US Pharma Marketers Celebrate DTC Drugs Legislation

21 September 2007

WASHINGTON DC: US pharmaceutical firms on Wednesday breathed an audible sigh of relief that new federal regulations stop short of banning direct-to-consumer ads - although for the first time they now face penalties if these are deemed to be misleading.

The compromise bill, which extends the powers of the Food and Drug Administration, boosts the number of FDA staff who will review ads.

And for the first time, it gives the regulator authority to fine advertisers up to $250,000 (€178k; £124.5k) a day for continuing to run ads flagged as misleading, and up to $500,000 daily for a second infringement within three years.

In addition, the FDA will get the resources to investigate the benefits or otherwise of including a telephone number in ads to which consumers could report problems.

The legislation, in negotiation for many months, is viewed as a victory for pharma advertisers and marketers who are celebrating the lack of significant impact on their $4.2 billion annual DTC adspend.

Health professionals and patients' advocacy groups had called for a moratorium of up to three years on DTC advertising of new medicines, prompted by the high profile safety debacles of Vioxx and others.

Campaigners are disappointed that their fierce lobbying has been unsuccessful in this regard.

And Democrat Senator Edward Kennedy, one of the strongest advocates of the three year moratorium, declared his concern at the House's acceptance of compromises.

"After so many recent instances in which Americans have been harmed by unsafe prescription drugs and contaminated food, America cannot afford inaction on this important measure," he said.

Data sourced from; additional content by WARC staff