FDA unveils draft guidance, MAPP on ANDA submissions

The Food and Drug Administration is moving full speed ahead into the new year, releasing two documents Wednesday as part of its ongoing Drug Competition Action Plan. The documents are aimed at making the generic approval process speedier and reducing the number of review cycles for abbreviated new drug applications, or ANDAs.

The first document is a draft guidance for the industry called “Good ANDA Submission Practices,” which outlines typical deficiencies in ANDA submissions that can delay approval. The agency noted that it takes on average foru cycles for an application to be approved, in several cases because the application lacks necessary information and not because the product doesn’t meet safety standards.

“These multiple cycles of review are costly and inefficient. They require a great deal of additional, avoidable work by both agency staff and the applicant and can delay the entry of generic competition,” FDA commissioner Scott Gottlieb said. “Through today’s guidance, as well as others from the agency, we can achieve one of the FDA’s key goals in 2018 — to reduce the number of review cycles — by helping applicants avoid these common deficiencies that lead to review delays and application cycling.”

Alongside the draft guidance, the FDA released a Manual of Policies and Procedures, or MAPP, called “Good ANDA Assessment Practices” that outlines for FDA staff the agencies practices for evaluating applications. Gottlieb said the MAPP formalized a streamlined assessment process and introduces templates to make each cycle more efficient. The MAPP also establishes necessary communication between the FDA and a company, requiring the FDA provide more details about an application’s deficiency, outline how to provide more information and offer more details on what new info should be provided in a subsequent application cycle.

“As with the draft guidance on submission practices, this MAPP should reduce the number of subsequent cycles that applications must undergo, and avoid the cycling of applications that is a significant cause of the delays in generic approvals,” Gottlieb said. “The MAPP also clarifies the roles and responsibilities of different review disciplines to reduce inconsistencies as well as duplicative and unnecessary work. This will greatly increase the efficiency and effectiveness of the agency’s generic drug review teams.”

Gottlieb said that efforts the agency implemented in 2017 have begun to yield results, with November marking the highest number of generic approvals in a single month in the agency’s history. Gottlieb promised continued efforts in the generics space as part of the Drug Competition Action plans, including efforts to accelerate the entry of complex generics and reduce the use of delay tactics by certain manufacturers.

“It’s part of our public health mission to ensure safe, effective, quality medicines are available to the patients that need them,” Gottlieb said. “Most importantly, the FDA will continue to be the gold standard for approval of all drug applications, and we will make sure that consumers can continue to trust in that assessment.”