Medical and Scientific Affairs
The KLS team understands that today’s medical/scientific affairs department plays a critical role in a company’s success and is an integral part of a meaningful compliance program. The KLS team is well versed in developing and implementing medical/scientific affairs strategies for all sizes of life sciences companies.
While medical/scientific affairs departments are not derived from any statutory or regulatory requirement, they have been developed by industry and encouraged by the FDA and the OIG to facilitate effective and legally compliant communications and interactions between life science companies and healthcare professionals.According to the OIG, separation of sales and medical/scientific functions are critical with respect to research, consulting and grant funding. For instance, the OIG recognizes that many grant-funded activities are legitimate and beneficial, but notes that contracts that originate through the sales or marketing functions—or that are offered to purchasers in connection with sales contacts—are particularly suspect. Additionally, the OIG and DOJ have included recommendations for the establishment of medical/scientific affairs departments or the performance of certain functions by medical/scientific affairs departments, in a variety of Corporate Integrity Agreements (CIAs).
The lack of clear regulatory requirements for medical/scientific affairs departments, combined with the evolving state of the life sciences industry has led to a number of issues for medical device and pharmaceutical companies to consider when establishing and maintaining a medical/scientific affairs department. Our team knows this and has extensive experience working with multiple-sized medical/scientific affairs departments to ensure that it and its interactions with other functional business units align with government expectations and industry best practices while meeting business objectives.