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As we begin a new year, we are switching
gears from discussing pharmaceutical marketing research’s role
in the reporting of Adverse Events (AEs), which has been our focus since
Topline's debut in October, and turning our attention to a
new regulatory topic rearing its head in our industry, “message-monitoring
research” or marketing research being conducted to demonstrate
compliance with detailing “on-indication.”
With the advent of Medicare Part D and the cost of drugs being shifted
its way, the federal government has great incentive to ensure that drugs
are promoted and used only for the specific indications for which they
are approved. Pharmaceutical companies that have been found guilty of
promoting their products off-label, via their sales representatives’
interactions with physicians, are now being required to conduct message-monitoring
research as part of consent decrees they sign with the government.
Developing a message-monitoring research project is not as simple as
it sounds, however. The pharmaceutical company and the marketing research
agency it selects to conduct the research must interact with, and obtain
approval from, the Office of the Inspector General (OIG) in a number
of key areas in the message-monitoring research process, such as the
methodology used (“aided recall” versus “unaided recall”),
timing of research waves and the selection of the types of questions,
physicians and sample sizes to be included in the project. It is important
to note that the OIG’s knowledge of, and involvement with, message-monitoring
research projects is still relatively new. Therefore, researchers working
with the OIG should not expect to hear hard and fast guidelines in such
matters, but should attempt to establish a partnership with the OIG
representative aimed at working through a mutually satisfactory process
for compliance.
As the government further tightens enforcement on off-label promotion
and as litigation between pharmaceutical companies increases, pharmaceutical
marketing researchers will be called upon more frequently to provide
assistance in the collection and analysis of data that will be used
by attorneys to attempt to satisfy the federal government, win a civil
suit, etc. In anticipation of this, researchers should know that their
work is likely to be challenged on various fronts and they should begin
working now to develop the core competencies needed to respond to this
new regulatory environment.
To download the complete January 2007 discussion on message-monitoring
research in the new regulatory environment, click the link on the graphic
image above.
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