The House passed broad-based FDA legislation July 11 that includes a package to reauthorize the medical device user fee program.

H.R. 2900, approved by a margin of 403-16, now needs to be reconciled with similar legislation (S. 1082) passed by the Senate in May before it can be signed into law (see chart: " ¹ What's New In H.R. 2900 ").

A House-Senate conference committee will start discussions on the bills "ASAP," according to a House staffer close to the matter. Individual members participating in the committee had not yet been selected as of July 13.

The user fee program expires Sept. 30, but it needs to be reauthorized before Congress goes on a month-long recess in August to avoid FDA having to take steps to reduce staff in preparation for budget cuts.

Both the House and Senate bills renew the device and drug user fee programs and contain additional provisions relating to FDA oversight of drug safety, pediatric product development and clinical trial registration, among others. The core device user fee provisions included in the bills adopt an FDA-industry negotiated proposal submitted to Congress in April.

The device industry generally supports the House language after successfully lobbying for certain changes at the committee level (² Also see "FDA User Fee Reauthorization Bill Cleared For House Floor Action" - Medtech Insight, 25 June, 2007., p. 3).

Distinctions Between House And Senate Bills

The most contentious issues expected to be on the table in the House-Senate conference primarily involve pharmaceutical oversight, with the question of whether to establish a legal abbreviated path for "follow-on" biologic therapies near the top of the list.

A provision impacting FDA's device and drug advisory panels represents another distinction between the bills. The agency's top candidates to serve on panels often have financial relationships with regulated companies. The House bill limits the agency to granting a conflict-of-interest waiver to one panel member per meeting. There is no such waiver limitation in the Senate bill.

The House proposal sets up an "irrational standard" that will make it more difficult for FDA to recruit qualified experts for each type of product under review, Rep. Michael Burgess, R-Texas, said on the House floor July 11 prior to the vote on the bill. Burgess voted in favor of the bill, but indicated he would try to change the waiver provision during conference proceedings.

Internally, FDA recently proposed a new policy that it says would significantly reduce the number of advisors with potential conflicts serving on agency panels by barring scientists with more than a $50,000 stake in interested companies from participating in a panel meeting and only allowing those participants with no conflicts to actually cast a vote (³ Also see "Draft Conflict-Of-Interest Policy Affects Status Of Many FDA Cmte. Members" - Medtech Insight, 26 March, 2007., p. 4).

The House also added a provision that would require, with no specific timeline, FDA to establish a mandatory unique device identification system.

The agency is already working to develop a UDI framework, but some device manufacturers are concerned about financial burden of having to label each of their products according to a new system and are still pressing for a voluntary UDI program unless a stronger case can be made for the safety advantages of taking the compulsory approach.

Additional language unique to the House version includes orders for two studies by the Government Accountability Office.

The first study would examine the 510(k) review process. Some members of the House believe FDA may be applying an overly broad interpretation of "substantially equivalent" in clearing devices based on comparisons to predicate devices.

The second study would analyze the prevalence and causes of hospital-acquired infections associated with medical devices, particularly reprocessed single-use devices.

Further, the House takes the step of authorizing an additional $7.1 million in annual Congressional appropriations specifically for postmarket device safety activities through 2012.

The Senate bill does not include any specific funding authorization for device postmarket activities.

User Fee Proposals Intact

The core user fee language of the bill allows FDA to collect $287 million in fees from device manufacturers over the next five fiscal years. In return, it commits the agency to meeting a new set of premarket performance goals and to a more interactive approach with industry when reviewing submissions (⁴ Also see "FDA Will Drop “Cycle” Goals, Prioritize Interactive Device Reviews" - Medtech Insight, 23 April, 2007., p. 7).

Device companies support the deal because it includes predictable fees, which will rise 8.5% annually, and lowers individual application fees compared to the current program. The latter change reflects a new emphasis on establishment registration fees which spreads the financial burden more evenly across the entire industry.

The legislation also includes larger discounts for small businesses compared to the current user fee program. Further, it contains several hard-fought-for changes to the fledgling accredited person facility inspection program that will purportedly make it easier for FDA-compliant companies to employ third-party auditors in lieu of FDA inspections.

H.R. 2900, like the Senate bill, adds incentives to spur development of devices for pediatric patients and new tracking requirements for products used in individuals 21 years old or younger.

One of the few provisions of the bill that troubles industry lobbyists is the proposal to give FDA authority to order postmarket studies as a condition of approval for devices "expected to have significant use in pediatric populations."

The language, recommended by the Institute of Medicine, is meant to improve the agency's ability to monitor product safety in children. Industry, however, warns that in some cases it could create unnecessary requirements that would dissuade companies from developing products for children.

The legislation also includes requirements for device and drug companies to register most of their clinical trials with the federal government as they are initiated and to publicize the results. However, under the proposal, device study information, unlike drug trials, will not be posted on a public HHS database until after product clearance or approval.

- David Filmore (d.filmore@elsevier.com)

FDA User Fee Reauthorization Passes House, Awaits Conference

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