The 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.

Rep. Charles Bass, R-N.H., introduced the Humanitarian Device Reform Act Oct. 14 alongside a series of Republican bills seeking to reform FDA device oversight. (See “ Also see "Flurries Of New Bills Advance Device Industry Interests In Congress" - Medtech Insight, 17 October, 2011. ” – “The Gray Sheet” Oct. 17, 2011.)

Under Bass’ bill, “the two devices that have already been approved under the pediatric profit allowance would have been allowed to skip pediatric device development altogether,” AAP notes.

Bass’ bill would remove a restriction on companies that prevents them from seeking profits on sales of devices approved under a humanitarian device exemption based on proof of safety and “probable benefit.”

The 2007 FDA Amendments Act already removed the profit restriction for humanitarian-use devices labeled for use in a pediatric population, but the new bill would take that step for all HDE devices.

However, in doing so, Bass’ bill would effectively offset what has been a relatively successful pediatric-focused incentive in place since 2007, the academy of pediatricians and pediatric specialists argues in an Oct. 20 letter to the New Hampshire representative.

“While we understand the desire to promote the development of devices for adults with rare diseases, your legislation does so in a way that virtually eliminates the incentive offered for children,” AAP president Robert Block writes.

Under current law, a device company can gain an HDE for both adult and pediatric indications and be able to profit on device sales to both populations as long as the product includes specific labeling for children. But if the profit restriction is lifted for all HDEs, there is no incentive for a company to seek pediatric labeling, AAP explains.

The 2007 pediatric HDE provision is scheduled to sunset next September. AAP is seeking a clean reauthorization as part of a broader FDA user fee bill, but Bass’ legislation inserts another alternative into the mix.

AAP points out that the number of pediatric humanitarian-use device designations has increased from four in 2004-2007 to 21 in 2008-2011. This has translated into two HDE approvals that have qualified for the new profit allowance – Medtronic’s Melody transcatheter pulmonary valve and Elana BV’s Elana laser-based surgical kit for neurosurgery.

“Under this new proposal, the two devices that have already been approved under the pediatric profit allowance would have been allowed to skip pediatric device development altogether, seek only an adult indication and still would have received the profit allowance incentive,” Block writes.

AAP is also critical of the fact that certain device safety checks associated with the pediatric HDE provision would be removed under Bass’ bill.

The academy says it hopes to work with Rep. Bass as part of the FDA device user fee reauthorization process to avoid legislation with unintended consequences for pediatric device development.

By David Filmore

Humanitarian Device Bill Would Gut Incentives For Pediatric Devices, AAP Says

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