April 24, 2023

Supreme Court Returns Abortion Pill Challenge to 5th Circuit

On the evening of April 21, the US Supreme Court issued a decision allowing the Biden FDA to continue its lax regulation of the abortion drug mifepristone while a legal challenge progresses through federal courts.

The Supreme Court's 7-2 decision sent Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration back to the 5th Circuit for a full hearing. That hearing is scheduled for May 17.

Justices Clarence Thomas and Samuel Alito dissented, arguing that the Biden DOJ and the abortion pill manufacturer Danco “are not entitled to a stay because they have not shown that they are likely to suffer irreparable harm in the interim.”

The lawsuit stems from a 2002 petition from doctors and pro-life groups challenging mifepristone's approval. That petition, which was stonewalled by the FDA for over 20 years, argued that the FDA unlawfully fast-tracked mifepristone's approval through a process intended for the treatment of life-threatening diseases. Further, the groups argue that the FDA's research does not support the drug's approval.

National Right to Life released a paper addressing seven myths about mifepristone's approval process and safety record. That paper can be viewed here.

The 5th Circuit ruling stayed by the US Supreme Court would have reverted mifepristone's regulatory status back to the standards used from 2000 to 2016. Those standards required in-person doctor visits, limited the abortion pill's use to the first seven weeks of pregnancy, prohibited the mail delivery of abortion pills, and required the abortion industry to report non-fatal adverse events.

Alliance Defending Freedom Senior Counsel Erik Baptist, who is representing the pro-life groups' challenge to the FDA, said the Supreme Court's decision was not unexpected.

“As is common practice, the Supreme Court has decided to maintain the status quo that existed prior to our lawsuit while our challenge to the FDA’s illegal approval of chemical abortion drugs and its removal of critical safeguards for those drugs moves forward,” Baptist said. “Our case seeking to put women’s health above politics continues on an expedited basis in the lower courts. The FDA must answer for the damage it has caused to the health of countless women and girls and the rule of law by failing to study how dangerous the chemical abortion drug regimen is and unlawfully removing every meaningful safeguard, even allowing for mail-order abortions. We look forward to a final outcome in this case that will hold the FDA accountable.”

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