FDA Issues Final Hatch-Waxman Rule Implementing Certain Provisions of the 2003 Medicare Modernization Act

Following is an excerpt from the Executive Summary (Click here for the Final Rule; 81 FR 69580)

“Title XI of the MMA addressed two key concerns identified in a Federal Trade Commission (FTC) report on anticompetitive strategies that may delay access to generic drugs by: (1) Limiting the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved and (2) establishing conditions under which a first applicant would forfeit the 180-day exclusivity period such that approval of subsequent ANDAs would no longer be blocked. FDA has been implementing the MMA directly from the statute since its enactment. Based on this experience, FDA is amending its regulations to implement portions of the MMA that pertain to 30-month stays and other matters not related to forfeiture of 180- day exclusivity.”  Click here to learn more about development of complex generics.