What’s the Deal With Off-Label Drug Use?

Improper Off-Label Usage of Prescription Drugs

Broadly speaking, “off-label” drug use occurs when a doctor prescribes a medication for a condition or ailment that is not specifically approved by the FDA. When the FDA approves a drug, the manufacturer is required to submit studies showing that a drug works for a specific condition and that it is safe. Sometimes, however, a drug is shown to have beneficial effects on a condition, but the FDA will not approve the drug for that specific use. For instance, I take a drug for migraine headaches that has only officially been approved for treatment of clinical depression. This is considered “off-label” use.

No law prevents a physician from writing a prescription for an off-label use, and private insurance companies (my own included) frequently pay for drugs even when used for an “off-label” purpose. Nevertheless, “off-label” drug use presents the potential for fraud. Drug companies are barred by the FDA from marketing a drug for off-label use – for obvious safety reasons.

This rule, however, has not stopped the deep-pocketed pharmaceutical companies from trying to find back door methods to promote their drugs for off-label uses, in order to increase their bottom line. A few years ago, GlaxoSmithKline paid over $1 billion to settle False Claims Act allegations regarding its illicit marketing of drugs, including Paxil and Wellbutrin, for off-label uses. Among other problems, the government found that GlaxoSmithKline had been paying kickbacks to doctors in exchange for prescribing the drugs for off-label purposes. (The total settlement was over $3 billion, but only about one-third was related to off-label marketing.)

Also, for patients with Medicare Part D, off-label drugs may present problems. Medicare Part D will only reimburse for a drug if it is used for a “medically accepted indication.” An on-label use is considered “medically acceptable” and “reasonable and necessary” for purposes of payment by Medicare. Likewise, if a major drug compendium – for instance, the United States Pharmacopeia – specifies that a drug can be used for a specific condition, even if it has not been so approved by the FDA, the drug is “medically accepted” and reimbursable by Part D. Thus, if a doctor prescribes a drug and falsifies the patient’s condition in order to secure payment, the claim is likely fraudulent and actionable under the False Claim Act.

If you have knowledge about any improper off-label marketing of prescription drugs, including the payment of kickbacks, or any other shenanigans involving off-label drugs and Medicare, give us a call for a free case evaluation.