Pharmaceuticals and the Law (LAW-719JJ-001)
Meets from 6/14-6/15. Students may earn academic credit for up to two credits per week in the summer semester (excluding full semester courses). This course counts toward the two credit per week limit. To register, email firstname.lastname@example.org.
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, "value-based" payment methods for drugs, 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.
This course will not use a textbook. Instead, required readings will be listed in the course syllabus. Required readings will include pertinent articles, cases, government enforcement guidance, and the like. Required readings will be accessible through on-line resources or will be posted to MyWCL.
First Class Readings
As explained in greater detail in the syllabus, students must complete certain reading assignments in advance of class.
Use your MyAU username and password to access the syllabus in the following format(s):