Congress Rips FDA on Enforcement

NEW YORK The House Committee on Government Reform has accused the Food and Drug Administration of being slow to enforce regulations prohibiting false or misleading advertising by pharmaceutical companies.

The committee did so in a Feb. 29 report prepared at the request of Rep. Henry Waxman of California, the ranking Democrat on the committee.

According to the report, 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 the methodology of FDA actions had “little deterrent effect” and was restricted to sending letters to drug manufacturers warning them to cease using an ad.

In a letter to FDA commissioner Dr. Mark McClellan, Waxman said he brought up similar issues in 2000, and that McClellan had replied in writing that repeat violators would face much stronger enforcement and that new guidance would be provided on provisions barring false or misleading advertising. Waxman’s letter yesterday suggested that no such steps have been taken.

Neither the FDA nor Waxman immediately returned calls seeking comment.