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Latest From David Filmore
The House Republican conference decision to pull the American Health Care Act from consideration means repeal of the medical device tax has died, at least in the short term. After hours of debate on the floor, and failing to gather enough votes to pass the bill, House Speaker Paul Ryan and President Trump called a halt to the Affordable Care Act repeal effort, saying they will now focus on other objectives, such as tax reform.
Lawmakers are circulating draft legislation that would create a new regulatory category, distinct from medical devices, combining in vitro diagnostics and laboratory-developed tests. The representatives say they don't have specific timing in mind for moving the bill forward. But it is being circulated just as the FDA user-fee reauthorization process is getting off the ground, presenting a possible legislative vehicle.
Symetis, Europe's No. 4 in the TAVR market, hopes its initial public offering, with a price range of €26 to €32 per share on Euronext Paris, will help build on its recent transcatheter mitral valve repair acquisition and its growing market position in TAVR.
FDA issued orders officially finalizing regulatory classifications and special controls for next-generation sequencing analyzers; "secondary display" devices for continuous glucose monitor data; and vibratory counter-stimulation devices for restless leg syndrome. And the agency is working towards formalizing 510(k) exemptions for future devices of these types as well.
President Trump's initial budget plan for US FDA would, it appears, make industry-paid user fees a much larger proportion of the agency's budget, but details are lacking. As is, the plan could complicate agreements that came out of FDA-industry user-fee negotiations last summer, but observers say this is just the first step in a process and Congress will ultimately decide. Trump would also shave 22% from the National Institutes of Health.
After months of waiting on whether President Trump would pick a conventional FDA commissioner candidate or go off the beaten path, the White House appears to be taking the former approach. Trump is expected to nominate Scott Gottlieb, a George W. Bush administration FDA alum, physician and long-time conservative voice on health policy. Gottlieb will favor reduced regulatory burdens, and industry hopes he will help push forward a device user-fee reauthorization agreement.