On November 22, 2011, the Department of Justice filed a one-count criminal information against Merck Sharp & Dohme, charging the company with violating the Food Drug and Cosmetic Act ("FDCA") for introducing a misbranded drug, Vioxx®, into interestate commerce. The charges relate to the company's promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration ("FDA"). Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – any use not specified in an application and approved by FDA – unless the company applies to the FDA for approval of the additional use. The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001.
Merck has entered into a plea agreement with the United States, under which it will plead guilty to the misdemeanor criminal charge for its illegal promotional activity and will pay a $321,636,000 criminal fine.
Merck is also entering into a civil settlement agreement under which it will pay $628,364,000 to resolve additional allegations regarding off-label marketing of Vioxx® and false statements about the drug’s cardiovascular safety.
On December 16, 2011, a change of plea hearing was held before U.S. District Court Judge Patti Saris in the District of Massachusetts. The Court conditionally accepted Merck's guilty plea to one count of misdemeanor misbranding. Sentencing is scheduled for March 16, 2012 at 2:00 PM. The hearing will take place in Courtroom #19 on the 7th floor of the Moakley Federal Courthouse in Boston, MA. The court hearing is open to the public.
For more information about this case, please visit the U.S. Attorney's Office website.
The announcement was issued in a DOJ Press Release (11/22/11).