NAA Praises FDA Drug Ad Proposal

By: Sandy Brown and Carl Sullivan The Newspaper Association of America is supporting the Food and Drug Administration's draft guidelines for prescription drug advertising.

On Wednesday, the FDA proposed that pharmaceutical companies make their direct-to-consumer advertising easier to understand.

"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. "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.

In part, the draft guidelines issued Wednesday propose alternatives to the lengthy and often confusing summaries of risk information for newspaper and magazine ads for prescription drugs, and advise 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 [direct-to-consumer] 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% 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.

Vienna, Va.-based NAA said that if implemented, the new guidelines would make print advertisements more relevant and user-friendly. "The brief summary [of a prescription drug's effects and effectiveness] need not be a lengthy recitation of numerous details about a medication that can only be understood by someone with a medical degree," said NAA President and CEO John F. Sturm. "Direct-to-consumer advertisements delivered through the newspaper provide consumers with timely and useful information in a convenient format. Allowing important health information to be communicated in a user-friendly manner, as the FDA has proposed, will greatly benefit consumers who get their news and information from newspapers."