On July 18, 2017, the Food and Drug Administration (FDA) hosted a public meeting entitled, “The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The meeting was a public opportunity for interested stakeholders to provide the FDA with information and policy recommendations about how to encourage competition while also maintaining access. Much of the meeting was spent on public presentations that were given to a panel composed of staff from a variety of offices in the FDA, including the Center for Drug Evaluation and Research (CDER), the Office of the Commissioner, and the Office of Generic Drugs.

Gottlieb Explains Drug Competition Action Plan, Announces New Guidance

The Commissioner of the FDA, Dr. Scott Gottlieb, gave brief opening remarks at the start of the meeting, highlighting the FDA’s new Drug Competition Action Plan, which was originally discussed in a post on the official blog of the FDA. The drug competition plan encompasses multiple areas where the FDA has some regulatory authority. It addresses topics such as the efficiency of the generic approval process, places where obstacles exist for generics entering the market, and places where the regulatory system is being gamed or taken advantage of.

Commissioner Gottlieb also announced that the FDA would be issuing two documents about the review process for an abbreviated new drug application (ANDA). First, the FDA will issue a “Good ANDA Assessment Practices” manual of policies and procedures (MAPP).  The MAPP will include a discussion of how the FDA hopes to streamline the ANDA review process through eliminating duplicative procedures, increasing efficiency, and other ideas. The second document is a “Good ANDA Submission Practices” guidance, which will lay out common deficiencies that the FDA sees in ANDA applications and ways to avoid these problems. These documents are going to be released by the end of the year.

Public Presentations Focus REMS, Pay-for-Delay, and Priority Review

The public presentations that were the majority of the meeting were given by a variety of stakeholders. Representatives from the Blue Cross Blue Shield Association (BCBSA), America’s Health Insurance Plans (AHIP), the Association for Accessible Medicines (AAM), and the Pharmaceutical Research and Manufacturers of America (PhRMA) all spoke. Other presenters included generic manufacturers and advocacy organizations.

The presentations, of which there were over 30, covered a great variety of topics related to generic drug competition. Risk evaluation and mitigation strategies (REMS), evergreening, pay-for-delay agreements, and the generic approval process were included in many of the presentations. Many presenters asked the FDA to end pay-for-delay agreements and to stop the use of REMS to thwart generic competition. A few presenters also requested that the FDA reconsider nomenclature for biosimilars and many encouraged the FDA to make the generic approvals process more efficient. Some encouraged the use of priority review, particularly for generics where there are three or less competitors.

Throughout the day, panelists often felt that many of the public presentations contained more high-level suggestions and asked that more specific information be provided in written comments. In addition, the panelists indicated that the agency was looking for fixes within the agency’s current authority, not action that must be taken by Congress.

All slides used by public presenters during the meeting will be publicly available. The public docket for the meeting will be open until September 18, 2017.

If your organization has any questions or would like assistance submitting public comments, please contact us at 202-558-5272 or gmandel@appliedpolicy.com.