In a huge victory for opponents of abortion rights, a Texas judge ruled on Friday that the US Food and Drug Administration’s approval of abortion pills in 2000 was illegal.
Judge Matthew Kacsmaryk ruled that the FDA “manipulated and misrepresented” certain parts of the drug approval process to “give the green light to large-scale elective chemical abortions.” Throughout the decision, Kacsmaryk used anti-choice rhetoric, including terms like “chemical abortion” and “abortionist” to describe medical abortion, a safe and effective regimen used for nearly 60% of all abortion and miscarriage services in the US
The ruling doesn’t take effect for another seven days, giving the Biden administration time to appeal. Scroll below to read the decision in its entirety.
“Given the intense psychological trauma and post-traumatic stress that women often experience from chemical abortion, this failure should not be overlooked or underestimated,” Kacsmaryk wrote in the decision.
Kacsmaryk’s statement echoes frequent claims by anti-abortion advocates who believe abortion harms women’s mental health and that many women regret their decision to obtain abortion services. But, according to Turnaway studywhich followed 1,000 women for 10 years and looked at the long-term effects of abortion access, abortion does not harm women’s mental health, and 95% of women who abort said their decision was the right one for them.
The article continues below.
At the same time on Friday, a federal judge in Washington state issued a ruling that prevented the FDA from removing mifepristone from the market. With the Biden administration now facing conflicting decisions on drug approval, legal scholars he speculated that the US Supreme Court will have to weigh in quickly.
It is unclear if the FDA will choose to withdraw approval of the drug, as the department has sole authority to approve and withdraw drugs from the market.
Whatever happens next, this decision is a blow to what little abortion access remains after the US Supreme Court struck down federal protections granted in Roe v. Wade from 1973.
“Today’s ruling is another big step toward the Republican goal of banning abortion nationwide and could throw our country into chaos,” said Senate Majority Leader Chuck Schumer (D). tweeted.
“Right-wing activists sought out an extremist judge who is vehement in his desire to take away women’s rights,” she said. “This ruling by an activist judge is totally out of step with the law and sets a dangerous new precedent.”
Alliance Defending Freedom, a conservative Christian legal group, filed the lawsuit in November in federal court in Amarillo, Texas, arguing that the FDA exceeded its authority 22 years ago and rushed the approval of mifepristone. The group claimed the FDA improperly approved mifepristone through an expedited process intended for drugs for life-threatening conditions, a category the organization said pregnancy does not fall into.
Kacsmaryk agreed with their decision, writing that “the FDA considered pregnancy a ‘serious or life-threatening condition’ and concluded that mifepristone ‘provides(d)(a) significant therapeutic benefit to patients over existing treatments.’ . The FDA was wrong on both counts.”
“Today’s decision outside of Texas is a victory 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 medical care. Finally, the FDA is being held accountable for its flagrant violation of its own rules to expedite the marketing of dangerous abortion drugs.”
Planned Parenthood President and CEO Alexis McGill Johnson described Kacsmaryk’s decision as an outrage that “exposes the use of weapons by our judicial system” to restrict abortion care in the US.
“I want to make it clear that access to mifepristone remains safe for now,” McGill Johnson said. “But we should all be outraged that a judge could unilaterally reject medical evidence and void 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 upheld, will have unprecedented and broad consequences that reach far beyond abortion.”
Alliance Defending Freedom intentionally filed the lawsuit in Amarillo because lawsuits filed in the district are almost always presided over by Kacsmaryk, a far-right Donald Trump appointee and former Christian activist. Kacsmaryk, who made the abortion pill decision, has characterized transgender people as having a “mental disorder” and demonstrates “a hostility to LGBTQ bordering on paranoia,” then-Senate Minority Leader Chuck Schumer (DN.Y.) said in 2019.
The FDA “never studied the safety of the drugs,” which cause “significant harm and injury to pregnant women and girls,” Alliance Defending Freedom argued in the lawsuit.
But years of research have shown that medical abortion, or the combination of the drugs mifepristone and misoprostol, is extremely safe and effective. When used together, mifepristone and misoprostol are more than 95% effective and safer than Tylenol. The combination is used in the US for miscarriage and abortion care during the first 10 weeks of pregnancy. Although the FDA once approved its use up to 10 weeks of pregnancy, the World Health Organization says Mifepristone can be used safely up to 12 weeks.
Major medical groups have repeatedly said that mifepristone is safe and that patients across the country should be able to access it. 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 statement. letter to the FDA in June.
Attacks against medical abortion increased in 2021 after the The FDA made it easier to access abortion pills through telehealth medicine, to limit in-person contact during the COVID-19 pandemic. Before the pandemic, patients could only access mifepristone from a certified prescriber in person at a hospital, clinic, or doctor’s office.
The FDA change led to the opening of online pharmacies like hello jane and abortion on demandwho virtually prescribed and mailed abortion pills to patients’ doors so they could manage their abortions at home.
Plan C, an advocacy organization that provides people with information on how to obtain abortion pills, emphasized that there are alternative routes to obtaining them.
“We know that full legal access to all forms of abortion, across all modalities and in all states for any reason, is what is needed to ensure that people can safely control their reproductive futures,” she said. Amy Merrill, digital director of Plan C. in a sentence. “In the absence of such a reality, we want people to know that alternatives still exist. Given the robust digital market for abortion pills, access to safe, self-managed abortion pills in the US has not stopped, and cannot stop.”
Misoprostol alone can also be used to induce an abortion, although it is not used in a clinical setting because it is not FDA-approved.
This method is often used abroad or when people are forced to self-monitor their abortions at home. The misoprostol method alone is less effective than the combination of mifepristone and misoprostol. Twelve tablets of misoprostol, four tablets dissolved under the tongue every three hours over the course of nine hours, will induce an abortion and cause cramping and bleeding that will end a pregnancy.
As access to medical abortion grew in 2021, lawmakers and religious groups opposed to abortion rights took notice. At least 18 states banned prescribing medical abortions by mail order or via virtual telehealth visits, and even more lawmakers are working to further restrict or ban medical abortions and procedures in the wake of Roe’s death. Although the ruling itself is unprecedented, It is not surprising that religious groups such as the Alliance Defending Freedom chose to attack access to medical abortion after successfully overturning Roe.
This is one of several significant legal victories for Alliance Defending Freedom in recent years. The conservative group was the main mover behind Mississippi’s 15-week abortion ban that resulted in the Supreme Court case overturning Roe v. Wade. Alliance Defending Freedom was also behind the 2018 Masterpiece Cakeshop case against the Colorado Civil Rights Commission, in which the Supreme Court ruled that it was constitutional for a Christian baker not to offer services to a same-sex couple.
Alliance Defending Freedom named the FDA and the US Department of Health and Human Services as defendants. The lawsuit was brought on behalf of four legal groups that oppose abortion rights: the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical and Dental Associations.
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