President Obama Signs Bipartisan FDA User Fee Legislation

McDermott Will & Emery

On July 9, 2012, President Obama signed legislation that reauthorizes the U.S. Food and Drug Administration (FDA) to assess user fees to support the agency’s review of marketing applications for drugs (including biologics) and medical devices, and, for the first time, authorizes the FDA to collect user fees on applications for generic drugs and biosimilars. The legislation, which is known as the Food and Drug Administration Safety and Innovation Act, also includes several provisions related to the FDA’s review and oversight of drugs, medical devices and biologics.

As expected, the law is a hybrid of the user fee bills approved in the Senate and House, respectively. The following table provides a brief overview of the manner in which the bill originally approved by the Senate, the bill originally approved by the House and the enacted law address various issues related to the regulation of drugs, medical devices and biologics.

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