Generic drug industry leaders arerising to support new legislationthat would make it illegal to introducea so-called authorized genericduring the 180-day exclusivity periodgranted by Congress for a genericmanufacturer that successfullychallenges a patent. The new Sensbill, introduced by Sens John D. (Jay)Rockefeller IV (D, WVa) and CharlesSchumer (D, NY), as well as theHouse version sponsored by RepsJo Ann Emerson (R, Mo) and ZachWamp (R, Tenn), would close whatgeneric industry groups consider aloophole in the federal law that wasdesigned to streamline the introductionof cheaper generic medicines.
Under the proposed Fair PrescriptionDrug Competition Act of2007, branded pharmaceuticalmanufacturers will be prohibitedfrom introducing an authorizedgeneric version of one of its owndrugs during the 180-day exclusivityperiod granted by law to thecompetitor that first secures approvalfor a generic version.
"The...exclusivity period has spurredcompetition, resulting in greateravailability of safe and affordablemedicines," said Kathleen Jaeger,president and chief executive officerof the Generic PharmaceuticalAssociation (GPhA). Predicting thatthe bill would "eliminate barriers tobringing generics to market," shesaid GPhA will work with "Houseand Senate cosponsors to pass thisimportant legislation."
Although the legislation enjoysbipartisan support on Capitol Hill,some generic industry leaders believeprospects for reform of theauthorized generics issue haveimproved measurably since the Democratstook control of Congress.