Senate Moves Closer to Giving FDA Power to Ban Drug Ads

Bill to Allow Two-Year Moratorium on New Meds to Get Floor Vote in June

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WASHINGTON ( -- A Senate committee yesterday moved a step closer to allowing the Food and Drug Administration to ban direct-to-consumer drug advertising for a product's first two years.

Republicans promised a floor fight over the DTC limits unless changes are made.

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Democrats on the Senate Health Education Labor and Pensions Committee defeated a GOP attempt to strip the ban from legislation reauthorizing fees for FDA review of new drugs. The committee was expected to send the legislation to the entire Senate later in the day, setting up a Senate floor vote in June.

GOP promises fight
Republicans promised a floor fight over the DTC limits unless changes are made. "I'm not going to go down without a fight on the floor if this proceeds. I do not think it is constitutional," said Kansas Sen. Pat Roberts, who expressed optimism that an agreement might be reached.

The full legislation sponsored by Sen. Ted Kennedy, D-Mass., the committee's chairman and Michael Enzi, R-Wyoming, the vice chairman. In a surprise move, Mr. Enzi was among the 10 Republicans who voted to replace it with an alternative from Mr. Roberts.

The Roberts plan would drop the ban, but give the FDA new authority to fine DTC advertisers for "false" or "misleading" advertising. Mr. Roberts called his proposal a "common-sense approach" intended to be overcome constitutional problems yet give the FDA more authority over DTC.

"Watching television, every second advertisement is for a new drug. It worries me," he admitted. but he appeared more concerned with giving the FDA an additional regulatory role. "Who are going to be the editorial board? The employees of the FDA? We don't know who these people are. I'm really troubled by this."

Not the answer
Sen. Tom Coburn, R-Okla., who is a doctor, said he also is concerned about the amount of drug ads, but doesn't think restricting advertising is the answer. "This is the foolish chasing the ridiculous. What it will eventually do is eliminate time that should be spent on drug safety," he said. "It seems like we are fixing something that is not a problem. I am not a fan of drug advertising, but I'm a big fan of the constitution."

Mr. Kennedy defended his proposal. "What we are looking at is the 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."

Ad groups said they are already joining with media companies to mount a no-holds-barred effort to overturn any ban. They warned that a limit on what they term already heavily regulated DTC advertising could set a precedent to enact limits for other kinds of ads. "This is extremely important for the ad community," said Dan Jaffe, exec VP of the Association of National Advertisers. "We have just begun to fight."
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