Revised MAPP Tightens FDA Scope for Prioritized Generic Drug Applications

Regulatory NewsRegulatory News | 31 January 2020 |  By 

The US Food and Drug Administration (FDA) on Thursday unveiled tweaks to its Manual of Policies and Procedures (MAPP) that explains new limits to when the agency prioritizes certain generic drug applications.

“This 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 on the update.

One of the major changes, according to the updated MAPP, is that FDA will no longer automatically prioritize all abbreviated new drug applications (ANDAs) that contain a paragraph IV certification, are submitted on the first day that any valid paragraph IV-containing application for the drug in question is submitted and are received as substantially complete.

Chad Landmon, chair of the law firm Axinn's intellectual property and FDA practice groups, told Focus: “It seems to me like the biggest impact of the MAPP change will be on those companies with Paragraph IV certifications where litigation has been filed and where there are others on the market.  They now will not be eligible for priority review unless they can demonstrate that they would be eligible for final approval before the goal date, which will require some showing that the patents and 30-month stay will be cleared.”

He also said he thought the revisions are part of an effort to lessen the burden on FDA with priority reviews and potentially to speed up approvals where products are more likely to get to market. “Of course, whether this change has a positive impact on review times will not become apparent for quite some time,” Landmon said.

The agency will still prioritize ANDAs if it’s a sole source drug (i.e., only one approved product listed in the Orange Book), if it relates to a drug shortage or a public health emergency, as well as if there are fewer than four approved therapeutically equivalent drug products (including both active and discontinued products and the reference listed drug (RLD)), and if there are no blocking patents or unexpired exclusivities for the RLD in the Orange Book. FDA is also requiring applicants to make explicit requests for priority reviews.

In addition, FDA says it will now prioritize submissions for complex generics (as defined in the GDUFA II Commitment Letter) that are dependent on the expiration of a patent or NDA exclusivity period if the original submission is submitted between 36 and 48 months prior to the expiration of the last applicable patent or exclusivity period, and only if there are not more than three approved drugs (including the RLD) in the Orange Book.

On 17 January, the House Energy & Commerce Committee sought more information from FDA Commissioner Stephen Hahn on the agency’s efforts to approve complex generic drugs more quickly. Landmon added that complex generics "often present complicated issues that can be particularly challenging for FDA for first-time generics. Although I think that we will see speedier reviews and approvals for complex products than we have traditionally seen, I do think that review times for these products will still lag."

And the agency will also speed the reviews of noncomplex products that are dependent on the expiration of a patent or new drug application (NDA) exclusivity period if the original submission is submitted between two and three years prior to the expiration of the last applicable patent or exclusivity period.

For supplements, FDA said it will prioritize their reviews if they are “(1) related to a drug shortage or public health emergency; (2) subject to legal requirements; or (3) where a delay would impose an extraordinary hardship on an applicant.” 

A spokesperson for the Association of Accessible Medicines (AAM), the generic drug industry group, said it is “assessing the potential impact of the changes to the overall generic program. This said, AAM supports FDA’s views that it should prioritize applications that will provide timely access to drug products with the greatest potential impact to public health.”

In addition to the updated MAPP, FDA also recently published a list of ANDAs that are competitive generic therapy (CGT) approvals, including information on whether they qualified for 180 days of CGT exclusivity.

Updated MAPP

FDA Summary


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