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Meets 6/16-17 9AM-5PM
As the government increasingly determines 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; and 6) the interplay between biopharmaceutical regulation and product liability. This is one of three courses focusing that can be counted towards a Pharmaceutical Law Series Certificate of Completion. Academic credit requirement: Take home exam, due 3 weeks after the course ends.
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 here to determine if books are currently available for purchase online.
First Class Readings
Not available at this time.