Pharmaceuticals and the Law (Online) (LAW-719JJ-E001)
Sonali Gunawardhana
Meets: 11:00 AM - 04:00 PM (Su)
Enrolled: 11 / Limit: 22
Notices
This course will meet virtually (on Zoom) on Sundays, 6/5, and 6/12 from 11:00 am - 4:00 pm ET (with 30 minutes of break each day). Three hours of additional class time will be experienced independently by students through asynchronous material. Students are required to have a device with a working microphone, camera, and internet connection to be able to fully engage and participate in all aspects of the virtual classroom lectures, discussions and exercises. Attendance will be taken and attendance in all class hours is required to receive academic credit.
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 introduce students to the broad range of legal and policy issues that impact the biopharmaceutical industry in the United States. Through reading materials, lectures and discussions, students will explore the complex regulatory framework governing pharmaceutical innovation and patient access to new therapies. Emphasis will be placed on students learning about drug pricing and regulation of drug plan financing (including pharmacy benefit management and rebate regulation) and the regulation of drug and biologic development, approval, and promotion. Additional topics that will be covered include: (i) fraud and abuse laws and regulations and "transparency" policy trends, including disclosure of and restrictions on interactions with healthcare providers; (ii) healthcare reform policy trends; (iii) statutory intellectual property protections for biopharmaceuticals; (iv) First Amendment issues arising in the regulation of various pharmaceutical industry activities; and (v) the interplay between biopharmaceutical regulation and product liability.
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.
This course does not use a textbook. All readings will be posted in the syllabus and/or on Canvas.
First Class Readings
Information about course readings are included in the syllabus.
Syllabus
Use your MyAU username and password to access the syllabus in the following format(s):
Adobe Acrobat (PDF)