The Supreme Court reinstates the requirement on in-person pickup of pregnancy-ending medications; CMS releases numbers on 2020’s final week of Marketplace open enrollment; the FDA updates safety information for filgrastim (Neupogen).
In a majority opinion issued yesterday by the Supreme Court, in a case that saw the FDA pitted against the American College of Obstetricians and Gynecologists (ACOG) among others, in-person pickup of medications used to end a pregnancy once again became mandatory. The ACOG argued against requiring visits to medical facilities to pick up the combination pill of mifepristone/misoprostol when it could be delivered or mailed. In addition, only mifepristone has an in-person requirement for pickup; misoprostol can be obtained from retail and mail order pharmacies. The requirement was first blocked in July 2020 by Judge Theodore D. Chuang of the Federal District Court of Maryland, reports The New York Times, because of the coronavirus disease 2019 pandemic; an October appeal to the Supreme Court returned the case to him and he upheld that decision on December 9.
Numbers on the final week of open enrollment for 2021 coverage, from CMS, show total enrollment just about equal to that for the entire enrollment period of 2020. Close to 8.3 million individuals chose plans for the first time (n = 1,884,174) or were automatically reenrolled in their current plans (n = 6,367,529). Florida had the highest total of plan selections, at more than 2 million, followed by Texas with approximately 1.3 million and North Carolina at over 500,000. New Jersey and Pennsylvania are not included in these accountings, having instituted their own state-based and health care exchange platforms for 2021 enrollment. Final enrollment numbers will be released in March.
Several safety-labeling changes were issued yesterday by the FDA for filgrastim (Neupogen), which is used to reduce the risk of infection from febrile neutropenia. Under “Warnings and Precautions,” prior to starting therapy with filgrastim, there must now be a confirmed diagnosis of severe chronic neutropenia (SCN). Treatment for SCN with filgrastim has been linked to the development of both myelodysplastic syndrome and acute myeloid leukemia. Label sections on adverse reactions, postmarketing experience, and patient counseling information were also revised.