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Shire's Citizen Petitions Too Old For FTC Action; Door Left Open For Amended Suit

 
• By Brenda Sandburg

 Court tosses FTC complaint alleging Shire used the citizen petition process to maintain a monopoly on Vancocin, says agency did not show company was 'about to violate' the law.

court house

Timing was a decisive factor in the Federal Trade Commission's suit against Shire PLC subsidiary Shire ViroPharama Inc. over its filing of 24 citizen petitions, as a court found that the agency had not shown Shire was "about to violate" a law and dismissed the complaint.

The agency filed suit against Shire in February 2017 alleging the company's use of FDA's citizen petition process constituted unfair competition under the FTC Act. The agency argued that Shire's meritless petitioning harmed competition by delaying approval of generic versions of its antibiotic Vancocin (vancomycin). FTC noted that Shire had filed a total of 46 regulatory and court filings between March 2006 and April 2012, including the citizen petitions and three lawsuits

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