The latest fight about abortion is once again in the courts. This time the battle is over “medical” abortion. Even before the Dobbs decision last year, there has been a move away from “surgical” abortions to medical abortions. (According to the latest statistics, it is close to a 50-50 split between surgical abortions and medical abortions.) The reasons for this trend are somewhat simple.
First, it is easy for a state to regulate surgical abortions. While most surgical abortions are not what most people would consider to be surgical, a surgical abortion is still a hands-on, in-person procedure. It requires an office, and a state can enact rules about that physical facility — size, location, and equipment.
Second, the need for a physical location for surgical abortions creates two problems. On the one hand, that makes it easy for anti-abortion activists to target the facility in various ways. On the other hand, the need for a physical facility makes it harder for patients to access the facility. Due to the regulations, an abortion clinic is rather expensive investment. As a result, abortion clinics are in the biggest cities. If you live in the rural part of your state, the nearest abortion clinic can be over three or four hours away.
By contrast, your local Ob-Gyn, who is unwilling to open a surgical abortion clinic, might be willing to write a prescription. And, if your local doctors are unwilling to do so, it is now possible to use tele-medicine to have a doctor write a prescription. Neither require a long trip to another city (and having to stay overnight for a twenty-four hour waiting period). And once the prescription is written, it can either be filled by the local pharmacy or (if the local pharmacy is unwilling to fill it) by mail. In short, a medical abortion is harder to regulate and puts less burden on the doctors and patients.
In the U.S., medications (along with food additives, medical devices, and cosmetics) are regulated by the Federal Drug Administration. Putting aside the issues about “off-label” uses, the initial approval of a medication requires a multi-step process. After laboratory studies and animal testing to show that a new medication looks promising, a pharmaceutical company gets permission to due patient trials. Typically, such trials includes a blind comparison in which some individuals in the trials get a placebo or existing medication and others get the medication being tested. The trials are looking for two things: 1) is the new medication more effective than existing treatments; and 2) what are the risks of the new medication (what are the side effects, how serious are they, how common are they). The results of these trials are submitted to the FDA. The FDA is tasked with deciding whether the new medication is an improvement (either generally or for a particular segment of the population) in terms of treating the condition with fewer significant risks than the existing medications. This analysis requires balancing the benefits of the new medication against the risks. In theory, a medication that works better with fewer risks than the existing treatment should be approved while a medication that works less well with more significant risks than the existing treatment should not be approved.
Furthermore, because clinical trials involve a limited number of patients, not all potential side effects are detected during the trials. Some side effects are not discovered until a new medication is approved for use by general public. But the law requires that such side effects be reported. At the very least, the side effect is added to the warning sheet that is given to patients. If the side effects are significant enough, the FDA might reconsider the approval of the medication.
Under federal law, if somebody thinks that the FDA has made a mistake in its decision on approving a medication, that person can ask a court to review that decision. Normally, this request is made shortly after that decision. (Failing to do so can invoke a doctrine known as “laches” which is a fancy way of saying that you lose because you waited too long to raise that issue.) And the challenge is typically made by the pharmaceutical company which is unhappy that their product was rejected rather than somebody complaining about a new medication is available to the public. But, of course, in the abortion scenario, there are folks who are unhappy that there is a medication that can be used to make it easier for women to have an abortion.
The medication currently at issue is mifepristone. In the U.S., mifepristone is commonly used as part of a two-drug protocol with misoprostol. Most doctors believe that the mifepristone-misoprostol protocol is better for their patients than the alternative of several doses of misoprostol. Mifepristone was approved back in 2000. There were two decisions issued on Friday. One was filed in Texas (in a location which all but guaranteed which judge would get the case) was heard by a long-time anti-abortion activist who got rammed through the Senate by Senator Turtle while Trump was president. Not surprisingly, this “judge” excused the delay in bringing the lawsuit (blaming the FDA for not rejecting the requests to reconsider the approval sooner) and the overwhelming evidence on which the FDA relied and gave credit to dubious studies suggesting a higher risk to mifepristone. In the other case, a judge in Washington entered an order upholding the initial approval and barring the FDA from restricting its use.
Needless to say, these two decisions put the FDA in a legally impossible position — both requiring it to cancel the approval of mifepristone and barring it from putting additional restrictions on the use of mifepristone. The FDA has already appealed the Texas decision which will go from the most ultra-conservative trial judge in the country to the most conservative appellate court (Fifth Circuit). The Wahington decision was made by a judge who was a career federal prosecutor who worked his way up to the senior “career” position in the local U.S. Attorney’s Office under a Republican appointee until being appointed to the bench during the Obama Administration. If somebody appeals that decision (and I am not sure who would), it would go to the most liberal appellate court (Ninth Circuit). In short, it looks like the U.S. Supreme Court will need to take this case (even if it is only to issue a summary per curium decision). I would anticipate, in the short-run, that either the Fifth Circuit or the U.S. Supreme Court will put a stay on the Texas order pending a final decision. Even if you assume that it is debatable whether the FDA failed to properly address the post-2000 requests from the wacky anti-abortion “medical” group seeking to have it reconsider the initial approval, the first request occurred almost two years after the initial approval, and preserving the status quo would dictate leaving the approval in place until any court-ordered reconsideration of the “evidence” on mifepristone by the FDA could occur.
Of course, the Texas petition is neither about the law nor about the facts. It is about power — the power of anti-abortion activists to use politics and judicial activists placed on the bench during the Trump Administration to micromanage the lives of women. Whether the U.S. Supreme Court is willling to play politics on this issue remains to be seen. If it does, the voters will know what we need to do in November 2024 to protect the rights of women as if it were not already clear enough.
