Monday, December 5, 2022
By Carrie Baker for Ms. Magazine.
Broadcast version by Roz Brown for Texas News Service reporting for the Ms. Magazine-Public News Service Collaboration
On Nov. 18, anti-abortion advocates filed a federal lawsuit challenging the FDA approval of the medication mifepristone in 2000-as well as subsequent updates to the approval in 2016, 2019 and most recently in December 2021, when the agency began allowing clinicians to mail abortion pills to their patients.
The lawsuit alleges the FDA did not have proof of the medication's safety, despite extensive evidence showing abortion pills are safe and effective-more so than many other medications, including over the counter drugs such as Tylenol.
"This is yet another attempt by anti-abortion extremists to force their beliefs on all of us," said Kirsten Moore, director of Expanding Medication Abortion Access Project (EMAA Project), which advocates for increased access to mifepristone for abortion and miscarriage care.
The conservative legal group Alliance Defending Freedom (ADF) filed the lawsuit on behalf of four antiabortion medical organizations and several doctors against the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services. ADF represented Mississippi in the case that led the Supreme Court to overturn Roe v Wade and they have helped draft anti-abortion laws adopted in many states.
The 113-page complaint argues the FDA unlawfully fast-tracked the approval of mifepristone in 2000 and did not have the required research to prove the safety of the drug under the labeled conditions of use.
To the contrary, a 2018 Government Accountability Office report concluded that the FDA "followed its standard review process when it approved the application ... for the drug Mifeprex" and "based its approval on reviews of peer-reviewed published studies, articles, and other information submitted by Mifeprex's sponsor." The FDA subsequently conducted extensive reviews of the mifepristone's safety again in 2016.
The ADF complaint regurgitates many of the objections raised by anti-abortion groups to the 2021 modification of the mifepristone approval. The FDA published a 40-page rebuttal letter to these objections, which ADF fails to address in their complaint.
Moore said the anti-abortion movement is trying to "put the genie back into the bottle" and is "trying to undo progress."
"When they look at the courts, they think, 'Why wouldn't the courts be friendly to us even if we are making new things up?' The Supreme Court just overturned a 50-year precedent that took away half the population's fundamental right to control their bodies, so why wouldn't they try?"
The ADF chose to file the case in the Amarillo Division of the Northern District of Texas, where it was assigned to a 45-year-old Trump appointee Matthew J. Kacsmaryk, who for five years before becoming a federal judge was deputy general counsel for First Liberty Institute, a Christian conservative legal organization that specializes in representing religious groups claiming they have experienced discrimination.
n 2015, Kacsmaryk wrote an op-ed for the National Catholic Register stating his opposition to same-sex marriage, no-fault divorce, birth control, abortion and sex outside of marriage-and his support for "complementarianism," a religious belief that assigns primary headship roles to men and support roles to women based on their interpretation of certain biblical passages.
"He is an anti-LGBT activist and culture warrior who does not respect the equal dignity of all people," said Sen. Dianne Feinstein (D-Calif.) during his Senate confirmation hearing, reading from a letter of the Leadership Conference on Civil and Human Rights. "His record reveals a hostility to LGBT equality and to women's health, and he would not be able to rule fairly and impartially in cases involving those issues."
Just last week Kacsmaryk ruled that the Biden administration wrongly interpreted a provision of the Affordable Care Act as barring healthcare providers from discriminating against LGBTQ+ Americans.
Texas is within the Fifth Circuit Court of Appeals, which has a majority of conservative judges-six of whom were appointed by Trump. This same court repeatedly upheld the Texas bounty hunter law last year.
Most shockingly, the ADF lawsuit asks Judge Kacsmaryk to revive the 1873 Comstock Law, which banned sending obscene literature, contraceptives, abortifacients or any sexual information through U.S. mails. After the Supreme Court ruled in Griswold v. Connecticut in 1965 that people have a fundamental right to access and use contraception, Congress removed the language concerning contraception in 1971, but left the part of the law criminalizing mailing abortifacients and information about abortion.
Before Roe v. Wade, federal courts ruled this part of the law applied only to "unlawful" abortions. After the Roe decision, the Comstock law remained on the books but was not enforced. Now that the Supreme Court has reversed Roe, ADF hopes to bring the law back into effect.
"The law that conservatives used to shut down contraceptive pills at the turn of the century-this is where they want to take us back to," said Moore.
The lawsuit seeks to reverse the increasing availability of medication abortion and telemedicine abortion. In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S. After a federal court lifted the FDA requirement that clinicians distribute the medication in person in July of 2020, telemedicine abortion services surged across the United States, becoming available in 20 states, expanding further after the FDA permanently lifted the in-person distribution requirement in December of 2021.
Carrie Baker wrote this article for Ms. Magazine.
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