A Trump-appointed judge in Texas is expected to ban the abortion pill on Wednesday.
Judge Matthew Kacsmarek of the US District Court for the Northern District of Texas will consider reversing the FDA’s approval of mifepristone, which is marketed as Mifeprex, which would halt its nationwide use.
Mifepristone is half of a two-drug cocktail – combined with misoprostol – that allows a woman to terminate her pregnancy in the comfort of her home.
The pill came to prominence in the wake of the US Supreme Court’s decision to overturn Roe v. Wade last summer. For women in the 24 states where abortion is either illegal or severely restricted, this may be their only recourse.
The majority of abortions in the United States are performed using this drug. The drugs recently became available at pharmacies across the US through a new Biden administration order — even in states where abortion is prohibited.
Abortion rights activists gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas Wednesday during the hearing
Judge Matthew Kaksmarek (pictured) is a Texas federal judge who will rule on the Mifepristone case. Appointed by former President Donald Trump, he took office in 2019
The issue in question is the Alliance for Hippocratic Medicine vs. the US Food and Drug Administration, It was first introduced late last year to challenge the Food and Drug Administration’s approval of Mifeprex in 2000.
It was filed by the anti-abortion group Alliance Defending Freedom (ADF).
The group says the drug was not properly screened for safety when it gained approval 23 years ago.
The ADF also argues that approval of the drug is voided by the Comstock Act of 1873 – which bans the sale of unethical or indecent products through the mail.
They argue that the law should make it illegal to send a drug through the mail, and the FDA’s approval to do so should be revoked.
Justice Kaksmarek, who was appointed by President Trump and then confirmed by a 52-49 vote in the Senate in 2019, is known as an anti-abortion advocate and is expected to rule in favor of the group.
The ruling will have far-reaching ramifications for American women, even in states where abortion remains legal.
Any move to revoke FDA approval would almost certainly be immediately appealed by abortion rights activists.
But the Fifth Circuit Court of Appeals that would weigh the case is also a highly political court.
Medication-induced abortions make up the largest share of abortions performed today due to the Supreme Court’s 2021 decision in Dobbs v. Jackson that removed federal protections for the procedure.
The drug has had FDA approval for more than two decades, which came after rigorous rounds of safety and efficacy testing and 12 years of safe use in France.
The ADF, on the part of the Alliance for Hippocratic Medicine and Anti-Abortion Healthcare Providers, argues that: ‘The Food and Drug Administration failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States.
To date, the FDA’s review, approval, and liberalization of chemical abortion drugs has spanned three decades, tied to four US presidential elections, and involved six separate agency actions. The plaintiffs are challenging those six FDA actions and asking the court to declare them illegal, set them aside, and overturn them.
More than a dozen states restricted access to abortions after Roe V. Wade’s coup
Women’s March organizers said they plan to hold a “kangaroo court” outside the Amarillo, Texas, courthouse, where protesters will wear fancy dress to suggest the case is based on fraud allegations.
They claim that the FDA abused its power by approving mifepristone on the accelerated approval pathway.
This is for new medicines that would benefit patients with severe or life-threatening illnesses more than what is currently available on the market.
They said the FDA’s approval pathway requires it to consider pregnancy a “disease,” in which the drug would provide “meaningful therapeutic benefit.”
“But pregnancy is not a disease,” the plaintiffs say in their complaint.
Mifepristone, when used with the stomach ulcer drug misoprostol, has been shown to be safe and effective in terminating pregnancy within approximately 10 weeks of a woman’s last period.
If a Texas judge rules in favor of the governors, the FDA will have to act. According to Rachel Repochy, a reproductive law expert at Temple University, the FDA could work to reapprove the drug, but that could take years.
Prof Reposhi told DailyMail.com: ‘The biggest problem is that the federal court is still telling a federal agency, which is the expert on drug safety and efficacy that 23 years ago, it didn’t properly approve the drug.
We haven’t really seen this where the court steps in to try to reverse engineer the drug approval process decades after the drug was on the market. We certainly haven’t seen it for a drug as safe as mifepristone.
The conservative argument that mifepristone is not safe stands up to guidance from obstetricians and gynecologists as well as the broader scientific community.
A meta-analysis of 87 clinical trials was published in the journal Contraception She emphasized that medical abortion is generally safe.
In the study, serious complications such as severe vaginal bleeding, pelvic pain, or infection that required hospitalization occurred in less than 0.3 percent of patients.
Studies show that mifepristone is safer and It sends fewer people To the emergency department of Tylenol and Viagra.
Abortion rights advocates gather outside the courthouse in Texas on Wednesday
In response, the Food and Drug Administration He said Ruling in favor of the anti-abortion plaintiffs: ‘It would upend the status quo and the interests of accreditation for patients and physicians who depend on mifepristone, as well as companies involved in the distribution of mifepristone. Thus, the balance of equity and public interest strongly favors the rejection of the plaintiffs’ motion.
The agency added that the court to cancel the 2000 approval would set a dangerous precedent.
“In general, if long-term drug approvals from the US Food and Drug Administration (FDA) were so easy, even decades after they were issued, drug companies would not be able to rely confidently on FDA approval decisions to develop the infrastructure for the pharmaceuticals they need,” the agency said. Americans rely on it to treat a variety of health conditions.
A preliminary injunction could interfere with Congress’ decision to assign the Food and Drug Administration responsibility for ensuring the safety and effectiveness of drugs. In performing this role, the FDA applies its technical expertise to make complex, scientific decisions about drug safety and efficacy, and those decisions deserve great respect.
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