BOSTON — The Advanced Medical Technology Association (AdvaMed; Washington) kicked off its annual meeting with a policy briefing, highlighting some of its imperatives for 2012, with issues of taxation dominating the agenda. Repeal of the device tax is obviously still high on the association's agenda, and Steve Ubl, president/CEO of AdvaMed, said the association's preference is that a repeal be packaged with legislation dealing with the oncoming fiscal cliff composed of other tax issues.

The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks at the number of lawsuits and withdrawn guidances, it’s difficult to avoid the urge to characterize the past three years in terms of clichés, such as “a bull in a china shop.” Perhaps the poster child for all this was the Menaflex 510(k), which we have discussed before. FDA’s rescission of this application was the most political move at FDA...

WASHINGTON – Rather than serve up across-the-board cuts mandated by sequestration that would slice deeply into the National Institutes of Health (NIH) budget, Congress needs to be more selective when carving out savings, Rep. Brian Bilbray (R-Calif.) said at a United for Medical Research (UMR) policy briefing in Washington last week.Mixing in a morality argument, Bilbray added, "For this city to accept across-the-board cuts regardless of what's going on would be as outrageous as any father or mother" employing the same strategy with the household budget.