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FDA to Drug Companies: Off-Label Use Ok

Doctors have always been able to prescribe whatever drug they want, for whatever they want. However, drug companies have only been allowed to advertise and market drugs that have been FDA-approved for specific uses or disorders. That means that generally an antidepressant drug can only be marketed and advertised for depression. If a company wants to market and advertise its drug for other uses, it has to go back to the U.S. Food and Drug Administration (FDA) and file additional applications, with a wealth of supporting research to support those uses.

Unless the research is strong and the market is potentially lucrative, many pharmaceutical companies choose to limit the amount of additional uses they seek FDA approval for.

Any use of a drug that hasn’t gained FDA approval is considered “off-label,” in that it is a use not on the drug’s label.

So how do doctors know what drugs to prescribe off-label for what conditions? Well, they might hear about it at a conference (continuing medical education, or CME, which as Dr. Carlat blogs about is often indirectly funded or sponsored by drug companies), or read about it in a favorite medical journal.

But drug companies have long viewed such a method as fairly unreliable.

So what if the FDA told pharmaceutical companies they could help educate doctors about these off-label uses?

The Wall Street Journal has the story, Boost for Off-Label Drug Use:

The Food and Drug Administration wants to allow drug companies to give doctors information about unapproved uses of prescription drugs, a controversial move that is already drawing objections from Capitol Hill. […]

The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine.

Ostensibly the FDA wants to publish such guidelines to help regulate a murky area of drug marketing and address this common use of prescriptions.

A fifth of all drugs are already being prescribed off-label, and amongst psychiatric drugs, it rises to 31% (Radley, et. al. 2006) — one out of three psychiatric drugs are being prescribed for a use not approved by the FDA. But this isn’t new news, and I suspect the actual number is even higher.

The real problem with off-label use is that it has less evidence, and lower quality evidence, to support prescribing the drug. In Radley et. al. (2006), they found:

No more than 30% of the off-label practices we observed were supported by strong scientific evidence.

That means in 70% of the data they analyzed — the vast majority — doctors were writing prescriptions for off-label use of drugs with minimal empirical evidence to support that prescription.

Which is absolutely fine, because it is a physician’s prerogative to use their own, individual clinical judgment to write such prescriptions.

But what’s going to happen when we let drug companies, who have a strong financial interest and inherent bias, to market their drugs for any and all off-label uses, using minimal evidence (e.g., a single published case study, for instance)?

We think it’s inappropriate for the FDA to allow drug companies to promote these additional off-label uses of drugs directly to physicians, because (a) such use has far less rigorous clinical data to support such widespread promotion; (b) the potential for abuse of this marketing to doctors is simply too high; and (c) pharmaceutical companies’ marketing departments have shown an uneven history of acting in the best interests of patient safety or a drug’s true effectiveness. If the FDA wants to clear up this murky area of their regulations, they should feel free to do so, but not by opening up even more marketing opportunities for companies.

Want to read more? We suggest Merrill Goozner’s FDA Proposes Lack-of-Evidence-Based Medicine Policy.


Radley DC, Finkelstein SN, Stafford RS. (2006). Off-label prescribing among office-based physicians. Arch Intern Med., 166(9), 1021-6.

FDA to Drug Companies: Off-Label Use Ok

John M. Grohol, Psy.D.

Dr. John Grohol is the founder of Psych Central. He is a psychologist, author, researcher, and expert in mental health online, and has been writing about online behavior, mental health and psychology issues since 1995. Dr. Grohol has a Master's degree and doctorate in clinical psychology from Nova Southeastern University. Dr. Grohol sits on the editorial board of the journal Computers in Human Behavior and is a founding board member of the Society for Participatory Medicine. You can learn more about Dr. John Grohol here.

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APA Reference
Grohol, J. (2019). FDA to Drug Companies: Off-Label Use Ok. Psych Central. Retrieved on October 30, 2020, from
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Last updated: 24 May 2019 (Originally: 17 Feb 2008)
Last reviewed: By a member of our scientific advisory board on 24 May 2019
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