Incoming FDA commissioner Mark McClellan, MD/PhD, is pledging to hold the agency to premarket review performance goals mandated under the "Medical Device User Fee and Modernization Act" if the bill becomes law.

In a response to written questions posed by Senate HELP Committee member Judd Gregg (R-N.H.), following an Oct. 7 confirmation hearing, McClellan articulated his support for the measure.

"If Congress passes the law that creates this user fee program for medical devices, I plan to work to ensure that the device program receives the funds it needs to adequately implement the program and meet the goals" the agency committed to in a May draft goals letter.

McClellan's promise to pursue additional funding and enforce performance goals could influence Senate debate on the device package; House and Senate staffers are reportedly meeting Oct. 15 to discuss the bill.

Under HR 3580, which passed the House Oct. 9, a device user fee program is contingent upon CDRH receiving an extra $15 mil. in appropriations each fiscal year. If the agency does not receive the additional funding in FY 2003-2004, the program automatically sunsets. Otherwise the program continues, and CDRH is expected to meet performance goals beginning in FY 2005. FDA outlined its performance commitments in a letter to the Senate HELP and Energy & Commerce Committees (¹ Also see "GAO Oversight Of FDA Performance Included In House Device User Fee Bill" - Medtech Insight, 7 October, 2002., p. 3).

Medical device regulation received considerable attention from Senate HELP members both during McClellan's confirmation hearing and in written questions afterwards. The committee favorably reported his nomination Oct. 9; a floor vote is expected before Senate adjournment, which has been extended to Oct. 18. However, a hold was placed on the nomination Oct. 10 by Sens. Jeff Bingaman (D-N.M.) and Blanche Lincoln (D-Ark.), who are attempting to regain Bush administration support for a bill that extends SCHIP to cover low-income pregnant women.

CDRH has indicated user fees are vital to sustaining the device review process. At a Women in Government Relations event Oct. 11 in Washington, D.C., FDA Acting Commissioner Lester Crawford acknowledged that "there's some chance [HR 3580] won't pass in this session of Congress, and Dr. McClellan and I will have to make some hard decisions, probably by the first of the year, and it's not going to be pretty."

Among the issues McClellan was asked to address were third-party inspection and review and combination products regulation, both of which are addressed in HR 3580.

HELP Chairman Edward Kennedy (D-Mass.) questioned how FDA could improve "timely and appropriate review and postmarket regulation" of combination products. McClellan replied that he supports provisions of HR 3580 that would establish "an Office of Combination Products in a manner that is consistent with recent agency actions to promote combination product reviews."

Sen. James Jeffords (I-Vt.) asked McClellan to "describe for which class of products the Congress should consider extending the use of third-party reviewers and third-party inspectors." Sen. Patty Murray (D-Wash.) also inquired about use of third-party expertise by FDA.

In response to Jeffords, McClellan said he favors using third parties "to supplement the agency's medical device good manufacturing practice inspections," although "there must be an opportunity to evaluate the success of the program."

McClellan reiterated his support for the third-party program in his response to Murray: "I believe that, with adequate procedures in place, the use of such third parties would enhance, rather than jeopardize the review process."

Third-party inspection and review of FDA-regulated devices remains a contentious issue, especially among congressional Democrats. Provisions in HR 3580 were pared down to address concerns of Reps. John Dingell (D-Mich.) and Henry Waxman (D-Calif.). Although he voted in favor of HR 3580, Dingell noted on the House floor Oct. 7 that he "remained concerned about the proper implementation of this third-party inspection program and will closely watch its development."

Kennedy has also opposed use of outside experts for review and inspection and still has concerns with third-party provisions in HR 3580, according to staffers. The Massachusetts Democrat has reservations about language in the device package relating to reprocessed single-use devices as well, aides say.

Another issue with HR 3580 that is yet to be resolved in Senate negotiations is the threshold for "small" companies, which will pay reduced user fees. The House user fee agreement defined small firms as those generating $10 mil. or less in annual sales. The Medical Device Manufacturers Association had proposed annual revenues of $100 mil. or less (² Also see "Two-Tiered User Fee Proposal May Exclude Small-Cap PMA Deferral" - Medtech Insight, 12 August, 2002., p. 7).

Gregg, an early proponent of device user fees, is circulating a compromise between the two proposals. According to staffers, Kennedy is willing to discuss revising the number. Reportedly, the Senate version of the device package may set the threshold at roughly $30 mil. in annual sales.

In addition to his position on HR 3580, McClellan was asked to provide his views on specific regulatory issues like the reclassification of colored contact lenses. "Do you believe that colored contact lenses not to correct vision should be regulated as cosmetics or medical devices?" Kennedy asked.

FDA is currently considering a proposal by contact lens maker Fashion Wear Services, Ltd. to regulate colored, noncorrective (plano) contact lenses as cosmetics (³ Also see "FDA Evaluates Cosmetic Lens Manufacturer Claims; UK Weighs Regulation" - Medtech Insight, 2 September, 2002., p. 3).

McClellan acknowledged that the issue is one he has not followed closely. "On one hand, contact lenses used for simply recreational or cosmetic purposes do have some of the same kind of health consequences as prescription contact lenses," he observed.

"On the other hand, there are concerns about whether...lenses can be regulated as a drug or as a cosmetic," he commented. "I know that is an important issue facing FDA. I would certainly like to make sure we handle that appropriately."

Kennedy used the cosmetic lens issue to launch into a more philosophical query. "The question really is about the nature of your commitment to using, preserving the full authority of the FDA to ensure the safety and effectiveness of [regulated] products," he said.

McClellan responded that he believes FDA "has a critical role...in making sure that the health claims made about products are truthful and not misleading. This is, as you pointed out, the core of the FDA's mission. We need to make sure that that mission is fulfilled." He noted that this can be accomplished "by applying good science, like good, state-of-the-art risk management techniques, [and] better use of available information to identify risks when they occur."

In terms of safety problems, McClellan indicated he would pay close attention to postmarket surveillance, particularly in the drug area.

Kennedy emphasized that postmarket surveillance "is extremely important as a concept in terms of drug safety and we have given new authority and resources for you to be able to [do] that effectively. We want to make sure that that is going to be a priority."

PDUFA III allows funding collected under FDA's drug user fee program to be devoted to postmarketing and surveillance activities. The device user fee bill authorizes increased appropriations for postmarket surveillance activities. For FY 2003, an additional $3 mil. is allocated to FDA; for FY 2004, $6 mil.; and for FY 2005 and each subsequent year, "an increase of such sums as may be necessary."

Pursuing another line of questioning, Kennedy sought McClellan's view on public access to reported conflicts of interest for advisory panel members, such as the web-based medium used by the National Academy of Sciences.

McClellan responded that "public access to reported conflict-of-interest information through web-based, e-government strategies is a complex issue involving the Privacy Act, the Freedom of Information Act and the Ethics in Government Act." While FDA has communicated with NAS about the e-government strategy, the academy "was unable to direct us to information concerning their model."

However, McClellan emphasized that "if confirmed, I will ask FDA staff to continue to look into the NAS strategy and other e-government models as potential benchmarks."

McClellan also reassured Kennedy and other committee members of his support of FDA's role in promoting the safety and effectiveness of the products the agency regulates.

For example, McClellan noted that "a key part" of FDA's authority involves regulation of labeling, which "requires that statements made about the product are truthful and not misleading, and the information of the warnings is conveyed."

McClellan Outlines Vision For Device User Fees, Third-Party Inspections

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