On May 8, 2012, the U.S. House of Representatives' Energy and Commerce Committee unanimously approved H.R. 5651, the "Food and Drug Administration Reform Act" ("Act").  The Act reauthorizes the Prescription Drug User Fee Act, the Medical Device User Fee Act, the Generic Drug User Fee Act, and the Biosimilars User Fee Act.  These user fee acts aid the review and approval of new drugs and medical devices.  The Act requires the Food and Drug Administration ("FDA") to meet certain performance goals, which allow the drug and medical device industry more interaction with the agency.

The Act also includes reforms to improve the FDA's medical device review and drug approval processes.  For instance, the Act would require the agency to withdraw its 510(k) modification guidance, which almost certainly would significantly increase device submissions.  In addition, the Act would improve access to the Accelerated Approval pathway for certain drugs, including drugs used to treat rare diseases. In addition, the Act addresses drug shortages by including reforms that would require the FDA to inform the public about certain drug shortages, improve any shortages through the modification of current reporting standards and approve needed drugs faster, and authorize the Government Accountability Office to examine the causes of and how to prevent shortages.

For more information, click here.  Megan Fanale Engel