Regulatory Focus™ > News Articles > House to Vote Wednesday on FDA User Fee Legislation

House to Vote Wednesday on FDA User Fee Legislation

Posted 20 June 2012 | By

The US House of Representatives is preparing to vote on a piece of user fee legislation known as the Food and Drug Administration Safety and Innovation Act (FDASIA) as early as Wednesday, 20 June, reports The Hill.

The bill, which would provide the US Food and Drug Administration (FDA) funding and make numerous regulatory reforms to the agency, had earlier passed both the Senate and House of Representatives in May 2012. The bill has since been before congressional negotiators who were working out differences in the respective congressional bills. The Senate bill will serve as the vehicle by which the legislation will be voted on, and an amendment will alter the bill to make it more like the House's version.

In a boost to the legislation, which is widely expected to easily pass through Congress after having received broad approval during its first pass-through, the Congressional Budget Office (CBO) said the legislation is expected to save taxpayers an estimated $311 million dollars between 2012 and 2022. CBO explained the legislation would likely result in cheaper drugs, thereby driving a portion of the savings. However, much of the savings come from a gap in when FDA collects fees and when it pays them out.

The current pace of the legislation puts it far ahead of its statutory reauthorization deadline, which must be done by 1 October 2012. Congress may be looking to get the legislation completed far in advance of the November 2012 election season due to the presence of national political conventions, campaigning and partisan rancor.

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The Hill - House to vote on final FDA bill Wednesday

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