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Bill Would Allow FDA to Fine Over-the-Counter Drug Advertisers

Non-Prescription Drug Modernization Act Introduced by Sens. Waxman, Kennedy, Rep. Allen 11/06/2007 01:15:00 PM Eastern

A just-introduced bill would give the Food and Drug Administration authority to regulate over-the-counter drug ads and would give it authority to levy monetary fines on advertisers.

over-the-counter drugs

Over-the-counter drug ads are currently under the Federal Trade Commission's jurisdiction, with the FDA overseeing ads for prescription drugs.

The Non-Prescription Drug Modernization Act was introduced by Democratic Sens. Henry Waxman (Calif.) and Ted Kennedy (Mass.) and Maine Democratic Rep. Tom Allen, in response to an FDA advisory about banning over-the-counter cough and cold medicines for kids under six.

The senators said even if the FDA wanted to follow its own recommendation, it would have to go through a lengthy rulemaking process during which the drugs could still be marketed. Their bill would allow the FDA to quickly ban marketing of the drugs while the rulemaking process was still under way.

"We are all concerned about the cough and cold medications for children that have been in the news reports lately," said Adonis Hoffman, senior vice president and counsel to the American Association of Advertising Agencies. "Nobody benefits from false or misleading advertising of any kind, whether it is for over-the-counter or prescription medications."

But, he added, there are already "ample and appropriate regulatory penalties in place to handle these problems. The authority of both the Federal Trade Commission and the Food and Drug Administration is intact. I'm not sure whether there is a need for new changes."


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