Earlier this week, 74 medical associations and societies sent a letter to the Centers for Medicare & Medicaid Services (CMS) asking it to exclude journal reprints and textbooks from federal Sunshine reporting requirements.  The physician organizations argued that CMS’ requirement for industry to report these items as gifts or transfers of value to physicians is “. . . contrary to both the statute and congressional intent and will potentially harm patient care by impeding ongoing efforts to improve the quality of care through timely medical education.”  The letter further points to the 2009 U.S. Food and Drug Administration (FDA) guidance for industry, Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices, arguing that “FDA guidelines for reprints provide that medical reprints should be distributed separately from information that is promotional in nature, specifically because the reprints are designed to promote the science of medicine, are educational, and intended to benefit patients.”

Posted by Cooley

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