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Gottlieb Flags Agency’s Commitment to Expanded Naloxone Access

November 1, 2018

FDA Commissioner Scott Gottlieb said the agency is considering ways to increase the availability of the opioid overdose drug naloxone, including expanded over-the-counter access.

The agency will convene a two-day meeting on Dec. 17-18 to gather feedback on how to expand the drug’s availability. The meeting will include members of the Anesthetic and Analgesic Drug Products Committee and the Drug Safety Risk Management Advisory Committee, who will consider “various strategies and their logistics, economic aspects and potential for harm reduction, as well as whether to co-prescribe naloxone with some or all opioid prescriptions,” Gottlieb said.

The committees will also consider the potential economic burden of co-prescribing naloxone with opioids and practical considerations such as the need for manufacturing volume growth and the potential for a sudden prescription spike to cause shortages.

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