FDA to Issue New Policies to Streamline Generic Reviews in 2017

In a recent public hearing, Scott Gottlieb, commissioner of the FDA announced two new policies to streamline the process for reviewing generic drugs. A generic drug is one that is comparable to an innovator drug in dosage form, strength, route of administration, quality, performance characteristics and intended use. The commissioner targets the end of 2017 for the issuing of these two new documents. The purpose of these documents is to streamline the submission and review of abbreviated new drug applications under the agency’s drug competition action plan.

The first of the documents is an internal manual of policies and procedures (MAPP) entitled “Good ANDA Assessment Practices” that will focus on removing any FDA review procedures that are deemed to be redundant and repetitive to make the review procedures more efficient.

The second of the documents will be a guidance on “Good ANDA Submission Practices” that will be added to the Center for Drug Evaluation and Research’s to-do list for the year, which already includes 13 other new and revised draft guidances for generic drugs. The guidance will detail common issues found in ANDA submissions and give sponsors advice on how to avoid those issues before submitting an application in the first place.

As a whole, the FDA is working on lifting barriers to generic drug competition by supporting increased competition in the market for prescription drugs through the approval of lower cost, generic medicines. The recent public hearing at the end of July solicited input on how the FDA’s rules are being used to create obstacles to generic access instead of ensuring the vigorous competition. As stated by Scott Gottleib, “innovation in pharmaceutical development is essential because it creates new and sometimes life-saving therapies. But access to lower-cost alternatives, once patent and exclusivity periods lapse, also is critical to the nation’s health.” To encourage generic drug development, the FDA posted a list of branded drugs that have no listed patents or exclusivities and for which the agency has yet to approve a generic drug application (ANDA). The agency also intends to expedite the review of any generic drug application for a product on this list to ensure that they come to market as expeditiously as possible.