Tag Archives: mifepristone

Supreme Court — Mifepristone

Thursday saw the first of two opinions on abortion — Food and Drug Administration vs. Alliance for Hippocratic (sic) Medicine.  The Alliance, a misnamed far-right group of doctors worked out a plan to belatedly challenge the FDAs various approvals of mifepristone — a drug commonly used for “medical abortions.”  The existence of this drug imposes a substantial barrier to far right attempts to eliminate abortions.

So conservative activists, represented by Mrs. Senator Hawley, went to their favorite one-judge division controlled in Amarillo, Texas to assure that their case would be heard by the “judge” that they put on the bench who agrees with their lawless approach to abortion.  While this judge gave the hypocritic doctors everything that they want, the Fifth Circuit cut back that ruling — holding that the challenge to the original approval of mifepristone came too late but upholding the judge’s decision to substitute his opinion of the medical facts about the risks associated with mifepristone by the medical experts at the FDA on the more recent changes by the FDA on the precautions that needed to be taken in prescribing mifepristone.

In a unanimous opinion (but with Justice Thomas writing a concurring opinion), Justice Brett Kavanaugh vacated the decisions of the trial judge and the Fifth Circuit.  But, as was always likely with this current batch of justices, the Supreme Court declined to uphold the FDA’s decisions.  Instead, they found that the Alliance and its members lacked standing to bring the case.  For non-lawyers, standing is the legal requirement that a party must be personally harmed by the defendant’s actions, and that you can’t just bring a case because you don’t like what the defendant is doing.  There were certain different theories raised by the Alliance that gave them adequate harm, but the Supreme Court found that none were legally valid. Continue Reading...

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Supreme Court Update

Before departing for the holidays, the Supreme Court had a couple of “gifts” of merits review in a couple of high profile cases with the possibility of a third before New Year’s.

Starting at the top of the list is the dubious case brought by Mrs. Senator Josh Hawley.  (Normally, the fact that a relative of a politician is involved in a case would not be noteworthy but whne you put yourself out as a power couple and you file the case in a location which assures that it will be heard by a judge who donated to the relative’s campaign and the relative played a large role in getting that judge appointed to the bench, this clearly qualifies as a team effort for which both share the blame.)  In this case, plaintiffs are a group of doctors who claim that they have standing to challenge the FDA’s decisions on approving Mifepristone because at some point they may be forced to provide treatment for a patient who took Mifepristone and had complications.  These political doctors sought to both invalidate recent changes to the guidance that the FDA gives on Mifepristone and its original approval.  Having filed the case in a location that assured them that the case would be heard by a judge who would twist the law and the facts to rule in their favor, they succeeded at the trial court on both parts of their case.  The FDA and the drug manufacture appealed this rubber stamp decision to the Fifth Circuit.  Even the Fifth Circuit could not twist the law in a manner that would allow them to affirm the decision as it relates to the original approval of Mifepristone, but they did find flaws in the administrative process which allowed them to affirm the decision with regards to the more recent changes approving a broader use for Mifepristone.  Everybody then sought U.S. Supreme Court review.  Several months ago, the U.S. Supreme Court stayed the Fifth Circuit’s ruling.  This past week, the Supreme Court granted the review sought by the FDA and the drug manufacturer, but denied the review sought by the medical hacks.

While this Supreme Court having any case related to abortion is always a matter of concern, the decision to take the FDA’s appeal and reject the appeal by the medical hacks is the best result possible for the pro-choice community.  And, the main issue in the case is the FDA procedures for approving medications and expanding “on label” uses after initial approval.  As such, the impact of a ruling against the FDA in this case would have a major negative impact on pharmaceutical companies.  As such, it is possible that six of the justices might put the abortion aspects of this case to the side and simply focus on it as an administrative procedure case.   If not, there is always the November elections. Continue Reading...

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What you Need to Know about the FDA

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. Continue Reading...

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