MARCH 01, 2007

Generic drug industry leaders are rising to support new legislation that would make it illegal to introduce a so-called authorized generic during the 180-day exclusivity period granted by Congress for a generic manufacturer that successfully challenges a patent. The new Sens bill, introduced by Sens John D. (Jay) Rockefeller IV (D, WVa) and Charles Schumer (D, NY), as well as the House version sponsored by Reps Jo Ann Emerson (R, Mo) and Zach Wamp (R, Tenn), would close what generic industry groups consider a loophole in the federal law that was designed to streamline the introduction of cheaper generic medicines.

Under the proposed Fair Prescription Drug Competition Act of 2007, branded pharmaceutical manufacturers will be prohibited from introducing an authorized generic version of one of its own drugs during the 180-day exclusivity period granted by law to the competitor that first secures approval for a generic version.

"The...exclusivity period has spurred competition, resulting in greater availability of safe and affordable medicines," said Kathleen Jaeger, president and chief executive officer of the Generic Pharmaceutical Association (GPhA). Predicting that the bill would "eliminate barriers to bringing generics to market," she said GPhA will work with "House and Senate cosponsors to pass this important legislation."

Although the legislation enjoys bipartisan support on Capitol Hill, some generic industry leaders believe prospects for reform of the authorized generics issue have improved measurably since the Democrats took control of Congress.