Medical Device Daily Washington Editor

WASHINGTON — The health subcommittee of the House Energy & Commerce Committee met yesterday to discuss potential amendments to the FDA reauthorization bill, but with only two days to go until the June 14 markup, some in the audience wondered if the hearing was more for show than for tell.

Complaints about the short time before mark-up were accompanied by complaints by the minority party that the process failed to include appropriate consultation between the parties, a situation that several members of the GOP discussed. However, such tactics are much more common in the House than in the Senate and are not historically unprecedented.

Subcommittee chair Frank Pallone (D-New Jersey), said that the issues had been discussed in subcommittee “over the past six weeks.” As for the majority party’s approach to the third-party inspection program, Pallone said “I realize that the medical device industry has concerns over this ... but I have not been convinced that changes are needed to improve participation in this program.” He said he was also averse to funding a program that suggested the agency was not up to the task of executing its mission.

Rep. Nathan Deal (R-Georgia), the ranking minority member, said that substantial disagreements remain between Democrats and Republicans, but that “there’s little time for the two sides to work together to move in a bipartisan fashion.” He said that he had hoped that Pallone would allow enough time to work through the issues prior to markup, and that he was “disappointed” in the failure to include FDA’s suggestions for the third-party inspection program. Deal said that the short schedule, including a full committee markup next week, “seriously jeopardizes” the prospects for a full vetting of the issues.

John Dingell (D-Michigan), the chair of the full Energy & Commerce Committee, said that “the committee is under considerable pressure to move a lot of legislation” and that this is the driver behind the failure to more fully include GOP considerations in the bill. Dingell said that he would attempt to rectify this in the days before mark-up and vote in the full committee. “I intend to see to it that this process is not only fair, but results in a good piece of legislation,” Dingell said.

Randall Lutter, PhD, FDA’s associate commissioner for policy and planning, was the sole member of the first panel and said that the administration’s proposal for MDUFMA “would ensure sound financial footing” for device review. However, he said that the agency has “technical concerns about the draft.”

He said that the administration supports reauthorization of the Best Pharmaceuticals for Children Act (BCPA) and the Pediatric Research Equity Act (PREA), but that an internal review requirement contained in the Democrats’ proposal “will make these successful programs virtually unworkable.” This is in part because the exclusivity of marketing rights would be trimmed from six months to three, reducing the incentive to conduct the necessary clinical trials to establish safety and efficacy of drugs in pediatric populations.

Provisions in the circulating draft addressing medical devices, Lutter said, “would require FDA to track adverse events separately for non-profit and for-profit devices. The public health benefit is not clear to us,” Lutter said, and would impose a “significant burden” on the agency.

Both the House and the Senate bills would allow product liability lawsuits to move forward in state and local jurisdictions regardless of the regulatory status of the drug or device in question. Those provisions, which would overturn the federal law pre-emption of state liability law, could lead to different product labeling from state to state. On this question, Lutter said that such a provision “could be interpreted to permit state law to undermine FDA’s conclusions” regarding product labels and risk evaluation and mitigation. “We believe that state law actions ... should not be endorsed in federal law” when they create the potential for jurisdictional legal chaos.

If it became law, the circulating draft would require risk evaluation and mitigation (REMS) plans to be devised for all drugs, and Lutter said that the agency’s preference would be that “the FDA be granted the discretion of applying REMS” if a problem arises. “We’re concerned about a broad application” that he said “applies to all products and can be lifted only under circumstances that would be very rare.” The only exceptions would be to products that incur no risk at all, and the provision would create a lot of unnecessary work for FDA. Lutter added that sponsors of new drugs already have to do all the work described in the REMS provisions and that post-market studies typically covered such considerations for approved drugs. He said that only 3% of post-market studies were not followed.

Stephen Ubl, president/CEO of the Advanced Medical Technology Association (Washington) said that the pre-emption language would undermine the agency’s ability to properly inform patients of the benefits and risks of drugs and devices and “would allow state courts, agencies and legislatures to second-guess FDA.” He also said that the 1976 Federal Food, Drug & Cosmetic Act, which installed federal pre-emption, was written to “avoid unduly burdening interstate commerce.”

As for the third-party inspection program, Ubl pointed out that FDA often inspects a plant only every six years as matters currently stand and that concerns regarding the quality of the third-party inspectors are addressed in part by the fact that the agency “inspects inspectors ... and can disqualify an inspector at any time.”

Ubl also noted that any language giving FDA the right to impose post-marketing surveillance for medical devices for pediatric use is redundant and that the incentives in BCPA are “not available to devices.” Ubl recommended that Congress beef up incentives under the pediatric humanitarian device exemption program as part of a response to the fact that pediatric clinical trials for devices are disproportionately expensive given their smaller potential market as compared to devices for adult use.