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Sales Team Training Requirements to Avoid Off-label Promotion: Best Practices for Social Media
Two aspects of pharmaceutical product promotion have had game-changing affects on the promotion and marketing of such products. One is the often discussed off-label promotion and another is impact of Sunshine Act on doctor-sales rep interactions. Both of these have elevated the number of digital interactions, mostly through social media, critical for all pharmaceutical sales personnel. FDA has publicly acknowledged that many regulated products have uses beyond what they have been approved for. FDA also recognizes that these unapproved uses may be beneficial to some patients. The so-called off-label uses may be well-known to the physicians and manufacturers. While there are no restrictions on a physician prescribing off-label uses of a product, manufacturers are prohibited for “actively” promoting an off-label use. However, FDA has recently released some rules under which manufacturers and sales personnel can indeed educate the physicians and, indirectly, even patients about new uses of their products. Since the implementation of Sunshine Act, physicians are increasing reluctant to directly meet with sales reps and rather expect more digital interactions than in-person. This seminar will discuss the regulatory perspective on training your sales and marketing teams to interact with doctors and other medical professionals using social media.
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Why should you attend:
Recently the US courts have made some high-profile decisions regarding FDA’s punitive actions to manufacturers accused of off-label promotion. The Caronia and Amarin cases, have been in much discussion since in that case the court sided with the defendant accused of off-label promotion leading to speculation of its impact on FDA’s enforcement of its rules regarding off-label promotion. The legal discussion apart, these cases have raised new regulatory questions about FDA-acceptable practices for promoting off-label uses for approved products. Also, the Sunshine Act reports created intense media scrutiny of doctor-pharma interactions leading to doctors being increasingly inaccessible to sales reps. These developments have changed how sales force, doctors and other medical professionals interact. This seminar will discuss the training of sales teams in the new regulatory and marketing scenarios using social media is a pivotal tool.
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