1 University of Pittsburgh Presentation to School of Pharmacy Department of Pharmacy and Therapeutics Outside Engagements within the Industry Relationship Policy June 17, 2010 by Theresa J. Colecchia, JD Barbara E. Barnes, MD David T. Wehrle, CPA, CIA, CFE

The Academic Medical Center Mission RESEARCH TEACHING PATIENT CARE INDUSTRY

What is a Conflict of Interest? A potential Conflict of Interest (COI) may exist if an individual’s outside interests (especially financial) may affect, or perceive to affect, his/her research, teaching, clinical, or administrative activities at the University/UPMC.

The Promotion of Gabapentin Promotional Budget = $40 M $19 M for “Professional Education”

Legal Actions and Settlements Against companies Fines/penalties/deferred prosecution agreements Mandatory disclosure of relationships Restriction of marketing practices Oversight Restrictions on CME funding Against individuals Investigations Restrictions on participation in NIH activities/Medicare & Medicaid Consequences of ghostwriting Against organizations Fraud & kickback investigations Restrictions on NIH activities Oversight on publications/guideline development

Public Benefits & Risks of AMC/Industry Relationships RESEARCH PATIENT CARE EDUCATION FUNDING CO-DEVELOPMENT TECH TRANSFER ACADEMIC EXPERTISE AND INDEPENDENCE POST-MARKETING SURVEILLANCE AVAILABILITY OF NEW DRUGS/DEVICES CO-DEVELOPMENT OBJECTIVE EVALUATION ONGOING DEVELOPMENT & IMPROVEMENT FUNDING OF GME/CME OBJECTIVE DISSEMINATION PROFESSIONAL SOCIALIZATION OF STUDENTS/RESIDENTS POTENTIAL FOR BIAS OF RESULTS (COI) & NON-COMPLIANCE WITH RESEARCH STANDARDS SKEWING OF RESEARCH AGENDA TOWARD NEW/COSTLY THERAPIES EXCESS USE OF EXPENSIVE, ? SAFE, NON-VALUE-ADDED THERAPIES & DIAGNOSTICS IMPACT OF COI ON PURCHASING SKEWING OF THE EDUCATONAL AGENDA BIAS AND PROMOTION NEGATIVE SOCIALIZATION OF STUDENTS/RESIDENTS BENEFITS RISKS

7 Outside Engagements with Industry—What is Allowed? True consulting, where payment is reasonable and related to the services provided, is permitted under the Industry Relationship Policy (IRP). Where consulting payments are made without services being provided, or where payment rates are out of proportion to the service provided, the payments may be considered kick-backs. Any consulting agreement, under University/UPMC policies, requires the prior approval of the department chair and/or dean.

8 Consulting Contract Guidelines A contract detailing the proposed services to be provided must be in writing; Faculty member should provide company with “Guidelines for Contracting with Outside Industry” (see IRP, FAQ # 7); Consultant cannot engage in promotional or marketing activities on behalf of the company; How do you know if it is promotional? Is it organized by the Marketing Dept or the R & D Dept.? Who invites the attendees? Who controls the content?

9 Consulting Contract Guidelines (cont’d) University’s/UPMC’s name and address cannot appear in the contract; consultant’s personal address must be used instead; Any non-compete clause in the contract cannot interfere with faculty member’s duties at the University/UPMC; Use of University/UPMC resources is not permitted; Use of consulting Addendum helps ensure that contract terms will comply with IRP (see the Policy Compliance Tools tab within the IRP Web pages on the COI Web site).

10 Acceptable/Not Acceptable Consulting Activities Not Acceptable “Pharmacist shall conduct and/or assist with any clinical studies and trials on behalf of Serum, LLC, including reviewing data, and assist with the preparation of any reports or articles regarding same.” Faculty are not permitted to conduct research as consultants. This work must be done, instead, through a sponsored research agreement with the company.

11 Acceptable/Not Acceptable Consulting Activities (cont’d) Not Acceptable “Develop strategies to implement approaches to improved patient care using E. Lixir & Co.’s Unidose dispensers. “Train pharmacists to use PharmAdventure, Inc.’s hi- speed pulverizing machine at University of Pittsburgh’s School of Pharmacy.” Acceptable “Serve on Galen, LLC’s scientific advisory board or data safety monitoring board.”

12 Consulting Contract Guidelines (cont’d) Compensation There must be a direct correlation between services provided and payment received. Contract must include specific, legitimate tasks and deliverables. …

13 Consulting Contract Guidelines (cont’d) Payment must be commensurate with the task performed; Hourly payment of more than $500 is deemed excessive; Consultant cannot be pre-paid for services.

