FDA Authorized to Spend New User Fees Under Just-Passed Senate Bill

The US Senate has approved a measure that would both continue funding government agencies at their currently-appropriated levels and grant the US Food and Drug Administration (FDA) access to user fees it is already authorized to collect, raising the possibility that US regulators will soon be given access to much-needed funding.

The bill, known as the continuing resolution (CR), is needed to prevent a potential government shutdown that will otherwise occur at the end of March when agencies run out of spending authority granted to them by the Congress.

A series of budget battles in the past few years have left the US government, including FDA, operating on a series on continuing resolutions that have maintained spending at fiscal year 2012 levels. That means FDA has been unable to spend the additional user fees, even as they are held in FDA accounts, because they are held to FY2012 levels of spending, and not the new levels called for in subsequent legislation.

The Senate bill seeks to remedy this situation by providing FDA explicit access to the user fees it was authorized to collect under the FDA Safety and Innovation Act (FDASIA) of 2012, including those for prescription drugs and medical devices.

The bill, which would fund the government through the end of the 2013 Fiscal Year (30 September 2013), still needs to be passed in identical form by the House and approved by the president by 27 March 2013, when the current CR expires.

For Regulatory Focus' prior explanation of the bill, please see our 13 March 2013 story, "Proposed Senate Bill would Increase FDA Funding by $24 Million, Restore User Fee Funding."