Case Detail

ViroPharma Inc. v. Hamburg
On March 21, 2012, the U.S. Court of Appeals for the District of Columbia Circuit dismissed a challenge to an FDA rule that makes it easier for generic drug makers to demonstrate that their products are bioequivalent to a brand-name drug already on the market. The court held that the brand-name drug company lacked standing to challenge the rule. The decision was a setback for WLF, which filed a brief urging reversal of a district court decision dismissing the case. WLF argued that the new rule is invalid because it was adopted without following the notice-and comment procedures required by the Administrative Procedure Act (APA). Because it dismissed for lack of standing, the appeals court did not reach WLF’s APA claim. WLF argued that the challenged FDA rule was not a mere “interpretive” rule designed to flesh out existing regulations, but rather was a “legislative” rule that effectively amended existing regulations, and thus was subject to the APA’s notice-and-comment requirements.
Case Status:
Case dismissed on standing grounds.
More Information and Downloads:
10/27/2011: Download the Brief
1/28/2011: Download the Brief

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