Summer 2020 Course Schedule

Pharmaceuticals & the Law (LAW-719JJ-E001)
Sonali Gunawardhana

Meets: 10:00 AM - 04:30 PM (Su)

Enrolled: 10 / Limit: 22

Administrator Access


Notices

This class meets for immersion class time (via Zoom) on Sundays May 31 and June 7, 2020 10:00 am – 4:30 pm ET, including breaks. Two additional hours of class time will be held remotely later in the summer in the form of online class discussions, pre-recorded modules, or other virtual content.

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.

There is no textbook for this course. Reading materials are all available online at the links provided in the draft syllabus.

First Class Readings

Please complete the reading in advance of class. Reading assignments are provided in the draft syllabus.

Syllabus

Use your MyAU username and password to access the syllabus in the following format(s):