House Bill Would Speed Generic Drug Approval Process

Generic versions of brand-name prescription drugs could be "brought to market" more quickly under legislation introduced yesterday by Reps. Sherrod Brown (D-Ohio) and Jo Ann Emerson (R-Mo.), CongressDaily/AM reports. The Greater Access to Affordable Pharmaceuticals Act, the House version of Senate legislation (S 812) introduced two weeks ago by Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.), aims to close certain "loopholes" in the 1984 Hatch-Waxman Act, which grants brand-name drug makers longer patents to "make up for" FDA approval delays. Brown said that some drug manufacturers have found ways to "fend off" generic competitors, including paying them to delay marketing of approved generic versions of certain drugs. In other cases, Brown added, "Changing the color of a pill or the pill bottle is sometimes enough to get you a new patent." The measure would "make it easier" for generic drug makers to "overcome efforts to block marketing" of their drugs. In addition, the measure would pass a six-month period of "exclusivity" -- given to the first generic maker of a drug -- on to a second drug maker if the first manufacturer delayed sale of its product. While generic drug makers support the legislation, the Pharmaceutical Research and Manufacturers of America said the measure "would overturn the careful balance" struck in the Hatch-Waxman law and "undermin[e]" incentives to research new drugs (Rovner, CongressDaily/AM, 5/17).