WASHINGTON, Feb. 22, 2011 /PRNewswire-USNewswire/ -- The fourth issue of FDLI's Food and Drug Policy Forum (Volume 1, Number 4) will be released February 22, 2011. Brian J. Malkin, Partner, and Andrew S. Wasson, Associate at Frommer Lawrence & Haug LLP, examine this emerging health care question: "Should FDA Undertake More Than A 'Ministerial' Role with Respect to Patent Information?"
Malkin and Wasson conclude that FDA needs to take a more active approach to patent regulation. "FDA's hands-off policy with regard to patents," they explain, "creates a vacuum often filled by parties with vested interests." The authors recommend that FDA take the following steps in order to become more involved in reviewing patents: develop the internal competency to review patents; review and refuse to list patents that do not meet FDA criteria; ensure that the submitted method-of-use patent applications do not claim a use for which the application is submitted and hire patent attorneys to ease the implementation of these recommendations.
FDLI's Food and Drug Policy Forum is a concise (approximately 10 pages), twice-a-month, peer-reviewed, digital publication on current food and drug policy topics. Posed in the form of a question, each issue provides subscribers and purchasers with pertinent background information, relevant research, a discussion of central issues, relevant resources and policy recommendations. The views, opinions and statements expressed in the Policy Forum are those of the authors. The Food and Drug Law Institute neither contributes to nor endorses Policy Forum articles. As a nonprofit 501 (c) (3) organization, FDLI does not engage in advocacy activities.
FDLI, 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. FDLI's scope includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco.
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SOURCE Food and Drug Law Institute