FDA unveils policy for drugs that face inadequate generic competition
The Food and Drug Administration announced today new guidelines for the use of a novel pathway that provides incentives for developing generic versions of drugs that currently face little or no competition.
“This new pathway for Competitive Generic Therapies, or CGTs, is a significant advancement in generic drug competition. Designation of a drug as a CGT can be granted to a company submitting an application for their generic drug when there’s inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. The designation, which was established by Congress when it granted the FDA new authorities in the FDA Reauthorization Act of 2017, provides certain incentives for industry to develop generics for drugs lacking competition that have been designated as CGTs,” FDA commissioner Scott Gottlieb said.
Under this pathway, companies may submit requests to designate a drug as a CGT at the time of submitting an abbreviated new drug application, or ANDA or at any time before the original ANDA submission. At the request of the applicant, the FDA may expedite the development and review of an ANDA for a drug that is designated as a CGT.
Gottlieb said that CGT designation can afford companies a number of early benefits, including product development meetings with the FDA to discuss specific scientific issues or questions they may have such as proposed study design or alternative approaches. These early benefits may also help to reduce the number of application review cycles ultimately decreasing the time it takes for the generic drug to receive approval.
Gottlieb continued, “If a CGT designation is granted, the application 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.
Gottlieb also said the FDA is working to make generic drug development more efficient and predictable. "We’re working to reduce approval times and to enhance the efficiency of certain aspects of the submission process for generic drug applicants. And we’re also working to provide the generic industry with increased transparency to provide greater certainty around timing of first possible generic entry and potential competition from other generic entrants, and to make the scale-up of manufacturing more efficient, to enable more informed decisions on how to prioritize their resources and come to market," he said.
“This new pathway for Competitive Generic Therapies, or CGTs, is a significant advancement in generic drug competition. Designation of a drug as a CGT can be granted to a company submitting an application for their generic drug when there’s inadequate generic competition for that drug, meaning there is not more than one approved drug in the active section of the Orange Book. The designation, which was established by Congress when it granted the FDA new authorities in the FDA Reauthorization Act of 2017, provides certain incentives for industry to develop generics for drugs lacking competition that have been designated as CGTs,” FDA commissioner Scott Gottlieb said.
Under this pathway, companies may submit requests to designate a drug as a CGT at the time of submitting an abbreviated new drug application, or ANDA or at any time before the original ANDA submission. At the request of the applicant, the FDA may expedite the development and review of an ANDA for a drug that is designated as a CGT.
Gottlieb said that CGT designation can afford companies a number of early benefits, including product development meetings with the FDA to discuss specific scientific issues or questions they may have such as proposed study design or alternative approaches. These early benefits may also help to reduce the number of application review cycles ultimately decreasing the time it takes for the generic drug to receive approval.
Gottlieb continued, “If a CGT designation is granted, the application 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.
Gottlieb also said the FDA is working to make generic drug development more efficient and predictable. "We’re working to reduce approval times and to enhance the efficiency of certain aspects of the submission process for generic drug applicants. And we’re also working to provide the generic industry with increased transparency to provide greater certainty around timing of first possible generic entry and potential competition from other generic entrants, and to make the scale-up of manufacturing more efficient, to enable more informed decisions on how to prioritize their resources and come to market," he said.