White House Throws Support Behind Senate User Fee Bill
Posted 17 May 2012 | By
The Obama Administration has indicated it "strongly supports passage" of user fee legislation currently in the US Senate, saying it will "help speed safe and effective drugs, medical devices and biosimilar biological products to patients."
The support of the White House-long expected but until now unannounced-comes as both chambers of the US Congress prepare to meet to vote on their respective versions of user fee legislation. The Senate is scheduled to vote on 17 May on its version of the legislation, known as the Food and Drug Administration Safety and Innovation Act (FDASIA), while the House has not yet scheduled its vote on the Food and Drug Administration Reform Act (FDARA). The House's bill is expected to be voted on by the chamber before it recesses for the 4 July holiday.
In its "Statement of Administration Policy" letter regarding FDASIA, the White House's Office of Management and Budget (OMB) explained it is supporting the bill because it brings down the cost of medicines, "enhances the tools available" to address drug shortages, and increases FDA's authority to address issues related to an increasingly globalized supply chain.
"Promoting innovation, safety, and access to medicines and devices is critical to the Nation's health, and the Administration supports this bipartisan legislation that contributes to this goal," concluded OMB.
OMB - Statement of Administration Policy