Generic / Regulatory Guidance

FDA announces new regulatory pathway for generics

Feb 18, 2019

The U.S. FDA has announced new, efficient guidelines for the use of a novel pathway that provides incentives for developing generic versions of drugs that currently face little or no competition.

Designation of a drug as a Competitive Generic Therapy (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.) Companies may submit requests to designate a drug as a CGT at the time of submitting an ANDA or at any time before the original ANDA submission.

According to the agency,  "there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients."

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.

Over the next year, the FDA also plans to advance additional policies and guidances to promote generic competition, said FDA Commissioner Scott Gottlieb in the press statement.