14 Does agreement provide legitimate tasks and deliverables? Not Acceptable “Autoclaves, Inc. will pay you a $4,000 per month retainer for your availability to be on our advisory board as needed. The board will meet as necessary.” Acceptable “Advise Autoclaves Inc.’s scientists on our experimental plans, protocols, and equipment purchases; consultant will not be expected to develop entire protocols.”

15 Is the type of compensation appropriate? Stock Options Not Acceptable “Consultant will receive 500 stock options upon signing the consulting agreement with Hexangular Cutting, Inc. and quarterly thereafter.” Acceptable “500 stock options will be awarded for each hour of service provided to Pharmaceutical Management Systems by the scientific advisory board member. Options will be awarded only upon receipt of periodic invoices detailing the dates, hours, and types of services provided by the member.”

16 Is the type of compensation appropriate? Royalties Not Acceptable “Tinctures & Tonics, Inc. will provide Consultant with 1% of royalties on net sales of products each annum.” Receipt of royalties as compensation is always prohibited.

17 Consulting Contract Guidelines Conveyance of IP Not acceptable “Consultant agrees to assign to E. Lixir & Co. all intellectual property rights, including, without limitation, patents, trade marks and copyrights, in the work performed hereunder.” Acceptable “Any assignment of intellectual property rights shall be subject to the superior rights of the University of Pittsburgh and UPMC, if any, under their respective Patent and Copyright policies, and only after they have waived such rights.” Note: the University does not assert rights in the copyright to “scholarly works.”

18 Speaking Contract Guidelines A contract detailing the proposed services to be provided must be in writing (e.g., an invitation is not sufficient); The Speaker’s Agreement Addendum helps ensure that contract terms will comply with provisions of the IRP (see the Policy Compliance Tools tab within the IRP Web pages of the COI Web site); Compensation for speaking is limited to a modest honorarium not to exceed $2,500 per event, and reimbursement of reasonable travel expenses;

19 Speaking Guidelines (cont’d) Presentation must be designed to promote evidence- based clinical care and/or to advance scientific research; Marketing activities and promotional speaking are not permitted; Speakers must make clear that views expressed are their own, not those of the University/UPMC;

20 Speaking Guidelines (cont’d) Speaker must control content of presentation, and content cannot be subject to company’s approval; Content must reflect a balanced assessment of current science and treatment options, and cannot focus on a single company’s product.

21 Speaking Contract Language Acceptable “ Advisor will speak at a half-day meeting of Balm & Gilead, Inc., to discuss the latest research surrounding the topical treatment of certain allergic drug reactions for an honorarium of $1,200 and agrees that this payment is at fair market value.”

22 Speaking Contract Language (cont’d) Not acceptable “You will receive $5,000 for attending a dinner meeting at Buena Vista Resort where new Tinctures & Tonics, Inc. products will be unveiled.” Not acceptable “Physician shall serve as a Tinctures & Tonics, Inc. advisor for ongoing physician education activities; shall conduct presentations, lectures, and meetings at medical conferences in coordination with T & T, Inc.; and shall conduct training of any employees, sales representatives, or distributors of T & T, Inc. products.”

23 Speaking Contract Language (cont’d) Not acceptable “Pharmacist shall provide presentation materials to Tinctures & Tonics, Inc. at least five days prior to their intended use in order to provide the company sufficient time to review and approve the materials. Presentation must comply with FDA requirements, and speaker agrees not to discuss off-label use of drugs.”

24 Speaking Contract Language (cont’d) Not acceptable “If the Speaker intends to use any materials (e.g., scripts, notes, handouts, slides, etc.) in connection with the presentation that will refer, directly or indirectly, by illustration, text or otherwise, to Autoclaves- manufactured or like products, the materials must be consistent with labeling or other literature provided by Autoclaves, Inc.”

Speaking Contract Language (cont’d) Not acceptable “ The Company may provide you with formal or informal training for speaking on Luscious Lozenges’ behalf. Upon request, the Company will provide you with technical assistance in preparing or making available slides, videos or other audiovisual materials. The Company may from time to time also provide you with suggestions or input on the Company approved presentations.”

Speaking Contract Language (cont’d) Not acceptable “Formal ‘Pharma Profile’ interview for the Apothecary Sales Newsletter focused on experience using the Panacea drug compounding system. This interview will focus on your experience with the product both in teaching and pharmacy work.”

27 Contacts Barbara E. Barnes, MD ; Theresa J. Colecchia, JD ; David T. Wehrle, CPA, CIA, CFE ;

28 For more information… On the University’s COI Web site: COI/Industry Relationship Policy pages: ex.htm