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

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.

Background

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:

FTC