This course will focus on the application of legal principles (principally the Federal Anti-Kickback Statute, The Federal False Claims Act, and the federal exclusion authority) to a variety of legal risk areas involving pharmaceutical manufacturers companies. While the laws noted above apply more broadly, the government’s most expansive use of these authorities has been—for many years—directed primarily   against pharmaceutical manufacturers. Government recoveries from pharmaceutical companies typically constitute the vast majority of federal recoveries year after year. 

These pharmaceutical issues are directly transferable to medical device manufacturers and diagnostics companies. The pharmaceutical manufacturer issues also often involve their relationships with managed care organizations, wholesalers, retail and specialty pharmacies, hospitals, physicians, and other   practitioners, showing the broader educational value of this focus. Maryland, as a major pharmaceutical hub, provides numerous employment options for graduates with a working knowledge of the relevant law and issues. 

This course will analyze relevant legal authorities and their application to life sciences arrangements and practices. This will entail exploring related contract, policy, business, pricing, reimbursement, coverage, and other issues. The topics reviewed will include examination of arrangements relating to life sciences marketing, interactions with medical personnel and other providers of health care services, contractual relationships with pharmacy benefit managers, other “middle men”, and distribution chain partners, as well as donations to charities providing patient financial assistance and interactions with third party payors.  

The course will incorporate significant written work, specifically the drafting of two regulatory analysis memoranda for a hypothetical client on an assumed set of facts. In addition, a variety of hypotheticals will be considered as group projects, allowing students to develop their oral advocacy skills in presenting those analyses to the class.