FDA Extends Comment Period For Direct-To-Consumer Advertising Guidances
This article was originally published in The Pink Sheet Daily
Executive Summary
The agency has reopened the comment period until Aug. 10 to allow additional time for conducting DTC research, Ad Division Director Tom Abrams says. FDA plans to conduct its own research on the content and format of the brief summary.
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FDA is reopening the comment period for its draft guidances on direct-to-consumer advertising through Aug. 10. "We got comments that folks wanted more time to do DTC research, complete DTC research and also more time to provide comments," Division of Drug Marketing, Advertising & Communications Director Tom Abrams said during a Drug Information Association audioconference May 27. "We encourage outside groups who have done research or are considering doing research to complete that research and to make it publicly available," he said. FDA issued draft guidances on the brief summary, disease awareness ads and medical device ads on Feb. 4 (1 (Also see "Alternatives To Brief Summary Outlined In Draft Guidance" - Pink Sheet, 4 Feb, 2004.)). The comment period originally closed May 10. A formal announcement of the extended comment period will be published in an upcoming Federal Register notice. FDA also plans to conduct its own research on DTC advertising. "We are planning to do research on the content and format of the brief summary," FDA Regulatory Counsel Kristin Davis said. "We are waiting until the current comment period closes to solidify our ideas for research because several groups are concurrently conducting research which will help us and guide us in our design objectives," she said. The Federal Trade Commission has said that FDA should test consumer comprehension of different presentations of risk information (2 (Also see "FTC Positive On FDA's Direct-to-Consumer Advertising Guidances" - Pink Sheet, 13 May, 2004.)). - Tericke Blanchard |