Medicare Prescription Drug, Improvement, and Modernization Act of 2003

Tags:

Mission:

Competition

Law:

Pub. L. No. 108-173, 117 Stat. 2066, codified in relevant part at 21 U.S.C. § 355(j) (Section 1102), 21 U.S.C. § 355 note (Sections 1111-1118)

Section 1102 provides that an applicant for an abbreviated new drug approval may forfeit certain exclusive marketing rights in specified circumstances, including an FTC or court determination that the applicant has entered into an anticompetitive agreement with certain other entities. Sections 1111-1118 require agreements between brand-name and generic pharmaceutical companies regarding the manufacture, marketing, and sale of generic versions of brand-name drug products to be filed with the Commission and DOJ.