submission date

FDA's Guidance

The agency's guidance "establishes FDA's expectations for the content, timing, and assessment of the PFC."  A generic drug applicant can benefit from FDA's shorter goal date for action for its priority ANDA if the facility information in PFC is provided two months ahead of the priority ANDA submission and is complete, accurate and unchanged

The draft guidance provides detailed instructions for ANDA applicants to follow when submitting PFCs. According to FDA, "[a] complete and accurate PFC allows [it] to begin the facility assessment process in advance of the planned ANDA submission. This critical 2 month lead time provides the Agency the opportunity to determine whether facility inspections will be needed, and when they are, to initiate inspection planning earlier in the review of the ANDA [...]."

In order to be complete and accurate, the PFC should include, among other things, a thorough description of the manufacturing process and testing facility, all study information, statement of ANDA eligibility for priority review, bioequivalence summary and site/organization information.4  

Timing of a PFC submission is critical. If the PFC is submitted less than two months before a priority ANDA, then it will not generally be eligible for FDA's shorter goal date. Moreover, FDA recommends that "Applicants should submit the [priority] ANDA no more than 3 months after submission of the PFC to reduce the likelihood of changes that result in the loss of eligibility for the shorter goal date." 

Given FDA's reluctance to allow submissions that do not meet its criteria, it is advisable for ANDA applicants seeking benefit of PFC to follow FDA's guidelines as closely as possible. If an applicant's first PFC is denied, the Agency is unlikely to review a second PFC for the same submission.

For Further Information

If you have any questions about this Alert or would like more information, please contact Frederick (Rick) R. Ball, Neelaabh Shankar, Ph.D., any of the attorneys in our Pharmaceutical, Medical Device, Pharmacy and Food industry group or the attorney in the firm with whom you are regularly in contact.

Footnotes



1 ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions Guidance for Industry (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm563507.pdf)

2 Modified from GDUFA reauthorization performance goals and program enhancements fiscal years 2018-2022 (https://www.fda.gov/downloads/forindustry/userfees/genericdruguserfees/ucm525234.pdf)

3 An applicant may be successful in PFC process if the PFC is submitted two months prior to the submission date of priority ANDA and the PFC is found to be complete, accurate, and remains unchanged.

4 Detailed information is provided in the Draft Guidance under Section IV.

Disclaimer:

This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.

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