FDA  has rescinded its approval of the preterm birth treatment Makena, officially pulling it from the market, in today's bite-sized hospital and health industry news from Maryland and New York.

• Maryland: FDA on Monday announced that it will require opioid manufacturers to supply prepaid mail-back envelopes to outpatient pharmacies and other dispensers for drugs distributed in outpatient settings. According to FDA Commissioner Robert Califf, the move is part of the agency's comprehensive approach to overcome the overdose crisis. "We believe these efforts will not only increase convenient disposal options for many Americans, but also reduce unfortunate opportunities for nonmedical use, accidental exposure, overdose and potential new cases of opioid use disorder," Califf said. "We're pleased to take this first critical step to increase mail-back envelope options in partnership with the  U.S. Postal Service." (George, MedPage Today, 4/3)
• Maryland: Last year, an FDA advisory committee recommended  pulling the preterm birth treatment Makena from the market after a confirmatory trial failed to show benefit. On Thursday, FDA rescinded its approval of Makena and the treatment, along with its generics, "cannot be lawfully distributed in interstate commerce." According to the agency, providers could still prescribe doses that have already been distributed but should "consider FDA's conclusion" about the drug's lack of effectiveness and potential risks. Previously, Covis Pharma, Makena's manufacturer, in March  agreed  to voluntarily withdraw the treatment, although the company noted that it still "stand[s] by Makena's favorable benefit-risk profile." With Makena off the market, there is no longer an FDA-approved treatment for reducing the risk of preterm birth. This decision "leaves patients with prior preterm birth without the only previously FDA-approved, treatment option available for recurrent spontaneous preterm birth, and it limits the options that our members have available to offer those patients," said Christopher Zahn, chief of clinical practice and health equity and quality for the  American College of Obstetricians and Gynecologists (ACOG). According to Zahn, ACOG will update its clinical guidance to help providers counsel patients currently undergoing treatment in the coming days. (González, Axios, 4/7; Robertson, MedPage Today, 4/6)
• New York:  Pfizer will buy the assets of  Lucira Health following a successful bid in an auction in the U.S. Bankruptcy Court in Delaware. Lucira, a California-based company, developed an at-home combination COVID-19 and flu test that received  emergency use authorization (EUA) from FDA in February. However, the company announced its bankruptcy around the same time, citing delays in the test's EUA, which was initially filed in May 2022 and expected in August ahead of the 2022-2023 flu season. According to the  San Francisco Business Times, court filings have not disclosed how much companies bid for Lucira, including Pfizer's final winning bid. Currently, Pfizer's purchase of Lucira's asset is scheduled to be heard by Bankruptcy Court Judge Mary Walrath on April 13. (Leuty, San Francisco Business Times, 4/6)