This course will examine laws administered by the U.S. Food & Drug Administration with a focus on the regulation of drug development and drug sales. Topics to be covered include the new drug approval process, regulatory obstacles to generic drug competition, regulatory sources of exclusivity in drug markets including the Orphan Drug Act and the Hatch-Waxman Act, reimportation of approved drugs from abroad, internet drug sales, prescription versus over-the-counter drug sales, and regulation of advertising claims made to physicians and consumers. We will also consider the relationship between drug regulation and other laws, including patent, antitrust and tort laws. Time permitting, we will examine recent state legislative measures designed to reduce the costs of new drugs. There will be no final examination. Students will be required to write a 25-page research paper.
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