On Friday, Trump-appointed anti-abortion extremist Judge Matthew Kacsmaryk issued a long-expected order revoking the FDA’s decades-old approval of mifepristone, one of the two drugs used for medication abortions. Kacsmaryk put his decision on hold for a week for the Justice Department to appeal to the right-wing Fifth Circuit. But, also on Friday, U.S. District Judge Thomas Owen Rice, who is based in Washington state, issued a conflicting order for the FDA to keep mifepristone on the market in 17 states and the District of Columbia. On Monday, the Justice Department asked Rice to clarify what it should do if Kacsmaryk’s order does go into effect, and asked the Fifth Circuit to stay Kacsmaryk’s order pending appeal.
The judges’ conflicting orders essentially ensure that this matter will be going to the Supreme Court as quickly as possible, where on the one hand, there are six anti-abortion justices, but on the other hand, at least a couple of them might recognize that giving the courts the authority to overturn FDA decisions isn’t just a decision about abortion and could create chaos.
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“People want to talk about this as an abortion case, but there are multiple threshold legal issues that have nothing to do with abortion,” Jonathan Adler, a professor at Case Western Reserve University School of Law, told NBC News.
The FDA has been in charge of deciding what drugs are safe and effective since Congress passed the Food, Drug, and Cosmetic Act of 1938. Under that authority, the FDA approved mifepristone for medication abortions back in 2000 and re-approved it in 2016 and 2019 based in part on the accumulated safety data through its years of use. Kacsmaryk, who was a conservative Christian activist before Donald Trump appointed him to a lifetime judgeship, is really reaching here. He doesn’t care about the science or the legitimacy of the judicial system. The question is whether two of the right-wing judges on the Supreme Court care enough about it to block this kind of precedent-incinerating move.
The Washington case that led to Rice’s order to keep mifepristone on the market in a large part of the country was brought by Democratic state attorneys general asking to have some restrictions on mifepristone lifted. Rice rejected that request on the basis of the same principles of administrative law that Kacsmaryk jettisoned. “It is not the Court’s role to review the scientific evidence and decide whether mifepristone’s benefits outweigh its risks without REMS and/or ETASU. That is precisely FDA’s role,” Rice wrote, while Kacsmaryk elevated his own views above the FDA’s authority and above the science.
The basic science is this: Mifepristone blocks the hormone progesterone, preventing the pregnancy from continuing to develop. Around 24 hours later, misoprostol is taken to soften the cervix and cause uterine contractions, expelling fetal tissue. This method has a 99.6% success rate. By contrast, misoprostol-only abortion has a success rate of around 80%. That means that banning mifepristone would increase the number of failed medication abortions that required medical follow-up and possibly surgical abortion. And that means more risks and more burdens for the people involved—yet Kacsmaryk claims that mifepristone is the safety issue. The mifepristone-misoprostol medication abortion regimen has a 0.4% chance of major complications and a mortality rate of less than 0.001%, while pregnancy and childbirth are far more dangerous. In fact, a lot of uncontroversial medications are more dangerous:
(Phosphodiesterase inhibitors = boner pills like Viagra)
The pharmaceutical industry has reason to be concerned about the prospect of the Supreme Court upholding Kacsmaryk’s decision as well. “If your approval can be withdrawn at a moment’s notice by a single judge,” I. Glenn Cohen, a Harvard Law School professor and bioethics expert, told The New York Times, “it’s really kind of a scary thing.”
The Justice Department is going ahead with its appeals while asking the Fifth Circuit to stay Kacsmaryk’s order and asking Rice for that clarification on what to do if it is faced with mutually exclusive orders. House Democrats are introducing a bill to reaffirm the fact, which is a fact, that the FDA is in charge of drug approvals, but don’t expect House Republicans to let that pass.
What everyone needs to be completely clear about is how outrageous Kacsmaryk’s order is. This is a medication that the FDA approved more than 20 years ago and re-approved since. There are literally decades of safety data, all pointing to the medication being safe and effective, even if Kacsmaryk doesn’t like what it does. The FDA’s legal authority here is unambiguous and past challenges to it have failed. The only reason Kacsmaryk could be upheld here is the right-wing justices’ antipathy to abortion and complete disregard for the law.
We can’t bet on the Supreme Court to strike Kacsmaryk down. But for now, mifepristone has not been banned.
Two abortion providers say they will keep prescribing mifepristone until the FDA orders them to stop
Our planned Ukraine episode will have to wait, as Donald Trump is being arraigned in New York City for his role in falsifying records to hide hush money paid to Stormy Daniels. This is the first of a potential slew of indictments coming Trump’s way, and we are here for a celebration of karmic justice—and to talk about what happens to the Republican Party after this.