February 09, 2017
The Federal Trade Commission (FTC) has filed a complaint in a federal district court charging Shire ViroPharma (ViroPharma) with violating antitrust laws that abuse government processes. The suit alleges that ViroPharma worked to delay generic competition of its prescription drug, Vancocin HCI (vancomycin) capsules.
“I have long advocated that the Commission target abuses of government processes that significantly harm competition and consumers; the Commission’s action today is another example of this ongoing commitment,” Maureen K Ohlhausen, acting chairman of the FTC, said in a press release (Federal Trade Commission [press release] February 7, 2017).
ViroPharma’s Vancocin capsules are used to treat Clostridium difficile-associated diarrhea (CDAD), a potentially life threatening bacterial infection.
According to the complaint, the capsules are not interchangeable with any other medications used to treat CDAD. Additionally, no other medication on the market constrained ViroPharma’s pricing of Vancocin capsules. ViroPharma obtained the rights to Vancocin capsules in 2004, and the company has raised the price of the drug significantly and continued to do so through 2011.
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The FTC reports that ViroPharma submitted 43 filings with the FDA, and filed three lawsuits against the FDA between 2006 and 2012. According to the FTC, they alleged that ViroPharma created a campaign of serial, repetitive, and unsupported filings with the FDA and courts to delay the FDA’s approval of their generic drug.
“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,” the FTC wrote in a press release. “Viropharma intended for its serial filings to delay the approval of generics, and thus competition and lower prices.”
According to the complaint, the FTC believes that ViroPharma started its petitioning campaign sometime in 2006 following a FDA recommendation—the recommendation was for companies who were seeking approval for generic equivalents of ViroPharma’s drug, where they could establish bioequivalence through test tube dissolution studies rather than through time-consuming and costly studies. In general, the FDA only requires studies involving sick patients for new drug applications.
The complaint states that ViroPharma failed to provide any clinical data to support its arguments. “Even after a panel of 16 independent scientific and medical experts considered ViroPharma’s unsupported arguments and then voted unanimously in favor of the FDA’s guidance for generic Vancocin Capsules, ViroPharma continued to repeat its rejected arguments, the complaint alleges,” wrote the FTC in a press release.
“Generic medications can save consumers millions of dollars,” Ms Ohlhausen added in a press release. “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.”
The FTC hopes to seek a court order permanently prohibiting ViroPharma from submitting repetitive and baseless filings with the FDA and the courts. The FTC vote to file the complaint 3-0, and both a public and sealed version were filed in the US District Court for the District of Delaware on February 7, 2017.
—Julie Gould (Mazurkiewicz)