Editor’s Picks: Notable Gray Sheet Stories From 2013

Fiscal uncertainty for federal agencies is nothing new, but the floor just about dropped out in 2013. This had important implications for an industry so reliant on FDA approval to market its products. First, in March, the budget sequestration on appropriated funds and industry user fees took hold, restraining some of FDA’s activities. (See [A#01131118019].) Things really fell apart six months later when the government shut down for 16 days after Congress couldn’t agree on federal appropriations. FDA’s device center made efforts to continue reviewing submissions already in the works during that period, but it was unable to accept any new submissions for review, and was barred from other activities as well. The affair led to a significant review backlog that FDA is still addressing. (See Also see "Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up" - Medtech Insight, 18 October, 2013..) But the agency may be able to look forward to some more funding stability, at least in the short term. A budget pact enacted in December is intended to avert a shutdown this year and offers two-year relief from sequestration. (See [A#01131216014].)

One silver lining for industry from last year’s budget gridlock was that it further raised the profile of companies’ efforts to repeal the 2.3 percent device excise tax, which was...