Sen. Al Franken and AdvaMed faced the Senate HELP Committee last week, urging legislators to increase financial incentives for devicemakers addressing pediatric indications. Franken and AdvaMed President and CEO Stephen Ubl argued that devicemakers should be awarded financial credits similar to those available to drugmakers, stating that pediatric populations are often too small for devices to be profitable.
Among specific proposals, Ubl requested an NIH survey to clarify pediatric device needs and a clearer regulatory pathway for humanitarian device exemption (HDE) products, which are designed to treat diseases affecting 4,000 or fewer patients each year. Ubl said HDE devices are hindered by a lack of guidance and encouraged the FDA to develop material "outlining appropriate types and levels of data necessary for approval." Finally, Ubl lobbied for a pediatric device R&D tax credit program as well as a tax credit for pediatric HDEs.
