A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at a renewed debate over whether and how the Food and Drug Administration (FDA) should regulate the pharmaceutical industry’s communication to physicians about off-label uses of drugs. When a drug is prescribed “off label,” that means it is being given to a patient for indications that have not been specifically approved by the FDA.
According to information issued by the Agency for Healthcare Research and Quality (AHRQ) in 2015, an estimated one in five prescriptions written are for off-label use. In some cases, such use is the accepted standard of care and recommended in clinical practice guidelines. The recent debate was spurred in part by high-profile recent court cases and shifts in the health care landscape.
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