Month: September 2017

FDA Law SSRN Reading List (August 2017)

Published on by Erika LietzanLeave a comment

Here’s a round up of FDA-law related readings posted to SSRN in August.

This excludes articles that were published before 2017 but posted on SSRN for the first time in August 2017.  It also omits pieces for which the abstract, but not the article, was posted.  As a result, for instance and unfortunately, it does not include Professor Jordan Paradise’s new piece, Regulatory Silence at the FDA: Impact on Drug and Biologic Competition.  The abstract indicates she explores the agency’s “reluctance” to wade into issues relating to patent law as well as the contribution of this “silence” to anti-competitive action that harms consumers.

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FDA’s Reliance on User Fees

Published on by Erika LietzanLeave a comment

Cross-posted on Notice & Comment.

On August 18, the President signed the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorized FDA to collect user fees in connection with new drugs, biologics, and medical devices for human use.  These user fee programs are colloquially known as PDUFA (innovator drugs and biologics), GDUFA (generic drugs), BsUFA (biosimilars), and MDUFMA (medical devices).

The White House had been urging Congress to change the structure of FDA’s user fee programs so that much of the agency’s programming is funded by user fees rather than appropriations.  Congress has more FDA user fee programs to reauthorize, however, and the Administration’s basic proposal is unlikely to go away.  I explain more of the history and the debate below.

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