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Franken Bill Offers Retroactive Profit Incentive For Humanitarian Devices

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.

A bill introduced last week in the Senate would retroactively remove the profit restrictions for companies selling any humanitarian-use devices to patients with rare diseases.

Currently, only humanitarian-use devices with data to support a pediatric indication on FDA labeling are exempt from restrictions on pricing the product above the costs of development, manufacturing and distribution,...

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