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Administrative Law and Elections Cases

By FindLaw Staff on March 02, 2010 9:49 PM

The D.C. Circuit decided one case on a matter of administrative law, specifically pertaining to the FDA, and another concerning elections.

Unity08 v. FEC, No. 08-5526, involved an Administrative Procedure Act challenge to the Federal Elections Commission's advisory opinion on the question of whether plaintiff would be required to register as a political committee before selecting candidates.  The court of appeals reversed summary judgment for defendant on the ground that, absent any compelling ground for distinguishing Machinists, plaintiff was not subject to regulation as a political committee unless and until it selected a "clearly identified" candidate.

Teva Pharms. USA, Inc. v. Sebelius, No. 09-5281, was an action challenging the FDA's policy that would allow not only plaintiff but all generic manufacturers to sell their approved losartan potassium products right out of the gate.  The court of appeals reversed summary judgment for defendant where there was nothing in the 2003 amendments to the Food, Drug, and Cosmetic Act that changed the structure of the statute such that brand companies should be newly able to delist challenged patents, thereby triggering a forfeiture event that deprived generic companies of the period of marketing exclusivity they otherwise deserved.

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