“This case has been a rigged game all along. It’s illegitimate,” said Sen. Ron Wyden (D-Ore.). “The case is an affront to the Constitution and to the rule of law in the United States of America.”
A federal judge in Texas will soon rule in a lawsuit filed by anti-abortion groups asking him to direct the U.S. Food and Drug Administration (FDA) to withdraw its approval for the widely-used abortion pill mifepristone and ban mailing all abortion pills nationwide. In public discussions of the case, most mainstream media and even many abortion rights advocates assume the FDA should comply with such a ruling. But not everyone does. U.S. Sen. Ron Wyden (D-Ore.), a long-time advocate for access to abortion pills who held the first congressional hearings on mifepristone in 1990, is calling on the Biden administration and the FDA to defy any ruling restricting abortion pills.
“President Biden and the FDA must ignore it,” said Wyden in an impassioned speech on the floor of the House on Feb. 16. “The FDA should go on just as it has for the last 23 years since it first approved mifepristone. The FDA needs to keep this medication on the market without interruption regardless of what the ruling says. Doctors and pharmacies should go about their jobs like nothing has changed.”
In the coming days a lawless Trump-appointed judge is expected to ban access to abortion medication nationwide. I'm calling on the FDA to protect the safety of every woman in America by keeping the drug on the market no matter the ruling. https://t.co/yWAbAOUTFr
— Ron Wyden (@RonWyden) February 16, 2023
One reason for defiance, said Wyden, is that the judge is an anti-abortion zealot, and the case has no merit. The judge in the case is 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.
Wyden described Kacsmaryk as a “lifelong right-wing activist. A partisan ideologue. An anti-abortion zealot who was hand-picked by Donald Trump and the Federalist Society to feign impartiality on the bench and deliver favorable rulings on the cases his fellow right-wing ideologues funnel his way.”
Kacsmaryk has made several extreme rulings in recent cases. Last November, he ruled that the Biden administration wrongly interpreted a provision of the Affordable Care Act as barring healthcare providers from discriminating against LGBTQ+ Americans. Then in December, Kacsmaryk ruled that teens must have parental consent to obtain birth control, overturning a decades-long precedent allowing minors to access birth control.
“He has issued constitutionally dubious and extraordinarily contentious opinions, has defied precedent on protecting LGBTQ employees and attacked the right to contraception by restricting minors’ access to it,” said Wyden, who called Kacsmaryk “the most lawless judge in the country.”
Wyden suggested anti-abortion extremists rigged the system to get an extremist, anti-abortion judge appointed to their abortion pill challenge. “Because of how judges in this federal district in Texas are assigned, the plaintiffs were able to use a procedural loophole and hotwire the judiciary. They could ensure Kacsmaryk was the only judge who could get the case. No shot of getting it assigned to somebody else,” said Wyden.
“This judge is not upholding the oath he took. He is not adhering to the Constitution. He is making a dangerous mockery of the rule of law. Something needs to be done about it,” said Wyden.
Wyden said he is skeptical of any ruling “from a lawless judge, picked by the litigants with no standing to bring a case that should be barred by the statute of limitations and has absolutely no merit.”
The lawsuit was filed last November by the conservative legal group Alliance Defending Freedom (ADF) in the Amarillo Division of the Northern District of Texas on behalf of four antiabortion medical organizations and several doctors against the 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.
Wyden argues the plaintiffs have no standing to bring the suit because they cannot show any actual harm or injury to demonstrate a direct impact by the actions of the defendant. He also argues it’s too late to challenge the FDA’s approval of mifepristone in 2000 because the statute of limitations allows challenges to FDA procedures for only six years. Finally, Wyden argues that the lawsuit has no merit.
This judge is not upholding the oath he took. He is not adhering to the Constitution. He is making a dangerous mockery of the rule of law. Something needs to be done about it.
Sen. Ron Wyden (D-Ore.)
In their 113-page complaint, the plaintiffs argue 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 that year or in 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.
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” (the brand name for mifepristone) 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.
“Congress long ago empowered the FDA, a body made up of scientists and clinicians, to approve or disapprove the use of new drugs—not states and certainly not activist judges,” said Wyden. “The FDA approved Mifepristone 23 years ago. For those looking to challenge that approval, well, it’s too late. The statute of limitations allows challenges to FDA procedures for only six years.”
Most shockingly, the ADF lawsuit asks Kacsmaryk to revive the 1873 Comstock Law, which banned sending obscene literature, contraceptives, abortifacients or any sexual information through U.S. mails. The Department of Justice last month issued an opinion that mailing abortion pills does not violate the Comstock law
The ruling threatens 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 over 20 states, expanding further after the FDA permanently lifted the in-person distribution requirement in December of 2021. After the Supreme Court reversed Roe v. Wade last June, abortion pills and telemedicine abortion became a critical way women were able to end pregnancies in states restricting abortion access.
Wyden calls for defiance of the ruling, noting that judges have no way to enforce their rulings:
“The power of the judiciary begins and ends with its legitimacy in the eyes of the public. It does not have the military backing of the executive branch or Congress’s power of the purse. A judge’s rulings stand because elected leaders and citizens have agreed that abiding by them is right and necessary to uphold the rule of law. That’s part of the social contract in America.
“But the judiciary must uphold its end of the social contract too. It must follow the rule of law and earn the confidence of the American people continually, every day, every month, every year. Recently that confidence has eroded, and it’s no secret why. Look at the Dobbs decision overturning Roe. Look at what is happening in Texas right now. Parts of the judiciary have morphed into a mob of MAGA extremists, conspiring with and willing to do the bidding of every right-wing group or former President that appears before it, no matter the cost to life and liberty.”
“There are moments in history where Americans and their leaders must look at circumstances like this one and say, ‘Enough.’ Not ‘let’s see how the appeals process plays out,’ or ‘Let’s hope Congress can fix this down the road.’ Just, ‘Enough.’”
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