Events Reporting System (AERS) of the FDA
which also continuously assesses the safety of
marketed drugs. This is often supplemented by
internal safety databases that are maintained by
pharmaceutical companies separately from gov-
ernmental databases.
Advertising, promotion and training
overview
This activity often described as ‘The Medical and
Social Conscience of a company’ largely resides
in the Medical Affairs department. In most large-
and medium-sized pharmaceutical companies this
responsibility lies with Medical Affairs. The
review of all materials, whether detail pieces pro-
vided in person to physicians in practice, slide sets
for speakers on behalf of the company, general
promotional material that is disseminated via
print, radio, TV or web must be reviewed and
approved by internal committees comprised of
Medical Affairs staff, regulatory and legal person-
nel. In addition to the company review, this mate-
rial must be sent to FDA at least by the first day of
use. Review by FDA’s DDMAC should be sought
for TVadvertisements.
In addition, any Field Sales instructions, Public
Relations, Financial Analysts Statements and Press
Releases should be reviewed for appropriateness
and approved or modified. Such review will also
involve both the Legal and Regulatory Affair
departments. Moreover, materials for medical liai-
son activities, communications to third party
insurers and responses to other inquires should be
reviewed prior to release. This is an important role,
given the significance for the company and time-
line pressures.
Medical science liaison (MSL) function
MSLs were introduced by the Upjohn Company in
the 1970s, initially as a scientific communication
tool to academia. The function has subsequently
been refined and now incorporates the dual func-
tions of scientific communication to key opinion
leaders (KOLs) and interaction with the same,
facilitating more direct and consequential interac-
tion of the scientific community with pharmaceu-
tical companies. KOLs can be recognized on an
international, national, regional or district basis,
and their involvement in increasingly earlier stages
of development enhances the relevance and
focuses the direction of pharmaceutical research.
MSL officers are scientists with MD or PhD or
PharmD qualifications. They are usually specia-
lized in an area of research, and thus, are often
experts in their own fields. Because they are usually
Medical Affairs employees, they do not report to
Sales and their job metrics are not determined by
commercial success. The separation of Sales and
MSL activities is important as otherwise would
lead to regulatory and legal ramifications.Continuing medical education
(CME) activitiesCME and associated credit requirements have
to be earned by health practitioners in most wes-
ternized countries to ensure that physician
knowledge and practice are up to date. The pro-
viders of this education may be universities,
professional associations or not-for-profit firms
or departments that are separate from sales
organizations within pharmaceutical companies.
Pharmaceutical manufacturers may provide
funding for these events, but may not be involved
in other aspects of the programs. In the United
States, the courses must comply with the relevant
accrediting bodies, and are subject to scrutiny
and monitoring.
Pharmaceutical companies are often requested
to financially support these programs. These
monies must not be disbursed by the company to
a given individual, but to the organization respon-
sible for the CME program (though this is often
administered by a third party, independent of either
provider or sponsor). In order to maximize inde-
pendence, often the budgets have been taken out of
Marketing and Sales and placed under the Medical
Affairs department, with an oversight committee
that ensures appropriateness of the grants. Speak-
ers at meetings are required to disclose any real or
potential conflicts of interest, including financial37.5 PRACTITIONER AND INVESTIGATOR INTERACTION 525