SOURCE: Cutting Edge Information

May 08, 2008 09:10 ET

Medical Affairs Departments Step Up Compliance Efforts, According to Pharmaceutical Leader Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwire - May 8, 2008) - A recent study by leading business intelligence firm, Cutting Edge Information, indicates that most pharmaceutical companies have altered the structure and procedures of their medical affairs departments due to increased regulation. According to the study, "Medical Affairs: Delivering Strategic Value," 92% of companies surveyed responded that recent OIG guidelines had significantly impacted their medical affairs structure, while 8% indicated the guidelines had caused a complete overhaul.

In efforts to remove any influence of sales on both science and science information, many companies have chosen to put firewalls in place between commercial organizations and medical affairs. Often, personnel of the two departments can only communicate through specified means or through a meeting of heads of the departments. At some companies, the two sides do not communicate at all.

Beyond communication, many companies have also removed any possible budgetary conflicts. Often, companies will set a dedicated budget or have the funds flow from the clinical side of the business. This separation of funds ensures that medical affairs is not influenced by brand or commercial interests when disseminating information.

Yet, many companies realize the need for different units to at least be abreast of the others' activities. This need is epitomized by the relationship between sales representatives and medical science liaisons. MSLs and sales reps share the same territory and both visit physicians. Coordination of visits is vital to maximizing the efficacy of visits. Furthermore, many MSL groups serve as scientific support for sales groups. Sales reps often require an information source to fully understand their product and ensure proper representation.

"The real challenge for companies is striking a middle ground," says research team leader Elio Evangelista. "Medical affairs departments must be able to determine their own course independent of commercial operations when it comes to science but, in the end, the science is still developed to be sold. So there needs to be some interaction."

"Medical Affairs: Delivering Strategic Value" was designed to explore pharmaceutical companies' medical affairs structures, resources and strategies. Download a free summary of the study or purchase the report at: .

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