A ruling was handed down by the 5th U.S. Circuit Court of Appeals in New Orleans just before midnight on Wednesday night. The ruling temporarily narrowed a decision by U.S. District Judge Matthew Kacsmaryk. The conservative-leaning circuit court preserved access to the abortion pill mifepristone for now but with restrictions.
Kacsmaryk created an earthquake with his ruling last Friday. He suspended the FDA approval of mifepristone. This breaches new territory for a federal judge to declare the FDA’s approval of a drug to be unsafe and ineffective. If Kacsmaryk’s ruling stands, it opens the door for others to challenge the FDA’s approval of other drugs. The judicial system would be in the business of drug approval and that’s a very slippery slope. Do we really want a judge to determine whether or not a drug should receive FDA approval?
This case is going to end up heading to the Supreme Court. It’s just a matter of time before a decision is made by the highest court on when the case will be heard.
For now, the pills will be available for sale but the period of pregnancy in which the drug can be used is reduced. There are also no sales by mail allowed.
From Dublin, the most abortion-friendly president, a “devout Catholic”, pledged to continue to fight for the sale of abortion pills through his spokesperson, White House Press Secretary Karine Jean-Pierre. KJP told reporters, “We are going to continue to fight in the courts, we believe the law is on our side, and we will prevail.”
Mifepristone was approved for use by the FDA in 2000 and is used in combination with a second drug, misoprostol. There is no precedent for a lone judge overturning the FDA’s medical recommendations.
The decision came after a 2-1 vote by the panel of judges Wednesday night.
But in the 2-1 vote, the panel of judges put on hold changes made by the regulator since 2016 that relaxed the rules for prescribing and dispensing mifepristone. Those included extending the period of pregnancy when the drug can be used from seven weeks to 10, and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.
The two judges who voted to tighten restrictions, Kurt Engelhardt and Andrew Oldham, are both appointees of former President Donald Trump. The third judge, Catharina Haynes, is an appointee of former President George W. Bush. She said she would have put the lower court ruling on hold entirely for now to allow oral arguments in the case.
I confess I have problems with the judge’s ruling against the FDA. As a pro-life Republican, I understand trying to limit the procedure but I don’t think that the judicial system entering the drug approval arena is the right way to go. If a court wants to restrict access, like the ruling against mail orders, that’s fine. That kind of ruling can go through the court system and will likely end up in the Supreme Court. But FDA approval of a drug is a different thing altogether.
A question remains about the ease of availability of abortion drugs. Pro-abortion people say that there will be dire consequences if the drug was pulled from the market. The judges, though, said that the FDA has made mifepristone more easily available since 2016, and that has proven to be less consequential than the initial approval of the drug in 2000. Where were these consequences during the first sixteen years when millions of women received mifepristone before more restrictions were eased?
If the appeals court’s ruling stands, the terms of use of the drug will remain as they are now. The FDA limits its use to up to seven weeks of pregnancy. A series of three in-person office visits are required. The first visit is to administer mifepristone, the second is to administer the second drug misoprostol, and the third visit is to address any complications. A doctor’s supervision is required and there is a reporting system for any serious complications from the use of the drug.
Some Democrat governors are beginning to stockpile the abortion drug, like the Governor of New York. Pharmaceutical executives signed a letter this week that condemns the Texas ruling. It warned that other drugs with FDA approval could be at risk if Kacsmaryk’s decision stands.
We’ll see where this case goes from here.
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