In 2007, Bristol-Myers Squibb paid over $500 million to settle lawsuits for its unlawful promotion of one of its drugs. In 2009, Eli Lilly paid over $1.4 billion (yes that’s “b” for billion) for unlawful promotion of Zyprexa. In 2013, GlaxoSmithKline paid $3 billion (yes, again, “b” for billion) for unlawful promotion of various drugs. And now, Johnson & Johnson agreed last week to pay $2.2 billion for unlawfully promoting one of it’s best selling drugs, Risperdal.
What’s going on here? Why are all of these Big Pharma companies unlawfully selling their drugs? The answer is… money. And it doesn’t matter how much these companies are fined by the Department of Justice, or how many lawsuits are filed by lawyers for the harms the unlawful promotion causes to patients; it doesn’t matter because these companies still make billions of dollars after paying the fines and the consumers they harm.
So how do these companies do this? Easy. They create a drug; any drug will do, and seek FDA approval of that drug. They go through extensive clinical studies to obtain the FDA’s narrow approval, which is put on a label for that drug. Then the FDA, to protect the public, says in its regulations that the drug company cannot promote the drug for anything other than it’s approved use. And companies are allowed to market their drug for on-label uses—but they cannot promote the drug for off-label uses.
Here’s where the gigantic loophole comes in. Doctors are allowed to prescribe drugs how they see fit for a particular patient. So, if a doctor believes a drug should be prescribed for off-label uses, there is no prohibition that keeps them for doing it. That’s where the drug companies come in. They promote the drug to the doctors to use for off-label uses. They promote these drugs in various ways, including, paying doctors to write prescriptions, paying key opinion leader doctors (so-called KOLS) to promote the drug to younger or less learned doctors, and paying researchers to write positive reviews in “peer reviewed” publications about off-label uses.
And while these drug companies face hefty fines from the federal government, state governments, and some lawyers, the companies still end up making millions, and in some cases, billions of dollars. The problem is that consumers and patients get hurt by the side effects of these off-label promoted drugs—in some cases, serious injury, including death.
Until the FDA begins to impose real and significant monetary fines against these companies, we’ll continue to see year in and year out a few billion here and there being paid in fines by these companies, while they continue to make many times over the amounts fined.