FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics

Regulatory NewsRegulatory News | 07 February 2017 |  By 

The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which first won FDA approval in 1986.

“Facing the threat of generic competition to its lucrative franchise, ViroPharma inundated the FDA with regulatory and court filings—forty-six in all—to delay the FDA’s approval of generic Vancocin Capsules. That number is, by far, the most filings that any firm has ever made to the FDA concerning a single drug product,” FTC said in its complaint.


Shire ViroPharma (Shire acquired ViroPharma in 2013 for $4.2 billion) bought Vancocin, which is indicated to treat Clostridium difficile-associated diarrhea, from Eli Lilly in November 2004.

According to FTC, from 2004 to 2011, Vancocin was ViroPharma’s largest revenue generating product, accounting for all of the company’s total net revenues until 2009 and up to 53% of the company’s total net revenues in 2011.

US sales of Vancocin grew from about $40 million in 2003 to almost $300 million by 2011.

Blocking Generics

Between March 2006 and April 2012, ViroPharma made at least 43 submissions to FDA and initiated three more proceedings in federal court to obstruct and delay the approval of generics, via:

  • 24 citizen petition filings submitted to FDA
  • 17 public comments regarding FDA’s in vitro dissolution guidance for generic Vancocin capsules
  • A public comment submitted to FDA related to the agency’s process in publishing bioequivalence guidance
  • A new drug application supplement for Vancocin, claiming three-year marketing exclusivity
  • A lawsuit challenging FDA’s document production in response to ViroPharma’s Freedom of Information Act document requests
  • A lawsuit challenging FDA’s in vitro dissolution guidance for another generic drug
  • A lawsuit challenging FDA’s response to ViroPharma’s Citizen Petition and related amendments and supplements, and FDA’s approval of Vancocin generics.

    “These repetitive, serial, and meritless filings lacked any supporting clinical data, which ViroPharma understood it needed to have any chance of persuading the FDA of its positions,” the FTC said. “Even after a panel of sixteen independent experts unanimously rejected its unsupported claims in August 2009, ViroPharma continued its petitioning campaign to obstruct and delay the FDA’s generic approval review process.”

    In April 2012, FDA put an end to ViroPharma’s challenges as they were deemed “unsupported” and “lack[ing] merit.”  But as FTC notes, “by that point, ViroPharma’s campaign had succeeded in delaying generic entry at a cost of hundreds of millions of dollars to patients and other purchasers.”

    FTC is claiming that ViroPharma has violated Section 5(a) of the FTC Act and it wants the US District Court of Delaware to permanently enjoin the company from engaging in such practices moving forward and “to order ancillary equitable relief to remedy the injury caused by Defendant’s violations.”
  • FTC


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