HELP Committee Releases Update User Fee Draft for Mark-up

The Senate Health, Education, Labor, and Pensions Committee has released a “Manager’s Amendment” to S. 934 FDA Reauthorization Act of 2017 that would reauthorize FDA’s user fee programs for another five years. The amendment was released in advance of a 5/10 mark-up by the committee, and it includes new sections on pediatric drugs/devices, improvements related to drugs, and device inspection and regulatory improvements, among other provisions.

For pediatric devices, the amendment calls for an assessment of pediatric device labeling needs based on a review of real world evidence collected on the off-label use of medical devices in children. it also calls for FDA to issue guidance on developing oncology drugs or biological products directed at molecular targets, including pediatric populations. For devices in general, the measure calls for FDA to establish a risk-based inspection, and review and improve the inspection process.