Why Tougher DTC Restrictions Were Killed

As the FDA Reform bill, which nows goes to President Bush for signing, is studied and debated, it may be easy to forget that just a few months ago there was a push to include tough restrictions on DTC advertising in the legislation. But that didn't happen. The reason - intense lobbying by advertising agencies and broadcasters, as well as drugmakers, of course.

The toughest restrictions in early drafts of the bill gave the FDA authority to block a drugmaker from advertising a med that carried serious safety concerns, writes The Wall Street Journal (subscription required). That was omitted. Instead, the FDA will get new power to require drugmakers to submit TV ads for review before they run, but can only recommend changes, not require them. The bill lets the agency levy fines for false and misleading ads.

It was "a success for the entire advertising community," Dan Jaffe, executive vp of the Association of National Advertisers, a trade group, tells the paper. Lobbying groups including the National Association of Broadcasters and the Advertising Coalition, which rep a variety of media interests and advertisers, swung into action. To them, the idea that regulators would be able to block ads about a new drug was a business disaster in the making.

Remember that, in the US, pharmaceuticals were the 10th-biggest advertiser in 2006, spending $5.3 billion, or 3.5 percent of the total $149.6 billion US ad market. Pharmaceuticals also registered the highest growth rate among the top 10 US advertisers, growing 13.8 percentto $5.3 billion from $4.6 billion in 2006.

Advertising and media firms also feared Congress might later try to enact such restrictions on other types of ads. "People just looked and they were incredulous," Harry Sweeney, chairman of Dorland Global, a health marketing and communications firm, tells the Journal. "You're getting into a very slippery-slope area."

The messages were conveyed through a campaign of visits, letters and calls to key lawmakers from advertising firms and broadcasters, as well as other media companies.

In the Senate, Kansas Republican Pat Roberts fought against the moratorium and won when his amendment was added to the bill. In the House, a subcommittee voted to kill the moratorium by adopting an amendment co-sponsored by Edolphus Towns, a Democratic congressman from New York City.

"We view the entire thing as a First Amendment issue," says Rick Blake, a staffer for Towns, who says his office heard from some media interests including the Advertising Coalition. Towns's amendment granted the FDA the power to impose fines on a drug company if its ads were found false and misleading. Currently, the agency must get a court to approve such penalties.

The fines will amount to $250,000 for the first violation in any three-year period, and won't go above $500,000 for any subsequent violation in a three-year period.

Drugmakers are pleased with the final language. "Many thought this was the moment...when moratoriums and other restrictions on DTC would flourish," says Rich Buckley, vp of federal government affairs at AstraZeneca. Instead, he says, consumer drug marketing "is here to stay."