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FDA user fees subject to sequester budget cuts?

by Jeffrey Clark on March 1, 2013

The budget cuts associated with sequestration appear eminent later this week, yet the life sciences industry is working hard to avoid its own monies invested in the FDA review process from being involved.

The FDA is facing an estimated 5% budget cut once the sequester is enacted.  That cut includes the user fees paid by industry to support its product reviews.  AdvaMed has voiced its intent to support FDA to protect user fees from budget cuts slated for the agency this week.  According to both groups, user fees paid by the industry should be protected and not part of appropriated funding, which is eligible for cuts.  From AdvaMed Chairman David Dvorak (CEO of Zimmer),  “The FDA should have full access to fees paid by industry and the agency should be properly funded to meet its obligations under the new user fee agreement.”

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