The FDA issued a guidance today that describes the what, when, and how (as well as other key elements) of its Competitive Generic Therapy (CGT) process. The CGT process was originated with the passage of the Food and Drug Administration Reauthorization Act (FDARA) of 2017. The CGT provisions permit expediting review of ANDAs for products with one or fewer products listed in the active section of the Orange Book for which there are no unexpired periods of exclusivity or patent protection at the time of ANDA submission. If CGT is granted, the first application to be approved will be awarded 180 days of exclusivity, blocking subsequent applications from marketing until the expiration of the exclusive period. The 180-day period of exclusivity begins only upon the date of first commercial marketing, and the FDA is not precluded from approving other ANDAs for the same product either before or after approval, but before first commercial marketing of the first approved ANDA designated as a CGT ANDA.
The guidance has three major sections:
COMPETITIVE GENERIC THERAPY DESIGNATION, which describes the timing of CGT requests and the process for requesting the designation.
CONSIDERATIONS FOR EXPEDITED DEVELOPMENT AND REVIEW OF COMPETITIVE GENERIC THERAPIES, which describe the consideration for expedited development and review and the actions the FDA may take to expedite product development and review.
COMPETITIVE GENERIC THERAPY EXCLUSIVITY, which outlines eligibility for CGT, the triggers and scope of CGT, relinquishment and forfeiture of CGT, defines the date of first commercial marketing, the relationship between CGT and PIV Hatch-Waxman exclusivity, as well as providing answers to procedural questions regarding CGT determinations.
There are some fairly complex scenarios the FDA outlines regarding various situations, so it is important to read the entire guidance to fully understand the consequences of actions of others and the interplay between different statutory provisions. The complete guidance can be found here.