Pharmacy Times, Volume 0, 0

The generic drug industry-supported legislation thatdirects the FDA to developnew ground rules for theapproval of generic biotechproducts has climbed to thetop of the congressional agendathis year in both the Houseand the Senate. Legislationwas introduced in both chamberslate last year by leadingDemocrats, including CaliforniaCongressman HenryWaxman and New York SensCharles Schumer and HillaryClinton. Although that bill languishedin committee underthe Republican leadership, theplan is expected to comeroaring back to life this yearwith Democrats now in controlof both houses of Congress.

Because development of atruly equivalent generic biotechproduct is more difficultand complicated than the productionof traditional genericdrugs, enactment of the industry-backed legislation wouldnot necessarily trigger an immediateupsurge in the availabilityof low-cost versions ofbiotechnology medicines.Instead, it would permit theFDA to determine whethergeneric manufacturers needto repeat expensive humanclinical trials in order to documentthe equivalency of theirproducts.