Catalyst Team Co-Edits Book on PDUFA and FDA User Fees

Press Release

Washington, DC –Nancy Bradish Myers, Catalyst Healthcare Consulting President, and Anne Petruska McNickle, Director of Research and Communications at Catalyst, are the co-editors of a new book that provides a 360-degree view of the evolving nature of user fee negotiations. The book, published by the Food and Drug Law Institute, was unveiled this week during the FDLI annual meeting in Washington, DC.

Ms. Myers also wrote or co-wrote two chapters; one is a first-of-its-kind exploration of user fees from the FDA perspective, and the other is a comprehensive analysis of “lessons learned” for future negotiators.

The book serves as a guide to user fee negotiators, as well as anyone involved in helping to shape, analyze and monitor user fee negotiations involving FDA-regulated industries.
Entitled PDUFA and the Expansion of FDA User Fees: Lessons From Negotiators, the book features insights from many of the most experienced user fee negotiators. For further information on the book, or to purchase, click here (Catalyst clients receive a 20% discount; see ordering information below.)

“Since passage of the first Prescription Drug User Fee Act almost 20 years ago, user fee negotiations and the legislative vehicles that authorize them have significantly changed the scope of FDA’s responsibilities,” Ms. Myers says. “After PDUFA paved the way to the acceptance of user fees, programs were created for other FDA-regulated industries, such as medical devices, animal drugs and animal generic drugs. With several additional user fee programs on the horizon, such as those for generics, biosimilars and food, the book is a timely and valuable addition to any negotiator’s toolkit.”

“Many issues reach across user fee programs and across industries,” Ms. McNickle states. “Our book addresses the history of user fee negotiations, approaches that have been taken by FDA and the regulated industries, the strategies that have worked in the past, and the lessons learned that can be applied across all stakeholders.”

Each chapter is authored by different expert negotiators, including:

  • Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research
  • Alan Goldhammer, PhD, former negotiator for PhRMA
  • Timothy Franson, MD, former industry negotiator and former VP at Eli Lilly
  • Vince Ventimiglia, JD, former Health Policy Director and Counsel for the Senate Committee on Health, Education, Labor, Pensions, and former congressional liaison for HHS
  • Keith Flanagan, Health Counsel to Sen. Michael Enzi, Ranking Member of the Senate Committee on Health, Education, Labor and Pensions
  • Stephen Northrup, former health policy advisor to Sen. Enzi
  • Lawrence Susskind, PhD, negotiation expert/MIT professor/Program on Negotiation at Harvard Law School.

Chapters include:

  • History leading to the first user fee program (PDUFA)
  • The biopharmaceutical industry perspective on negotiation user fees
  • A view of user fee negotiations through the FDA lens
  • A clear explanation of Congress’ role in enacting user fees
  • Insight into how user fees expanded to medical devices
  • Advice from professional negotiators on how to bring new tools to the table
  • Overall lessons learned for stakeholders

Leaders in patient advocacy, consumer advocacy, and the animal health world also contributed to the book.

On April 5, during the FDLI annual meeting, Ms. Myers moderated a panel discussion on stakeholder experiences with user fee programs and lessons learned for future negotiators, as explored in the book. The panel included several of the book’s authors.

Following the panel discussion, the editors and authors were featured at a book signing event as part of the FDLI meeting.

Note: Catalyst clients receive a 20% discount on the book; for ordering information, please contact Anne McNickle at annemcnickle@04298e3.netsolhost.com.

About Catalyst
Catalyst is a niche consulting firm that provides clients with strategic regulatory insight and advice as they position biopharmaceutical companies, trade associations, and patient advocacy organizations on regulatory and health policy matters before the FDA and other regulatory agencies.

Catalyst President Nancy Bradish Myers, JD, is a Washington-based attorney with expertise in health care law and regulation, policy development, government relations and political analysis. Her leadership positions have spanned the federal government, drug and biotechnology industry associations, health insurance and the equity research/investment world. At FDA, she served in a number of roles, most recently as special assistant and senior strategic advisor in FDA’s Office of the Commissioner.

Anne Petruska McNickle is Director of Communications and Research at Catalyst Healthcare Consulting, Inc., where she specializes in regulatory strategy, research, and communications. Previously, she worked in industry, in the areas of reimbursement and strategic communications. Ms. McNickle has also been a health care journalist, covering Capitol Hill for The Pink Sheet and serving as Managing Editor of Health News Daily. She has also held senior consulting roles at a number of firms in the Washington, DC area.

More information about Catalyst is available at http://catalysthcc.com/

About the Food and Drug Law Institute
The Food and Drug Law Institute, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. As a not-for-profit 501(c)(3) organization, FDLI does not engage in advocacy activities. FDLI’s mission is to provide education, training, and publications on topical food and drug law; act as a liaison to promote networking as a means to develop professional relationships and idea generation; and ensure an open, balanced marketplace of ideas to inform innovative public policy, law, and regulation. More information is available at http://fdli.org/

2018-05-24T22:55:08+00:00