WASHINGTON, DC: US lawmakers last week took a significant step toward a ban on direct-to-consumer advertising of newly approved medicines. The Democrat-controlled Senate is expected to vote in June to empower the Food and Drug Administration to limit ads for two years after the product appears on the market.

The measure is part of legislation to renew the program requiring pharma firms to help pay for FDA reviews of their products [WARC News: 15-Jan-07].

Republicans strongly believe an ad ban is unconstitutional. Vowed Senator Pat Roberts: "I'm not going to go down without a fight on the floor [of the Senate] if this proceeds."

He has put forward a compromise alternative to ditch the ban but allow the FDA to financially penalize companies for "false" or "misleading" ads. He claims this is a "common-sense approach" to overcome the free speech issue and give the FDA more control.

The bill's sponsor, Democrat senator Edward Kennedy is unmoved: "What we are looking at is a very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA ... wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs."

The US DTC ad industry is worth around $5 billion (€3.67bn: £2.49bn) annually. Manufacturers and media groups have, until now, lobbied successfully against federal regulation.

The Pharmaceutical Manufacturers Association of America adopted voluntary guidelines last year in a bid to head off legal moves. But the Democrats' capture of Congress in November brought legislation back into sharper focus.

Dan Jaffe, evp of the Association of National Advertisers believes the introduction of a DTC ads ban could be the start of similar intervention across other sectors.

He says: "This is extremely important for the ad community. We have just begun to fight."

Data sourced from AdAge.com; additional content by WARC staff