These policies should ensure that a legitimate need exists for all consulting services, consultants are chosen based on their qualifications and expertise and not their prescribing ability, the company's medical department is involved in selecting or validating the consultants' qualifications, and the provided services and terms of compensation are documented in a written agreement.

Policies should also require a rationale for and a limit on the number of consultants invited to the meeting, clearly defined meeting objectives, sufficient time allotted for the consultants to provide feedback, and a method of recording and utilizing the advice obtained at the meeting. In addition, company personnel should be prohibited from evaluating the consultants' prescribing habits pre-and post-meeting.

An effective compliance program demands long-term attention, adequate resources, and support from senior management. Equal effort must be spent communicating the policy to employees, conducting training of staff, developing procedures as needed to support the policy, and performing periodic audits to assess adherence to the policy.

The Food, Drug, and Cosmetic Act

This act prohibits manufacturers from marketing or promoting their products for uses outside of the approved product labeling.

The Anti-Kickback Act

This act prohibits manufacturers from offering anything of value to a customer or potential customer. If one purpose of the payment is to induce or reward the referral or generation of business, payable in whole or part by a federal healthcare program, money, gifts, products, or services are prohibited.

The False Claims Act

This act imposes civil penalties on persons or entities that knowingly submit a fraudulent claim for payment to the federal government. Where a company's off-label promotion results in government reimbursement for the company's product, this may lead to liability under the False Claims Act. This act contains a qui tam provision that allows whistleblowers to bring lawsuits directly against companies for alleged violations of the Act, and to share in any recovery made by the government.

Guiding Light PhRMA offers direction for companies on how to conduct legitimate consultant meetings.

The PhRMA Code on Interactions with Health Care Professionals, which became effective July 1, 2002, distinguishes between bona fide consulting services (where it is appropriate to provide reasonable compensation) and token consulting services. The Code identifies a number of factors that support the existence of a bona fide consulting arrangement:
1) The company has identified a legitimate need for the consulting services in advance.
2) The services to be provided and the basis for payment of those services are documented in a written agreement.
3) The criteria for selecting the consultants are directly related to the identified purpose. Also, the persons responsible for selecting the consultants have the expertise to evaluate whether the consultants meet these criteria.
4) The number of consultants retained is not greater than the number reasonably needed to achieve the business purpose.
5) The retaining company maintains records regarding the consultant relationships and makes appropriate use of the services provided by the consultants.
6) The venue and circumstances of any meeting with consultants are conducive to the consulting services, activities relating to the services are the main focus of the meeting, and any social/entertainment events are subordinate in time and emphasis.

Geoffrey M. Levitt is vice president and chief counsel of regulatory and research at Wyeth. He can be reached at levittg@wyeth.com