FDA publishes guidance on Competitive Generic Therapies

The US  Food and Drug Administration (FDA) has published new draft guidance on a pathway intended to boost the development of generics and lower drug prices.

The agency announced the guidance, which includes details on the Competitive Generic Therapies (CGT) pathway for the approval of new drugs, in  a press release issued on Friday, February 15.

In the release, the FDA said there were “several hundred” branded drugs which had no exclusivity rights or patent protection, but no generic competition.

The CGT designation is designed to provide a route to faster approval of abbreviated new drug applications (ANDA). Congress first created it in the FDA Reauthorization Act of 2017.

The FDA’s  new draft guidance on the implementation of the CGT pathway included details of how companies can apply for CGT designation.

Companies can apply for CGT designation at the time of filing an ANDA. This designation can provide companies with early benefits in the application process, including product development meetings with the FDA.

This additional interaction with the agency is intended to reduce the time it takes for a drug to be granted approval. CGT designation may also provide a drug with 180-day period of marketing exclusivity, if it is the first approved ANDA for that drug and “meets other conditions”.

According to the press release, the FDA approved the first five ANDAs for generic drugs with CGT designation between August and December 2018.

“The FDA’s implementation of this new pathway is an important part of our broader effort to foster generic competition and help address the high cost of drugs and improve patient access to important medicines”, last week’s release said.

In August of last year, LSIPR  reported that the first CGT designation had been awarded to a potassium chloride oral solution which is used to treat and prevent hypokalemia in patients that are on diuretics.

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