Thursday, May 29, 2014

Must Read! FDA Law Blog--As Senate and House Lawmakers Slog Through FDA Appropriations Bills, FDA’s To-Do List Grows

By Kurt R. Karst –     
On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along with an accompanying report.  The House Appropriations Committee vote follows a May 22nd mark-up session by the U.S. Senate Committee on Appropriations of its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (S. 2389).  The Senate Committee approved that measure by a 16-14 vote, along with an accompanying report, and they will go on to the full Senate for consideration.  As is typical of FDA appropriations bills and reports, lawmakers heap on various recommendations and directives.  We’ve gone ahead an extracted those items from each of the documents and added some links to background information.  We’re not going to get into all of the appropriations funding numbers.  Instead, we’ll leave that to the folks over at the Alliance for a Stronger FDA (see here).

House Fiscal Year 2015 FDA Appropriations Bill & Report
In what seems to be an effort to strongarm FDA into action on finalizing a guidance document on abuse deterrence opioid development (see our previous post here), Section 734 of the House bill provides:
continue to read here
 

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