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CIAO DATE: 5/5/2007
The Truth about the Drug Ads
John E. Calfee
March 2007
Abstract
Looming on the horizon is a political battle over direct-to-consumer advertising (DTCA) of prescription drugs.The Prescription Drug User Fee Act (PDUFA) is up for renewal, as it has been every five years since 1997. First passed in 1992, PDUFA authorizes the Food and Drug Administration (FDA) to collect fees from pharmaceutical companies submitting new drugs for approval, as well as a separate annual fee for each prescription drug on the market. (Before PDUFA, taxpayers alone funded FDA product reviews.) Because user fees cover most salaries of FDA drug regulators, the pharmaceutical industry, Congressional leaders, and the FDA itself all support renewal. But this time around, Congress is expected to tack on provisions dealing with drug safety and other matters, especially DTCA.