Court says FDA must restore abortion pill safety measures, pending Supreme Court review

By Carole Novielli - Posted at Live Action:

Published August 16, 2023

The U.S. Court of Appeals for the Fifth Circuit ruled on Wednesday to allow the abortion pill mifepristone to remain “available to the public under the conditions for use that existed in 2016″ while it vacates more recent expansions of the drug’s approved use under the Food and Drug Administration’s (FDA) safety requirements (REMS). Those expansions removed the in-person dispensing of the abortion pill and enabled the drug to be shipped by mail — and also expanded the use of the pill from seven (7) weeks to 10 weeks.

In addition, the Court’s abortion pill ruling will allow the “generic version of mifepristone,” which was approved in 2019, to “be available under the same conditions as Mifeprex.”

However, as Bloomberg states, “The decision… won’t have an immediate impact on access to the medication, mifepristone. The pill remains available under an April order from the US Supreme Court that will stay in effect until the high court rules again on the matter or refuses to hear the case on appeal.”

Calling the decision a “victory for women’s health,” Alliance Defending Freedom (ADF), which represents the plaintiffs in the case, claimed in a press release that the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration found that the FDA must restore critical safeguards for chemical abortion drugs.

Continue here.

See also:

• FDA erred in easing access to abortion pill, appeals court rules | Baptist Press
• Breaking: FDA must restore vital safeguards for chemical abortion drugs, 5th Circuit rules (pregnancyhelpnews.com)
• Reining in the FDA | WORLD (wng.org)