Abstracts

There are numerous opportunities and venues for physicians to collaborate with pharmaceutical and device companies in the areas of research and education. Given the increasingly regulated health care environment and the recent well-publicized fines assessed by the government on drug companies for improper marketing activities, we reviewed current laws, regulations and guidance that are relevant to physicians when establishing relationships with industry. We reviewed federal and state fraud and abuse and drug/device marketing laws and regulations, as well as agency interpretations and applications of such laws, including Compliance Program Guidance For Pharmaceutical Manufacturers published by the Office Of Inspector General ([quot]OIG[quot]) of The United States Department of Health and Human Services; the Food and Drug Administration[apos]s 1997 Final Guidance on Industry-Supported Scientific and Educational Activities; and, various recent Corporate Integrity Agreements between the OIG and pharma/device companies. We also reviewed the relevant professional and trade association guidelines and codes of ethics on commercial activities between physicians and industry, including, the Pharmaceutical Research and Manufacturers of America ([quot]PhRMA[quot]) Code on Interactions with Healthcare Professionals; the American Medical Association[apos]s ([ldquo]AMA[rdquo]) policies on [italic]Continuing Medical Education[/italic] and [italic]Gifts to Physicians from Industry;[/italic] the 2004 Accreditation Council for Continuing Medical Education ([quot]ACCME[quot]) Standards For Commercial Support; and , the AdvaMed Code. Although physician-industry relationships are undergoing a significant amount of regulatory scrutiny and several recent legal actions have resulted in substantial liability, physicians may permissibly continue to enter into financial relationships with industry for proper educational, research, product development, consulting and publishing activities that are commercially reasonable, based on the fair market value of the services to be rendered by the physician and are free from the influence or primacy of market or sales considerations over the independent clinical, educational and editorial discretion and judgment of the physicians involved. A recognized body of relevant laws, regulations, and guidance frame the general boundaries of physician-industry relationships. Knowledge of these boundaries will help physicians mitigate the potential problems associated with these relationships.