title: New federal guidelines for physician-pharmaceutical industry relations: the politics of policy formation.
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 The draft Guidance questioned the legality of many arrangements heretofore left to the discretion of physicians and drug companies, including industry-funded educational and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.
authors.affiliation: Center on Medicine as a Profession (CMAP), College of Physicians and Surgeons, Columbia University, New York, NY, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Chimonas
authors.forename: David J
authors.initials: DJ
authors.lastname: Rothman
mesh_terms: D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D005607:Fraud / Q000331:legislation & jurisprudence / Q000517:prevention & control; D037921:Gift Giving; D033161:Government Regulation; D017408:Guidelines as Topic / Q000592:standards*; D006291:Health Policy / Q000331:legislation & jurisprudence*; D007356:Insurance, Pharmaceutical Services; D007373:Interinstitutional Relations; D010820:Physicians / Q000191:economics / Q000331:legislation & jurisprudence*; D011050:Policy Making; D011057:Politics; D012109:Research Support as Topic / Q000331:legislation & jurisprudence; D012955:Societies, Medical; D014146:Training Support / Q000331:legislation & jurisprudence; D014481:United States; D037041:United States Government Agencies