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Around the nation: Judge imposes mifepristone restrictions but keeps it on the market


The U.S. Court of Appeals for the 5th Circuit on Wednesday ruled that a number of decisions by FDA to make mifepristone more widely available didn't take safety concerns into account, and that the pills should not be available through telemedicine appointments or the mail, in today's bite-sized hospital and health industry news from Illinois, Louisiana, and Maryland.

 

  • Illinois: The Joint Commission and the National Quality Forum (NQF) announced on Wednesday that they will combine, which the two organizations said will allow them "to build upon their shared expertise in measuring quality and rationalizing the measurement landscape, so the focus shifts from competing measures to advancing key outcomes." NQF will remain independent in its standards and practices development, though the majority of its board will be appointed by the Joint Commission. "We believe that by combining the unique capabilities of each organization, we can better support focused improvement in healthcare," said Jonathan Perlin, president and CEO of the Joint Commission. (AHA News, 8/16; Devereaux, Modern Healthcare, 8/16)
  • Louisiana: The U.S. Court of Appeals for the 5th Circuit on Wednesday ruled that a number of decisions by FDA to make mifepristone more widely available didn't take safety concerns into account, and that the pills should not be available through telemedicine appointments or the mail. "In loosening mifepristone's safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," Judge Jennifer Walker Elrod wrote in her ruling. "It failed to consider the cumulative effect of removing several important safeguards at the same time." Judge Elrod stayed her ruling, however, until the Supreme Court rules on the case, meaning mifepristone will remain on the market and available by mail and telemedicine for now. (Frieden, MedPage Today, 8/16; Kimball, CNBC, 8/17)
  • Maryland: FDA has granted accelerated approval to elranatamab, a bispecific antibody for treating relapsed/refractory multiple myeloma that has been treated with at least four other regimens. The drug is approved for adults with a treatment history that includes a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody. In a statement from Pfizer, Ajay Nooka, from the Winship Cancer Institute of Emory University, said elranatamab "provides a much-needed new option for heavily pretreated multiple myeloma patients who are struggling with relapsed myeloma." (Bankhead, MedPage Today, 8/15)

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