FDA Releases New ANDA Draft Guidance

The FDA has released new draft guidance aimed at encouraging generic drug competition as part of its continued implementation of the Drug Competition Action Plan. Two new documents seek to address the goal of reducing the time it takes to get a generic drug approved, and lessen the number of review cycles undergone by generic applications.

The draft guidance for industry, “Good Abbreviated New Drug Applications (ANDA) Submission Practices,” highlights common and recurring deficiencies that the FDA notices in generic drug applications that could lead to a delay in their approval, and seeks to help applicants amend those deficiencies.

The FDA is also taking new steps to enhance the efficiency of the drug review process; published as a companion to the draft guidance is a “Manual of Policies and Procedures” (MAPP). This document outlines ANDA assessment practices for FDA staff and formalizes a more streamlined generic review process.

The press release also stated that the FDA will be taking additional steps throughout the coming year to improve its own practices and help to guide industry to make sure generic drug applications can be acted upon as efficiently as possible.

In June 2017, FDA Commissioner Scott Gottlieb, MD, unveiled a plan to facilitate increased competition in the prescription drug market through the approval of more lower-cost generic medications. The course of action, referred to as the Drug Competition Action Plan, seeks to address the issue of patients being unable to afford medicines they need through three main goals: 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.

Generic drugs are responsible for saving the US health system $1.67 trillion in the last 10 years. In a statement, Gottlieb said, “We could see even greater cost savings if we helped more safe and effective generic drugs get to market sooner, after patent and statutory exclusivity periods have lapsed, by addressing some of the scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs.”

Since June 2017, Gottlieb has made strides to address these obstacles: in August, 2017, he announced formation an FDA committee of senior agency staff to head the Drug Competition Action Plan.