Mifepristone was approved by the FDA in 2000 and is one of two drugs used for chemical abortion, the other being misoprostol. in Texas, US Judge Matthew Kacsmaryk issued Order to stay with FDA Approval of Mifepristone. He also included a seven-day grace period for the court of appeals to seek relief against the order.
Danko Laboratories, the manufacturer of Mifeplex, the trade name for Mifepristone, appealed To the Fifth Circuit seeking stay of the Kacsmaryk judgment.
Fifth Circuit Ordered Only Partial Suspension of Kacsmaryk’s command.
The ruling said that mifepristone would remain approved during the appeals process, but that changes made to mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) in 2016 would no longer apply.
Starting in 2016, FDA changed the four REMS parameters for achieving mifepristone. This would extend the maximum gestational age of the fetus to 70 days, reduce the required face-to-face consultation to his one, allow non-physicians to prescribe the drug, and eliminate reports of non-fatal adverse events. I was.
Another change is that in 2021, the FDA announced that it would allow mailing of mifepristone at enforcement discretion, and in 2023, the FDA permanently removed the requirement to dispense mifepristone in person.
A new order from the Fifth Circuit has allowed the FDA to return mifepristone regulation to what it was in the 2000s, requiring approval of mifepristone if the pregnancy is less than 50 days gestation, requires three in-person visits, and is valid. Allowed only if supervised by a qualified physician and required to be reported. Must be done for all adverse events.
Controversy over the mailing of abortion pills was also factored into decisions centered on the Comstock Act of 1873.
The Comstock Act states:[e]Articles or objects designed, modified, or intended to perform abortions” and “[e]Any article, device, substance, drug, drug, or thing advertised or described in a manner calculated to induce or apply another person to use or apply it to perform an abortion , “Items that cannot be mailed”.
Alliance Defending Freedom’s representative team of attorneys held a press conference to announce their acceptance of the verdict.
“What the Fifth Circuit has done here is that it really recognized that FDA’s action was illegal from the start, and it also implemented a number of requirements to undo FDA’s action. That’s it,” said Life and Regulatory Practices at the Center for ADF.
Hawley said “FDA put politics ahead of the health of women and girls” when it “removed all meaningful safeguards” against the use of dangerous chemical abortion drugs. .
The Fifth Circuit’s partial stay of appeal now faces future litigation over the Fifth Circuit’s ruling and its 2000 initial recognition, which could lead to litigation with the U.S. Supreme Court. I have.
https://thetexan.news/u-s-fifth-circuit-court-restores-fda-restrictions-on-abortion-pill-mifepristone-prevents-mail-order/ U.S. Fifth Circuit Court Reinstates FDA Restrictions on Abortion Drug Mifepristone, Bans Mail Order Sales