Off-Label Drug Use and the First Amendment

When we go to doctors for treatment and medication, we want to believe the medications are safe. And when we hear the phrase “FDA-approved,” we generally believe the drug or medication has undergone extensive testing and that the FDA wouldn’t approve a drug — and a doctor wouldn’t prescribe it — if it weren’t safe.

But what a doctor will prescribe medication for and what the FDA has tested a drug for may not always match up. Here’s what you need to know about off-label drug prescription and use.

Off-Label on the Wrong Side of the Law

When a drug is approved by the Food and Drug Administration, it is generally for a specific purpose. But drug manufacturers will sometimes push doctors to prescribe the drug for other purposes, to increase sales. For instance, the FDA approved the use of a drug called Zofran to help cancer patients undergoing chemotherapy battle their nausea. But drug maker GlaxoSmithKline has been accused of marketing Zofran to pregnant women as an aid for morning sickness, without FDA approval. Zofran was never tested or approved for this purpose in human patients, and it turns out that it can cause birth defects.

The FDA calls this kind of prescription and use of a drug “off-label” drug use. And while healthcare providers are permitted to prescribe a drug for an unapproved use (in situations where there might not be an approved drug to treat a disease or medical condition or if a patient has tried all approved treatments without seeing any benefits), drug companies have been prohibited from promoting off-label uses of a drug to healthcare providers. In fact, GSK pleaded guilty to off-label promotion of Zofran and other drugs in 2012 and agreed to pay $3 billion in fines. But those days may be changing.

Is Promotional Speech Free Speech?

In a recent case, a sales rep for a pharmaceutical company had his conviction for off-label promotion overturned, after a court found that “the government prosecuted Caronia for mere off-label promotion” that, unlike what GSK was charged with, was not proven to be false or misleading. The U.S. Second Circuit Court of Appeals determined that federal law does not prohibit “the truthful off-label promotion of FDA-approved prescription drugs,” so as long as drug companies do not lie to or mislead healthcare providers, such promotion is protected commercial speech under the First Amendment.

This may mean doctors will be prescribing more drugs for off-label purposes, and it may be up to patients to determine whether the benefits of off-label drug use outweigh the risks.

If you’ve been injured by a drug that was prescribed for an unapproved use, contact an experienced injury attorney in your area.

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