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US FTC sues Shire ViroPharma for delaying generic entry of Vancocin

PBR Staff Writer Published 08 February 2017

The US Federal Trade Commission (FTC) has charged that Shire ViroPharma abused government processes via serial, sham petitioning to delay generics and maintain its monopoly over Vancocin HCl Capsules.

The watchdog filed a complaint in the US District Court for the District of Delaware. It wants the court to prohibit the pharma from submitting repetitive and baseless filings with the US Food and Drug Administration (FDA) and the courts.

Besides, the FTC is also seeking the courts to give a ruling to result in required equitable relief that also includes both restitution and disgorgement.

FTC acting chairman Maureen Ohlhausen said: “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.

“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.”

FTC had argued that because of the company's actions, customers had to spend an additional hundreds of millions of dollars for their medication.

Used for the treatment of the potentially life-threatening bacterial infection, C.difficile-associated diarrhea (CDAD), ViroPharma’s Vancocin Capsules cannot be replaced with other medications to continue the disease treatment, and no other drug was there to restrict their pricing as per FTC.

The industry watchdog stated that ViroPharma had increased the drug price drastically and continuously ever since it acquired its rights in 2004 up to 2011. Two years later, in 2013, ViroPharma was acquired by Shire for nearly $4.2bn.

The FTC has further alleged that ViroPharma in a bid to sustain its monopoly on the drug and avoid competition indulged in serial, repetitive and unsupported filings with the FDA to put off the regulator’s approval of the generic version of the medication.

Shire acquired ViroPharma in January 2014, and sold Vancocin in August 2014. The company did not play any role in ViroPharma’s challenged petitioning, which took place between 2006 and 2012.

Shire said it believes the FTC’s challenge to ViroPharma is wholly without merit, and will defend the claims.