FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FTC’s Shire Appeal Denied in Fight Over Citizen Petitions

March 6, 2019
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The U.S. Court of Appeals for the Third Circuit upheld a Delaware federal district court’s decision to throw out an FTC lawsuit that sought to curb alleged misuse of citizen petitions to delay market entry of generic drugs.

The FTC had called for a permanent injunction against Shire, claiming the company sought to exploit the citizen petition procedure to delay generics of its antibiotic Vancocin (vancomycin). Shire used “serial, repetitive and unsupported filings,” an unfair method of competition barred by the FTC Act, the commission claimed.

But the appeals court agreed with the Delaware judge who dismissed the FTC’s complaint in March 2018, arguing that the drugmaker “is not currently violating the law, nor is it alleged to…do so anytime in the foreseeable future.”

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