Quality of the estimate. December, p. 47 - Health Care Compliance ...

showed that the company viewed
its continuing medical education
(CME) program as an effective
promotional program for
Neurontin’s off-label use.
The government often scrutinizes
companies that hire medical
professionals to do what the
companies perceive sales representatives
cannot do under US Food
and Drug Administration (FDA)
guidance. In the Warner-Lambert
case, for example, the medical
liaisons from the Medical Affairs
department allegedly “initiated
off-label promotions by raising
off-label subjects” and presented
themselves to HCPs as scientific
experts when, in fact, they were
not. The government suggested
that the medical liaisons had a
deceptive air about them and
allegedly succeeded in accessing
physicians (whom sales representatives
had been unable to access)
because they gave the appearance
of having a scientific background.
Warner-Lambert ultimately pled
guilty and agreed to pay more
than $430 million, in addition to
executing a CIA requiring largescale
compliance efforts by the
company. The CIA included the
requirement that Warner-Lambert
(now Pfizer, Inc.) implement policies
and procedures that address
sponsorship or funding of research
or related activities (including
clinical trials, market research, or
authorship of articles and other
publications) that are designed
to ensure that company funding
or sponsorship of such activities
complies with all applicable
regulations and requirements. 2
Additionally, the 2009 Pfizer CIA
demonstrates the risks associated
with medical liaisons being perceived
as Sales field counterparts,
as opposed to Medical Affairs staff,
allegedly causing off-label HCP
discussions to take place. Indeed, as
part of its 2009 CIA, Pfizer agreed
to apply provisions of its CIA to
Medical Affairs personnel and their
participation in HCP interactions
at meetings or events and clarify
their role at such events. 3
CIAs and government complaints
have signaled a common focus
on payments to physicians that
allegedly occurred under the guise
of traditional Medical Affairs
educational activities. Some
examples include grant program
payments relating to “observational”
patient studies, consulting
arrangement fees, and advisory
meeting expenses. 4 Further,
although investigator-initiated (or,
“investigator-sponsored”) clinical
trial grant programs encourage
physicians and clinical investigators
to study drug company
products and release their findings,
the government may view
them as kickbacks in exchange
for referrals. Significantly, at least
three pharmaceutical manufacturers
(AstraZeneca, Novartis, and
Allergan) currently operate under
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
CIA-mandated business policies
related to investigator-initiated
trials. Notably, all three company
CIA’s use nearly the exact same
language throughout the Investigator
Sponsored Trial (IST)
section, changing only the name
of the company and the amount
of days each company is given to
complete their duties. All three
CIAs require each manufacturer
to enter into written agreements
describing the scope of the clinical
research or other work to be
performed, the fees to be paid,
and compliance obligations for
the researchers. 5
Each CIA also requires researchers
to be paid according to a centrally
managed, pre-set rate structure
that is determined through a
company-conducted fair market
value (FMV) analysis. Annual
budget procedures must also be
created that identify the scientific
or business need for the researchers,
how many will be required,
the activities to be performed,
and the projected cost of those
activities. Compliance personnel
are also encouraged to review the
budgets to ensure that they are
being used for legitimate means.
CIAs also require a needs assessment
to be completed prior to
obtaining researchers. The needs
assessment is to identify the
business or scientific need for the
information to be provided by
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December 2011
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