small and the scope of services seems to be reasonably well defined. The advisors
seem to have been selected based on their expertise in the areas where advice
is needed. The compensation appears consistent with the Code’s provision
that consultant fees should be reasonable and based on fair market value.
Nevertheless, holding consultant meetings at resort locations is not appropriate
under the Code. The facilities chosen should be conducive to the services provided
as well as reasonable and appropriate to the conduct of the meeting. In addition,
only modest meals may be offered to such consultants, and companies should
not provide recreational or entertainment events to the health care professional
consultants in conjunction with these meetings. It would not be appropriate to
pay for the cost of the spouse of the advisor. If the spouse attends, it should be at
the cost of the advisor.
Q16. Company A considers whether to invite 300 physicians/consultants to
a two-day and one-night speaker-training program at a regional golf
resort. All attendees would be compensated for their participation, and
their expenses would be reimbursed. Prospective speakers would be
selected based on recommendations of the Company’s district managers
and an assessment of their qualifications by the Company’s medical or
scientific personnel. Each of the attendees would be required to sign an
agreement in advance covering the services they will provide. They would
be educated by a faculty on the full range of data surrounding the disease
state and the Company’s drug product, on presentation skills, and on
FDA regulatory requirements.The Company needs to train 300 speakers
in order to ensure that enough speakers will actually be available when
needed. Training sessions take both days, and the Company provides for
a few hours of golf and expensive meals, such as lobster and filet mignon.
Does this program conform to the Code? If so, is it appropriate to pay for a
spouse of the healthcare professional, as well?
A. No. This arrangement would not conform with the Code. Speaker training is
an essential activity because the FDA holds companies accountable for the
presentations of their speakers. However, the Code provides that speaker training
meetings should be held at appropriate venues and specifically states that
resorts are not appropriate venues for training speakers. Moreover, providing
entertainment (e.g., golf) and expensive meals to a healthcare professional in a
speaker training program would not comply with the Code, although modest
meals may be offered to attendees. The Company does appear to satisfy
provisions in the Code that require potential speakers to be selected based on
defined criteria such as medical expertise, knowledge and experience and to
undergo extensive training that would result in a valuable service being provided
to the company. The arrangement also appears to meet reasonable indicia of
a bona fide consulting relationship. The number of speakers being trained is
important; if significantly more participants were trained than the company
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