FDA’s draft guidance clears path for generic competition

By Maggie Lynch

- Last updated on GMT

(Image: Getty/iryna imago)
(Image: Getty/iryna imago)

Related tags Generic drug Generic drugs Guidance Fda Manufacturing complex generic competition

US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.

The US Food and Administration’s (FDA) guideline for its competitive generic therapies (CGTs) pathway are outlined in the agency’s draft guidance; its latest instruction to create competition in the industry while encouraging transparency and efficiency while giving patients greater access to affordable drugs.  

With this pathway, companies can submit requests to designate a drug as a CGT when submitting an abbreviated new drug application (ANDA) or at any time before the ANDA submission.

A CGT can be given as a designation for a generic drug when there’s inadequate generic competition for that therapy meaning no more than one approved medication.

From this designation, the FDA can expedite the development and review of an ANDA. This can afford the applicant company early benefits, which may help to reduce the number of application review cycles – in turn, decreasing the time it takes for the generic drug to receive approval.

The CGT pathway was established by Congress when it granted the regulatory agency new authority in the FDA Reauthorization Act of 2017. The act can provide certain incentives for the industry to develop generics for drugs lacking competition that have been designated as CGTs.

The FDA has granted more than 100 CGT designation requests since 2017; between August and December 2018, the FDA approved the first five ANDAs for generic drugs designated as CGTs.

Sabril generic approval

In January 2019, the FDA approved the first generic​ for Sabril (vigabatrin). The generic anti-convulsant is manufactured by Teva and was granted approval under the CGT pathway.

At the time of the approval, Gottlieb stated, “Today’s action [to approve generic vigabatrin tablets] demonstrates that there is an open pathway to approving products like this one.”

With the draft guidance now published, the FDA said in a statement​ that it aims for more drugs to be submitted and approved by the agency. 

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