Shire Responds To U.S. FTC Civil Action
LEXINGTON, Massachusetts, February 7, 2017 /PRNewswire/ --
Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) acknowledges the decision announced today by the U.S. Federal Trade Commission ("FTC") to file a civil action against one of its subsidiaries, Shire ViroPharma (ViroPharma) related to citizen petition submissions ViroPharma filed regarding one of its products, Vancocin, an antibiotic for the treatment of severe bacterial infections.
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. 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.
ADDITIONAL BACKGROUND
ViroPharma filed an initial citizen's petition challenging a change in a FDA policy in 2006. At the time, no generic forms of Vancocin had been approved under the FDA's longstanding bioequivalence standard, which required in vivo testing. In 2006, the FDA disclosed that it had changed its policy to permit in vitro testing to establish bioequivalence instead of in vivo testing.
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. Although the FDA ultimately modified its policy to require in vivo testing for bioequivalence in some instances, it declined to return to a policy that did not allow any in vitro testing as ViroPharma had advocated. In 2012, the FTC initiated an investigation of ViroPharma's conduct relating to the citizen petition and subsequent filings.
Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG) acknowledges the decision announced today by the U.S. Federal Trade Commission ("FTC") to file a civil action against one of its subsidiaries, Shire ViroPharma (ViroPharma) related to citizen petition submissions ViroPharma filed regarding one of its products, Vancocin, an antibiotic for the treatment of severe bacterial infections.
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. 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.
ADDITIONAL BACKGROUND
ViroPharma filed an initial citizen's petition challenging a change in a FDA policy in 2006. At the time, no generic forms of Vancocin had been approved under the FDA's longstanding bioequivalence standard, which required in vivo testing. In 2006, the FDA disclosed that it had changed its policy to permit in vitro testing to establish bioequivalence instead of in vivo testing.
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. Although the FDA ultimately modified its policy to require in vivo testing for bioequivalence in some instances, it declined to return to a policy that did not allow any in vitro testing as ViroPharma had advocated. In 2012, the FTC initiated an investigation of ViroPharma's conduct relating to the citizen petition and subsequent filings.