Truthful drug ads face unfair crackdown.

• Position: FDA

A Food and Drug Administration and Department of Justice crackdown on the dissemination by drug manufacturers of information regarding "off-label" uses of prescription drugs has been condemned by the Competitive Enterprise Institute, Washington, D.C. Pharmaceutical maker Pfizer announced it paid $2,300,000,000 to settle civil and criminal charges stemming from the off-label promotion of four drugs. Earlier this year, Eli Lilly and Co. settled a similar case for $1,400,000,000.

"Off-label prescribing is not only common in every field of medicine, but frequently is considered to be the recognized standard of care," notes Gregory Conko, a CEI senior fellow. "Physicians can even be subject to malpractice liability if they don't use treatments for off-label indications when doing so constitutes the medically recognized standard of care. So, it makes no sense for the FDA to criminalize off-label promotion in all cases."

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When the FDA gives the go-ahead to new drugs or medical devices, they are approved to treat specific conditions in particular populations, which are identified on the products' labels. Once they are on the market, though, physicians are free to prescribe drugs and devices for any safe and effective use, including ones not indicated on the label. "By some estimates, as many as 60% of all prescriptions written are for off-label uses," adds Conko...