Lawmakers have yet to settle on language to reauthorize multiple FDA pediatric provisions that expire this September in the lead-up to House and Senate markup sessions this week.

Two device pediatric provisions need to be reauthorized this year to continue: a profit allowance for products that are approved via humanitarian device exemption and include a pediatric indication, and a grant program for nonprofit consortia to aid development, production, approval and distribution of pediatric devices. (See Also see "Pediatric Device Developers Counting On Easier Path To Market" - Medtech Insight, 14 April, 2008..)

Both programs were established in the 2007 user fee law, but they are not fully addressed in the 2012 user fee reauthorization draft bills released by House and Senate committees last week. The Senate Health, Education, Labor and Pensions Committee plans to mark up its FDA user fee bill on April 25. The House Energy and Commerce Health Subcommittee is also planning a markup this week. (See in this issue, Also see "Senate Plans FDA User Fee Markup This Week; House Not Far Behind" - Medtech Insight, 23 April, 2012..)

The American Academy of Pediatrics argues that the draft House provision removes any financial incentive to study devices in children.

A user fee discussion draft in the House includes a provision allowing all HDE devices to be priced for profit. This would be an expansion of current law, which allows only products with a pediatric indication to yield profits; HDE devices intended only for adults are currently subject to a long-established policy that limits prices to R&D, fabrication and distribution costs.

But pediatric groups, including the American Academy of Pediatrics, argue that the draft House provision removes any financial incentive to study devices in children, which was the purpose of the 2007 statute. See Also see "Humanitarian Device Bill Would Gut Incentives For Pediatric Devices, AAP Says" - Medtech Insight, 24 October, 2011..) Pediatric groups remain in negotiations with House Republicans in an effort to replace the current draft HDE language with compromise language that has already been reached in the Senate.

That language, supported by the American Academy of Pediatrics and Medtronic, among others, and included in the Senate “committee print” of user fee legislation posted by the HELP Committee on April 18, would reauthorize the pediatric profit allowance. In addition, it would extend the profit allowance to adult-only HDEs when the products are intended to diagnose or treat conditions that do not occur in children or where the numbers are so small that pediatric device development would be “impossible, highly impracticable or unsafe.” (See Also see "Senate Draft Bill Compromises On Profit Incentive For Humanitarian Devices" - Medtech Insight, 26 March, 2012..)

The House draft also does not include language to reauthorize the pediatric device consortia grants, which are funded under current law at $6 million per year.

The Pediatric Medical Device Safety and Improvement Reauthorization Act was introduced separately in February by Reps. Mike Rogers, R-Mich., and Edward Markey, D-Mass. The bill, which reauthorizes the grant program at the current funding level, is expected to be added to the user fee legislation during House Health Subcommittee markup, according to sources close to the legislative efforts.

Drug Exclusivity "Pay-For" Delay

Meanwhile, in the Senate, the pediatric device consortia grants are apparently being held up by disagreements over how to pay for certain drug pediatric provisions.

The Senate committee print includes only a “sense of the Senate” that Congress should reauthorize pediatric provisions, including the device consortia and several key drug programs, but no actual reauthorizing language.

According to a source involved in the negotiations, the provisions are being held up by concerns among some lawmakers about how to pay for the reauthorization of market-exclusivity incentives for drug makers to study products in children.

If that issue is worked out, it is expected that bipartisan legislation introduced April 17 by Sens. Jack Reed, D-R.I., Lamar Alexander, R-Tenn., Patty Murray, D-Wash., and Pat Roberts, R-Kan., would be incorporated into the Senate user fee bill during the HELP Committee markup. Their Better Pharmaceuticals and Devices for Children Act includes a reauthorization of the device consortia grants, but with annual funding of $4.5 million, rather than the current $6 million.

Negotiations Continue On Pediatric Device Reauthorization Provisions

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