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FDA Reform Act Passed by House of Representatives

Posted By Monica J. Newman, Friday, June 8, 2012
The House approved H.R. 5651, the Food and Drug Administration Reform Act, in a 387-5 vote.  The bipartisan bill includes provisions to help address the nationwide drug shortage issue. In particular, as a result of the efforts of 16 EMS/CCT-related organizations, the report language accompanying the bill clarifies that drugs used for treatment in emergency care situations, including resuscitation, are to be included in the FDA's drug shortage notification process. Furthermore, Rep. Burgess (R-TX) secured an additional component of the GAO study in the legislation that would evaluate how providers are compensating for a lack of access to preferred drugs in caring for their patients and whether there are impediments to their ability to adjust accordingly that can be ameliorated.

Tags:  Drug Shortage 

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FDA User Fee Bill Passed By Senate

Posted By Monica J. Newman, Friday, June 8, 2012
The Senate passed S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1.  The bill maintains the revisions to the drug shortage notification process that our group of 16 EMS/CCT-related organizations sought during the bill's development at the Committee level.  The Senate Health, Education, Labor and Pensions (HELP) Committee amended the statutory language in its bill to cover manufacturers of drugs used in the provision of emergency medical care and surgery and included all sterile injectable drugs as well. (The original draft included "life-supporting" and "life-sustaining" drugs, but did not make specific reference to drugs used in emergency situations.)

Tags:  Drug Shortage 

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