FDA Prioritizes ANDAs Ready For Launch After 180-Day Exclusivity Expires

In effort to speed competition and lower drug prices, US regulator will prioritize review of generic drug applications likely to be ready for approval on or shortly after the expiration of first-filer's exclusivity; experts say the move appears to formalize what once had been an informal Office of Generic Drugs policy.

With the US FDA's announcement that it will prioritize review of abbreviated new drug applications (ANDAs) ready for approval once a first generic's marketing exclusivity expires, the agency appears to be formalizing an informal generic review division policy, with the aim of speeding competition and lowering drug prices.

On Nov. 9, FDA announced it would consider for priority review those generic drug applications that are likely to be ready for approval on or shortly after the expiration of an ANDA first-filer's 180-day exclusivity for the same reference product.

Priority Review Policy Expansion

"Submissions for drug products blocked by 180-day exclusivity that have been tentatively approved or submissions for drug products blocked by 180-day exclusivity that OGD determines will likely be ready for approval upon or shortly after expiration of the 180-day exclusivity may receive a priority review when such exclusivity is triggered."

The policy marks a formal expansion of FDA's priority review framework for generic applications. In June, FDA announced plans to prioritize generic applications when there are fewer than three ANDAs approved for a reference listed drug and no blocking patents or exclusivities. (Also see "FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit" - Pink Sheet, 27 Jun, 2017.)

The expansion to the ready-for-approval category of products was incorporated into a revised Manual of Policies and Procedures (MaPP) governing the prioritization of original ANDAs, amendments and supplements. (See box.)

'Benefit Of Brisk Competition'

FDA's expansion of the priority review pathway to more generics is part of the agency's Drug Competition Plan and was previewed by Commissioner Scott Gottlieb at the Association for Accessible Medicines' recent Fall Tech Conference. (Also see "More ANDAs To Be Eligible For Priority Review, Gottlieb Says" - Pink Sheet, 8 Nov, 2017.)

“The FDA has a public health obligation to do all we can to help patients get access to the medications they need, and that means taking steps within the scope of our authorities to make sure that appropriate competition helps improve access to affordable drugs,” Gottlieb said in an announcement about the revised MaPP.

By prioritizing the review of applications that can be approved immediately after a first-filer's exclusivity expires, "consumers can have the benefit of brisk competition from multiple other generic entrants" soon after the 180-day period lapses, Gottlieb said. "This can improve affordability and access to important drugs.”

A New Policy, But Not Really?

While FDA framed the announcement as a policy expansion, some industry veterans suggested the revised MaPP appears to formalize what was once a longstanding practice in the Office of Generic Drugs to prioritize subsequent ANDAs that were ready for approval after a first-filer's exclusivity ends.

"That's essentially what we used to do when I was at OGD back in the day," said Robert Pollock, a former OGD acting deputy director who currently serves as a senior advisor and outside director to the board at Lachman Consultants.

The revised MaPP "legitimatizes what we used to do in the past," Pollock said, suggesting this prioritization approach "kind of fell out of favor a little bit" due to the sheer volume of ANDAs at the agency.

Nevertheless, "I think it's a good thing because it will certainly drive down prices much faster after the 180-day period," he said.

Kurt Karst, a director at Hyman Phelps and McNamara, said he suspects the internal policy at FDA is to get approvals out as quickly as possible once a first-filer's 180-day exclusivity expires. "I think the MaPP therefore reflects and is now an outward-facing policy on what FDA's goals have been all along," he said.

In addition, "it probably to some extent reflects current policies within OGD in terms of expediting review of applications where 180-day exclusivity has been forfeited or waived or relinquished," he said.

It's unclear how many ANDAs fall into this newly expanded bucket of prioritized applications.

The agency told the Pink Sheet it cannot speculate as to how many ANDAs might qualify for a priority review under the MaPP or the additional number of ANDAs expected to qualify annually pursuant to the latest policy expansion.

"For example, with respect to ANDAs expected to qualify annually for priority review under this MaPP revision, this number will vary from year to year and will depend upon the number of ANDAs that are awarded 180-day exclusivity, the number of times 180-day exclusivity is triggered in a calendar year, and the number of subsequent applicants that have been submitted for a particular product," FDA said.

'Prioritization Factors'

The revised MaPP lists readiness for approval upon expiration of 180-day exclusivity among the "prioritization factors" that may qualify an original ANDA, amendment or supplement for priority review

Other prioritization factors include: first-filed ANDAs with a paragraph IV certification; submissions related to drug shortages or public health emergencies; and applications referencing "sole source" products for which there are no blocking patents or exclusivities.

"If an original ANDA, amendment, or supplement meets one of the prioritization factors in this MaPP, the submission will be eligible for a 'priority review,'" the document states. "Submissions that are eligible for a priority review may receive either a shorter goal date or an expedited review" as defined in the MaPP. (See table.)

The Generic Drug User Fee Act II (GDUFA II) commitment letter defines a "priority" application as a submission affirmatively identified as eligible for expedited review pursuant to CDER’s ANDA prioritization MaPP.

Under GDUFA II, which took effect Oct. 1, FDA has committed to act on 90% of priority original ANDAs within eight months if the applicant submits a complete and accurate Pre-Submission Facility Correspondence two months prior to the application submission, or within 10 months if the applicant does not submit a Pre-Submission Facility Correspondence two months prior.

Standard review applications have a 10-month goal date.

ANDA Prioritization Definitions
Expedited Review	FDA will strive to act on an ANDA as soon as possible, including prior to the goal date if possible. An expedited review, though, does not result in a shorter goal date.
Priority Review	FDA will either (1) give a shorter goal date or (2) grant an expedited review.
Shorter Goal Date	In accordance with the GDUFA II Commitment Letter, FDA commits to one of the following: (1) for original ANDAs, an 8-month goal date; (2) for major amendments, a 6- or 8-month goal date; or (3) for prior approval supplements, a 4- or 8-month goal date.
Source: CDER MaPP 5240.3 Rev. 4 "Prioritization of the Review of Original ANDAs, Amendments and Supplements" (Nov. 9, 2017)