FDA Takes Unprecedented Steps In Bid To Push OTC Switch

FDA has taken unprecedented steps to encourage an Rx-to-OTC drug switch by creating a sample label and initiating consumer testing, normally initiated by industry. In doing so, FDA hopes to spur efforts to make a popular opioid overdose treatment available over-the-counter. However, it remains unclear if a current license holder of the drug will willingly initiate the process. “This is the first time the FDA has developed a model Drug Facts label (DFL) for a specific drug, and initiated the...