The New Health Dialogue

The FDA's credibility is on a roll lately.

Last week, they revoked approval of Avastin for treating matastatic breast cancer, after the evidence made it clear that the drug doesn't work.

Now, as Duff Wilson of the New York Times reports, Merck has agreed to pay federal and state governments $950 million for illegal marketing of its painkiller, Vioxx. $321 million of the settlement is a criminal fine; the remainder will go to reimburse Medicare and Medicaid for unwarranted use of the drug.

Vioxx was pulled from the market in 2004, after findings that it increased the risk of heart attack, stroke, and death, but this round of fines is unrelated to the drug's health risks. Rather, the fines and reimbursements are based on Merck's illegal "off-label" marketing. The company pushed Vioxx for rheumatoid arthritis before it had FDA approval for that use. That's why this is a victory for the regulator--hefty fines like this one are a credible threat that will (hopefully) deter other companies from marketing off-label uses of their products.

The total financial fallout around Vioxx now stands at nearly $6 billion. An earlier payment of almost $5 billion settled lawsuits from people whose family members were harmed by the drug. A case by Merck investors claiming they were misled about the drug's risks is ongoing.