September 20th, 2007

House Approves FDA Bill That Leaves Out Ad Curbs

By Ira Teinowitz
Advertising Age

Legislation Doesn't Impose More Restrictions on DTC Messaging

The House of Representatives today voted 405 to 7 to endorse new drug-approval procedures that allow the Food and Drug Administration for the first time to fine marketers for misleading direct-to-consumer drug ads.

Ad groups today hailed the legislation, which could be considered by the Senate tonight and sent to President George W. Bush next week, as a major win for the industry because it avoids ad curbs that had been initially a threat. The final compromise legislation leaves out a number of curbs that could have had a significant impact on the more than $4.5 billion spent annually on DTC ads.

‘Significant victory’
“It is one of the most significant victories for advertising and commercial speech in the past two decades,” said Jim Davidson, lobbyist for the ad and media groups. “It was an earned victory attributable to very hard work on the part of a broad coalition of media and advertising associations and companies.”

Originally both House and Senate leaders had suggested the FDA be allowed to ban ads for new drugs in a product’s first two or three years and further proposed that all ads for new drugs carry a special logo and a warning that not all side effects may have been found. There had also been proposals to require drug makers to devote more ad space to warnings and strike a better balance between positive and negative messages.

None of those made it into the final bill.

Instead, as passed, the legislation’s main effect is to boost the number of people at the FDA who will review ads. It also gives the FDA new authority to fine advertisers up to $250,000 a day for continuing to run any ads challenged as misleading and up to $500,000 a day for a second instance within three years.

In addition, the bill gives the FDA resources to study whether requiring ads to include a phone number to report drug problems would be beneficial.

Range of FDA issues
The new limits are part of broad legislation that also affects how the FDA inspects foods and drugs and tracks reports of drug problems and the fees marketers pay to get FDA approval.

Advances in some of those other areas were praised by representatives and senators. “This bill will give FDA urgently needed new resources, strengthen FDA’s ability to protect consumers from dangerous drugs, provide important incentives to develop drugs for children, safeguard the food we give our families and feed to our pets, help reduce the cost of medicine by ending abusive practices that deny consumers access to generic drugs, and address many other urgent priorities that face the nation,” said Sen. Edward Kennedy, D-Mass., who chairs the Senate Health Education Labor and Pensions Committee.

Though he said he wasn’t happy with some of the compromises made, “after so many recent instances in which Americans have been harmed by unsafe prescription drugs and contaminated food, America cannot afford inaction on this important measure.”


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