Stage set for Senate to shackle DTC advertisers

Bill would allow ban of up to 2 years and require FDA to pre-clear drug ads

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The $4.5 billion drug-ad industry is about to realize its worst fear.

The Senate's health committee has set a tentative late-March date to consider legislation from Sens. Ted Kennedy, D-Mass., and Michael Enzi, R-Wyo., that could dramatically curb direct-to-consumer advertising for prescription drugs. Committee officials wouldn't confirm that exact date last week.

Advertising groups expect the bill would allow the Food and Drug Administration to ban DTC ads for newly approved drugs for up to two years. It would require pre-clearance of drug ads by the FDA, and drug companies would have to state in ads when their drugs were approved. The legislation would also require a warning in ads that "the existing information may not have identified or fully assessed all serious risks" of use.

Pharmaceutical companies voluntarily pre-clear their spots with the FDA, but ad groups say mandatory pre-clearance would allow the agency to demand changes in ways that would leave marketers with little recourse.

Consumer groups and Sen. Kennedy argue that the FDA review of advertising doesn't go far enough. A recent Annals of Family Medicine study suggested drug ads are more emotional than informational, and may convince Americans they're sicker than they really are.

Ad groups have been especially worried about the issue this year because Congress needs to reauthorize drug-approval user fees by this fall, and any user-fee legislation is likely to include the committee's proposal. The FDA has proposed a fee hike to speed drug reviews; the money would fund the hiring of additional staff to review DTC advertising.

"Mandatory pre-approval amounts to prior restraint, which is a violation of the First Amendment and could be very expensive," said John Kamp, executive director of the Coalition for Health Care Communication. "Given the current hysteria around the Hill on drug safety, the ad rules could change quickly without any opportunity for the public to object."

James H. Davidson, a lobbyist for ad groups on DTC issues, said the requirement to add language to DTC ads listing the date drugs are approved, along with a statement that all side effects aren't known, further limits how much can be said in a 30-second ad that already must include language about potential side effects. "You are adding more words that don't talk about the product," he said.

Ad groups argue that the proposal amounts to unconstitutional prior restraint of commercial speech. The Pharmaceutical Research and Manufacturers Association, which supports drug-safety legislation, last week expressed concern about the DTC limits.

"We are concerned that proposed [DTC] restrictions could have the perverse and unintended effect of chilling the communication of truthful, accurate and useful information about the benefits and risks of available drug products to health-care practitioners and patients, which would be contrary to the public health," Senior VP Ken Johnson said.

In 2005, he said, PhRMA's board greenlighted a voluntary set of principles for DTC ads that took effect in January 2006. "FDA officials and media reports have indicated that advertisements airing since have tended to be more educational and informative," he said.
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