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Defense policy analysis, commentary and discussion.
Last year, Congress reauthorized the Food and Drug Administration’s user fee system for drugs and devices made to address human needs, and this year lawmakers are working on similar legislation for the growing industry of animal pharmaceuticals.
The House Energy and Commerce Committee last week approved a bill (HR 1407) to reauthorize through 2018 user fees for brand-name and generic animal drugs to fund the FDA’s approval processes. Current law (PL 110-316) authorizing those user fees expires at the end of fiscal 2013.
Under FDA revenue recommendations, the animal drugs industry would pay about $23.6 million in fiscal 2014 and $21.5 million in each of the subsequent four years. In addition, the generic animal drugs industry would pay roughly $7.3 million in fiscal 2014 and $30 million annually through 2018.
A companion version of the legislation (S 622), sponsored by Tom Harkin, D-Iowa, passed the Senate on May 8 by unanimous consent.
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