Today, the FDA issued a guidance document titled “Competitive Generic Therapies (CGT)” which describes the new statutory requirements under section 506H of the FDA Reauthorization Act of 2017 (FDARA). CGT was enacted to promote and incentivize the development, expedite the review (and thus approval) of certain previously approved drugs with little or no competition. In addition, in some cases, the incentives of the provisions include a 180-day period of exclusive marketing for the first approval “of a drug with a CGT designation for which there were no unexpired patents or exclusivities listed in the Orange Book at the time of original submission of the ANDA”. This guidance document describes the process for designation, the various incentives the FDA may offer and the how, when, and where these incentives can be accomplished.
The guidance states:
FDA may designate a drug as a CGT after determining that there is inadequate generic competition for that drug. The term inadequate generic competition is defined to mean, with respect to a drug, that there is not more than one approved drug in the active section of the Orange Book. This may either be the reference listed drug (RLD) or a drug approved in an ANDA referencing the same RLD as the drug for which designation as a CGT is sought.
The guidance also notes that individual strengths are considered to be individual listed drug products and thus a drug with multiple strengths, one of which is no longer marketed but in the discontinued section of the OB, may be eligible for designation as a CGT.
Requests for designation can be submitted concurrently or any time before the submission of the ANDA. FDA will not consider a request filed after ANDA submission to be a timely filed submission and the product will not be eligible for consideration as a CGT unless the ANDA was subject to a refuse-to receive (RTR) action and the request is included in the response to that RTR action letter. There are certain caveats regarding the RTR scenario, so be certain to read the guidance carefully. Procedural issues are described for requests submitted for CGT designation pre-ANDA submission and concurrently submission with the ANDA.
Considerations for expedited development are discussed relative to the potential for pre-ANDA and development meetings and outline FDA’s thinking on when it may be appropriate to grant such meetings. To facilitate development, the FDA may take the following actions:
- Product development meetings
- Pre-submission meetings
Interestingly, the FDA notes that it will try to expedite the review of the ANDA but the GDUFA goal dates will not be shorter unless the product also qualifies for priority review (i.e., has an 8-month GDUFA goal date if a pre-submission facility correspondence is submitted 60-days prior to ANDA submission). The guidance lists actions the FDA may take to expedite review, including mid-review-cycle meetings, coordinated review of CGTs, and the use of good ANDA assessment practices, all of which are further explained in the document.
CGT exclusivity may be eligible for award if the ANDA applicant is not only the first firm (there can be multiple awards if two or more firms obtain approval on that first day) to receive approval for a drug with CGT designation but also “commercially markets the drug within 75 calendar days after approval of the ANDA.” The commercial marketing triggers the 180-day period of CGT exclusivity for all firms if more than one is approved on the same day. There are exceptions based on other exclusivities that an ANDA applicant may have, so read the sections on CGT exclusivity carefully to assure you have a full understanding of the rules of the road.
There are also corollary provisions for relinquishment or selective waiver of CGT exclusivity consistent with such provisions applied for other exclusivities that FDA awards. This is consistent with the FDA goal of promoting competition in the market.
FDA describes the potential forfeiture provisions of CGT as follows:
FDA interprets this language to mean that the first approved applicant will forfeit eligibility for CGT exclusivity if the applicant fails to market within 75 days, beginning on the day after the date on which approval of the first approved applicant’s application for the CGT is made effective, and not the date of approval itself. FDA further interprets this language to mean that a first approved applicant forfeits only its own eligibility for CGT exclusivity and such forfeiture does not affect the eligibility of any other first approved applicants.
There is a lot more covered in the 22-page guidance and some of it is intricate in nature, so be certain to digest it fully. The complete guidance can be found here.