Corporate Integrity Agreement Medical Affairs


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. There is, however, a tension between the two trends. Customer-oriented and proactive information efforts can be commercial in nature. Given that medical teams are more aligned with the trade policy areas, this could compromise the usefulness of the independent perspective and evaluation of medical affairs. We have followed the recent enforcement measures and the corresponding CIA for several large companies. KPMG has taken into account the role of medical cases in recent comparisons. 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. iPad apps can help. An app offers spending limits on meals; Here, technology forms abstract compliance problems in real-life scenarios. Other tools are 30- to 60-second videos that simplify compliance issues. These offer beautiful alternatives to “reading a black and white SOP.” Medical services are playing an increasingly important role for pharmaceutical companies. As the government has tightened its control over drug promotion, companies have withdrawn from the traditional distribution model. Medical affairs have emerged in their wake. You have scientific and clinical experience and you form an important firewall between research and development and the commercial aspect of drug marketing. Medical staff have a lot of work to do, but they can manage important head-of-thinking relationships, present educational information, answer off-label questions from health care providers, and publish test data. 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. 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.” 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. Second, as legislation, regulatory guidelines, sector codes and supplier restrictions have limited the interactions of health care professionals, companies have increasingly focused on medical issues to fill this gap. Two examples were cited in KPM`s presentation