Industry Seeks Clarity on CGT Draft Guidance

Regulatory NewsRegulatory News | 22 April 2019 |  By 

Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity.

The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and December, FDA approved the first five abbreviated new drug applications (ANDAs) for generic drugs designated as CGTs (the first was approved last August), which qualified for 180-day exclusivity.

But the draft guidance’s descriptions of the application process and 180-day exclusivity are raising questions from companies.

For instance, Pfizer notes how FDA discusses designation of a drug as CGT consistent with the FDA Reauthorization Act of 2017, but later indicates that generic applicants must request designation at or prior to submission of an Abbreviated New Drug Application (ANDA) in order to be considered timely.

“Updated draft or final guidance should clarify whether every generic applicant who is seeking CGT exclusivity must submit a request for designation, or once the Agency designates a drug as CGT, no additional applicants need to submit a request for designation?” Pfizer says.

The company further questions what will happen to a product’s CGT designation if a discontinued application is moved back to the active section of the Orange Book, and the product no longer has “inadequate generic competition.”

On the question of 180-day exclusivity, Pfizer also calls on FDA to “clarify whether the limitation between 180-day patent challenge exclusivity forfeiture and CGT exclusivity means that the product would never be eligible for CGT designation and exclusivity, no matter the amount of generic competition available for the product at the time a generic applicant seeks CGT designation.”

Industry group AAM and Teva Pharmaceuticals also call on FDA to update its “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic” to include sole-source ANDAs and to identify products that have a pending ANDA that requested CGT designation.

Similar to Pfizer, Apotex seeks further detail on the timing and steps of the CGT designation and exclusivity processes.

For example, in order to avoid the submission of a potentially unnecessary ANDA, an applicant may wish to submit an amendment to a pending application or prior approval supplement to an approved application for an additional or different product strength. “Based upon FDA’s guidance, it does not appear that FDA would grant CGT designation to a new strength if submitted in a supplement or amendment even if, because each strength is considered to be a separate product, it is otherwise eligible,” Apotex says.

The Florida-based generic drugmaker also calls on FDA to clarify what it means by “commercial marketing” when it says that in order to receive 180 days of CGT exclusivity, an applicant must commercially market a product designated as a CGT within 75 calendar days after approval.

“For example, a company could reasonably provide FDA with a copy of shipping information or an order form, but the underlying ‘introductory’ transaction could be very small. We request that FDA provide additional examples of what will and will not be sufficient to establish ‘commercial marketing’ for purposes of triggering CGT exclusivity,” Apotex says.

Similarly, Teva says the narrow 75-day window “requires manufacturers to start operational readiness activities ‘at‐risk’ in order to avoid exclusivity forfeiture.”

And Perrigo calls on FDA to include a section in the guidance “that instructs the applicant on the information that should be included (e.g., cover letter reference and CGT Grant Letter) in the original ANDA when a CGT designation has been granted prior to submission.”

Perrigo also requests further clarity on whether expedited reviews for CGT products apply only to complex products, or if non-complex products with CGT designation could receive expedited review if the applicant has participated in product development or pre-submission meetings.



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