Inside Medicine: Why is an off-label drug prescribed?

02/07/2013 12:00 AM

02/07/2013 8:55 PM

Chances are that at some point you received a prescription from a doctor for an off-label drug.

That means the doctor prescribed a pill for a reason that was never approved by the FDA and for which there may be little rigorous science to support its new use.

It is entirely legal for a doctor to use a drug for an indication that was not approved. However, at least for the moment, it is illegal for a drug company to promote drugs to be used for reasons that have not been approved.

In the past three years Glaxo, Abbott, Lilly and Pfizer have each paid billions of dollars in fines for promoting drugs for unproven conditions. But these fines don't seem to stop them.

Could it be the profits they get are far larger than the penalties they are forced to pay?

Now drug companies are challenging whether the federal government can prevent them from saying anything they wish – the companies say they have the right to free speech even if they are promoting a drug for an unapproved use.

Usually a drug is developed, extensively tested and approved for just one purpose – say, depression. Yet, estimates are that nearly a quarter of all prescriptions are for off-label use, and of those nearly 75 percent have poor or no scientific proof of effectiveness.

Most doctors will not tell you they are prescribing a drug for you that has not been proved effective for the condition you have.

It seems there are three reasons doctors might not tell you they are prescribing a drug for an indication that has not been approved or tested. The first is that they may not be aware which drugs have been approved for which indications. Secondly is a fear that if they tell a person the drug isn't approved it might frighten them into not using the drug. The third reason is that such a discussion takes time, and time is in short supply for doctors.

Many times off-label drug use is so common that it becomes standard practice, for example, using some anti-seizure medicines or antidepressants to treat chronic pain. The companies that make these drugs decide not to go back to the FDA for approval because to do so would cost them additional money and the studies required might show they don't actually work.

What can you do?

At a minimum, ask your doctor if the drug you are taking has been approved for your condition. If not, ask why the doctor recommened using that drug – but be open-minded because sometimes there may be a very good reason to use an off-label drug.

We also need to hope the courts protect the government's obligation to limit commercial speech by drug companies who want to sell a product without providing rigorous evidence to show it works.

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