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Patricia O'Connell
Senior Communications Manager

Wiley Rein & Fielding’s John F. Kamp Co-Authors Book on Strategies to Win FDA Drug Approvals and Then Stay in Compliance with FDA Rules

May 6, 2005

Washington, DC—Wiley Rein & Fielding attorney and executive director of the Coalition for Healthcare Communication John F. Kamp, a recognized leading advocate of drug marketing issues, and Wayne L. Pines, an expert on regulatory and media matters involving pharmaceuticals and biologics and a former FDA's associate commissioner for public affairs, have authored the just published book Making Your Case to the FDA. The book is the latest volume in FDAnews' six-book series edited by Kamp and Pines titled Strategies for Winning at the FDA.

Making Your Case to the FDA unveils successful communication strategies used by pharmaceutical companies and their advisors to accelerate the drug approval process. In doing so, it illuminates the inner workings of the agency and recommends best practices for communicating with regulators before, during and after a product's approval.  The book covers the two most important and distinct aspects of the FDA's communication pipeline: what to do while an application is pending and complying with post-approval advertising and promotion rules.

Numerous medical executives prize Dr. Kamp’s public policy expertise, and he is a frequent speaker at industry meetings on the legal and political issues surrounding drug marketing.  He serves on the public advisory committees of the American Academy of Family Physicians and WebMD, and is an editorial advisor for the Rx Compliance Report and the FDA Advertising and Promotion Manual.

To purchase a copy of Making Your Case to the FDA, visit .