FDA Closer to Banning New Drug Advertising

Apr 18, 2007  •  Post A Comment

A Senate committee is moving forward with legislation that would allow the Food and Drug Administration to ban advertising for the first two years of a new drug’s existence. It’s the most serious congressional threat yet to the $4.5 billion spent annually on direct-to-consumer drug ads, much of it on TV.

Rejecting Republicans’ appeals that the ad limits are unconstitutional and likely would be overturned in court, Democrats on the Senate Health Education Labor & Pensions Committee, on a party-line vote, today defeated a GOP attempt to strip the new ban from legislation reauthorizing fees for FDA review of new drugs.

The committee action is likely to set up a June Senate floor vote, and Republicans promised a floor fight over the DTC limits unless changes are made. Advertising and media groups backed the GOP.

“I’m not going to go down without a fight on the floor if this proceeds. I do not think it is constitutional,” said Sen. Pat Roberts, R-Kan. He said he’s still hopeful of reaching an agreement, but believes strongly that the DTC limits go too far.

The new limits on DTC are part of a congressional backlash to the amount of drug ads on TV and the nature of some of those ads.

The pharmaceutical industry has established a code in response to some complaints, and media companies have also stepped up their scrutiny of drug ads, but there have been calls for further limits.

Advertiser, media and pharmaceutical groups argue that drug ads prompt people to go to their doctors and lead to better health. Critics argue the ads promote requests for unneeded drugs and often don’t make clear the risks of using a drug.

The limits on drug ads were included in an act sponsored by Sen. Ted Kennedy, D-Mass., the committee’s chairman and Michael Enzi, R-Wyoming, the committee’s vice chairman. In a surprise today, Sen. Enzi today was among the 10 Republicans who voted to replace it with the alternative from Sen. Roberts.

Roberts’ plan would have eliminated the DTC ban; it also would have given the FDA new authority to fine DTC advertisers for “false” or “misleading” advertising.

Sen. Kennedy and Democrats defended the DTC ban, saying it would be used rarely and that the proposal was far less stringent than limits recommended in an Institute of Medicine report from the National Academy of Sciences.

“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,” said Sen. Kennedy.

Ad groups said they are already joining with media groups to mount a no-holds-barred attempt to overturn any ban. They warned that a limit on DTC advertising could be a precedent to congressional limits on other kinds of TV 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.”

(Editor: Horowitz)