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Around the nation: FDA authorizes OTC use of Narcan


FDA on Wednesday ruled that Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter (OTC), in today's bite-sized hospital and health industry news from the District of Columbia, Maryland, and Idaho.

 

  • District of Columbia: The 5th Circuit Court of Appeals on Thursday upheld a lower court's decision to prevent the government from enforcing its COVID-19 vaccine mandate on federal employees. The ruling reverses the decision of an appeals panel, which ruled last April to uphold the vaccine requirement for federal employees. While there was some debate over whether the Texas district court that ordered the preliminary injunction had the jurisdiction to file — since the Civil Service Reform Act (CSRA) protects employees from federal employers engaging in unfair or unwanted practices — the appeals court found that the case falls outside the scope of CSRA's jurisdiction. "Plaintiffs' complaint does not challenge any personnel action reviewable under the CSRA. Nor does it challenge any personnel action they could hypothetically incur in the future," the court said. "Rather, plaintiffs claim that the President's vaccine mandate violates the U.S. Constitution and the [Administrative Procedure Act]." (Shapero, The Hill, 3/23)
  • Maryland: FDA on Wednesday ruled that Narcan can now be sold OTC — a move many experts believe will reduce the high drug fatality rates in the United States. The OTC authorization intends to address a "dire public health need," according to FDA Commissioner Robert Califf. Following FDA's decision, Narcan, a spray version of naloxone, which has already saved thousands of people from opioid overdoses, should be more widely available. "Today's approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it's available and help reduce opioid overdose deaths throughout the country," Califf said. "We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price." Narcan manufacturer Emergent BioSolutions said it does not expect OTC sales to begin until late summer, citing manufacturing changes. (Moreno, Axios, 3/30; Mulvihill, AP/STAT, 3/29; Ovalle, Washington Post, 3/29; Moreno, Axios, 3/29; Hoffman, New York Times, 3/29)
  • Idaho: Gov. Brad Little (R) signed a bill authorizing execution by firing squad amid a nationwide shortage of lethal-injection drugs, making it the latest state to revert to older methods of capital punishment due to the shortage. Last week, the state legislature passed the measure with a veto-proof majority. Under the legislation, firing squads will only be used if the state is unable to acquire the drugs necessary for lethal injections. "While I am signing this bill, it is important to point out that fulfilling justice can and must be done by minimizing stress on corrections personnel," Little said. "For the people of death row, a jury convicted them of their crimes, and they were lawfully sentenced to death. It is the responsibility of the state of Idaho to follow the law and ensure that lawful criminal sentences are carried out." (Associated Press, 3/25)

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