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US FDA Sends Fewer Warnings on Drug Ads

WASHINGTON, Oct 1 (Reuters) - U.S. regulators have sharply cut the number of warnings sent to drugmakers for false or misleading advertising, a U.S. lawmaker said Tuesday.

The Food and Drug Administration, which monitors drug promotions, issued between January 1999 and December 2001 more than 250 letters to companies about problems in their ads, according to Rep. Henry Waxman, a California Democrat.

From December 2001 through September 1, 2002, the agency sent only 19 such letters, a 70 percent drop.

"It appears that FDA is now granting major drug manufacturers virtually a free pass," Waxman wrote in a letter to Health and Human Services Secretary Tommy Thompson.

The FDA has cited companies for failing to adequately warn about potentially serious side effects, making false effectiveness claims and promoting drugs for unapproved uses.

Waxman said the decline in FDA enforcement actions "may be a welcome development for the drug industry, but it poses serious dangers to public health."

"I urge you to direct FDA to reverse course and resume effective enforcement" of prohibitions against false and misleading ads, Waxman wrote to Thompson.

Drug companies must submit copies of ads to the FDA for review at the same time they circulate them, and the quantity is rising. The number of television and radio ads aimed at consumers and submitted to the FDA jumped by 75 percent in 2002 compared to 1999-2001, Waxman said.

The decline in FDA advertising warnings came after a requirement imposed in November 2001 that the FDA's Office of Chief Counsel review all warning letters, Waxman said.

The FDA's chief counsel, Daniel Troy, previously represented the drug industry in cases challenging the FDA's authority to regulate advertising, Waxman said.

Officials at the FDA and HHS were not immediately available for comment.


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