“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.

“We have come up with a number of recommendations that we believe will help spur the creation of new medical devices and diagnostics to treat rare and neglected pediatric diseases.

“The first step is to assess exactly what are the current unmet needs regarding treatment of pediatric diseases. We believe the National Institutes of Health ( NIH ) should have primary responsibility for data collection efforts and basic research questions associated with pediatric medical device needs. Once such data is collected and prioritized, NIH should publicize its findings to help all interested stakeholders understand potential pediatric device development gaps.

“We must create a regulatory environment where innovation to address these unmet needs can thrive. AdvaMed urges FDA to develop general guidance for its humanitarian device exemption ( HDE ) program outlining appropriate types and levels of data necessary for approval. Lack of guidance ultimately hinders the use of the HDE program for devices that treat or diagnose diseases and conditions that affect fewer than 4,000 patients, including pediatric populations.

“Medical technology companies also face potentially enormous R&D costs in developing new pediatric devices with little hope of recouping their investment due to the small market for some products. To help mitigate these costs, AdvaMed proposes Congress create a strong pediatric device R&D tax credit program as well as a tax credit for pediatric HDEs similar to the tax credit that currently exists for orphan drugs.

“We look forward to further discussing these and other recommendations we have developed with Congress, NIH, FDA and other key stakeholders in the hopes of furthering the development of advanced medical technologies to treat and cure rare and neglected pediatric diseases.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit http://www.advamed.org/.

Source: Media Newswire