Postmarket User Fees Floated At House Subcommittee Hearing

From the May 21, 2007, issue of "The Gray Sheet"

The chairman of the House subcommittee overseeing reauthorization of medical device user fees is signaling that he might push to have a portion of industry-provided funds specifically allocated for FDA postmarket activities.

"Postmarket surveillance issues ... are equally as important" to achieving expedited premarket review, House Energy and Commerce Subcommittee on Health Chairman Frank Pallone, Jr., D-N.J., said during a May 16 hearing.

Under the Medical Device User Fee & Modernization Act, enacted in 2002 and set to expire Sept. 30, FDA collects fees from device manufacturers submitting applications for marketing approval. The fees are expressly intended to help FDA speed up the premarket review process.

While the user fee reauthorization proposal (MDUFMA II) negotiated between industry and FDA and passed in the Senate as part of the FDA Revitalization Act May 9 does not address postmarket surveillance issues, "it may be necessary to ensure some of the user fees" go toward that end, Pallone said.

The congressman pointed out that the original user fee law (MDUFMA I) included authorization for appropriations for postmarket surveillance activities, "although the funds were never appropriated under the previous Republican-led Congresses."

In addition, while MDUFMA I called for user fees to go toward the "process for the review of device applications," that term is defined in such a way as to include certain postmarket-relevant activities, such as the "evaluation of postmarket studies required as a condition of approval of a premarket application."

Also among the activities that user fees may be allocated toward under MDUFMA I are "compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements or premarket notification submissions."

But recall efforts, postmarket facility inspections and other bread-and-butter surveillance and compliance activities can only draw on Congressional appropriations.

In MDUFMA II, "we did not go into any specific proposals" on postmarket surveillance because "our sense was if we can ensure adequate funding for the agency, we will be in a fairly good place for postmarket safety," stated FDA's Jeffrey Shuren, assistant commissioner for policy.

In the user fee reauthorization language passed by the Senate, the industry fees are "dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices." As in the current program, user fees in the new proposal could only be collected each year if Congress appropriates above a certain funding threshold.

When Rep. Pallone asked Shuren whether FDA would "have a problem" if a certain percentage of user fees were specifically allocated for postmarket activities in MDUFMA II, Shuren responded: "What we would prefer ... is that we have the funding and then we can apply it" using our own discretion. "We think we have that already."

CDRH Director Dan Schultz floated in 2005 the possibility of new user fees to help fund the center's postmarket activities. Industry opposes such an expansion of the program.

Report Is Overdue On User Fee Safety Impact

Rep. Henry Waxman, D-Calif., who has been a vocal critic of FDA's enforcement abilities, cited the "well publicized cases of safety problems" with certain implantable defibrillators, coronary stents and contact lens solutions in recent years.

In particular, he pressed FDA, represented at the hearing by Shuren and Schultz, about a study required in MDUFMA I to evaluate how the device user fee program might impact FDA's ability to conduct postmarket surveillance. The requirement also calls for a recommendation from the Secretary of Health & Human Services "as to whether, and in what amounts, user fees collected under such user fee program should be dedicated to postmarket surveillance if the program is extended beyond fiscal year 2007."

The report, due Jan. 10 and over four months late, "would be useful in this reauthorization" process, Waxman emphasized. FDA's Shuren responded that the report is in its "final phase" at HHS and "we are expecting to get it out soon."

Waxman added that "I hope [the report issues] within a matter of a week or two because we're going to reauthorize this program in the subcommittee and ought to have the benefit of a report on this."

Device Safety Legislation?

Congress has been highly critical of FDA's oversight of product safety - particularly in the wake of Merck's Vioxx market withdrawal in 2004 and Guidant's high-profile cardiac rhythm management recalls in 2005 - but legislative proposals have primarily focused on beefing up the agency's drug authority. Still, comments made at the May 16 hearing confirm continued concern on the Hill specific to device safety.

Hill staffers speaking on background say several members of Congress have raised the possibility of device safety provisions beyond what was discussed at the hearing, specifically extending to devices some of the drug safety provisions that were passed in the Senate's Revitalization Act.

They point to provisions that would task FDA to establish an "active surveillance and assessment" infrastructure that links up the agency's drug adverse event surveillance system with other federal databases, private sector health-related databases, electronic health records, and other sources to provide regular trend reports.

The staffers do not suggest there is major momentum toward adding medical devices to this language and industry opposes it, having successfully lobbied against any changes on this front in the Senate bill.

Hearing Touches On SUDs, Third Party Inspections

A House version of a device user fee reauthorization bill has yet to be introduced, but the Bush Administration is pushing for approved legislation by August.

There were no major concerns presented by the subcommittee about the core components of the proposal hammered out between FDA and industry - namely, authorization for the agency to collect $287 million in industry fees over the next five years and in return commit to a new set of premarket review performance goals.

Other aspects of the proposal that did receive extra attention include provisions for expanding FDA's "accredited person" (AP) third-party inspection program and the absence of any provisions on reprocessed single-use devices (SUDs).

The FDA proposal includes several provisions aiming to make it easier for companies to participate in the AP program. The program allows firms to fulfill FDA inspection and other international regulatory body requirements during a single visit from an FDA-approved third-party inspector, but there has been very slow adoption by device manufacturers.

"To date, we've seen very poor results from this," Waxman noted. "And I'm concerned that we're allowing outsiders to do what is essentially FDA's job." However, Shuren emphasized that the goal of the third-party program is to "allow us to actually better direct our resources" to higher risk devices.

Safety concerns with SUD reprocessing have been addressed in MDUFMA I and clarifying legislation in 2005 that tacked on more requirements for reprocessors to clearly mark products that have been reprocessed.

SUD reprocessing is not specifically addressed in MDUFMA II. "I continue to be alarmed about the reprocessing of SUDs, and at a minimum believe that patients should be made aware when a single-use device that has been reprocessed is being used on them during a procedure," Rep. Pallone said.

"I am worried that the MDUFMA II proposal does not focus on SUDs at all ... Further regulation may be required," he added. But Shuren responded: "At this point we are not looking for additional changes in the oversight of single-use devices."

Paul LaViolette, chief operating officer of Boston Scientific and AdvaMed board member, and Kelvyn Cullimore Jr., CEO of Dynatronics and Medical Device Manufacturers Association board member, represented industry at the May 16 hearing. Both strongly supported the user fee reauthorization as negotiated with FDA.

Also testifying at the hearing were Diana Zuckerman, president of the National Research Center for Women & Families; Diane Dorman, VP-public policy for the National Organization for Rare Disorders; and Steven Grossman, executive director of the FDA Alliance, which is focused on increasing the agency's budget.

- Jon Dobson

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