FTC Files Civil Action Against Shire Subsidiary For Generic Antibiotic DelayBy
The US Federal Trade Commission (FTC) has filed a civil action in federal district court against Shire ViroPharma, a wholly owned subsidiary of Shire, related to citizen petitions submitted by ViroPharma to the US Food and Drug Administration (FDA) regarding ViroPharma’s antibiotic, Vancocin (vancomycin) capsules, for treating severe bacterial infections. In its civil action filing, the FTC alleges that ViroPharm’s citizen petition submissions were a delaying tactic to keep generic versions of its antibiotic off the market.
The FTC seeks a court order permanently prohibiting ViroPharma from “submitting repetitive and baseless filings with the FDA and the courts, and from similar and related conduct as well as any other necessary equitable relief, including restitution and disgorgement,” said the FTC in a statement.
Vancocin capsules were approved by the FDA in 1986. The drug is indicated for treating C. difficile-associated diarrhea (CDAD) and enterocolitis caused by Staphylococcus aureus infection. ViroPharma acquired the rights to Vanocin capsules in the US and its territories from Eli Lilly and Company in November 2004 for $116 million and royalties on net sales. Lilly retained the rights to vancomycin, the active ingredient in Vancocin, outside the US.
According to the FTC, Vancocin capsules are not reasonably interchangeable with any other medications used to treat CDAD, and no other medication constrained ViroPharma’s pricing of Vancocin capsules. The agency says in its complaint that ViroPharma raised the price of the drug after the company acquired it and continued to do so through 2011. ViroPharma reported net sales of Vancocin of $125.9 million in 2015, its first full year of sales after acquiring the drug from Lilly. In 2011, full-year net sales were $288.9 million, according to ViroPharma’s annual report.
The FTC also says that ViroPharma “waged a campaign of serial, repetitive, and unsupported filings with the FDA and courts to delay the FDA’s approval of generic Vancocin capsules.” ViroPharma submitted 43 filings with the FDA and filed three lawsuits against the FDA between 2006 and 2012, according to the FTC. The FTC states that 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.” It is the FDA’s practice to refrain from approving generic applications until it has resolved any pending relevant citizen petition filings.
ViroPharma filed an initial citizen’s petition challenging a change in an FDA policy in 2006. At the time, no generic forms of Vancocin had been approved under the FDA’s bioequivalence standard, which required in vivo testing. In 2006, the FDA disclosed that it had changed its policy to permit in vitro testing to establish bioequivalence instead of in vivo testing, according to Shire.
Shire acquired ViroPharma in January 2014 for $4.2 billion and divested Vancocin in August 2014. In response to the FTC civil action, Shire released a statement, saying that it “played no role in ViroPharma’s challenged petitioning, which took place between 2006 and 2012. Shire believes the FTC’s challenge to ViroPharma is wholly without merit, and will vigorously defend these claims. ViroPharma’s actions were in furtherance of its fundamental right to petition the government, which is guaranteed and protected by the First Amendment, and raised legitimate issues with the US Food and Drug Administration involving complex scientific questions that had significant public health implications”.
Shire also states that in its original petition and in multiple supplements to the petition over the course of six years, ViroPharma challenged on scientific grounds the FDA’s adoption of a lower in vitro threshold for approving generic versions of Vancocin. “Although the FDA ultimately modified its policy to require in vivo testing for bioequivalence in some instances, it declined to return to a policy that did not allow any in vitro testing as ViroPharma had advocated,” Shire says. In 2012, the FTC initiated an investigation of ViroPharma’s conduct relating to the citizen petition and subsequent filings.
Source: Shire and Federal Trade Commission