Medical device companies have begun to lobby House members to exclude a provision from a bill to reauthorize the Prescription Drug User Fee Act that would require them to conduct pediatric tests on their products to receive FDA approval, CongressDaily reports. The Senate version of the bill (S 1082) passed on May 9 included the provision, and Reps. Edward Markey (D-Mass.) and Mike Rogers (R-Mich.) have proposed a similar measure in the House. According to CongressDaily, medical device companies "focus on the more lucrative adult market, often leaving children to rely on adult-size devices."

Mark Leahey, executive director of the Medical Device Manufacturers Association, said that the provision would eliminate incentives for medical device companies to make products available for children. He said, "As currently structured, if there's an open-ended process where companies could be subjected to condition of approval studies in a pediatric population they never intended to market to, they're just going to contraindicate their device, saying 'not for pediatric use,' and this whole bill that was supposed to develop an incentive to develop pediatric devices will actually lessen the number available to them."

Craig Burton, HHS deputy assistant secretary for legislation, said, "There is a certain danger for the device industry that in five years, when this bill comes up for reauthorization again, hopefully, that some of the same issues facing the drug industry in this bill, in terms of the focus on drug safety, continuing increase in user fees, will be facing the device industry as well" (Edney, CongressDaily, 5/18).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.