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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, but the “Patient Access to Medical Innovation Act,” introduced Nov. 15 by Sens. Al Franken, D-Minn

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