Clinton to Offer Scaled-Back Plan for Pediatric Exclusivity Bill
As the Senate Health, Education, Labor and Pensions Committee today begins work on the reauthorization of the 1997 FDA Modernization Act's pediatric exclusivity provision, Sen. Hillary Rodham Clinton (D-N.Y.) will offer an amendment that would "scale back some of the provisions that are especially lucrative for the industry," the Wall Street Journal reports. The pediatric exclusivity rule allows drug companies to receive a six-month patent extension if they conduct clinical research on a drug's effectiveness on children. Sens. Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio) have offered the Best Pharmaceuticals for Children Act S 838, the reauthorization bill that would continue the exclusivity provision. However, the Journal reports that the program has been a "boon" for pharmaceutical companies who use the law to delay the "dramatic" declines that their brand-name drug sales experience after generic versions enter the market. Generic drug makers say that the program "has exacted a steep price" for consumers. According to the Generic Pharmaceutical Association, the cost to consumers of the "unfettered market access" for three top-selling drugs that have recently been granted the six-month extension is about $1.96 billion. Clinton said, "Why should there be a windfall for performing the public service of testing a drug to see if it can be used in children? It is harder to test in children, and it's understandable why there needs to be an incentive. But the incentive can be somewhat limited when it comes to the blockbusters." Under Clinton's proposal, drugs with annual sales of more than $800 million would have their exclusivity period reduced form six months to three. Still, the Journal reports that the current program has strong support. Dodd said, "We've got to keep our eye on the ball here. I realize that in some cases, there may be levels of profits the companies themselves didn't anticipate. [But] we're getting trials and we're getting products that we didn't before. ... My view is this is working very, very well." More than 300 drugs have been tested for use in children since the program began in 1997 (Adams, Wall Street Journal, 8/1).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.