Texas Judge Halts FDA Approval For Abortion Pill Mifepristone

The ruling from a Texas judge will go into effect in seven days, giving time for the Biden administration to appeal.
Mifepristone and misoprostol are the two drugs used in a medication abortion.
Mifepristone and misoprostol are the two drugs used in a medication abortion.
ROBYN BECK via Getty Images

In a massive win for opponents of abortion rights, a Texas judge ruled on Friday that the U.S. Food and Drug Administration’s 2000 approval of abortion pills was unlawful.

Judge Matthew Kacsmaryk ruled that the FDA “manipulated and misconstrued” certain parts of the drug approval process in order “to greenlight elective chemical abortions on a wide scale.” Throughout the decision, Kacsmaryk used anti-choice rhetoric including terms like “unborn child,” “chemical abortion” and “abortionist” to describe medication abortion, a safe and effective regimen used for nearly 60% of all abortion and miscarriage care in the U.S.

The ruling does not go into 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 while the terms “unborn human” 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 women often experience from chemical abortion, this failure should not be overlooked or understated,” Kacsmaryk wrote in the decision.

Kacsmaryk’s statement echoes frequent claims of anti-choice advocates who believe that abortion harms women’s mental health and that many women regret their decision to get abortion care. But, according to the Turnaway Study, which followed 1,000 women over 10 years and analyzed the long-term effects of abortion access, abortion does not harm women’s mental health, and 95% of women who have abortions said their decision was the right one for them.

The Department of Justice immediately filed an appeal directly to the U.S. Court of Appeals for the Fifth Circuit. U.S. Attorney General Merrick Garland said in a statement that the Justice Department “strongly disagrees with the decision” and “will be appealing the court’s decision and seeking a stay pending appeal.”

“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” Garland said. “The Department will continue to defend the FDA’s decision.”

The article continues below.

Texas Judge Halts FDA Approval For Abortion Pill Mifepristone by Alanna Vagianos on Scribd

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 rulings on approval of the drug, legal scholars speculated that the U.S. Supreme Court will need to quickly weigh in.

Garland said in his statement that the DOJ is also reviewing the decision out of Washington state.

Earlier this week, Washington Gov. Jay Inslee (D) announced that the state had purchased 30,000 doses of mifepristone ahead of the impending decision from Kacsmaryk. Inslee also said he asked the University of Washington to buy an additional 10,000 doses of the medication.

It is unclear if the FDA will choose to pull approval of the drug since the department has the sole authority to approve and remove medications from the market. Sen. Ron Wyden (D-OR) was the first to float this idea on Friday, imploring the Biden administration and the FDA to ignore the ruling.

A small handful of abortion networks and providers, including Hey Jane, Trust Women and Whole Woman’s Health, promised last month that they would not immediately stop providing mifepristone if Kacsmaryk ruled against the FDA.

Whole Woman’s Health re-upped that promise on Friday night following the Texas judge’s ruling. “We follow directives from the FDA, and not anti-abortion judges in Texas who lack any formal medical training. Whole Woman’s Health will continue to dispense Mife[pristone] in our clinics and our Pills by Mail Program for the next week as we monitor both decisions,” the abortion provider with six clinics in five states tweeted.

Vice President Kamala Harris reacted to the news in a Friday night statement: “Simply put: this decision undermines the FDA’s ability to approve safe and effective medications ― from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin ― based on science, not politics.”

“Each person in our nation should have the right to access safe and effective medication which has been approved by the FDA,” Harris said. “In the face of attacks on a woman’s right to access an abortion, our Administration will continue to fight to protect reproductive freedom and the ability of all Americans to make health care decisions with their doctors free from political interference.

Whatever happens next, this decision is a staggering blow to what little abortion access remains after the Supreme Court last summer overturned the federal protections granted in the 1973 Roe v. Wade case.

“Today’s ruling is another massive step towards Republicans’ goal of a nationwide abortion ban and could throw our country into chaos,” Senate Majority Leader Chuck Schumer (D) tweeted.

“Rightwing activists sought out an extremist judge who is vehement in his desire to take women’s rights away,” he said. “This ruling from an activist judge is wildly out of step with the law and sets a dangerous new precedent.”

Rep. Nancy Pelosi (D) reacted to the news on Twitter, calling the decision an “outrageous attack” on women’s health, adding that it “threatens to rip away access to the full range of reproductive health care, further restrict the right to choose and inflict suffering on millions of women and their families.”

