8 February 2017Americas

FTC accuses Shire ViroPharma of antitrust violation

The US Federal Trade Commission (FTC) has filed a complaint against Shire ViroPharma, accusing the pharmaceutical company of violating antitrust laws.

According to the FTC, ViroPharma abused government processes to delay generic competition of its Vancocin HCl Capsules (vancomycin hydrochloride), an antibiotic used to treat severe bacterial infections.

The suit, which was filed yesterday, February 7 at the US District Court for the District of Delaware, alleged that ViroPharma’s actions have resulted in consumers and other purchasers paying hundreds of millions of dollars too much for their medication.

Maureen Ohlhausen, FTC acting chairman, said in a press release: “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.”

She added that 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 Ohlhausen.

In the complaint, the FTC said that because of the unique characteristics of Vancocin, it is not reasonably interchangeable with other medications used to treat Clostridium difficile associated disease and that no other medication constrained ViroPharma’s pricing of the capsules.

“After ViroPharma acquired the rights to Vancocin capsules in 2004, it raised the price of the drug significantly and continued to do so through 2011,” said the agency.

The FTC alleged that ViroPharma inundated the Food and Drug Administration (FDA) and courts with “a campaign of serial, repetitive, and unsupported filings” to delay approval of generics and exclude competition.

In the complaint, the FTC claimed that the filings lacked “any supporting clinical data”, which ViroPharma understood it needed to have any chance of persuading the FDA of its positions.

In 2012, the FDA disposed of ViroPharma’s filings, stating that they were “unsupported” and “without merit”.

But by that point, ViroPharma had successfully delayed generic competition. According to the FTC, without the serial petitioning abuses, generic entry would have probably occurred by July 2010, or even earlier.

The FTC has asked the court for a permanent injunction prohibiting ViroPharma from submitting “repetitive and baseless” filings with the FDA and courts.

In response to the allegations, parent company Shire responded to the FTC in a statement: “Shire acquired ViroPharma in January 2014 and divested Vancocin in August 2014. The company played no role in ViroPharma’s challenged petitioning, which took place between 2006 and 2012.”

It added: “Shire believes the FTC’s challenge to ViroPharma is wholly without merit, and will vigorously defend these claims.”

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Americas
11 April 2017   Shire Viropharma has filed a motion to dismiss a complaint by the Federal Trade Commission, following competition allegations made against the pharmaceutical company.
Americas
12 April 2018   The US Federal Trade Commission is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.

More on this story

Americas
11 April 2017   Shire Viropharma has filed a motion to dismiss a complaint by the Federal Trade Commission, following competition allegations made against the pharmaceutical company.
Americas
12 April 2018   The US Federal Trade Commission is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.

More on this story

Americas
11 April 2017   Shire Viropharma has filed a motion to dismiss a complaint by the Federal Trade Commission, following competition allegations made against the pharmaceutical company.
Americas
12 April 2018   The US Federal Trade Commission is to appeal against a court’s decision to dismiss its competition complaint against Shire ViroPharma, a subsidiary of pharmaceutical company Shire.