Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, and Bethany Hills, a Member of the Firm in the Health Care and Life Sciences practice, in the New York office, were quoted in an article titled "FDA's Performance, Medicare Coverage, Pressure from Excise Tax on 2014 Agenda."
Following is an excerpt:
FDA regulations state when a 510(k) must be submitted, but the agency has said the language used in this regulation sometimes leads to varying interpretations of when a 510(k) is required for a modification. To address this issue, the FDA issued a guidance document in 1997. The 2011 draft guidance was meant to update and replace the 1997 one, but the agency has been using the 1997 guidance since the 2011 guidance was pulled.
"For a couple of decades, companies felt like they understood reasonably what was expected of them in the way of new premarket notifications for modifications of existing devices," attorney Bradley Merrill Thompson, of Epstein Becker & Green in Washington, told Bloomberg BNA. "Then FDA came out with its new guidance, and controversy ensued. Now we have no guidance, and manufacturers are left largely to grope in the dark."
While he said that the FDA is likely to come out with new device modification guidance in 2014, he added, "we have little way of knowing whether it will be an improvement." ...
And Thompson told Bloomberg BNA, "I believe the Administration is committed to producing the FDASIA report as early in 2014 as possible, taking into account the government shutdown this fall. FDA will obey the Congressional directive not just because it is a Congressional directive, but also because of the mounting political pressure for Congress to step in and change the statute. I think the Administration will want to get its ideas out there in the public discussion just as soon as possible." ...
Thompson predicted that 2014 will bring a lot of activity in the regulation of health information technology. The use of software is growing exponentially with the Stage 3 meaningful use program and the growing amount of health-care data, he said. ...
He also mentioned the introduction of a bill, Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act (H.R. 3303), introduced in October 2013 by Rep. Marsha Blackburn (R-Tenn.). ...
Thompson is general counsel for the mHealth Regulatory Coalition, which wants lawmakers to take a "wait and see" approach for new legislation on health information technology (8 MELR 5, 1/8/14). ...
Attorney Bethany J. Hills, of Epstein Becker & Green in New York, told Bloomberg BNA that there will be "a continued emphasis on superiority for reimbursement coverage determinations and the need for comparative effectiveness results will shape how device companies deal with the convergence of payer, regulatory and provider pressures." Indeed, Hills said, "companies will likely need to demonstrate superiority in clinical trials. This is a different standard than is often required in the FDA process."
Device companies may even consider conducting defensive clinical studies to frame any competitor's studies, she added. The FDA's proposed rule in February 2013, titled "Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices," is another piece of evidence that the CDRH is continuing to focus on this issue, she said. ...
Epstein Becker & Green's Hills said "one area that could be the next target for False Claims Act expansion is the area of device modifications that have not been submitted to the FDA for a new 510(k)." ...
And Hills said that state attorneys general "should be on the radar of every medical device company."
"They are increasingly using the False Claims Act (and parallel state statutes) to pursue Medicaid dollars. I think that once the Sunshine Act detail is available publicly, these databases will become the basis for state attorney general investigations." She predicted that the current AG focus on drug and food labeling will ultimately shift to device labeling. "Labeling and advertising is a natural fit for their existing areas of expertise, although often in different industries," she said. "State AGs appear to be using experience in linking Medicaid payment to only approved uses of drugs to making a similar link [in the device arena]—arguing that Medicaid payments for medical devices are conditional upon the scope of the FDA approval."
