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U.S. House Passes FDA Reform Act

Jun 21, 2012

The bipartisan bill includes provisions to help address the nationwide drug shortage issue.

On June 1, 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, 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.

In the last week of May, the Senate passed S. 3187, the Food and Drug Administration Safety and Innovation Act, by a vote of 96-1. This bill included statutory changes to the drug shortage notification process to cover manufacturers of drugs used in the provision of emergency medical care and surgery, as well as all sterile injectable drugs. (The original draft bill only included "life-supporting" and "life-sustaining" drugs, but did not make specific reference to drugs used in emergency situations.)

The House and Senate will now move to a Conference Committee to iron out the differences between the two bills.