Device-related FDA reform legislation will be pending in the House when the 107^th Congress returns for its second legislative session in January.

The "Preparing FDA for the 21^st Century Medical Technology Act" (HR 3580) was introduced Dec. 20 by Reps. Anna Eshoo (D-Calif.) and Jim Greenwood (R-Penn.). Co-sponsors for the bipartisan bill include Reps. Joe Barton (R-Tex.), Ed Bryant (R-Tenn.), Peter Deutsch (D-Fla.), Frank Pallone Jr. (D-N.J.), Edolphus Towns (D-N.Y.), and Fred Upton (R-Mich.).

The end-of-year introduction allows AdvaMed to work during the holiday recess to rekindle grassroots support for the bill, as well as to garner sponsors and co-sponsors in the Senate for companion legislation. Sens. Christopher Dodd (D-Conn.) and Judd Gregg (R-N.H.) are among those that have been mentioned as possible sponsors of a Senate version.

HR 3580 includes a number of provisions that reflect AdvaMed's legislative agenda and marks the start of the medical device trade association's push for 2002 FDA reform.

Among measures outlined in an earlier draft of the bill is a stipulation that an office of combination products and product jurisdiction be established within six months of the enactment of the provision. AdvaMed has maintained that an office of combination products would facilitate timely review by creating an entity where the authority, responsibility and accountability for coordination of combination products would reside. A recent external review by an FDA Science Board subcommittee supported reforms for combination products (¹ Also see "FDA Science Board, Industry Seek Combination Product Review Reform" - Medtech Insight, 19 November, 2001., p. 7).

The bill also places jurisdiction for in vitro diagnostics totally within the Center for Devices and Radiological Health, another item on AdvaMed's agenda. If such a provision were enacted, it would impact manufacturers of HIV tests that currently submit premarket applications to the Center for Biologics Evaluation and Research.

Another item sought by AdvaMed that was integrated into the bill is an expedited 120-day review provision for breakthrough technologies. Under the provision, FDA has 30 days to decide whether to assign priority status for a given device. In cases of a denial, the device center has ten days to grant an appeal.

The bill also formalizes the modular PMA process, clarifies FDA's ability to work with individuals and groups on guidance documents and adds a provision for electronic labeling.

Changes to statutory language related to reporting requirements, indications for use and collaboration meetings are also included.

In addition, HR 3580 encourages the agency to make greater use of outside experts, a change that the external FDA Science Board recommended earlier this year and that FDA acknowledged as an important part of its strategic plan (² Also see "CDRH Drafts Strategic Game Plan To "Skate Where The Puck Will Be"" - Medtech Insight, 8 October, 2001., p. 3). Specific provisions include establishment of a "fellowship program" and expanded use of third-party contractors.

The bill would also allow FDA to farm out premarket application reviews to third-party contractors. The measure also expands the third-party 510(k) program, allowing applications with clinical data to undergo third-party review. Though the current third-party 510(k) program has not enjoyed a high level of industry participation, industry reps have argued that making more complex device applications eligible would boost interest.

The reforms include a process whereby FDA would use third-party contractors to conduct manufacturer inspections, an idea FDA has considered. Among FDA concerns were how the agency would obtain resources to contract with third parties. Under the draft bill, firms would compensate third-party contractors for services rendered.

The option to contract with third parties would also be voluntary and therefore represents something of a compromise position for the device industry compared to the pharmaceutical industry's user fee program.

The device industry, comprised of numerous small firms as well as large corporations, has generally been split over the issue of whether to apply a Prescription Drug User Fee Act model as a means to speeding up product reviews.

Under PDUFA, manufacturers submitting a new drug application and abbreviated NDAs pay set fees for each submission. Though the device bill was introduced as a stand-alone bill, it could eventually be incorporated into legislation renewing PDUFA, which must be re-authorized in 2002.

FDA Reform Bill Introduced Dec. 20 By Reps. Greenwood, Eshoo

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