FDA Issues Revamped Drug Ad Guidelines

NEW YORK The Food and Drug Administration said it has taken steps to strengthen its oversight of medical and pharmaceutical advertising.

“We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible,” said FDA commissioner Mark McClellan, in a statement issued on Wednesday. “Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn’t in drug promotion.”

Last week, Rep. Henry Waxman, ranking Democrat on the House Committee on Government Reform, accused the FDA of being slow to enforce regulations prohibiting false or misleading ads by pharmaceutical companies [Adweek Online, Jan. 30].

In part, the draft guidelines issued today by the FDA propose alternatives to the lengthy and often confusing summaries of risk information for consumer print ads for prescription drugs and advises manufacturers on compliance with federal risk disclosure rules for consumer broadcast ads.

Waxman blasted the new guidance, saying in a statement that it “misses the crux of the problem, which is FDA’s abysmal failure to take strong action against the false and misleading claims in current DTC ads. Today’s guidelines don’t even address the proliferation of misleading television ads.”

A Jan. 29 report prepared at the request of Waxman said enforcement actions by the FDA fell 75 percent in 2003, compared with the “last years of the Clinton administration.” It also found that FDA responses to “false and misleading advertisements were not timely,” and that FDA enforcement actions were restricted mainly to sending warning letters to drug manufacturers.

This story updates an item posted earlier today with Rep. Waxman’s response.