Pharmaceuticals & the Law (LAW-719JJ-001)
Daniel Kracov
Meets: 09:00 AM - 05:00 PM (WTh) - Yuma - Room Y404
Enrolled: 11 / Limit: 22
Notices
There are no notices at this time.
Description
As the government determines or influences virtually every aspect of how drugs are developed and delivered to patients, it is important to understand the complex framework governing pharmaceutical innovation and patient access to new therapies. This course will provide an introduction to the range of legal and policy issues relevant to the biopharmaceutical industry, including: (1) the regulation of drug and biologic development, approval, and promotion; (2) laws and regulations governing access to biopharmaceuticals and other types of care under large government healthcare programs; (3) fraud and abuse laws and regulations and "transparency" policy trends, including disclosure of and restrictions on interactions with healthcare providers; (4) "healthcare reform" policy trends, including cost containment, expanding coverage for the uninsured, and improving the quality of healthcare; (5) statutory intellectual property protections for biopharmaceuticals, including patent-related processes and various exclusivities; (6) the interplay between biopharmaceutical regulation and product liability; and (7) First Amendment issues arising in the regulation of various pharmaceutical industry activities.
Textbooks and Other Materials
The textbook information on this page was provided by the instructor. Students should use this information when considering purchases from the AU Campus Store or other vendors. Students may check to determine if books are currently available for purchase online.
Course materials/reading list are accessible are generally available online or provided at the links below. Course materials consist of pertinent articles, cases, government enforcement guidance and the like. Students are expected to complete all of the assigned reading.
First Class Readings
Congressional Research Service, How FDA Approves Drugs and Regulates Their Safety and Effectiveness (https://fas.org/sgp/crs/misc/R41983.pdf)
Beaty v. FDA (http://legaltimes.typepad.com/files/beaty-opinion.pdf)
FDA Admissibility Determination for Sodium Thiopental Entry (https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/ORA/ORAElectronicReadingRoom/UCM555224.pdf)
Syllabus
Use your MyAU username and password to access the syllabus in the following format(s):
Microsoft Word (DOC)