- U.S. District Judge Matthew Kacsmaryk questioned President Joe Biden's administration lawyers on whether the federal regulatory approval of the abortion pill mifepristone was proper.
- The judge is reportedly considering a request by anti-abortion groups to ban sales of the drug nationwide.
- The judge raised the possibility of keeping the drug on the market but re-imposing some restrictions lifted by Biden's administration, including requiring it to be dispensed in person rather than by mail.
- Kacsmaryk said he would rule "as soon as possible."
- Related: New York Governor, Attorney General Ask Three Pharmacy Operators' Commitment Over Abortion Drug Access.
- The anti-abortion groups sued the FDA in November, accusing the agency followed an improper process to approve mifepristone in 2000. It did not adequately consider the drug's safety when used by girls under 18.
- The plaintiffs are asking Kacsmaryk for a preliminary order halting sales of mifepristone nationwide - even in states where abortion is legal - while their lawsuit proceeds.
- Lawyers for the U.S. Justice Department and an attorney for mifepristone's manufacturer, Danco Laboratories, argued that the plaintiffs had no standing and that mifepristone has an impressive safety and efficacy record, Reuters reported.
- Major medical organizations have weighed in on the side of the FDA, saying mifepristone "has been thoroughly studied and is conclusively safe."
- Photo via Wikimedia Commons
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in