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Pharmaceuticals & Law (LAW-719-009)
As government increasingly determines the environment for how drugs are developed and delivered to patients, it is critical for biopharmaceutical manufacturers to engage in the policy realm to promote patient access to appropriate care and to preserve medical innovation. This course will provide an introduction to the range of legal and policy issues relevant to the pharmaceutical industry, including: 1) the regulatory regime governing drug development, approval, and promotion; 2) the 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) intellectual property protections for biopharmaceuticals, including patents and data exclusivity; and 6) product liability and biopharmaceuticals. This is one of four courses focusing on Pharmaceutical Law that can be counted towards a Pharmaceutical Law Certificate from American University Washington College of Law. 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.
The syllabus is available in the following format(s):