US FDA prepping risk advice for drug ads

The U.S. Food and Drug Administration plans to give pharmaceutical companies new guidelines on how to make potential side effects clear in their advertisements, a senior FDA official told Reuters on Friday.

The agency is aiming to have guidelines published this year, said Thomas Abrams, director of the agency’s Division of Drug Marketing, Advertising, and Communications.

“We think this is important to give guidance to industry on how to best get risk information out to both the health-care professionals and consumers,” Abrams said in an interview.

Abrams also said he expected the FDA would issue more warning letters to companies this year about misleading ads because the agency had hired an extra seven reviewers last year, bringing the total to 29.

The additional staff comes as more companies look to the Internet to promote their products, using YouTube videos, social networking and other technologies.

Abrams said the FDA was actively monitoring promotions on the Internet including on social networking sites.

By Susan Heavey and Lisa Richwine
WASHINGTON (Reuters)