National and Institutional Guidelines on Conflict of Interest in Physician-Industry Relationships

1. National and Institutional Guidelines on Conflict of Interest in Physician-Industry Relationships

2. Objectives • List the agencies that regulate industry • Be familiar with conflict of interest guidelines regarding physicians’ relationships with the pharmaceutical industry • Be familiar with your own institutional guidelines

3. Guidelines on Physicians’ Interactions with Industry • In recent years, there has been an increase in regulatory guidelines in the area of conflict of interest involving physicians especially those with the pharmaceutical industry • There are many reasons for this increase including: • Influence that pharmaceutical marketing can have on patient care • Bias in research and results reporting • Rising costs of health care • Fraud and abuse

4. Guidelines on Physicians’ Interactions with Industry • American Medical Association (AMA) • Association of American Medical College (AAMC) • American College of Physicians (ACP) • Accreditation Council for Continuing Medical Education (ACCME) • Office of Inspector General (OIG) of Department of Health and Human Services (DHHS)

5. AAMC • The final report of the AAMC Task Force (June 2008) on Industry Funding of Medical Education examines the benefits and pitfalls associated with industry funding of medical education, and offers principles, recommendations, and guidelines to assist members in refashioning industry relationships to better conform to high standards of medical professionalism. https://www.aamc.org/members/foci/

6. AAMC Recommendations • Academic medical centers should establish a central CME office through with support and funds for CME activity are coordinated and overseen • Pharmaceutical samples (if permitted) should be centrally managed. Provide vouchers for low-income patients. • Site access by pharmaceutical representatives restricted to non-patient care areas and by appointment only • Site access by devise manufacturers in patient care requires appointments, credentialing, and disclosure and consent by patients • Exclude professionals with financial relationships with drug manufacturers from Pharmacy and Therapeutic Committees and the FDA Advisory Committees. • Faculty should not serve as members of speakers’ bureaus.

7. AMA • The American Medical Association (AMA) has an extensive code of ethics. It includes several sections concerning conflicts of interest, including a section on gifts to physicians from industry, conflicts of interest in biomedical research and managing conflicts of interest in clinical trials. • They also have a Web site dedicated to their guidance on gifts to physicians from industry, including educational programs with CME credit. http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics.shtml

8. ACP • The ACP Ethics, Professionalism and Human Rights Committee developed a revision in College policy on industry gifts, hospitality, services and subsidies in a two-part paper on physician-industry relations. The first part is intended to serve as a guide for physicians, and the second part is aimed at offering recommendations to medical education providers and medical professional societies. http://www.acponline.org/running_practice/ethics/issues/relations/

9. ACCME • The ACCME Standards for Commercial Support describe practices that the ACCME considers appropriate for accredited providers to ensure that their CME activities are independent, free of commercial bias and beyond the control of persons or organizations with an economic interest in influencing the content of CME. http://www.accme.org/dir_docs/doc_upload/700a1624-d6f0-46d8-a4bc-88e12a56eca2_uploaddocument.htm

10. OIG • OIG set its views on the value and fundamental principles of compliance programs for pharmaceutical manufacturers and the specific elements that pharmaceutical manufacturers should consider when developing and implementing an effective compliance program. oig.hhs.gov/authorities/docs/03/050503FRCPGPharmac.pdf

11. PhRMA Guidelines on Physicians’ Interactions with Industry • The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-based pharmaceutical and biotechnology companies which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. • PhRMA members alone invested an estimated $50.3 billion in 2008 in discovering and developing new medicines. Industry-wide research and investment reached a record $65.2 billion in 2008. • Developed and published “Code on Interactions with Health Care Professionals” which took effect Jan 2009.

12. PhRMA Guidelines on Physicians’ Interactions with Industry • “Ethical relationships with healthcare professionals are critical to our mission of helping patients by developing and marketing new medicines. An important part of achieving this mission is ensuring that healthcare professionals have the latest, most accurate information available regarding prescription medicines, which play an ever-increasing role in patient healthcare. This document focuses on our interactions with healthcare professionals that relate to the marketing of our products.” http://www.phrma.org/code_on_interactions_with_healthcare_professionals

13. Institutional Guidelines Do you know your own institutional guidelines?

14. Conflict of Interest Policies at Academic Medical Centers

15. “The key to success is collaboration. Industry cannot do this alone, physicians cannot do this alone, medical and communications companies can’t do this alone.” Mike Saxton, Director of Clinical Education at Pharmacia