Humanitarian Device Bill Would Gut Incentives For Pediatric Devices, AAP Says
This article was originally published in The Gray Sheet
Executive SummaryThe American Academy of Pediatrics says a bill introduced in the House earlier this month intended to encourage more device makers to target rare diseases would undermine an effective incentive in place to spur development of devices for children.
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Lawmakers in the House and Senate are still hammering out language to allow companies to continue to profit on humanitarian device exemptions with pediatric indications, and to reauthorize a grant program for non-profit pediatric device consortia.
More devices approved under a humanitarian device exemption could be priced for profit if draft Senate language is enacted, but restrictions are included to ensure that current pediatric incentives are not gutted.
A bill by Sens. Franken and Alexander to retroactively remove the profit restriction for all humanitarian-use devices is intended to give device firms more incentive to develop products for rare conditions, but an influential pediatric group says it will have unintended consequences.