Learning the Art and Science of Negotiation: Tools for All User Fee Stakeholders (Book Chapter)

PDUFA and the Expansion of FDA Usser Fees: Lessons from Negotiators
April 2011

"Learning the Art and Science of Negotiation: Tools for All User Fee Stakeholders" is a chapter in the book PDUFA and the Expansion of FDA User Fees: Lessons from Negotiators.

Since the first Prescription Drug User Fee Act was passed almost 20 years ago, user fee negotiations and the legislative vehicles that authorize them have significantly altered the scope of the Food and Drug Administration's (FDA) responsibilities. PDUFA and the Expansion of FDA Usser Fees: Lessons from Negotiators serves as a guide to stakeholders preparing for any user fee negotiation, whether it's for a new program, or reauthorization of an existing one. The book draws on the institutional knowledge of the most experienced user fee negotiators, offering a unique view of the evolving nature of such negotiations; it offers practical insights for those at the negotiating table, as well as for anyone involved in helping to shape, analyze, monitor or understand user fee programs.

Lawrence Susskind's chapter, "Learning the Art and Science of Negotiation: Tools for All User Fee Stakeholders", uses a question-and-answer format to address issues relevant to Prescription Drug user Fee Act (PDUFA) negotiators from the pharmaceutical industry, the Food and Drug Administration, and patient advoctes and consumer protection organizations. The questions were derived from an informal survey of PDUFA negotiators, and the answers are informed by the Mutual Gains Approach to negotiation and the work of researchers at the Program on Negotiation at Harvard Law School. Questions covered in the chapter include:

  • What should we do if there is internal disagreement among stakeholders?
  • What are the sources of leverage in negotiation when the stakes are very high, but both sides know that neither is going to walk away?
  • How do you deal with "win-lose" oriented players when you are trying to promote a win-win approach to negotiation?
  • And many others.

Order PDUFA and the Expansion of FDA Usser Fees: Lessons from Negotiators.