Saturday, April 14, 2012

FDA Hears Testimony on Naloxone Access and Potential for Over-the-Counter Status

This past Thursday, April 12, the U.S. Food and Drug Administration (FDA) held its first ever workshop on naloxone availability and use in emergency first aid in the United States. The event marks an important first step in the federal government taking greater responsibility for overdose prevention efforts, and by all accounts FDA was looking for ways to be a constructive partner with local peer distribution efforts.  More information on the goals of the meeting, the agenda, and a speakers list may be found on the FDA website

While the goal of rescheduling naloxone to remove prescription requirements faces significant bureaucratic hurdles, FDA may be able to take other measures in the near term, such as approving emergency importation of naloxone from manufacturers in Europe or elsewhere in order to address the stock-outs and price hikes plaguing overdose projects in recent years.

We'll soon have more analysis about the meeting and next steps from several participants. In the meantime, Time magazine's Maia Szalavits continues her quest to make completely OPA redundant with an excellent first-take on the meeting

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