MSL-KOL Engagement: Ensuring Compliance23 Aug 2011 • by Natalie Aster
After its initial function to build rapport with KOLs, the MSL role has evolved from being a support to sales reps to the forefront of pharmaceutical practice. Lode Dewulf, chief medical affairs officer at Brussels-based UCB, reflects on this central transformation in the pharma business. “In many ways, MSLs have developed as a new role over the past two decades as did the Medical Affairs function itself,” he says. “Medical Affairs now has the mandate for all medical activities related to marketed products and also provides input to both clinical development and to commercialisation. Within Medical Affairs, the MSLs are the field-based medical partners for physicians and other healthcare stakeholders.”
Yet with that role has come a responsibility to comply with regulations governing off-label promotion. Once deemed ‘a cost of business’, fines are now ‘big business’: In September 2009, Pfizer paid $2.3 billion to settle charges of improperly promoting four products. The question is, how does the industry ensure, and be seen to ensure, no off-label promotion?
FirstWord’s report, MSL-KOL Engagement: Ensuring Compliance offers a rare look at how Medical Science Liaison (MSL) balances the needs of good KOL engagement with the regulatory requirements and laws around off-label promotion.
MSLs walk a fine line between connecting with physicians who may report using products off-label and complying with the regulatory rules on off-label promotion. They need to ensure that they follow the regulations to avoid serious legal and financial penalties to the companies they work for. In an emerging and sometimes contentious field, MSL-KOL Engagement: Ensuring Compliance provides professionals with up-to-date insights, expert opinion and advice from both a US and EU perspective.
Published: June 2011
Price: US$ 495.00
How can MSLs reduce their risk of breaching regulatory requirements when their company’s products are used off-label? MSL-KOL Engagement: Ensuring Compliance examines how MSLs are being used to engage physicians in a way that traditional sales no longer can. Casting a net over the current regulatory environment both in the US and EU, the report addresses the increasingly critical need for MSLs to be compliant with the rules on off-label promotion while also connecting with physicians who may be using a product for “off-label” use. Offering insight into the increased scope of the MSL and the importance of having Standard Operating Procedures in place, the report delves into tracking and reporting, compensation metrics and key enforcement policies.
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