Rescue Medicine Switch Concept Draws Criticism
This article was originally published in The Tan Sheet
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.
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Industry has opposed establishing an intermediate class of drugs between Rx and OTC, and FDA has held it does not have authority to require firms to allow products to be approved for behind-the-counter access or some other alternative distribution. But the creation of some form of third route to access appears likely.
The only inhalers to treat asthma available after Dec. 31 will be prescription products.
Prescription asthma drugs on the brink of patent expiry could breathe new life into Rx-to-OTC switches, but not without fierce opposition from some health care providers.