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.
What Companies Should Do
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,".)