FDA announces steps for generic drug review to promote access and lower drug prices

The FDA announced additional steps to encourage generic competition as part of the continued implementation of the Drug Competition Action Plan.

This plan has three main components:

• reducing gaming by branded companies that can delay generic drug entry;
• resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and
• improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.

Specifically, the FDA is releasing two documents that together will streamline and improve aspects of the submission and review of generic drug applications (known as Abbreviated New Drug Applications, or ANDAs).

Through the new guidance, as well as others from the agency, FDA can achieve one of their 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.

While industry does its part to improve the quality and completeness of applications, the FDA also is taking new steps to enhance the efficiency of the review process. FDA is publishing a companion to the guidance in the form of a Manual of Policies and Procedures (MAPP) — “Good ANDA Assessment Practices” — which outlines ANDA assessment practices for FDA staff. The document formalizes a more streamlined generic review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete.

Among other things, the new MAPP establishes that when the FDA determines that an ANDA cannot be approved in its current form, reviewers should provide more detail to generic applicants to explain the deficiencies with the application; outline details on how this information should be provided; and provide more detail, when available, on the additional information that the generic applicant must provide to the agency to support an approval decision during the next application cycle.

This new MAPP does not alter the important Generic Drug User Fee Amendments II review goals or program enhancements, nor does it alter the regulatory requirements for ANDA approval. Rather, the goal of the MAPP is to guide FDA staff to help ensure it works more efficiently with the goal of improving review times.