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Is My Medication FDA Approved for Off-label Use?

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Yes, with an explanation.  Of course, if your doctor is prescribing a medicine, it must be approved by the Food and Drug Administration (FDA). But, it may not be approved for your specific condition.  Let me explain.

The FDA is charged with determining when a drug is considered safe and effective and can be brought to the marketplace.  Bringing a drug from the research bench to the pharmacy is a complex and arduous process that takes many years, even when it’s running smoothly and on schedule.  As you might expect, there are often unforeseen obstacles that will extend the timeline to approval when the FDA requires more studies to address their concerns.  Often, the drug must be abandoned at some point in the process, after millions of dollars of R & D investment.  We should consider this reality before we demonize PhRMA reflexively, which has become sport today. 

Guardians of Safety

When a drug is ultimately approved, this approval is only for a specific medical indication.  For example, a new antibiotic may be approved to treat a urinary tract infection (UTI). Physicians, however, are free to prescribe any medicine for any reason.  For example, a physician may prescribe the ‘UTI medicine’ to treat a pneumonia, if the physician believes this would be an effective option.

Does the FDA object to this ‘off-label’ use?  Not at all.  They recognize that off-label use is often appropriate and standard care that is supported by medical evidence.  Patients should recognize that most prescriptions that we physicians write are for off label use.  Moreover, if you ask your doctor the next time you are in the office what are the official FDA approved uses of your medications, I think that he will stumble in his response.  Why?  Because most of us don’t know the official FDA indications of many of your medicines.  I know this makes us sound sloppy and incompetent, but we’re more focused on choosing the right medicine than on whether it’s ‘approved’.   Similarly, patients should be more concerned if the choice of a drug is rationale than if the FDA has approved it for your particular condition.  Moreover, some illnesses have no FDA approved drugs for them, yet there are effective medicines available, which we physicians will prescribe.

Find out if your medicines are off-label or approved.  You might be surprised.  Remember, off-label may be on-the mark.  
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