FDA Publishes Final Guidance on Competitive Generic Therapies

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The US Food and Drug Administration (“FDA”) recently issued a final guidance on the Competitive Generic Therapies (“CGT”) program. The CGT program created a new pathway by which the FDA may designate a drug with “inadequate generic competition” as a CGT. The FDA would do so at the request of an applicant, and may also expedite the review of an Abbreviated New Drug Application (“ANDA”) for a drug in the CGT pathway.

The guidance describes several aspects of the CGT program, including the following:

CGT Designation: A drug may be designated as a CGT if there is a finding of inadequate generic competition, meaning that “there is not more than one approved drug included in the active section of the Orange Book.” Once a drug is designated as a CGT it will remain as such even if there is no longer inadequate generic competition prior to approval. Applicants may submit a request for a CGT designation with the original ANDA submission, or any time prior to that. The FDA intends to decision on a designation request within 60 calendar days of receipt.

Considerations for Expedited Development and Review of CGTs: Applicants for drugs that have CGT designations can request expedited development and review of ANDAs. To determine whether to expedite development, the FDA will consider a number of factors, including the complexity of developing an ANDA for the drug; the potential public health impact of the product, including the severity of the condition treated and the size of the patient population, as well as the availability of therapeutic alternatives; and the impact on FDA resources. In acting on the review of a CGT drug, the FDA will “strive” to make a decision on the ANDA as soon as possible, including prior to the GDUFA goal date. The FDA may take a number of actions to expedite review, including mid-review-cycle meetings, coordinated review for CGTs, and the use of good ANDA assessment practices.

CGT Exclusivity: The FDA Reauthorization Act (“FDARA”) of 2017 created a new 180-day marketing exclusivity for drugs designated as CGTs. This marketing exclusivity applies to CGTs that have an approved ANDA and for which there are no unexpired patents or exclusivities listed in the Orange Book. In addition, the manufacturer must commercially market the CGT drug within 75 calendar days after the approval of the ANDA.

The guidance also notes that CGT exclusivity will be forfeited if the applicant does not market the CGT within 75 days after the date on which the corresponding ANDA is made effective.

 

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