Access to abortion pills is at stake today as a Trump-appointed judge in Texas considers revoking their authorization.
Judge Matthew Kacsmaryk of the US District Court for the Northern District of Texas will consider withdrawing the Food and Drug Administration’s (FDA) approval of mifepristone, marketed as Mifeprex, which would limit its use nationwide.
Mifepristone is one half of the two-drug cocktail – along with misoprostol – that allows a woman to terminate her pregnancy in the comfort of her own home.
The pills gained traction after the US Supreme Court decided last summer to overturn the Roe v. Reversing Wade Case. For women in the 24 states where abortion is illegal or severely restricted, it may be their only option.
The majority of American abortions are performed with this drug. The drugs are now available in pharmacies across the US — even in states where abortion is banned — under a recent Biden administration order.
Abortion rights advocates rallied outside the federal building and the J Marvin Jones courthouse in Amarillo, Texas at Wednesday’s hearing.
Judge Matthew Kacsmaryk (pictured) is a Texas federal judge who will rule in the mifepristone case. He was appointed by former President Donald Trump and took office in 2019
The case in question is the Alliance for Hippocratic Medicines v. the US Food and Drug Administration, which was first filed late last year to challenge the FDA’s approval of Mifeprex in 2000.
It was submitted by the anti-abortion group Alliance Defending Freedom (ADF).
The group claims the drug was not properly tested for safety when it was approved 23 years ago.
The ADF also argues that the drug’s approval is revoked by the Comstock Act of 1873, which prohibits the sale of indecent or obscene products through the mail.
They argue that the law should make it illegal to send the drug by mail and remove the FDA’s approval for it.
Judge Kacsmaryk, who was nominated by President Trump and confirmed 52-49 in the Senate in 2019, is known as a pro-abortion advocate and is expected to rule in favor of the group.
The ruling will have far-reaching consequences for American women, even in states where abortion remains legal.
An effort to withdraw FDA approval would almost certainly be immediately challenged by abortion rights activists.
However, the Fifth Circuit Court of Appeals, which would consider the case, is also politically deeply conservative.
As a result of the Supreme Court’s 2021 decision in Dobbs v. Jackson, which removed federal protections for the procedure, drug-induced abortions account for the majority of abortions performed today.
The drug has been FDA approved for more than two decades, after rigorous rounds of safety and efficacy tests and 12 years of safe use in France.
The ADF of the Alliance for Hippocratic Medicine and Anti-Abortion Care Providers argues: “The FDA failed American women and girls when it put politics before science and approved chemical abortion drugs for use in the United States.
To date, the FDA’s review, approval, and deregulation of chemical abortifacients spans three decades, correlates with four U.S. presidential elections, and includes six separate regulatory actions. The plaintiffs have challenged these six FDA actions and are asking the court to declare them unconstitutional, reverse them and set them aside.”
More than a dozen states have restricted access to abortion after Roe V Wade’s ouster
Organizers of the women’s march said they plan to hold a “kangaroo court” outside the courthouse in Amarillo, Texas, where protesters will be dressed in costumes to indicate the case is based on fraudulent claims.
They claim that the FDA abused its authority by approving mifepristone through the accelerated approval process.
It is reserved for new drugs that can help patients with a serious or life-threatening disease than are currently available on the market.
They said the FDA’s approval process requires pregnancy to be considered a “disease” for which the drug would provide “significant therapeutic benefit.”
“But pregnancy is not a disease,” the plaintiffs state in their complaint.
Walgreens says it will NOT sell abortion pills in 20 Republican-controlled states
The nation’s second largest pharmacy will not sell the abortion-inducing drug mifepristone, even in states where abortion is still legal.
Mifepristone, when combined with misoprostol, the anti-ulcer drug, has been shown to be safe and effective in terminating a pregnancy within about 10 weeks of a woman’s last period.
Should the Texas court rule in favor of the conservatives, the FDA would have to step in. According to Rachel Rebouché, an expert on reproductive rights at Temple University, the FDA may work to re-approve the drug, but that could take years.
Professor Rebouché told DailyMail.com: “The bigger problem is that this is still a federal court telling a federal agency, which is an expert on drug safety and efficacy, that it has failed to correctly categorizing a drug that was approved 23 years ago.
“We’ve never seen this before, where a court steps in to try to reverse-engineer a drug approval process decades after the drug hit the market. We certainly haven’t seen that in a drug as safe as mifepristone.”
Conservatives’ argument that mifepristone is unsafe is at odds with the guidelines of obstetricians and gynecologists, as well as the wider scientific community.
A 2012 meta-analysis of 87 clinical trials published in the journal Contraception confirmed that drug-induced abortions are generally safe.
In the study, less than 0.3 percent of patients experienced serious complications, such as B. heavy vaginal bleeding, pelvic pain, or an infection that required hospitalization.
Studies show that mifepristone is safer and sends fewer people to the emergency room than Tylenol and Viagra.
Abortion rights advocates gather outside the Texas courthouse on Wednesday
In response to an anti-abortion ruling, the FDA said: “It would undermine the status quo and the vested interests of patients and physicians addicted to mifepristone, as well as companies involved in the distribution of mifepristone, if it were to changed upside down. The consideration of fairness and the public interest therefore speaks strongly for the rejection of the applicant’s application.’
The agency added that the court would set a dangerous precedent by overturning the 2000 permit.
The agency said: “In general, pharmaceutical companies cannot confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure on which the… Americans depend for a variety of health problems.”
An order would overturn Congress’s decision to give the FDA responsibility for ensuring the safety and effectiveness of drugs. In performing this role, the FDA applies its technical expertise to make complex scientific determinations about the safety and effectiveness of drugs, and these determinations deserve great respect.’
Source link
Crystal Leahy is an author and health journalist who writes for The Fashion Vibes. With a background in health and wellness, Crystal has a passion for helping people live their best lives through healthy habits and lifestyles.
