The House Energy and Commerce Committee expects to mark up a pediatric medical device bill in June. The goal is to have the Pediatric Medical Device Safety and Improvement Act (HR 1494) ready for a floor debate and vote in July, according to committee staffers.

Health subcommittee members expressed general support for the bill during a May 22 hearing on FDA programs affecting safety and innovation in pediatric therapies.

The bill, introduced in March by Edward Markey, D-Mass., and Mike Rogers, R-Mich., seeks to encourage manufacturers to develop more devices with children in mind and strengthen FDA's ability to monitor devices used in pediatric patients.

"There are few medical devices designed to be used in kids," subcommittee chair Frank Pallone, Jr., D-N.J., said. "Instead, doctors are often forced to jury rig devices designed to treat adults. The new legislation will encourage device manufacturers to do the research and development necessary to provide our children with devices that will treat their small and growing bodies."

The House bill is similar to pediatric device language included in the FDA Revitalization Act (S 1082) passed by the Senate earlier this month (¹ 'The Gray Sheet' May 14, 2007, p. 4).

As in the Senate provisions, the House version removes profit restrictions on devices approved through FDA's humanitarian device exemption (HDE) program when they are specifically designed for pediatric use. The HDE program allows devices intended for use in less than 4,000 U.S. patients annually to be approved more quickly, but currently prohibits companies from charging more for the products than it costs to produce and distribute them.

The House bill also authorizes $6 million annually through 2012 for demonstration projects to connect device inventors with manufacturers and promote pediatric device development.

Further, the bill requires FDA to provide annual reports to Congress on the number of devices approved with potential pediatric applications.

Another section of the pediatric bill changes language in Section 522 of the Federal Food, Drug and Cosmetic Act to allow FDA to require postmarket studies of devices "expected to have significant use in pediatric populations" as a condition of 510(k) clearance or PMA approval. It also would give FDA authority to extend 522 studies for pediatrics beyond the current three-year limit.

Industry generally supports the bill, but representatives are concerned the surveillance section could make postmarket surveillance requirements more common when products might be used in children even in the absence of other pending safety and effectiveness questions (² Also see "Industry Dissatisfied With Senate-Approved Pediatric Device Provisions" - Medtech Insight, 14 May, 2007., p. 5).

"What will this do to people who today serve that market, that individual patient, that doctor, that small population, if there is potentially a regulatory hammer hanging over their head that they may end up having to foot all sorts of additional costs and additional studies?" Ed Rozynski, VP-Global Government Affairs for Stryker, asked the committee.

"In the end ... we want to make sure that if we change FDA's current authority that we do not create such an imbalance that people are further encouraged to go serve adult populations, as opposed to serving much smaller children's populations," he said.

The House bill also currently includes a section not in the Senate-approved version that requires the creation of a publicly accessible database of any postmarket studies and surveillances either ordered by FDA under Section 522 or agreed to by a manufacturer as part of a PMA or HDE approval or 510(k) clearance.

CDRH already formed such a public database on its own in April to make it easier to track the status of postmarket data collection (³ Also see "No More Secrets: CDRH Post-Approval Study Web Site Goes Live April 6" - Medtech Insight, 2 April, 2007., p. 26).

- Ingrid Mezo (i.mezo@elsevier.com)

Markup Of Pediatric Device Bill Slated For June In House

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