President Obama Signs Bipartisan FDA User Fee Legislation


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.

Please see full alert below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© McDermott Will & Emery | Attorney Advertising

Written by:


McDermott Will & Emery on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.