Industry Dissatisfied With Senate-Approved Pediatric Device Provisions

From the May 14, 2007, issue of "The Gray Sheet"

Device industry lobbyists are seeking changes to provisions in the Senate user fee reauthorization bill relating to medical devices for children.

Approved by the Senate May 9, the FDA Revitalization Act (S 1082) covers a broad range of FDA issues, including the reauthorization of the Medical Device User Fee & Modernization Act, which is strongly supported by the device industry.

The bill's pediatric device provisions, derived from legislation introduced in March by Sen. Christopher Dodd, D-Conn., seeks to encourage the development of devices for children and adolescents and ensure sufficient regulatory oversight of the products.

To this end, the bill removes the profit restrictions on devices approved via FDA's humanitarian device exemption (HDE) program when the products are designed to treat children.

The HDE program provides a quicker path to market for devices intended to benefit fewer than 4,000 U.S. patients annually, but currently does not permit companies to charge more for the products than it costs to develop, manufacture and distribute them.

The legislation also authorizes $6 million per year through 2012 for demonstration projects aimed at linking pediatric device inventors with potential manufacturers and developing pediatric device prototypes.

AdvaMed President Steve Ubl, however, says more could be done. "We are a bit disappointed that the provisions are a little light on incentives," he said.

Specifically, Ubl points to another part of the Reauthorization Act that rewards drug makers with extra time on the market without generic competition for studying their products in children as a possible model.

"We are internally discussing what those incentives will look like [for devices], but I think the drug example sets something out that should be looked at," Ubl said.

AdvaMed had engaged Senate staff in an attempt to insert language for devices based on the drug incentive and is now working with Rep. Anna Eshoo, D-Calif., and other lawmakers to draft new language for a House pediatric device bill, yet to be introduced.

Mark Leahey, executive director of the Medical Device Manufacturers Association, however, is skeptical that the drug exclusivity provision is transferable to devices.

"You can't just put the drug model on top of the device model and expect it to work," he said, noting the short turnaround, iterative nature of device development.

MDMA is pushing for changes to another component of the pediatric provisions dealing with postmarket surveillance.

Taking cues from an Institute of Medicine report issued in 2005, the bill amends section 522 of the Food, Drug & Cosmetic Act to give FDA the power to order postmarket studies as a condition of PMA approval or 510(k) clearance for devices that are "expected to have significant use in pediatric populations."

Leahey is concerned that allowing the agency to order postmarket studies, under the threat of fines or other legal actions defined in section 522, simply because a product might be used in children, will produce "movement to require [studies] more for pediatrics than otherwise needed," he said.

"There could be a scenario in which a smaller company, never intending [a device] for the pediatric population, never promoting it for the pediatric population ... if FDA thinks that the product has 'significant use' - and that has not been clearly defined - in the pediatric population, then the manufacturer will be required to do a condition-of-approval study, which will cost millions of dollars."

Leahey says the final result could in fact deter the development of products for use in children.

"We hope to work with both the Senate and the House to achieve the objective to provide oversight where needed, but also not requiring additional requirements that may actually provide a disincentive to develop pediatric products," he said.

- David Filmore

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