Medical Device Daily Washington Editor

WASHINGTON — There are a number of perspectives of FDA's pre-emption of state liability law where PMA devices are concerned, and likewise there are a lot of views as to whether the Medical Device Safety Act of 2009 (MDSA) is a shoo-in for the House of Representatives. One question on the issue, however, seems incontrovertible: Rep. Henry Waxman (D-California), chairman of the House Energy and Commerce Committee, wants the bill out of committee and on the House floor promptly.

The annual FDA/FDLI meeting, hosted by FDA and the Food and Drug Law Institute (FDLI; Washington), included a session providing a legislative update, and while much of the discussion revolved around the agency's regulation of food and other products, the congressional aides in attendance spent some time talking about bills that will have a big impact on device makers.

Rachel Sher, counsel to the majority party for the House Energy and Commerce Committee, said of Waxman that he is eager to see to it that Congress "levels the playing field" with regard to a patient's right to sue over harm sustained in connection with medical devices. She said Waxman does not appear to be concerned about allegations that MDSA "will stifle innovation." In Waxman's view, she said, the bill "will simply return things to the status quo, and enacting this legislation will be a very high priority."

However, the Energy and Commerce Committee has a number of distractions, including climate change legislation. Beyond that, "one of [Waxman's] highest priorities" is follow-on biologics, Sher said, adding that any bill addressing this class of FDA-regulated products should "ensure early resolution of patent disputes."

Waxman is also said to be keen on food safety legislation, and the emphasis seems to be on inspections. According to Sher, Waxman "will look at" a bill proposed by Rep. Rose DeLauro (D-Connecticut) that would take food regulation out of FDA, a statement which seems to suggest that DeLauro's bill will gain little traction. Sher stated that the food industry has to be on board with respect to putting resources into inspections – policyspeak for user fees, implicitly for third-party inspections in this case – because "we cannot inspect our way" out of the current situation.

A senior staffer for the GOP's contingent in the Senate Health, Education, Labor and Pensions Committee (HELP), who spoke on the condition that his remarks not be attributed, said of the Senate that "the issue that is first and foremost ... is healthcare reform." HELP committee chairman Ted Kennedy (D-Massachusetts) wants a markup by early June, "which will consume all of staff time just to get a bill prepared," he said. The staffer also reminded the audience that any HELP Committee legislation will have to be reconciled with a parallel effort on the part of the Senate Finance Committee, chaired by Sen. Max Baucus (D-Montana).

The staffer noted that tobacco legislation is also on the radar screen, but many member of the GOP are of the view that FDA has no philosophically appropriate role in tobacco regulation, and any such legislation will have to cut through quite a thicket to get any attention this year.

Drug reimportation is also likely to morph into a legislative laggard this year. Thanks to Medicare Part D, the staffer said, "reality has moved past the rhetoric" on reimportation, and he also broke the news to the crowd that the Republican Party had held up the vote on Governor Kathleen Sebelius (D-Kansas) because of a number of concerns, including her ties to a Kansas-based provider of late-term abortions.

Alan Slobodin, chief counsel for the GOP members of the Energy and Commerce Committee, said that ranking member Rep. Joe Barton (R-Texas) is possessed of a "strong willingness to work with chairman Waxman" on a number of items. "We're at a very interesting time in oversight of FDA," thanks to the GAO's report, Slobodin said, adding that Barton's view of devices is that they are "a high-risk area," without elaborating.

John Manthei, a partner at the DC law firm of Latham & Watkins advised the audience, "I think you're going to find that FDA and the Hill connect in ways" that may seem historically unprecedented. He also hinted that the pace of legislative action regarding FDA is going to pick up.

"The five-year comfort zone that industry felt with FDA ... is over," he said, noting that Congress had passed laws overhauling FDA in 1992, 1997, 2002 and 2007. FDA-related legislation "is an annual event at this point," he opined.

As for pre-emption, Manthei said that Waxman thinks "FDA itself ... did not seem to have a concern that labels would be filled up with useless warnings" based on Waxman's review of internal FDA documents. "That among other reasons," is why pre-emption will pass.

"The votes are there" to pass the bill, Manthei said. This is not necessarily the view of officials at the Advanced Medical Technology Association (AdvaMed; Washington), who said in a recent press briefing that some Blue Dog Democrats may waver on the matter (Medical Device Daily, April 17, 2009).

Manthei reminded the audience that Waxman was critical of FDA's guidance for off-label discussions of devices between device makers and doctors, and said of this and other issues that "industry needs to be prepared to engage the Hill to ensure their voices are heard." He also stated that an increase in the scientific skills set at FDA suggests that the agency will want yet more data from industry, which will have to keep Congress attuned to its concerns over approval times should the additional demands stretch out those approval times.

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