Clinical Compliance Programs: Investigator Payments, GCPs, and More….

Clinical Compliance Programs:Investigator Payments, GCPs, and More…. Teri Crouse, J.D. Director of Compliance for Healthcare & Marketing

High Level Overview • …And More • OIG Guidance and Medical departments • CME / ACCME • Field-Based Medical Personnel • Transparency and Firewalls OR • How to achieve separation between commercialization and medical/scientific areas

Counseling Medical on OIG Compliance • What is your client’s current perspective on compliance? • Medical generally: GCP mentality, process/SOP focused • OIG focus is INTENT: Not just what, but also why

Grant ($) Pharma Company Healthcare Provider INTENT Purchase ($) “Intent” and “One Purpose” • Question is intent: not impact, not amount, not whether legitimate service was rendered,… • Kickback if any one purpose of offer is to induce …

Opportunities to establish perceptions of improper intent are numerous • Example: Investigator-initiated grant program • At initiation of request • Prior to consideration • During consideration • When communicating decision • During conduct of research The standard of scrutiny • “There is no true intent, only perception of intent”

“Intent” and Investigator Payments • Difficult to get Medical/Scientific areas to understand the “follow the money” mentality • Fair Market Value • What work is being performed? • What is the value of the researcher’s time “on the market”? • Are you hiring a world thought leader? • A regional thought leader? • Can this site / investigator speed up your trial? • He / she has a large pool of potential patients • He / she has a proven track record in conducting clinical research and following GCPs

Question of intent in Medical Science Liaison role: • MSLs provide special medical expertise in addressing HCP questions regarding company products • vs. • MSLs discuss company products with HCPs to promote off-label uses of company products “Intent” and off-label promotion • Question of intent in medical research: Conduct and publish off-label studies to answer important scientific questions and disclose those answers to the medical community vs. Conduct and publish off-label studies to promote off-label use through investigators’ study experience and physicians hearing study results

“Intent” and the For-Profit Pharma Company • “But ultimately, isn’t everything we do • designed to sell our products?” • Intent vs. consequence • General intent vs. specific intent

Ensuring Behaviors Align with a Valid Intent • Exercise: • Clearly define the purpose of your activity, • Vigorously align your actions with that purpose • Challenge anything that creates contrary perceptions

Ensuring Behaviors Align with a Valid IntentExample: Investigator-initiated Grant Program • Roles of Medical and Marketing • Funding source • Communications with requester • Consideration of request • Monitoring progress of research • Valid decision-making • Criteria for decision-making • Application of criteria • Source of request • Amount of request • Follow through • Structure of grant support • Monitoring progress

ACCME and CME • Increasing concern over “control” by sponsors • Reaction: increased stringency on conflict of interest rules • Increased stringency toward role of sponsor in CME • What is the future of Pharma-sponsored CME?

Confusion over Field-Based Personnel • Sales reps vs. Medical Science Liaisons • Promotional or not? • Where to draw the line

Role of the Sales Representative • To detail customers on your products • To provide samples • To provide customer service • They are the face of your company to your customers • - Being Responsive, but not always the Responder

Role of the Medical Science Liaison • To interact with Thought Leader physicians • To develop relationships with potential research physicians • To help evaluate potential research physicians • To answer questions (not to prompt questions!) • To provide customer service They are also the face of your company to your customers - Being Responsive, but not always the Responder

A hypothetical situation • A customer asks a sales rep if the company could provide funding for an upcoming regional medical society conference. • Does the rep respond: • Can you tell me how many other doctors on my call list will be there and will there be a presentation about my product? • No problem doc, since you are such a big writer. • C) You will have to submit a grant request to the appropriate department at my company. Here’s the information on how to submit your request.

A hypothetical situation • A customer tells a sales rep she is considering doing a small study with your product and wants to know if she could get a research grant. • Does the rep respond: • I’ll check with my district manager. I think he has some extra money right now. • Only if you’re going to purchase the product. • Our medical department evaluates all research funding requests based on the scientific merit of the proposal. I can only provide you with the contact information for that department.

A hypothetical situation • A customer asks your rep to do a literature search for information about one of the known side effects of your product. • How does the rep respond: • Runs to the university medical library and copies all the articles he can find. • Tells the doctor not to worry about that side effect, it’s really not a big deal. • Tells the doctor he will submit a request for your medical department to send the information they have related to the side effect.

A hypothetical situation • While your rep is making a sales call on a customer who is being considered for participation as a clinical investigator, the customer complains that they have contacted the medical person at your company with a question, but haven’t received back a reply. • How does the rep respond: • Tell me your question, and I’ll contact the medical person again for you. • Tell me your question, I can probably answer it for you. • I will contact the medical person or their supervisor and ask them to get back with you as soon as possible.

Policy & Procedures Corrective Actions Owner Compliance Program Implement a complete Compliance Program Discipline Process Training Monitor & Audit Communication And the answer is…. • How can you be certain that your sales reps would know that only answer C is appropriate in each of these hypothetical situations?

Summary • In order to maintain the “firewall” between Sales & Marketing and Medical Personnel • Develop clear policies and procedures • Provide training on ”real world” scenarios • Monitor to assure compliance • Take corrective action, if necessary

Clinical Compliance Programs: Investigator Payments, GCPs, and More….