Pharmaceutical giant Merck has been ordered to pay nearly $1 billion in fines and damages for promoting its drug Vioxx for off-label uses. Vioxx, which was pulled from the market years ago, was marketed for treating conditions it wasn’t approved for.
Unsubstantiated claims about revoked drug
Part of the function of the Food and Drug Administration is to keep food and drug producers from making false claims about their products unless it has been proven a basis in fact exists for the claims a company makes about its products. That doesn’t always stop drug producers from pushing medications for uses they haven’t been approved for.
Merck, one of the largest global pharmaceutical companies, recently settled criminal and civil charges brought by the Justice Department, according to Reuters, for illegally marketing the company’s drug Vioxx for rheumatoid arthritis when the drug wasn’t approved for that use. The company agreed to pay $950 million in fines and penalties, including $321.6 million in criminal fines and $648.4 million in civil settlements. The drug was revoked from the market in 2004 when Vioxx began causing heart trouble in patients taking the drug.
Drug was approved before revocation
An investigation into Merck’s off-label marketing of Vioxx has been going on for several years. The company alerted shareholders of a pending $950 million charge in October of 2010.
According to CBS, Merck first got FDA approval to sell Vioxx, or rofecoxib, as a painkiller in 1999. However, Merck marketed the drug to physicians as being useful for rheumatoid arthritis from 1999 to 2001, when the FDA warned the company to stop doing so. Vioxx was approved for marketing as a drug for RA in 2002. The drug was pulled from the market two years later, when it was found to double the risk of heart attack in patients who were taking it. Merck was also found to have made false statements to physicians and Medicare about the safety of Vioxx.
The company has paid $4.85 billion out in lawsuits over the harmful effects of Vioxx. The company has also entered into an agreement with the Office of the Inspector General, according to Forbes, to allow federal authorities access to the company to ensure compliance.
Off label use common
Doctors, according to the Los Angeles Times, can prescribe whatever medications they deem appropriate. However, under the Food and Drug Cosmetic Act, according to USA Today, drug companies can’t legally market drugs for conditions the drug hasn’t been clinically proven to treat.
Plenty of medications are found to work for other things. For instance, according to WebMD, anti-psychotic medication bupropion is sold as both the well known anti-depressant Wellbutrin and as Zyban, a smoking cessation aid.
Los Angeles Times: http://articles.latimes.com/2011/nov/07/opinion/la-ed-drugs-20111107
USA Today: http://content.usatoday.com/communities/ondeadline/post/2011/11/merck-pleads-guilty-pays-950m-over-vioxx-marketing/1
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