Naloxone Switch: Door Opener For Other NDAs That Swing On Consumer Education
This article was originally published in The Pink Sheet Daily
Health care professionals provide naloxone in an outpatient setting in “highly successful programs,” but FDA approval of a switch rests on whether “just putting the drug on the store shelf for anyone to purchase with no training or guidance on use” will be safe, says nonprescription drug division head Theresa Michele.
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FDA considers switching some prescription “antidotes” to restricted nonprescription status so consumers who can self-identify their need for the drugs and who previously had a prescription can easily access them during life-threatening events, says CDER Director Janet Woodcock.
CDER compliance office director Donald Ashley offers a cautionary note to temper expectations for the FDA’s enforcement in the supplement sector. “We continue to warn the public about products very often sold as dietary supplements that contain hidden drugs,” he says.
UCLA professor Chris Tang says like most US businesses relying on supplies or production from outside the country, particularly from China, consumer health and beauty and personal care product companies should expect at least another year of supply disruption.