Disputing drug-ad rereg

As lawmakers and regulators mull whether to tighten rules governing advertising and labeling for prescription drugs, the Media Institute is telling the government to back off.

"The First Amendment provides no exemption to allow the regulation of speech about pharmaceutical products," the institute said in comments filed with the Food and Drug Administration last week.

In 2000, drug companies spent approximately $1.4 billion on TV ads, 60% of the total $2.5 billion spent on "direct-to-consumer" (DTC) prescription-drug ads, which includes print, radio and billboards. Prescription-drug makers are now among the top 20 spenders among TV advertisers.

Advertisers are looking to protect a big new ad category. In 1997, the Food and Drug Administration changed the rules so that pharmaceutical companies could advertise on TV.

Among the rules the drug industry and advertisers have opposed in the past is the prohibition on advertising drugs for uses for which they have not been approved.

They oppose the ban, they say, because doctors are permitted to prescribe medicines for additional uses once a product comes on the market.

The groups cite a Supreme Court decision this past summer that struck down a ban on advertising by druggists who reformulate medicines or mix them from their own bulk supplies.