WASHINGTON (Reuters) - The U.S. Federal Trade Commission filed a complaint against Shire ViroPharma on Tuesday, accusing it of abusing government processes in order to fend off generic competition to its antibiotic Vancocin HCl, the agency said in a statement.
The company filed repeated and “unsupported filings” with the U.S. Food and Drug Administration between 2006 and 2012 in order to slow approval of generic competitors to Vancocin, the FTC said.
ViroPharma, which has since been purchased by Shire PLC, began filing petitions with the FDA in 2006 when the agency set a streamlined procedure for proving that generic rivals were the same chemically as Vancocin.
Vancocin, an antibiotic that targets bacteria in the digestive tract, was developed by Eli Lilly and sold to ViroPharma in 2004, according to the FTC complaint.
ViroPharma flooded the agency with 46 petitions and other filings between 2006 and 2012, when a generic version was finally approved, the FTC said in its complaint. The FDA had been prepared to approve a generic version in 2010 but was slowed by the blizzard of filings by a full two years, the FTC said.
”These repetitive, serial, and meritless filings lacked any
supporting clinical data, which ViroPharma understood it needed to have any chance of persuading the FDA of its positions,” the FTC said in its complaint.
The Irish drug company Shire PLC completed its purchase of ViroPharma in 2014. The company did not immediately respond to a request for comment.
“Generic medications can save consumers millions of dollars. When we have reason to believe that a branded drug company misuses government processes to unlawfully maintain a monopoly by delaying generic entry, the FTC will act to protect competition,” said acting FTC Chairman Maureen Ohlhausen in a statement.
Reporting by Diane Bartz; Editing by Andrea Ricci