Merck has agreed to pay $950 million to settle Vioxx marketing charges. Pleading guilty to illegally advertising now-banned painkiller Vioxx (rofecoxib), Merck Sharp & Dohme will be paying millions in fines and penalties to the United States government as well as individually to 43 states and the District of Columbia. Previously disclosed litigation with seven states remains outstanding.
Merck promoted Vioxx from 1999 to 2002 for the treatment of rheumatoid arthritis (RA); however, Vioxx had no indication for that disorder during that time, Forbes explained. The FDA approved Vioxx® for three indications in May 1999. Vioxx was not approved for use against RA until April 2002; however, Merck promoted Vioxx® for almost three years and was admonished for this conduct in a September 2001 FDA warning letter, said the U.S. Justice Department (DOJ).
As the DOJ pointed out, under the mandates of the Federal Food, Drug, and Cosmetic Act (FDCA), drug makers must specify the intended uses of a product in its new drug application to FDA; it is illegal for a drug maker to promote medications for off-label or unapproved uses.
As part of agreement action, Merck agreed to plead guilty to a misdemeanor under the FDCA over Vioxx marketing by Merck representatives to physicians in the U.S. for the treatment of RA prior to FDA approval of the drug for that purpose. Merck noted that, under the plea agreement, the U.S. acknowledged that there was no basis for a finding of high-level management participation in the violation and recognized its full cooperation with its investigation.
In its statement, Merck also stated that this agreement releases it from civil liability concerning the government’s allegations over how it marketed Vioxx in the U.S., adding that the civil settlement does not constitute any admission by it of any liability or wrongdoing. Meanwhile, Forbes noted that the criminal plea and civil settlement are part of other illegal conduct on Merck’s part, such as statements its representatives made about Vioxx’s cardiovascular safety. Ultimately, Merck pulled Vioxx from the market in 2004 over deaths and illnesses linked to increased heart risks.
Also as part of the agreement, Merck entered into a new corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services, said the DOJ, which explained that this agreement replaces Merck’s current CIA and builds on Merck’s existing comprehensive compliance program.
“When a pharmaceutical company ignores FDA rules aimed at keeping our medicines safe and effective, that company undermines the ability of health care providers to make the best medical decisions on behalf of their patients,†said Tony West, Assistant Attorney General for the Civil Division of the DOJ.
“Today’s resolution appropriately reflects the severity of Merck’s conduct; it is yet another reminder that the United States will not tolerate misconduct by drug companies that bends the rules and puts patient safety at risk,†announced Carmen M. Ortiz, U.S. Attorney for the District of Massachusetts. “Any marketing activity that ignores the importance of FDA approval, or that makes unsupported safety claims about a drug is unacceptable, and will be pursued vigorously in both the criminal and civil arena.â€
