MEMORANDUM

SUBJECT:

Faculty At Risk in Relationships with Pharmaceutical/Medical Device Companies

Mr. James Sheehan, U. S. Attorney of PATH fame, gave a recent presentation on federal enforcement activities directed against drug/device manufacturers. He highlighted the implications of recent government successes, such as the TAP case (promoting drug switching through a kick-back arrangement) and the improper promotion of Neurontin (Pfizer) for off-label uses. The government is aggressively pursuing a theory that improper payments and other methods are being used to distort clinical decision-making. This memo should serve to alert you to enforcement activities that carry a potential for faculty to become involved in an investigation of a manufacturer.

Paid Consultant Arrangements. It is illegal for a manufacturer to promote the "off-label" use of a drug/device. In lectures or papers, faculty can promote off-label uses based on their professional opinion. However, a faculty member who is paid to give a presentation or has other financial relations with a drug/device company and advocates an off-label use could be viewed as providing "off-label marketing" and be held personally liable if implicated in a government investigation of the company. Be aware that UC policy may not extend legal defense for activities found to be illegal.

Self-assessment questions:

a. Do you have any financial relationship with a firm for which you advocate the use of its product? Are you being paid to give a talk? Do you receive research support, an educational grant, or support for your training program from the company? Are you a consultant to the company? Are you ghost writing papers or presentations for the company? Did the manufacturer's marketing or sales staff initiate the agreement or direct the research or grant?

b. Does the lecture or paper broadly discuss a topic and the various drugs/devices used in that field or does it focus on the one drug/device produced by the sponsoring company? Does the company limit or control what you can say? Is the information presented complete, truthful, accurate and unbiased or could it be characterized as false/misleading promotion of a product? Is your financial interest and industry sponsorship revealed in the lecture materials? (Financial interest disclosure is required for all programs carrying UCSD CME accreditation).

c. The government is also investigating alleged instances of improper influence by companies on clinical decisions at academic medical centers. Does your relationship to a company raise conflict of interest considerations? Do you participate in any UCSD purchasing or product selection decisions regarding a company with a financial relationship to you? This could constitute a violation of UC policy and implicate you in a government investigation. Have you revealed the existence of a conflict? Do you excuse yourself from product selection decisions? Do you receive any form of financial support from the company? Consultant fees, research grants, support of your department or your trainees?

Other Improper Influences By Manufacturers. False or misleading information; paying agents to make formulary recommendations; offering samples for physicians which are then resold; gifts, payments, and other compensation arrangements can be suspect. Sensitive areas include;

a. "Unrestricted educational grants": A grant for unspecified educational purposes is suspect. ACCME accreditation of CME courses, prohibit the company from controlling the content of the program. However, a company can direct funds to a specific CME program.

b. Compensation must pass a Fair Market Value test. Excessive payment or an unreasonable consultant fee raises suspicions. Is the compensation appropriate for the work and time (effort) involved? Is the payment for bona fide consulting or advisory services?

c. So called "consultants meetings," where doctors receive a fee for attending a conference covering a company's drug are suspect.

d. Preceptorships. Practice of paying doctors a grant or a stipend to allow a company representative to accompany the doctor during patient care and the representative offering advice regarding the patient's treatment to promote the use of company drugs. Legitimate educational activities for company representatives are allowed, but should be approved by the CME Office. Company representatives can participate in patient care, for example, in monitoring defibrillator performance, but this should be based on a contract between the company and UCSD.

e. Provision of drugs as samples which are then administered for a fee by the physician.

f. After market "research" where the physician receives an excessive fee for supplying data, but the real purpose is to switch the patient to a drug/device produced by the company.

The propriety of any particular arrangement can only be determined after examining the facts and circumstances of that situation. A practice which is "suspect" may not be illegal or it could be properly structured. Therefore, if you are involved in any situations identified in this memo you should seek advice from the Compliance Office (619-471-9152) or the Compliance Officer, Dr. Mittman (619-543-2664). Be careful with new and existing business relationships. All new agreements and contracts need to be reviewed by UC through the Vice Chancellor's Office (Robin Samit 858-822-3474) to protect you and UCSD. Do not sign agreements on behalf of UCSD; authority to do so is limited to certain personnel. You should never sign a contract or similar document without prior legal review.

Charles Mittman, M.D., Corporate Compliance/ Privacy Officer