Prescribing medications can be tricky for some physicians, depending on what their patient has, how they want to treat it, and what is available for prescription. And, it’s particularly difficult if the condition they are trying to treat is either not responding to the traditional treatments or there really isn’t anything yet that has been developed for it. This is where off-label prescribing comes in.
When the FDA approves a medication, it approves it for one or more specific conditions. It okays the dosage ranges, the frequency it can or should be taken, how long it can or should be taken and who should or shouldn’t take it. They base their decision on multiple trials and studies, where they should be given accurate information on how patients responded to what and how. However, the FDA doesn’t practice medicine and can’t tell doctors what they can and cannot do with their medications.
What does off-label mean?
Many times, when doctors prescribe a medication, particularly a newer one, they may notice that the medication not only does what they wanted it to do, but it does other things. Instead of side effects, these are good outcomes. Let’s say you have asthma and you have severe hip pain. Your doctor prescribes you a new pain medication to help you with your pain, but then you find out that your asthma is under better control.
At first glance, that could be because the less pain you have, the less stress your body is under and this could result in better breathing. However, if more patients with the same two problems or similar problems, take that same medication and come up with the same results, news may begin to spread that the medication may not only be just good for problem A, it may also help problem B.
Later on, if a doctor is at a loss as to what to prescribe for someone but she’s read that this particular pill does what she’s looking for – although it’s not FDA approved for it – she just may prescribe it for a trial period. If it works, that news gets out and before you know it, there’s a new use for the drug.
Is it legal?
Yes, it is legal for a doctor to prescribe medications off-label. What is NOT legal is for pharmaceuticals to promote their medication for off-label use. They may only, by law, promote and sell their product for the FDA-approved indication.