SENATE MAJORITY LEADER ENDORSES TWO-YEAR DTC AD BAN

Voluntary Moratorium Would Apply to New Drugs on Market

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WASHINGTON (AdAge.com) -- The battle over direct-to-consumer drug advertising was ratcheted up a notch this morning after Senate majority leader Bill Frist called for a voluntary moratorium on DTC ads during the first two years of a drug.
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Mr. Frist said current drug advertising aimed at consumers offers “fantasyland images” and needs to be replaced with more useful information “that boldly addresses safety head on” and includes information on risks as well as benefits. The Tennessee Republican, who is a doctor, also announced he had requested the General Accounting Office review the effectiveness of Food and Drug Administration oversight of DTC advertising.

Pre-review authority
Mr. Frist warned that if drug companies didn't step forward voluntarily to rein in their ads, he would propose legislation to require limits. He also said the FDA should have authority to require pre-review of DTC ads. (Most DTC ads are, in fact, submitted for pre-review, but the submission is currently voluntary.)

“Everywhere I go people are coming up to me and saying direct-to-consumer advertising has gone overboard,” Mr. Frist said this morning on the Senate floor.

DTC ad spending alone in 2004 hit $4.43 billion, according to TNS Media Intelligence.

In a statement Mr. Frist said DTC ads lead to inappropriate prescriptions, fuel drug spending, oversell benefits and undersell risks.

Compromising 'patient safety'
“Used appropriately direct-to-consumer advertising can empower patients ... but research evidence indicates that this blitz in direct marketing has unwittingly led to inappropriate prescribing, which can compromise patient safety and care,” he said.

In April Sens. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee, and Christopher Dodd, D-Conn., had proposed banning DTC advertising for two years after the FDA approves a new drug.

But the endorsement of the Senate majority leader dramatically increases pressure on pharmaceutical companies to rein in their ads. Already Bristol-Myers Squibb has adopted a voluntary one-year moratorium for its new products even as the Pharmaceutical Research and Manufacturers of America is readying revisions to the industry ad code.

Misplaced concern
Advertising groups today defended the marketing strategy, saying that the concern about increased prescription costs is misplaced if additional prescriptions lower overall health costs by preventing health problems from escalating.

Dan Jaffe, executive vice president of the Association of National Advertisers, said there is nothing in law or in medicine that warrants an across the board two-year ban. He said such a delay could lead to patients who are ill not getting treatment because they were unaware of new products that could treat their conditions.

“It seems to go too far,” he said. “It would have enormous impact.”

FDA warning letters
The announcement today came in the same week the FDA continued its crackdown on DTC advertising with three more warning letters to pharmaceutical companies for misleading advertising and marketing.

That brings to 16 the number of letters the FDA's Division of Drug Marketing, Advertising and Communications has sent out in the first six months of this year, compared to nine and 10, respectively, sent out in the first six months of 2004 and 2003.

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