- The Federal Trade Commission on Tuesday accused a Shire plc subsidiary of filing dozens of "sham" petitions with the Food and Drug Administration in an effort to delay generic competition to its branded prescription drug Vancocin HCI.
- In a complaint filed in federal district court, the FTC alleged that Shire ViroPharma filed 43 citizen petitions with the FDA (along with 3 lawsuits) over a seven-year period, knowing that the FDA typically waited to approve generic drugs until it had resolved any outstanding citizen petitions.
- Shire, who bought ViroPharma in January 2014, said the FTC's charges were without merit and announced its intent to defend itself against the FTC's claims.
In the FTC’s eyes, Shire ViroPharma’s actions were a deliberate attempt to maintain a monopoly over Vancocin HCI, which is used to treat C.difficile-associated diarrhea.
And, according to the complaint, ViroPharma’s efforts led consumers and other purchasers to pay hundreds of millions of dollars more for the drug.
After ViroPharma acquired the rights to Vancocin in 2004, the company allegedly raised prices significantly through 2011, taking advantage of its dominant market position.
Then ViroPharma “waged a campaign of serial, repetitive, and unsupported filings with the U.S. Food and Drug Administration and courts to delay the FDA’s approval of generic Vancocin Capsules, and exclude competition,” the FTC said in its statement announcing the filing of the complaint in U.S. District Court for the District of Delaware.
As the FTC tells it, these filings were more frequent than the industry norm and weren’t backed up with clinical data to support the claims made in the petitions.
But Shire says that’s not the case.
“In its original petition and in multiple supplements to the petition over the course of six years, ViroPharma challenged on scientific grounds the FDA’s adoption of a lower in vitro threshold for approving generic versions of Vancocin,” Shire said.
The adoption of that policy in 2006 made it easier and less time-consuming to establish bioequivalency between would-be generic copies and branded Vancocin.
Shire argues the petitions were anything but frivolous and “raised legitimate issues.”
The Lexington-based biopharma has since divested Vancocin and emphasizes that it played no direct role in ViroPharma’s petitioning activities, which occurred before it acquired the company.