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New FDLI Monograph Provides Expert Guidance on Selling Pharmaceuticals, Biologics to Federal Government

Thursday, July 29, 2010 Drug News J E 4
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WASHINGTON, July 28 In FDLI's latest monograph, Selling Pharmaceuticals and Biologics to the Federal Government: Federal Supply Schedule and Federal Pricing Requirements, Joy Sturm, Allison Pugsley and Stephen A. Smyers of Hogan Lovells US LLP detail how pharmaceutical and biologics manufacturers can deal effectively with government contracting requirements and price calculation requirements. The 73-page monograph (Volume 1, #5) succinctly describes how a manufacturer's commercial pricing decisions can have a significant impact on product pricing in the federal marketplace and, thus, on a drug or biologics company's bottom line.

As the monograph notes, manufacturers who seek to receive federal funds under certain Medicaid and Medicare programs must agree to participate in the Federal Supply Schedule (FSS) and Veterans Health Care Act of 1992 (VHCA) contracting and pricing programs. Increased federal enforcement efforts surrounding these programs, coupled with the recent extension of the VHCA federal pricing requirements to the Department of Defense's nationwide TRICARE pharmacy program, have stimulated manufacturers -- of all sizes -- to place additional emphasis on their federal contracting and pricing functions, according to the monograph.

This monograph provides lawyers, business leaders and pharmaceutical and biologics decision-makers with a user-friendly understanding of the mechanics of pricing calculations and federal contracting requirements; how common commercial pricing and discounting arrangements can affect the prices that a company must charge the government for its drugs and biologics; and how to spot issues and develop strategic thinking to minimize compliance risk and maximize commercial outcomes.

FDLI's Monograph Series is designed to provide in-depth, practical analysis and guidance on complex issues in food and drug law. Monographs are available by subscription (6 issues per volume) or individually, as downloadable PDF files.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.

SOURCE Food and Drug Law Institute
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