The Senate Health, Education, Labor and Pensions Committee is holding a hearing today to see how the development of new treatments and cures for neglected pediatric conditions can be promoted.
“Today’s Senate HELP Committee hearing will shed important light on ways to encourage the development of new treatments and cures for rare and neglected pediatric diseases. Advances in medical technology have helped save and improve the lives of children around the world, and our industry is committed to providing innovative solutions to the health care challenges faced by this vulnerable population," according to AdvaMed president and CEO Stephen J Ubl.
Ubl goes on to make several recommendations to drive the creation of new devices to treat these diseases. The first is evaluating current unmet needs in this area. AdvaMed hopes the National Institutes of Health can lead data collection efforts. Second, the organization wants FDA to develop general guidance for the humanitarian device exemption program that outlines what is necessary for approval. AdvaMed says use of the HDE, which is meant for devices that diagnose or treat conditions affecting fewer than 4000 patients, is hindered by the lack of such guidance. Ubl also suggests that Congress create a pediatric device R&D tax credit and a pediatric HDE tax credit similar to the one that exists for orphan drugs.
Read the full statement here.