FDA Breaks Down Barriers to Prioritizing Generic Drug Approvals

The Food and Drug Administration issued updates to its policy on prioritization of generic drug applications to make better use of the agency's limited resources.

The Manual of Policies and Procedures 5240.3 (MAPP) establishes policy and procedures for how agency review staff will prioritize the review of abbreviated new drug applications, amendments and supplements. The update “aims to efficiently allocate limited agency resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants,” FDA said with the MAPP's January 30 release.

Submissions that FDA deems eligible for priority review are awarded either a shorter goal date for approval or an expedited review in accordance with the most up-to-date version of the MAPP.

Under the latest MAPP revision, FDA will initiate priority review of an ANDA at the agency's own initiative in lieu of an applicant’s explicit request for priority review only if the drug is related to a drug shortage, a public health emergency or if there are less than three FDA-approved drugs.

The revision also places greater emphasis on supplements. FDA will prioritize an ANDA supplement or an amendment to an ANDA supplement if the submission is related to a drug shortage or public health emergency, subject to legal requirements or where a delay to make the change that the supplement describes would impose an extraordinary hardship on the applicant.

"This allows FDA’s Office of Generic Drugs to prioritize the supplements that will have the greatest impact on generic drug access," the agency said of the new prioritization criteria.

The revision modifies policy on the “first filer” status for applications with paragraph IV patent certification, too. These applications are used to seek FDA approval before a brand name drug's patent expires under the Drug Price Competition and the Patent Term Restoration Act of 1984.

“Under the previous prioritization policy, roughly half of all ANDA submissions were designated as priority submissions, including many products that could not be marketed for several years as a result of blocking patents or exclusivities,” Sally Choe, director of the Office of Generic Drugs at the agency’s Center for Drug Evaluation and Research, said about the MAPP's past iterations.

“This practice strained the agency’s limited resources and did not support the agency’s goal of ensuring that ANDAs for those drugs with the greatest potential impact on public health are prioritized,” Choe added. As such, FDA will cease to prioritize all submissions from first filers throughout the entire course of the review. It will no longer automatically prioritize an ANDA containing a paragraph IV certification upon original submission for being the first to file.

Rather, FDA will now prioritize review of an original ANDA submission with a paragraph IV certification if it will be ready for final approval at or before the goal date for that submission.

The MAPP newly outlines a set of circumstances under FDA will prioritize such an ANDA with a paragraph IV certification that becomes eligible for approval during the review cycle, as well.

Updates look to tackle the barriers to market entry that persist even with priority review. Such barriers may have included a drug's patent, a 30-month stay or a 180-day exclusivity period.

FDA said that it "does not believe that this revision to the MAPP increases the applicant’s risk of forfeiting 180-day exclusivity for failure to obtain tentative approval within 30 months after the day" of the original submission of the ANDA. The agency pointed to the 30-month timeframe as an opportunity under the second iteration of the Generic Drug User Fee Amendments for multiple review cycles to correct issues with an original ANDA and receive a tentative approval.

FDA will also now prioritize original ANDA submissions for noncomplex products if submitted between 24 and 36 months before the last applicable patent or exclusivity period expires thanks to the new policy on submissions dependent on patent expiration or an NDA exclusivity period.

Applicants are now required to appropriately document and submit to FDA litigation updates for priority review to be granted as part of applications that have paragraph IV patent certification under the latest version of the MAPP. This policy change comes as generic and biosimilar developers continue to face costly patent litigation reportedly keeping drug prices high.

The revision also nixes certain policy statements, including applying the prioritization criteria throughout all review stages. A new responsibility directs the Office of Pharmaceutical Quality regulatory project managers to coordinate the prioritization of OPQ reviews with OPQ disciplines. Additional clarifications impact submissions for sole-source drug products.

The latest version of the MAPP, which OGD first issued in October 2006 to modify the earlier "first-in, first review" approach, updates the November 2017 iteration. The move forms part of FDA's initiative to promote generic drug competition via guidance and other policy updates.