PREP Course #11: Interactions with Industry What Most Docs Ask About

Transcription

1 PREP Course #11: Interactions with Industry What Most Docs Ask About Presented by: Lou DiGiovanni, Corporate Compliance & Emmelyn Kim, Research Compliance January 23,

2 CME Disclosure Statement The Northwell Health adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the Northwell Health for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planner, Kevin Tracey, MD and Tina Chuck, MPH have nothing to disclose. Lou DiGiovanni & Emmelyn Kim have nothing to disclose. 2

3 Objectives Discuss appropriate practices when interacting with industry 3

4 Content Review relevant institutional policies on gifts and interactions with industry, consulting agreements with industry and conflict of interest Describe the external activity review process Impact of open payments, media and transparency FAQs from docs including consulting arrangements, industry sponsored events and meals, research and presentations 4

5 Key Policies # Gifts and Interaction with Industry #GR087 Review of External Consulting Agreements with Industry for Feinstein Researchers & associated forms Other documents available on the Intranet: FAQs for Interactions with Industry Form: Outside Activity Form - Department Chair Sign Off 5

6 Policies and Forms Available on the Intranet 6

7 What s the Process for Engaging in External Activities? Notification & Approval: Obtain approval from the Department Chair (or Chief Medical Officer approval for Chairs) Document approval use the outside activity form or equivalent form Disclose: Annual Mandatories Disclose external interests and any potential conflicts Research disclosures Disclose external interests annually or within 30 days of any significant financial interest Ad Hoc request through Compliance; COI Committee reviews 7

8 Things to Consider About Individual Consulting Arrangements Ensure the time spent does not conflict with your professional responsibilities & should be performed during non-system work time unless otherwise approved Avoid participating in any industry-sponsored speaker s bureaus where you don t have control over the content Consult your attorney before signing any individual agreements Disclose industry payments and consulting arrangements 8

9 COI Policies # Conflicts of Interest and Recusal #GR065 Review and Management of External Interests (COIs) in Research (Individual) GR082 Review and Management of Institutional Financial Conflict of Interest in Research Other research related information available online: Global/National PI and Study Leadership COI Guidance ORC web site --> COI 9

10 A bit of history 10

11 Other influences on objectivity? 11

12 Open Payments 12

13 Recent Open Payments Data 13

14 Open Payments Information regarding registration, disputes and other resources: 14

15 Recent research Receipt of industry-sponsored meals was associated with an increased rate of prescribing the promoted brand-name medication to Medicare patients. Reference: JAMA Intern Med. 2016;176(8): doi: /jamainternmed

16 JAMA: May 2, Articles 3 Editorials Reconsidering Physician- Pharmaceutical Industry Relationships Complex and Multifaceted Aspects of COI 2 Original Investigations Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing ( modest but significant changes ) 1 Patient Page 1 Hypothetical Case Study 16

17 FAQs 17

18 Investigator Meetings Can an industry sponsor pay for travel & meals to an investigator s meeting as part of a clinical trial? If related to the conduct of the trial & reasonable Think about including this in the sponsor budget up front 18

19 Advisory Boards Request to join a company s scientific advisory board. Usual concerns: in writing, fair market value, approval of Chair (time commitment, use of Northwell resources and so on) Recent enforcement actions: Sham advisory boards-no material scientific contribution ( see, listen, raise hands, get paid ) 19

20 Advisory Boards Key principles: Evidence-based findings Allows for opportunities for critical exchange among peers Permits objective expression of one s own views Does not allow industry to control the content of ones views, opinions or statements 20

21 Procurement Procurement informs Compliance of surgeon s disclosure that she wishes to use implant from company she partly owns or has consulting relationship. Usual concerns: safety, price, and so on. Three prongs of managing conflict of interest: o Disclosure-update annual questionnaire o Recusal-participation in product selection o Fairness-price, terms 21

22 Videos Company proposes audio-visual recording of interview with physician concerning new product in order to educate other physicians. Usual concerns: his own ideas (prohibition on Speakers Bureau type engagements), cannot mention brand names, in writing, Chair approval, no use of work time and so on. Other issues: co-marketing (cannot use name and position for promotional purposes; no testimonial), cannot be on Northwell premises, placement on company website (is that marketing or education?) 22

23 Training for FDA approved Devices Manufacturer gets new (under a year) FDA approval for new device-new technique that is taught only by researcher-faculty member of medical school in Sunbelt City. Manufacturer proposes to pay modest transportation, accommodation and hands-on education for Faculty Member. No purchase yet & no CME credit. Education cannot be obtained elsewhere. Can Faculty Member attend? Usual concerns: in writing, Chair approval, and so on. Other concerns: does it satisfy exception for hands-on training? 23

24 Industry Support A department wants to obtain an unrestricted grant from a pharmaceutical company. What steps are needed? Solicitation should be for charitable, educational, academic purposes and approved by the Chair, etc. Certification that support is not provided to influence purchasing decisions or research outcomes Northwell determines how $ is spent and funds are distributed to the department or program; plans, operates & controls aspects (ACCME standards) 24

25 Meals Is it okay to accept meals from industry in an off campus setting? If so, what would be things to consider? -Ok if complies with ACCME standards -For approved outside activities (non-promotional/nonsales related) ensure it is modest and reported -Disclosure requirements and Open payments Reminder that no meals are accepted on campus 25

26 Questions? Contact: Lou DiGiovanni at P: (212) The Corporate Compliance Director for your facility Or the Compliance Help Line: Research Compliance for research related issues: Emmelyn Kim at P: (516) Or the ORC inbox: General line: (516)

27 Thank you. 27