The FTC said the company filed “serial, repetitive and unsupported” citizen petitions, which allow members of the general public to ask the Food and Drug Administration to refrain from approving a generic drug over potential health concerns.
ViroPharma, which Shire acquired in 2014, submitted 43 citizen petitions with the FDA and launched three lawsuits against the agency from 2006 to 2012. While the FDA was prepared to approve a generic version of Vancocin HCl in 2010, ViroPharma’s filings prevented them from doing so for two years.
“The number and frequency of ViroPharma’s petitioning at the FDA are many multiples beyond that by any drug company related to any other drug,” the FTC said in a statement. “ViroPharma knew that it was the FDA’s practice to refrain from approving any generic applications until it resolved any pending relevant citizen petition filings.”
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