The FDA has issued a new policy it says is intended to improve access and increase competition for drugs that lack generic competition.
The new pathway for Competitive Generic Therapies (CGTs) creates a designation that can be granted to a company submitting an application for their generic drug when there is not more than one approved drug in the active section of the Orange Book. The designation, established by Congress in the FDA Reauthorization Act of 2017, provides certain incentives for industry to develop generics for drugs lacking competition.
Companies may submit requests to designate a drug as a CGT at the time of submitting an abbreviated new drug application (ANDA). Early benefits of CGT designation may include product development meetings with the FDA to discuss specific scientific issues or questions in efforts to reduce the number of application review cycles, ultimately decreasing the time it takes for the generic drug to receive approval.
CGT designated applications may be eligible for a 180-day period of marketing exclusivity provided the applicant is the first approved ANDA for that CGT and meets other conditions.
A full statement on the CGT proposal from FDA Commissioner Scott Gottlieb, MD is available online.