GenBioPro, the maker of generic mifepristone, made a bid to establish a backstop Wednesday, should the Supreme Court decide to restrict one of its primary products.
This is smart…it shows the lawlessness of what is happening in the courts, but also keeps the approval in place so that when sanity prevails the drug can be sold again. It probably does more, FDA approval is an important thing looked at by many agencies…it’s possible a state law would still allow the sale of any “FDA approved” drug in some circumstance no matter what the Supreme Court tries to pull.
It bears repeating that we are looking at judges undoing a multi-year science based process that determines the safety of drugs we take simply because they want to force women to carry babies to term (or die trying). The harms involved are huge, and beyond the scope of abortion, as everything is on the table to be undone by judicial fiat…and those drugs save lives and make people able to function when they wouldn’t be able to otherwise. It’s criminally cruel by the judges and organizations doing this, but they obviously don’t care about anything but forcing the nation to follow their twisted ideology.
Justice Department lawyers have been hammering the novelty of the rulings in their filings, warning that greenlighting these opinions means flinging wide the floodgates for all kinds of challenges to the FDA’s authority. [emphasis added]
Sadly, this is a feature to many in the GOP and the “business world” that are looking to dismantle the “Administrative State.”
And this medication isn’t just for abortions.
Cushing’s syndrome[edit]
Mifepristone is used for the medical treatment of high blood sugar caused by high cortisol levels in the blood (hypercortisolism) in adults with endogenous Cushing’s syndrome who also have type 2 diabetes mellitus or glucose intolerance and have failed surgery or cannot have surgery.[22][23]
Mifepristone has also been used to treat symptomatic leiomyoma (uterine fibroids) and endometriosis.[28]
Gifted link; no paywall.
This is such a cluster.
ETA:
This suit demonstrates the absurdity of the Fifth Circuit’s ruling, saying it would be simple/easy/straightforward for the FDA to return to the old regulations on Mifepristone from pre-2016. The FDA can’t just flip a switch and go back to the way things were at some prior date. Things have progressed with multiple layers of approvals, so you can’t just revoke one from years (and years) ago and assume everything will resolve itself smoothly.
Given that there isn’t a study showing that Mifepristone is an “imminent hazard,” would it even be legal for the HHS secretary to issue such a statement, as required to decertify it?
Long time ago Gloria Steinem wrote a treatise on how menstruation would be handled if men were subject to this quirk of nature, e.g. paid days off, free products, even bragging about how long and how much. Same thing with birth control. If men could get pregnant, a smooth glide path to contraception would exist at little or no cost and certainly with no red tape.
I have a pet theory without a shred of evidence. The fifth circuit un-approved the generic version by accident. They stuck a pin in the calendar at 2016 and reversed all changes after that… including the approval of the generic drug that is identical to the approved Danco drug… and the drug used in most medication abortions. Just didn’t realize it was in there. Feels liberating to believe they just screwed up. Hence no explanation for the change they didn’t realize they’d made.
[due to] the enforcement risk and uncertainty it has created, GenBioPro is suffering irreparable financial and reputational harm
Hey, Republican businesspeople… is this getting government out of our lives?
Some of these “true believers” believe that it is a woman’s lot in life to suffer. And women should be eternally grateful that God/Jesus lets them go to heaven.
Well, those same people don’t want to know what I believe in that would have a negative impact on their lives, but I am sure as blazes not going to inflict that on them by stacking the courts to rule in my favor and make them suffer.
Wait, they get to go to heaven?
These unprecedented court orders, GenBioPro argues, don’t trump the congressionally-delegated processes the FDA must follow to remove its product from the market.
Somehow I don’t have much hope for this strategy of “go to the courts to get them to order that the courts can’t do that”.
Someone has to keep the place sparkly clean.
Mifepristone Maker Tries To Establish Safety Net
When I read the headline I was hoping for a safety net along the lines of a network of mail order pharmacies in Mexico and Canada.
If the Supreme Court approves the Fifth Circuit decision, it can be safely assumed that contraception, Covid vaccines and pretty much anything that needs approval by the FDA will face potential revocation by the courts. They will guarantee judicial chaos in the medical sector. How are doctors expected to make any sort of informed decision about healthcare drugs?
We famously have the most difficult and lengthy drug approval process in the world (both for good and for ill). The people who run the FDA would have to be absolute fools to allow the integrity of that process to be delegitamized.
Have any of these manufacturers filed an amicus brief with SCOTUS on the pending appeal from 5th Circuit? That would seem the most immediate and direct way to make a plea for their rights
If that happens, expect the extremists to use the courts to force the United States Postal Service to enforce the Comstock Acts. Orwell would not be surprised.