Progress On Adding OTC Drugs To US Market? Room To Move But Label Format Limits Options
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.
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“We created a warning wallpaper, which means it looks like one block of overwhelming warnings,” says drug labeling expert Julie Akers. Technology has changed the world with nonstop access to information on multiple devices from myriad digital sources, but DFLs remain one-dimensional, static media.
US FDA encourages firms to “identify and avoid potential problems before the product is marketed” by comparing proposed names against the agency’s best practices recommendations and seeking the agency’s input.
In Drug Safety Communication, FDA says it is requiring labeling changes for Rx as well as OTC NSAIDs due to risk of rare but serious kidney problems in an unborn baby.