
MASSDEVICE ON CALL — If Congress can’t come to terms on a new fiscal plan, it may leave the FDA "underfunded," according to analysts at Avalere Health.
The fiscal cliff deal lawmakers put in place at the end of last year staved off automatic cuts for a couple of months, but the reductions are slated to kick in at the beginning of March, unless a new deal is reached.
"An underfunded FDA could lead to FDA review clocks being reset or delayed, which would affect a sponsor’s ability to obtain product approval – thus delaying patient access to cutting edge medical innovations," according to an Avalere press release. "Furthermore, the potential for an underfunded FDA is exacerbated by the fact that the Continuing Appropriations Resolution, 2013 sets appropriations for FDA in fiscal year 2013 at FY 2012 levels."
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