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FDA Issues Draft Guidelines Regarding Off-Label Use of Drugs and Devices

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AP060125137913.2e16d0ba.fill-735x490According to a 2007 JAMA report, up to 75 percent of the cancer drugs used in the U.S. are prescribed off-label, and up to 90 percent of patients suffering from rare diseases are given at least one drug on an off-label basis, and 75 percent of the drugs currently on the market don’t have indications for use in children.

Although off-label drug use has been in existence for many years, determining the appropriateness of such prescribing by physicians can be difficult. The prevalence of off-label use has prompted the U.S. Food and Drug Administration (FDA) to issue draft guidance intended to clarify the agency’s recommendations regarding medical products, including off-label drugs and devices.

The FDA and Off-Label Drug Use

Since 1962, the FDA has required drug companies to establish a drug’s safety and efficacy through adequate and well-controlled clinical trials, and does not allow manufacturers from directly marketing a medication or device for uses that have not been approved by the agency. These approved “on-label” uses must be listed on the drug or device’s labeling. But physicians are allowed by the FDA to prescribe drugs or devices for “off-label” uses other than what they were originally approved for.

Although there is sometimes strong evidence to support off-label use of a drug or medical device, a study published last year in JAMA Internal Medicine found that approximately 80 percent of the off-label prescriptions reviewed were not supported by strong scientific evidence. The study also found that the rate of side effects for off label drugs was about 44 percent higher than for on-label medications.

But another 2016 study concluded that increased adverse drug events associated with off-label uses of drugs existed only when such use lacked strong scientific evidence, and off-label uses of drugs with strong scientific evidence had roughly the same risk of adverse drug effects as those prescribed for on-label use.

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