FDA speedy review program for generic drugs with limited or no competition

In order to improve patients access to treatment they require, the US FDA implemented a program of prioritized review of abbreviated new drug application (ANDA) for reference drugs having fewer than 3 ANDAs approved.

This program is based on the submission of a pre-submission facility correspondence (PFC) 2 to 3 months before the planned ANDA submission. These PFCs give the agency the opportunity to determine the need of facility inspections and initiate their planning earlier, enabling FDA to shorten the ANDA review timeframe by 2 months.

A draft guidance has been published to detail information and format required for these PFCs. In addition to general information including manufacturing process and bioequivalence summary, the applicant is requested to submit a statement of ANDA eligibility for priority review.

8 criteria for eligibility to priority review are defined:

  • Generic product for which fewer than 3 ANDAs are approved for the reference drug and no blocking patents
  • Submissions for sole-source drug products
  • Submissions related to drug shortages
  • Submissions related to public health emergencies
  • Submissions subjects to special review programs (such as President’s Emergency Plan for AIDS Relief)
  • Submissions related to certain government purchasing programs
  • Submissions subject to statutory mandates or other legal requirements
  • Supplements requested for public health reason or because of unforeseen events to manufacturing facilities (21 CFR 314.70(b)(4))

To help the applicants, FDA released a list of off-patent active ingredients with limited or no competition that will be updated every 6 months. Drugs listed in part I of the list can be subject to ANDA submission immediately, whereas drugs in part II are subject to prior discussion with the agency due to potential legal, regulatory or scientific issues.

If you want to know more about this program, have a look at the documents published by FDA on the subject: