Medicare Prescription Drug, Improvement, and Modernization Act of 2003





Pub. L. No. 108-173, 117 Stat. 2066, codified in relevant part at 42 U.S.C. § 1395w-101 note (section 110), 21 U.S.C. § 355 note (sections 1111-1118), 21 U.S.C. § 355(j)5 (section 1102))

Section 110 of this Act requires the FTC to study and to issue a report on differences in payment amounts for pharmacy services provided to enrollees in group health plans that utilize pharmacy benefit managers, along with recommendations regarding any need for legislation to ensure the fiscal integrity of the voluntary prescription drug benefit program. 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. In addition, it requires the filing of certain agreements between generic drug manufacturers if both have filed certain types of applications with the U.S. Food and Drug Administration for the same brand-name drug product. Section 1102 further provides that the 180-day period of marketing exclusivity given to certain generic drug applicants will be considered forfeited if there is a binding determination in a FTC or DOJ action that an agreement with another applicant violated antitrust laws.