Alliance Defending Freedom, a conservative Christian legal group, filed the suit in November in a federal court in Amarillo, Texas, arguing that the FDA went beyond its authority 22 years ago and fast-tracked the approval of mifepristone. The group claimed that the FDA incorrectly approved mifepristone through an expedited process meant for medications for life-threatening illnesses ― a category the organization said pregnancy does not fall under.

Kacsmaryk agreed in his decision, writing that the “FDA deemed pregnancy a ‘serious or life-threatening illness’ and concluded that mifepristone ‘provide[d] [a] meaningful therapeutic benefit to patients over existing treatments.’ FDA was wrong on both counts.”

“Today’s decision out of Texas is a win for the health and safety of women and girls,” Katie Glenn, state policy director of Susan B. Anthony Pro-Life America, said in a statement. ”The ruling reaffirms that pregnancy is not an illness and abortion is not health care. Finally the FDA is being held accountable for its egregious violation of its own rules to fast-track dangerous abortion drugs to market.”

Planned Parenthood President and CEO Alexis McGill Johnson described Kacsmaryk’s decision as an outrage that “exposes the weaponization of our judicial system” to restrict abortion care in the U.S.

“I want to be clear that access to mifepristone remains safe for now,” McGill Johnson said. “But we should all be enraged that one judge can unilaterally reject medical evidence and overrule the FDA’s approval of a medication that has been safely and effectively used 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 broad and unprecedented consequences that reach far beyond abortion.”

Alliance Defending Freedom intentionally filed the lawsuit in Amarillo because suits filed in the district are almost always presided over by Kacsmaryk, a far-right Donald Trump appointee and former Christian activist. Kacsmaryk, who handed down the decision on abortion pills, has characterized transgender people as having a “mental disorder” and demonstrates “a hostility to the LGBTQ bordering on paranoia,” then-Senate Minority Leader Chuck Schumer (D-N.Y.) said in 2019.

The FDA “never studied the safety of the drugs,” which cause “significant injuries and harms to pregnant women and girls,” Alliance Defending Freedom argued in the lawsuit.

But years of research have shown that medication 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 around the U.S. for miscarriage and abortion care through the first 10 weeks of pregnancy. Although the FDA once approved its use up until 10 weeks of pregnancy, the World Health Organization says mifepristone can be safely used until 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 treatment and management for 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 ramped up in 2021 after the FDA made it easier to access abortion pills via telehealth medicine, in order 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 physician’s office.

The FDA’s change led to the opening of online pharmacies like Hey Jane and Abortion on Demand, which virtually prescribed and mailed abortion pills to patients’ doorsteps so they could manage their abortions at home.

Plan C, an advocacy organization that provides people with information on how to obtain abortion pills, stressed that alternative routes to obtaining abortion pills do exist.

“We know that full legal access to all forms of abortion, through all modalities and in all states for any reason, is what is needed to ensure people are able to safely control their reproductive futures,” Amy Merrill, Plan C’s digital director, said in a statement. “In the absence of such a reality, we want people to know that alternatives still exist. Given the robust digital marketplace for abortion pills, access to safe, self-managed abortion with pills in the US has not been ― and cannot be ― stopped.”

Misoprostol alone can also be used to induce an abortion, although it is not used in the in-clinic setting because it’s not approved by the FDA.

This method is often used abroad or when people are forced to self-manage their abortions at home. The misoprostol-only method is less effective than the mifepristone and misoprostol combination. Twelve misoprostol tablets — four tablets dissolved under the tongue every three hours over the course of nine hours — will induce an abortion and lead to cramping and bleeding that will end a pregnancy.

As access to medication abortion grew in 2021, lawmakers and religious groups that oppose abortion rights took notice. At least 18 states banned prescribing medication abortion via mail or by virtual telehealth visits, and even more lawmakers are working to further restrict or ban medication and procedural abortions in the wake of Roe’s demise. Although the ruling itself is unprecedented, it’s not surprising that religious groups like Alliance Defending Freedom chose to attack access to medication abortion after successfully seeing Roe overturned.

This is one of several major legal wins for Alliance Defending Freedom in recent years. The conservative group was the main driver behind the Mississippi 15-week abortion ban that resulted in the Supreme Court case that overturned Roe v. Wade. Alliance Defending Freedom was also behind the 2018 case Masterpiece Cakeshop v. Colorado Civil Rights Commission, in which the Supreme Court ruled it was constitutional for a Christian baker not to offer services to a same-sex couple.

Alliance Defending Freedom named 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: the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians and the Christian Medical & Dental Associations.

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