Don't Assume Your ANDA Will Be Designated, US FDA Tells Aspiring Competitive Generic Therapy Sponsors
Executive Summary
Final guidance clarifies that all sponsors who want CGT designation, which can bring exclusivity upon approval, should request it.
Every sponsor who wants a competitive generic therapy (CGT) designation must request it because the US Food and Drug Administration will not grant them en masse.
The CGT designation is designed to spur additional generic industry interest in drugs with no competition. Sponsors that receive approval of a designated product can receive 180 days of exclusivity barring the FDA from approving additional ANDAs for the product.
Newly finalized guidance on the designation clarifies that FDA officials interpret the process as “specific to a particular application and drug product” and not automatically applying to a group of ANDAs.
“Each applicant that wishes to request designation of a drug as a competitive generic therapy should submit a request to FDA for such designation,” the agency wrote in the final guidance, issued on 13 March.
More than one sponsor of an ANDA for the same reference product can receive the CGT designation. But the agency wrote in the final guidance that ANDA sponsors should not assume a designation will apply to the entire group.
“Although a drug may be a CGT because it has ‘inadequate generic competition,’ FDA does not interpret CGT designation to automatically apply to all applications for such drug, and CGT designation therefore should be requested for each application,” the agency added in a footnote.
Both points clarify FDA explanations in the original guidance on the eligibility criteria and timing of requests for the designation.
CGT is available for sponsors of generics with not more than one approved drug. Designees are eligible for the exclusivity upon approval if the sponsor begins product marketing within 75 days.
Designees also can receive additional meetings with agency staff and senior leadership, timely advice and a cross-discipline project lead during the development and assessment processes. While the agency will work to act on CGT designees faster, an earlier goal date is not guaranteed through the program. (Also see "Competitive Generic Therapies Get Help With Development, But Not Goal Date" - Pink Sheet, 19 Feb, 2019.)
Clarification On Exclusivity Triggering Events
The FDA also clarified in the final guidance that marketing of an authorized generic prior to approval of a CGT designee for a first approved applicant would not trigger the 180-day exclusivity.
The FDA only wrote in the draft guidance that CGT exclusivity can be triggered by marketing of an authorized generic by the first approved applicant.
A nuance of the exclusivity award requiring that it not begin until commercial marketing starts confused some sponsors. Until the date of commercial marketing, the agency is free to approve other ANDAs for that product.
The agency requires sponsors to notify them of the date marketing begins in order to establish the approval cut-off. While Apotex Inc. obtained the first-ever CGT approval, the company missed out on CGT exclusivity because the agency completed an approval of another application before Apotex’s notice of commercial marketing arrived. (Also see "ANDA Sponsors In Drivers Seat For Competitive Generic Therapy Exclusivity" - Pink Sheet, 18 Feb, 2019.)
The agency did not change anything in the guidance to suggest the Apotex situation could not occur again, emphasizing the need for sponsors to notify the agency of commercial marketing as soon as possible.
FDA officials also said in the guidance that a sponsor could voluntarily abandon, or relinquish, CGT exclusivity at any time, regardless of whether it had been triggered. In addition, the agency wrote that sponsors only may “selectively waive” exclusivity, meaning the sponsor permits approval of some ANDAs during its exclusivity period, after it has been triggered by commercial marketing.
The FDA added an example in a final guidance footnote detailing how a selective waiver could occur: IF a sponsor gained approval and began marketing of a CGT designee, triggering the exclusivity, while another ANDA for the same product was pending, under the rules the second ANDA would be blocked from approval. But the first CGT designee could agree to a selective waiver and allow the second application to be approved, meaning both products could use the remainder of the exclusivity.
More CGT Applications Under Review
After a slow start, the CGT program is gaining popularity.
Congress created the CGT program in the 2017 FDA Reauthorization Act. The agency approved three designated products in fiscal year 2018 and 15 in FY 2019.
The agency reported 81 CGT designees were awaiting FDA action at the end of FY 2019 and another 32 were awaiting sponsor action. At the end of FY 2018 there were 45 designees awaiting FDA action and another two awaiting sponsor action.
The CGT program is one of several laws and internal FDA policies that are intended to increase and streamline generic drug approvals. Other programs include a priority ANDA assessment that is two months shorter than the standard review period. The agency also has policies in place allowing for expedited assessments for qualifying applications. (Also see "New ANDA Review Pathways: Should You Be A Priority Or Expedited?" - Pink Sheet, 13 Nov, 2017.)