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This article was originally published in The Gray Sheet

Executive Summary

DEVICE USER FEE LEGISLATION NOT LIKELY IN 1993, Rep. Richard Durbin (D-Ill.) predicted at a March 23 hearing on FDA appropriations for fiscal 1994. The chairman of the House Appropriations agriculture subcommittee, which is responsible for FDA appropriations, made the comment in response to testimony presented by the Health Industry Manufacturers Association. "I do not think [user fee legislation] is going to happen this year for your industry," Durbin said. At the hearing, HIMA executive vice president Ted Mannen reiterated HIMA's opposition to device user fees. "User fees are a tax on the innovativeness of the small, entrepreneurial companies that principally make up our industry...Even if plowed back into FDA, which I understand cannot be assumed,...user fees would simply not be effective against the underlying [device review] problem. To do that will require hard, internal steps by FDA itself." Mannen added: "To actually fix the underlying product review problem -- to make the core process clear, predictable, and effective -- requires a commitment, a will, that money cannot buy ...We should not reward gridlock with user fees." Durbin suggested that the device industry might be convinced of the need for user fees in the future. "I understand your association's position on user fees, but in all candor we've heard this before from the drug companies, and ultimately they decided it was in their best interest to sit down and work out" legislation. User fee legislation for the prescription drug industry was passed in October 1992. Provisions for device user fees were initially in the bill and were taken out because of industry opposition and a desire to speed up establishment of drug user fees ("The Gray Sheet" Aug. 17, 1992, p. 2). The drug legislation stipulates that all user fee funds go towards FDA's drug program. Although the Clinton Administration's economic plan, released in January, calls for drug and device industry user fees that would go to the federal Treasury for deficit reduction, members of Congress who sponsored the drug user fee bill reportedly have secured assurance from the administration that the language of the law will be adhered to and that all funds will go to FDA. While Mannen argued that user fees are not a solution to CDRH's product review problems, he did urge "enhanced appropriations" for "the new structural demands" the device center is facing. Mannen cited several examples, such as CDRH responsibilities in implementing the Mammography Quality Screening Act of 1992 and the Clinical Laboratory Improvement Amendments of 1988. FDA Commissioner David Kessler also cited these duties in his plea for greater resources at a March 16 appropriations hearing ("The Gray Sheet" March 22, p. 1). Mannen also raised the issue of medical suppliers who plan to stop selling some device materials, calling it "perhaps the most ominous" new demand on CDRH. Dow Corning has announced its intention to cease marketing implant-grade silicone for long-term implants by March 31 ("The Gray Sheet" March 15, I&W-1), and DuPont is discontinuing sales of materials used in permanently implantable devices ("The Gray Sheet" Feb. 8, p. 12). Mannen said that the lack of materials "could result in a serious shortage affecting pacemakers, hip and knee joints, and many other kinds of implants." Manufacturers that do find new sources of materials "may have to submit new 510(k)s and [premarket approval application] supplements to satisfy FDA's premarket review criteria. The overall effect could be to send a potentially large number of new submissions into a system already seriously backlogged." FDA has proposed a plan that would allow manufacturers that substitute alternative silicone materials for Dow Corning silicones to keep their devices on the market pending FDA review of special submissions showing that the new materials are "not substantially different" from Dow Corning's products ("The Gray Sheet" March 15, I&W-1).



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