Healthy Skepticism Library item: 4586

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Chimonas S, Rothman DJ.
New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation.
Health Aff (Millwood) 2005 Jul-Aug; 24:(4):949-60
http://www.healthaffairs.org/

Abstract:

In October 2002 the federal government issued a draft “Compliance Program Guidance for Pharmaceutical Manufacturers.” The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and research grants, consultantcies, and gifts. Medical organizations and drug manufacturers proposed major revisions to the draft, arguing that current practices were in everyone’s best interest. To evaluate the impact of their responses, we compare the draft, the changes requested by industry and organized medicine, and the final Guidance document (issued in April 2003). We also explore the implications—some intended, others unanticipated—of the final document

Keywords:
Drug Industry/economics Drug Industry/legislation & jurisprudence* Fraud/legislation & jurisprudence Fraud/prevention & control Gift Giving Government Regulation Guidelines/standards* Health Policy/legislation & jurisprudence* Insurance, Pharmaceutical Services Interinstitutional Relations Physicians/economics Physicians/legislation & jurisprudence* Policy Making* Politics* Research Support/legislation & jurisprudence Research Support, Non-U.S. Gov't Societies, Medical Training Support/legislation & jurisprudence United States United States Government Agencies