One in Five Prescriptions Written for Non-FDA Approved Uses

1 in 5 Prescriptions Written for “Off-Label” Purposes

It isn’t uncommon for doctors to write prescriptions for drugs for off-label purposes.  For example, using a diabetes drug to treat an endocrine disorder or a cancer drug to fight migraine headaches.  In fact, one study found that 1 in 5 prescriptions written in doctor’s offices is for an off-label purpose.  The problem is that while some of these drugs used for off-label purposes do help, others do not and can cause further complications for the patient.

Why Doctors Write Off-Label Prescriptions

If off-label prescriptions have the chance of adding complications to patients’ lives, then why do it?  There are many reasons that doctors prescribe off-label, say experts.  First, it could be a last resort attempt to treat a problem that hasn’t responded to anything else.  Second, it could be convincing anecdotal evidence from other doctors who say that the medication works well for treating off-label medical conditions.  Third, off-label prescribing isn’t really “good” or “bad” since there aren’t many studies to provide evidence either in favor or against off-label prescriptions.

The Hurdle to Obtain FDA Approval for Off-Label Uses 

So why don’t prescription drug companies just go through the process of applying for FDA approval for an off-label use of one of their drugs?  The main reason comes down to cost: it costs drug companies millions of dollars to do research and perform the clinical trials necessary to meet the requirements of the FDA.   Plus, companies may not see it as worth it to go through this process a second time for a drug that’s already been approved by the FDA for a different use.  Doctors are therefore left to make a decision themselves when it comes to prescribing a drug.  Sometimes doctors don’t know if a drug is FDA approved for a condition, prompting some experts to call for a nationwide database that would allow doctors to instantly access this information.