Largest-ever fine imposed by the FDA for promoting off-label drug use

Pharmaceutical giant Pfizer crossed the line recently when the company paid doctors to attend lavish meetings that promoted FDA-approved drugs for uses and in doses not approved by the FDA. In response, the FDA has made a strong statement by fining Pfizer $2.3 billion--yes, that's right: billions--the largest fine ever imposed for such a violation. 

The benefits of off-label prescriptions

After approving a new prescription drug, the FDA works with the pharmaceutical company who developed it to create a "drug label." This is a report that contains detailed information about the drug and its uses. Once the FDA approves the report/label, it makes the drug available to physicians and pharmacists.

Physicians in the U.S. can legally prescribe any approved drug for any purpose they consider medically appropriate. (The exception being for controlled substances such as opium.) This is what's known as "off-label" use and it is lawful even if that use is not officially authorized on the drug label, as long as that use is medically valid.  What's not legal, however, is the promotion of a drug's off-label uses.

Physicians and drug companies are equally aware that a number of drugs have proven effective for disorders other than those the drugs were developed to treat and, further, the doctors and drug manufacturers know that many drugs are widely used for unapproved purposes. These uses remain off-label because the drug makers have not had the time or money to put these drugs through the large clinical studies in humans that must be completed before the FDA will approve the drug for a new use. 

When your doctor prescribes off-label drugs

Should you worry that your doctor may be inappropriately prescribing off-label drugs for you? Probably not. A doctor might to decide to give you a drug for a particular use that has not been officially authorized by the FDA, but you need not be concerned if you have chosen a doctor who makes wise treatment decisions.

If you learn that your doctor has prescribed an off-label drug for you and you are worried about it, you might ask him or her:

• What evidence supports the off-label use of this drug for my condition?
• What risks or side effects have been associated with off-label uses of this drug?
• Is it likely that this drug will be more effective than one of the approved drugs?
• Will my health insurance cover the costs of the off-label use of this drug?