Labeling Language of Pediatric Exclusivity Law Causes Friction
A provision in the pediatric exclusivity bill passed with unanimous consent by the Senate last week is "creating friction" between generic and brand-name drug makers, CongressDaily reports. The provision says that even when a brand-name drug receives three years of exclusive marketing rights for stating new pediatric uses on its label, generic companies can continue to sell their version of that drug for use in adults (Fulton, CongressDaily, 10/22). The bill (S 838), sponsored by Sens. Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio), would reauthorize 1997's FDA Modernization Act, granting drug companies that conduct clinical research on a drug's effectiveness in children a six-month patent extension on that drug. It would also expand the law to include newborns, establish an FDA Office of Pediatric Therapeutics and set up a "privately funded foundation" to research other drugs "commonly used by children." (California Healthline, 10/22). Generic drug makers say the labeling provision "merely clarifies current law," adding that the Senate bill would allow HHS to require warnings on the labels of generic drugs that are not approved for use in children. But CongressDaily reports that Bristol-Myers Squibb, whose adult diabetes drug Glucophage has received both the three-year marketing exclusivity provided by the labeling law and the six-month exclusivity provided by the FDA Modernization Act, would "get less market time if the Senate [labeling] language becomes law." Bristol-Myers has "launched a major campaign" to insert language into the House bill (HR 2887), which is currently under consideration, that would grant the company an exception for Glucophage. The current House bill does not contain the generic drug marketing provision, but sources said it may be added before the bill comes to the floor, perhaps this week. Pat Donohue, Bristol's director of public affairs, said, "The company is committed to vigorously defending its intellectual property." But a generic drug industry official said, "This proves that some of the most outstanding research happening at certain brand Rx companies is in the field of patent law" (CongressDaily, 10/22).