Because of this fine line, MSL teams need clear guidelines for processing off-label applications, including specific SOPs. SOPs can help avoid the risk of illegal interactions between business and medical colleagues. Nadal noted that Bayer has gone from 20 SOPs to “up to 60 or 70 SOPs” in order to completely mechanize the process and bring everything “to a science.” Continued regulatory pressure has shifted many business responsibilities to medical affairs – staff with medical and clinical experience bridging the gap between research and development and the commercial sector. Health professionals understand the complex research behind their drugs and play a crucial role in scientific exchanges between companies and health professionals. Recently, their role has expanded to include health economics and outcome research (HEOR) and pharmacovigilance. Because of the importance of credible medical information and increased control of medical affairs, companies must constantly update their policies and provide interdisciplinary training between medical and commercial services. Due to the lack of clear instructions, business medical services face serious compliance problems. Juan Nadal, Managing Director of Bayer Healthcare, stressed the importance of cooperation between medical affairs and compliance services. At Bayer, they even placed a compliance officer in medical affairs. MSL answers to off-label questions are a hot topic. If an off-label discussion is initiated by a physician (an “unsolicited request”), medical questions may discuss off-label data as part of the application. However, the FDA reviews requests for off-label information that are “solicited in any way” by a manufacturer or its representatives to request applications.
The FDA can provide this evidence that a company intends to use the drug outside of what has been specifically approved or approved by the FDA. Clear strategies, including well-developed SOPs and in-depth communication documentation, are essential for businesses to deal with the off-label issues that medical staff deal with on a daily basis. However, the grey areas – off-label applications for proactive visits to doctors and HEOR discussions with administered markets – are both the most controversial and difficult issues to fully plan. Although there is currently no legal obligation for medical matters, the FDA and OIG encourage them to facilitate effective and law-ad-to-law interactions between life sciences companies and health professionals. Since 2004, several Corporate Integrity Agreements (CIA) have emphasized that the role of medical affairs is an important compliance tool and requires control over medical information activities. Saffron noted that his experience as a KPMG advisor was unique and “refreshing” for Bayer, as it was the Medical Affairs Department that did not require clear compliance or legal guidance, guidelines and guidance on medical communication. Other auditors found that their companies have taken a proactive approach to prescribing clear guidelines. “People in the field need sound bytes,” one person remarked, with a strong emphasis on what they can and cannot say.