In February, the Federal Trade Commission filed a complaint in federal district court charging Shire ViroPharma Inc. with violating the antitrust laws by abusing government processes to delay generic competition to its branded prescription drug, Vancocin HCl Capsules. The complaint alleges that because of ViroPharma’s actions, consumers and other purchasers paid hundreds of millions of dollars more for their medication.
FTC has been looking for similar case
Congress amended federal law in 2007 in the hopes of curbing underhanded petitions. It authorized the FDA to flatly reject petitions that clearly don’t raise legitimate issues, and told the FDA not to delay generics unless public health would be jeopardized.
But it’s not clear that the action worked as intended. In a report to Congress last year, the FDA said it “continues to be concerned that [the amendment] may not be discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues.”
As was reported, Wilson Sonsini Goodrich & Rosati PC partner Seth Silber, a former FTC lawyer, told Law360 that the ViroPharma case represents the culmination of the commission’s years long interest in challenging flimsy petitions.
“I think the FTC, probably from that time [of Congress’ amendment] to present, has been looking for a good case,” Silber said. “They obviously thought they had a good fact pattern.”
What is a citizen petition?
A citizen petition is a request for the FDA to take an action such as evaluating a drug’s safety or effectiveness. When used appropriately, it could raise awareness of legitimate concerns with a drug. But when used inappropriately, it could extend the brand firm’s monopoly by delaying FDA approval of generic drugs. This delay could result in literally millions of dollars a day being transferred from consumers to drug companies
FTC argument
The FTC alleges that to maintain its monopoly, ViroPharma waged a campaign of serial, repetitive, and unsupported filings with the US Food and Drug Administration and courts to delay the FDA’s approval of generic Vancocin Capsules, and exclude competition. According to the FTC, ViroPharma submitted 43 filings with the FDA and filed three lawsuits against the FDA between 2006 and 2012.
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. 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. ViroPharma intended for its serial filings to delay the approval of generics, and thus competition and lower prices.
Shire response
The company notes it 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. 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 U.S. Food and Drug Administration (“FDA”) involving complex scientific questions that had significant public health implications.