Managing the Risks in a Changing Landscape: Physician Relationships with Pharmaceutical Companies

1. Managing the Risks in a Changing Landscape: Physician Relationships with Pharmaceutical Companies Murray G. Sagsveen General Counsel American Academy of Neurology (c) 2008 American Academy of Neurology 1

2. Perspective From a Medical Association • PhRMA Code • ACCME • Minnesota Law • AMA Opinions • Other • Senate Committees (E.g. Sen. Grassley) • Academy Guidelines • Conflict of Interest Policies • OIG Guidelines (c) 2008 American Academy of Neurology 2

3. Code on Interactions with Healthcare Professionals • Adopted by the Pharmaceutical Research and Manufacturers of America (PhRMA) • First version effective July 1, 2002; update effective January 1, 2009 • Governs relationship of PhRMA members with physicians and other healthcare professionals • Addresses 15 separate topics • http://www.phrma.org/code_on_interactions_with_healthcare_professionals/ (c) 2008 American Academy of Neurology 3

4. PhRMA Code • Basis of interactions • Informational presentations by reps and accompanying meals • Prohibition on entertainment and recreation • Pharmaceutical company support for CME • Pharmaceutical company support for third-party educational or professional meetings • Consultants (c) 2008 American Academy of Neurology 4

5. PhRMA Code (cont’d) • Speaker programs and speaker training meetings • Healthcare professionals who are members of committees that set formularies or develop clinical practice guidelines • Scholarships and educational funds • Prohibition of non-educational and practice-related items (c) 2008 American Academy of Neurology 5

6. PhRMA Code (cont’d) • Educational items • Prescriber data • Independence and decision making • Training and conduct of company representatives • Adherence to code (c) 2008 American Academy of Neurology 6

7. Quiz – Q. 1 Under the Code, may items such as stethoscopes be offered to healthcare professionals? (c) 2008 American Academy of Neurology 7

8. Quiz – Q. 2 Under the Code, could a company provide healthcare professionals with pens or clipboards designed to be used by healthcare professional or patients in the healthcare professional’s office along with brochures that provide educational information about the company’s product? (c) 2008 American Academy of Neurology 8

9. Quiz – Q. 5 Under the Code, may golf balls and sports bags be provided if they bear a company or product name? (c) 2008 American Academy of Neurology 9

10. Quiz – Q. 8 Can a field sales representative conduct an informational presentation accompanied by a meal for healthcare professionals in a restaurant down the street from the hospital? (c) 2008 American Academy of Neurology 10

11. Quiz – Q. 18 Under the Code, may a healthcare professional’s spouse or other guest be included in a meal with a pharmaceutical company representative that is provided in connection with an informational presentation by or on behalf of the company, if the healthcare professional pays for the spouse or guest? (c) 2008 American Academy of Neurology 11

12. Minnesota Law MN Stat. § 151.461: “It is unlawful for any manufacturer or wholesale drug distributor, or any agent thereof, to offer or give any gift of value to a practitioner. A medical device manufacturer that distributes drugs as an incidental part of its device business shall not be considered a manufacturer, a wholesale drug distributor, or an agent under this section…” (c) 2008 American Academy of Neurology 12

13. Minnesota Law • However, gift does not include… • Professional samples for free distribution • Items valued >$50 in a calendar year • Payments to sponsor of an educational program for bona fide educational purposes • Reasonable honoraria/expenses of CME faculty • Legitimate consulting services • MN Stat. § 151.47 requires public reporting (c) 2008 American Academy of Neurology 13

14. ACCME • Accreditation Council for Continuing Medical Education, www.accme.org • Standards to Ensure the Independence of CME Activities • American Academy of Neurology is accredited by ACCME for its CME programs • Six standards (c) 2008 American Academy of Neurology 14

15. ACCME Standards • Independence • Resolution of Personal Conflicts of Interest • Appropriate Use of Commercial Support • Appropriate Management of Associated Commercial Promotion • Content and Format without Commercial Bias • Disclosures Relevant to Potential Commercial Bias (c) 2008 American Academy of Neurology 15

16. AMA Opinion E-8.061 • Any gifts should serve educational function • Individual gifts of minimal value are permissible (e.g., pens and notepads) • Defines legitimate “conference” or “meeting” • Physician shouldn’t accept industry $ for CME registration, travel expenses, lost revenue • No gifts should be accepted if strings are attached (i.e., to affect prescribing practices)

17. Other… • Senator Grassley (R-IA) and others are investigating payments by pharmaceutical companies to physicians and organizations • AAN has adopted Principles Governing AAN Relationships With External Sources of Support • AAN has adopted Policy on Conflicts of Interest, which requires disclosure • HHS OIG may update guidelines (c) 2008 American Academy of Neurology 17

18. Contact information… Murray G. Sagsveen, JD, CAE General Counsel American Academy of Neurology 1080 Montreal Avenue St. Paul, MN 55116 Voice 651-695-2780 Fax 651-361-4880 Email msagsveen@aan.com (c) 2008 American Academy of Neurology 18