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Drugs Versus Dietary Supplements: Part 1 -- Double Standard at the FDA: Editorial

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We usually don't think of prescription drugs as “alternative” health care options that are held to a lower standard of regulation, compared to standard medicine. However, about 20% of U.S. prescriptions are written for conditions other than what they have FDA approval for. This is called “off-label” prescribing, and is perfectly legal. But many patients assume that every prescription has met rigorous FDA standards for effectiveness, and this is not true.

A survey reported in the Archives of Internal Medicine examined off-label prescribing practices. The authors used the DRUGDEX system from Micromedex to evaluate the evidence to justify each off-label indication. They classified the indications as scientifically supported if effectiveness has been shown in controlled trials or observed in clinical settings. By these criteria, 73% of the off-label uses failed; they were thus classified as having little or no scientific support. Off-label prescribing has the benefit of offering more treatment options, just as dietary supplements, chiropractic, acupuncture, and other alternatives offer more options. But the labeling regulations are very different.

The FDA has a double standard for labeling of drugs and dietary supplements. For dietary supplements, the FDA requires a disclaimer if the labeling makes any claim for health benefits. The standard warning is:

“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

To be consistent, off-label prescriptions should carry a similar disclaimer. I propose:

“This prescription is an off-label usage of the drug, and has not been evaluated by the FDA. This product has not been approved to diagnose, treat, cure, or prevent the disease it was prescribed for.”

I think Americans have the right to make informed decisions about our health care. We deserve full and accurate information about what we're getting.

by Linda Fugate, Ph.D.


Radley, David C, Finkelstein, Stan N, Stafford, Randall S. Off-label prescribing among office-based physicians. Archives of Internal Medicine 2006 May 8;166(9):1021-1026.

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