5 things ASC leaders need to know about the abortion pill ruling

On April 7, a federal judge in Texas ruled to suspend the FDA's approval of mifepristone, a drug used in medication abortions, effective April 14. 

Five things to know: 

1. Medication abortion has been approved since 2000.

2. Mifepristone is part of a two-drug regimen intended to terminate a pregnancy in the first 10 weeks. The judge in the case did not rule on the second drug in the regimen, misoprostol, which can be used on its own to terminate a pregnancy but is slower and less effective. 

3. The ruling marks the first time a U.S. court has called for a drug approval to be rescinded despite the FDA and the drugmaker opposing its removal.

4. The lawsuit, filed against the FDA by four organizations and four physicians, targets both the drug's safety and efficacy and calls into question the federal government's ability to approve it. "The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an 'illness' and argue that these dangerous drugs provide a 'meaningful therapeutic benefit' over existing treatments," the plaintiffs said in a court document. "But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion," the document said. "In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs."

5. Danco Laboratories, a manufacturer of mifepristone, and the FDA appealed the ruling April 7.

Read more about the ruling here

Copyright © 2023 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Webinars

Featured Whitepapers

Featured Podcast