In a massive win for opponents of abortion rights, a Texas judge ruled on Friday that the US Food and Drug Administration’s 2000 approval for the abortion pill was invalid.
Judge Matthew Kacsmaryk ruled that the FDA “deceived and misrepresented” certain parts of the drug approval process in order to “provide elective chemical abortions on a large scale.” Throughout the ruling, Kacsmaryk used anti-choice rhetoric including terms like “unborn child,” “chemical abortion” and “abortion” to describe medical abortion, a safe and effective regimen used for nearly 60% of all abortion and miscarriage treatments in the United States. ACE.
The ruling did not take effect for seven days, giving the Biden administration time to appeal. Scroll below to read the decision in full.
In the first footnote of the 67-page document, Kacsmaryk explains why he believes using the term “fetus” is inaccurate when the terms “unborn human being” or “unborn child” are appropriate, citing an anti-choice book titled “Embryo : A Defense of Human Life.”
“Considering the intense psychological trauma and post-traumatic stress that women often experience from chemical abortions, this failure should not be forgotten or downplayed,” Kacsmaryk wrote in the decision.
Kacsmaryk’s statement echoes the claims of anti-choice advocates who believe abortion harms women’s mental health and that many women regret their decision to seek abortion care. However, according to the Turnaway Study, which followed 1,000 women for more than 10 years and analyzed the long-term effects of abortion access, abortion did not harm women’s mental health, and 95% of women who had an abortion said that the decision was right for them.
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In the same hour on Friday, a federal judge in Washington state issued a competing ruling that blocked the FDA from removing mifepristone from the market in 17 states and the District of Columbia, where abortion is currently legal. Since the Biden administration is now facing contradictory decisions on the approval of the drug, law graduate speculation that the US Supreme Court should consider it soon.
Earlier this week, Washington Governor Jay Inslee (D) announced that the state had purchased 30,000 doses of mifepristone ahead of Kacsmaryk’s impending decision. Inslee also said he asked the University of Washington to purchase an additional 10,000 doses of the drug.
It is unclear if the FDA will choose to pull the drug’s approval because the department has sole authority to approve and remove drugs from the market.
“We are following directives from the FDA, and not an anti-abortion judge in Texas who has no formal medical training. Whole Woman’s Health will continue to dispense Mife[pristone] in our clinic and the Pills by Mail Program for the next week as we monitor the two decisions,” abortion providers with six clinics in five states. tweeted. at least two additional abortion networks or providers ― Hey Jane and Women of Faith ― promised last month that they would not immediately stop providing mifepristone either.
Whatever happens next, this decision is a staggering blow to what little access to abortion remains after the Supreme Court last summer overturned the federal protection provided in the 1973 case Roe v. Wade.
“Today’s ruling is another big step forward for Republicans in their goal of a nationwide abortion ban and could lead to chaos in our country,” Senate Majority Leader Chuck Schumer (D) said. tweeted.
“Right-wing activists are looking for extremist judges who are obsessed with women’s rights,” he said. “This ruling by an activist judge is inconsistent with the law and sets a dangerous new precedent.”
Rep. Nancy Pelosi (D) react to the news on Twitter, calling the decision a “horrific attack” on women’s health, adding that it “threatens to tear away access to comprehensive reproductive health care, further restricting the right to choose and suffering for millions of women and their families.”
Alliance Defending Freedom, a conservative Christian legal group, filed the lawsuit in November in federal court in Amarillo, Texas, arguing that the FDA overstepped its authority 22 years ago and fast-tracked mifepristone’s approval. The group claims that the FDA wrongly approved mifepristone through a fast-track process intended for drugs for life-threatening illnesses — a category the organization says pregnancy does not fall into.
Kacsmaryk concurred in his decision, writing that “the FDA considers pregnancy a ‘serious or life-threatening illness’ and concludes that mifepristone ‘provides[d] [a] achieve meaningful therapeutic benefits for patients through existing treatments.’ The FDA is wrong on both counts.
“Today’s decision out of Texas is a win for the health and safety of women and girls,” Katie Glenn, director of state policy for Susan B. Anthony Pro-Life America, said in a statement. “The ruling reaffirms that pregnancy is not a disease and abortion is not health care. Finally, the FDA is responsible for breaking its own rules to rush dangerous abortion drugs to market.
