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Meetings at which peripheral activities become the focal point are likely to attract scrutiny.
The US Department of Justice (DOJ) has become increasingly watchful of doctors' participation in consultant meetings. While these meetings represent a valuable opportunity for companies to obtain doctors' advice on clinical research and business strategies, the government believes some companies may be using meetings to promote unapproved uses of drugs or influence doctors' prescribing decisions.
Geoffrey M. Levitt
Within the last three years, DOJ has accused at least two pharma companies of using consultant meetings as a tool to promote company products off label. In the 2003 government investigation of Warner-Lambert relating to the off-label promotion of Neurontin (gabapentin), the government alleged that one of Warner-Lambert's marketing tactics was to solicit opinion leaders or high prescribers to act as "consultants." In fact, the doctors' only responsibilities included attending meetings and listening to presentations about off-label uses of Neurontin, instead of the intended consulting activities.
Warner-Lambert, which was acquired by Pfizer in 2000, pleaded guilty to violations of the Food, Drug, and Cosmetic Act and paid hundreds of millions of dollars in fines to settle liabilities under the False Claims Act and state consumer protection laws. Pfizer also entered into a Corporate Integrity Agreement, which imposed detailed requirements for training, monitoring, operating procedures, and other compliance-related functions.
Cecilia H. Burke
In December 2005, DOJ accused Eli Lilly of employing a similar tactic. Documents filed by DOJ, in connection with the settlement, allege that Lilly sought to broaden the market for Evista (raloxifene)—which had a disappointing first year of sales—by promoting it for unapproved uses. As part of this alleged scheme, Lilly organized a market research summit and other consultant meetings during which the company discussed unapproved uses of Evista. Lilly later calculated the incremental new prescriptions written by the doctors who attended the meetings.
As a result, Lilly pleaded guilty to engaging in off-label promotion of its product Evista in violation of the Food, Drug, and Cosmetic Act. The settlement included $36 million in fines and a consent decree of permanent injunction, which requires Lilly to implement effective training and supervision of its Evista marketing and sales staff and ensure that any future off-label marketing is detected and corrected.
It makes sense that consultant meetings are subject to special scrutiny. Meetings not only involve large numbers of healthcare professionals, but they also can include discussion of off-label information about products as well as entertainment and other social activities. Sometimes these activities, which should be peripheral, become the focal point of these meetings. This is likely to attract government scrutiny.
While DOJ recognizes that these meetings can serve a valid business purpose, the potential for abuse exists due to consultants' ability to prescribe or recommend the company's products. Therefore, pharmaceutical companies must ensure that there is a legitimate business need for the meeting, and that it focuses on obtaining the necessary guidance from physicians.
The recent lawsuits are only one reason why pharma should take the government's concerns seriously. With the implementation of the Medicare Part D prescription drug benefit, DOJ is likely to intensify its efforts to investigate off-label promotion: The government is now responsible for paying a greater share of prescriptions so it has more incentive to ensure that doctors only write necessary scripts.
In light of this heightened scrutiny on pharma/consultant relationships, companies should take precautions to protect themselves from legal trouble. Companies should create new policies on consultant use, or evaluate their existing ones to ensure that they can withstand governmental scrutiny. (Companies can turn to the PhRMA Code on Interactions with Health Care Professionals for guidance on how to review and structure consultant relationships. See "Guiding Light,".)
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.
Laws of the Land Pharma's interactions with healthcare professionals are governed by a number of laws, including:
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 firstname.lastname@example.org