New FDA Guidelines Focus on Emphasizing Risks
The FDA has posted new draft regulations on its website. While these guidelines aren’t binding, they will help improve approval process by avoiding problems with omitting or minimizing important risk factors and information.
The FDA will take public comment for 90 days before issuing new guidelines.
Now the guidelines suggest instead of generally stating “certain monitoring” the label should state exactly what type of monitoring is needed along with its frequency. For example, certain monitoring should be replaced with monthly blood tests for liver damage.
The FDA will be reviewing the “net impression” of advertising to determine if the information relays an accurate impression.
For example, smiling people, changing camera angles, and upbeat music may obscure the more serious message of the potential for harm. The FDA could consider these tactics as overall misleading impression.
Last year, a congressional hearing criticized Schering-Plough’s Nasonex, an anti-allergy medication ad campaign. The ad featured a bee that flew around during a description of side effects but simply hovered while benefits were explained.
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