Planned Parenthood President and CEO Alexis McGill Johnson described Kacsmaryk’s decision as an outrage that “exposes the weapons of our justice system” to limit abortion care in the US.
“I want to be clear that access to mifepristone remains safe today,” McGill Johnson said. “But we should all be outraged that one judge can unilaterally reject medical evidence and deny FDA approval of a drug that has been used safely and effectively for more than two decades.”
“This decision could threaten the FDA’s role in this country’s public health system and — if allowed to stand — will have far-reaching and unprecedented consequences that go beyond abortion.”
Alliance Defending Freedom intentionally filed the lawsuit in Amarillo because suits filed in the district are almost always led by Kacsmaryk, a far-right Donald Trump appointee and former Christian activist. Kacsmaryk, who handed down a ruling on the abortion pill, has characterized transgender people as “mentally disturbed” and has shown “hostility toward LGBTQ people that borders on paranoia,” Senate Minority Leader Chuck Schumer (DN.Y.) said in 2019.
The FDA “never studied the safety of these drugs,” which caused “significant harm and harm to pregnant women and girls,” the Alliance Defending Freedom said in the lawsuit.
But years of research have shown that medication abortions — or the combination of the drugs mifepristone and misoprostol — are safe and effective. When used together, mifepristone and misoprostol more than 95% effective and safer than Tylenol. The combination is used throughout the US for the treatment of miscarriage and abortion during the first 10 weeks of pregnancy. Although the FDA once approved its use up to 10 weeks of pregnancy, the The World Health Organization said mifepristone can be used safely for up to 12 weeks.
Major medical groups have repeatedly said that mifepristone is safe and should be accessible to patients across the country. The drug is “a safe, effective and important component of the treatment and management of early pregnancy loss … and induced abortion,” the American Medical Association and the American College of Obstetricians and Gynecologists wrote in a letter to the FDA in June.
Attacks on medication abortion increased in 2021 after The FDA is making it easier to access the abortion pill through telehealth medicine, to limit direct contact during the COVID-19 pandemic. Before the pandemic, patients could only access mifepristone from a certified prescriber directly in a hospital, clinic or doctor’s office.
FDA changes lead to the opening of online pharmacies like Hey Jane and Abortion on Demandwhich is almost prescribed and delivers abortion pills to the patient’s doorstep so that they can arrange an abortion at home.
Plan C, an advocacy organization that provides information on how to get the abortion pill, insists that alternative routes to getting the abortion pill do exist.
“We know that full legal access to all forms of abortion, through all modalities and in all countries for any reason, is what is needed to ensure that people can safely control their reproductive futures,” said Amy Merrill, digital director of Plan C, in a statement. . in the statement. “In the absence of these facts, we want people to know that alternatives still exist. Because of the strong digital market for the abortion pill, access to safe and self-administered abortion with the pill in the US has not – and cannot – stop.
Misoprostol alone can also be used to induce abortion, although it is not used in a clinic setting because it is not approved by the FDA.
This method is often used abroad or when people are forced to arrange an abortion at home. The misoprostol-only method is less effective than the combination of mifepristone and misoprostol. Twelve tablets of misoprostol – four tablets dissolved under the tongue every three hours for nine hours – will cause an abortion and cause cramping and bleeding that will end the pregnancy.
As access to medication abortion increases in 2021, lawmakers and religious groups opposed to abortion rights are paying attention. at least 18 countries banned prescription drug abortions by mail or by virtual telehealth visit, and even more lawmakers worked to limit or ban prescription drug and procedural abortions after Roe’s death. Although the punishment itself was unprecedented, not surprising that religious groups like the Alliance Defending Freedom chose to attack access to medical abortion after successfully seeing Roe overturned.
This is one of the major legal victories for the Alliance Defending Freedom in recent years. Conservative groups were the main drivers behind Mississippi’s 15-week abortion ban that resulted in the Supreme Court case that overturned Roe v. Wade. Alliance Defending Freedom is also behind the 2018 case Masterpiece Cakeshop v. Colorado Civil Rights Commission, in which the Supreme Court ruled that it is constitutional for Christian bakers not to offer services to same-sex couples.
Alliance Defending Freedom names the FDA and the U.S. Department of Health and Human Services as defendants. The lawsuit was filed on behalf of four legal groups that oppose abortion rights: Alliance for Hippocratic Medicine, American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatricians and Christian Medical & Dental Associations.