Drug Regulation: Current Issue

Catalog description

Elective Course Course Requirement: final paper Fulfills Current Concentration Elective: Business Law- Corporate Governance and Transactions Track, Business Law- Health Care Law Track, Government- Basic Government Track, Government- Health Law Track, Litigation- Civil Litigation Track, Litigation- Criminal Litigation Track From opioids and new pharmaceutical drugs to recreational and medicinal marijuana, this course examines government regulation of drugs, both lawful and illicit. Specifically, the course will explore federal regulation of drugs subject to the jurisdiction of the U.S. Food and Drug Administration (FDA) and address the public policy choices underlying the substantive law, FDA enforcement power, expedited approval of cancer drugs, compassionate use of experimental drugs, safety of prescription drugs, and drug advertisement restrictions. The course will also examine the Drug Enforcement Administration and consider marijuana legalization, using it as a paradigm for unpacking issues of state jurisdiction, federalism, preemption, and business regulation, to name a few. Also considered will be drug product liability litigation including similarities and differences between pharmaceutical cases and other product liability cases and the legal doctrines governing such lawsuits such as failure to test, inadequate warning, preemption, and medical causation. This will afford an opportunity to consider the practical application of these doctrines, evidentiary problems with expert witnesses, and jury instruction and selection strategies. Weaving into discussions throughout the course will be thorny legal and policy issues including: meanings of possession or distribution of an illicit drug; eliminating mens rea requirements for simple drug possession and due process implications; calculating drug quantities for purposes of sentencing; the impact of drug laws on…