The Washington Post is reporting that a federal judge in Texas has blocked FDA approval of a key abortion medication:
A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
The highly anticipated ruling puts on hold the Food and Drug Administration’s approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days to give the government time to appeal.
U.S. District
Judge Matthew J. Kacsmaryk, a nominee of President Donald Trump with long-held antiabortion views, agreed with the conservative groups seeking to reverse the FDA’s approval of mifepristone as safe and effective, including in states where abortion rights are protected.
The New York Times reported:
Less than an hour later, another federal judge in Washington state issued a ruling that directly contradicted the Texas decision, ordering the F.D.A. to make no changes to the availability of mifepristone.
The conflicting orders by two federal judges appear to create a legal standoff likely to escalate to the Supreme Court. The drug will continue to be available at least in the short-term since the Texas judge stayed his own order for seven days to give the F.D.A. time to ask an appeals court to intervene. …
The lawsuit in Washington state was filed against the F.D.A. by a dozen Democratic attorneys general. In a preliminary injunction in that case, Judge Thomas O. Rice blocked the agency from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”
The ruling by Rice, an Obama appointee, means that the approval of mifepristone is not affected in 12 Democratic-controlled states despite Kacsmaryk’s decision. The states are Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, New Mexico, Rhode Island, Vermont, Hawaii, Maine, Maryland and Minnesota. Washington, DC, and Michigan, CNN reported.
“It’s not the Court’s role to review the sceientifi evidence and decide whether mifepristone’s benefits outweigh its risks. … That is precisely FDA’s role,” Rice said.
Later Friday, Attorney General Merrick Garland, in a statement, said the U.S. Justice Department “strongly disagrees” with the Texas judge’s decision and will appeal it.
Anti-abortion groups went judge shopping to file the lawsuit to challenge the FDA’s approval of mifepristone, an abortion inducing drug, in Amarillo, Texas, where Kacsmaryk is the one federal judge presiding. The FDA is headquartered in Maryland.
Amarillo didn’t even have an abortion clinic before Texas all but banned the procedure in 2021, The Texas Tribune reported.
Alliance Defending Freedom, a conservative legal group that has been involved in ant-iabortion litigation, filed the lawsuit in November on behalf of four antiabortion medical organizations and four doctors who say they have treated patients with mifepristone.
Here’s what The Texas Tribute reported about Kacsmaryk’s background before and after he joined the federal bench:
Before Kacsmaryk was appointed to the federal bench by President Donald Trump in 2019, he was deputy counsel for the First Liberty Institute, a deeply conservative religious liberty law firm based in Plano.
Under his leadership, First Liberty was involved in several legal fights over reproductive health care, including trying to block the “contraception mandate” which required health insurers to pay for birth control. Kacsmaryk himself has been outspoken in his opposition to LGBTQ rights.
Since Kacsmaryk joined the bench, the Texas attorney general and private litigants have brought their most contentious suits to Amarillo, largely with the desired outcome. He reinstated the Trump-era “Remain in Mexico” policy on behalf of Texas. He struck down efforts from the Biden administration to protect LGBTQ workers and trans youth. And he ruled that a longstanding federal program that gives teens confidential contraception violated state law.
The lawsuit was filed by the Alliance Defending Freedom, a conservative law firm representing anti-abortion doctors and medical associations who allege harm from treating patients who have used misabortion-inducing medication.
Vice President Kamala Harris said the Texas judge’s decision set “a dangerous precedent,” CNN reported. She spoke to reporters at an airfield in Nashville after meeting with Democratic lawmakers in Tennessee a day after two black representatives were expelled from the legislature after supporting demonstrators calling for gun safety measures in the wake of a school shooting.
“It is contrary to what makes for good public health policy to allow courts and politicians to tell the FDA what it should do,” Harris said.
"As a general matter, I'll say that there is no question that the president and I are going to stand with the women of America and do everything we can to ensure that women have the ability to make decisions about their health care, their reproductive health care," Harris said.
The judge’s ruling invalidates the FDA’s 23-year-old approval of mifepristone. If the unprecedented ruling stands, it could make it harder for patients to get abortions even in blue states such as New York and California where abortion is legal.
More than half of the abortions in the U.S. are medication abortions which use a two-drug regimen — first administering mifepristone and then misoprostol. Misoprostol can induce abortions on its own, but is less effective and more prone to cause side effects like nausea.
Mifepristone blocks a hormone that allows a pregnancy to develop. The Times reported that In a court filing in the case, the FDA said that overturning its approval of mifepristone would “cause significant harm, depriving patients of a safe and effective drug that has been on the market for more than two decades.”
In June 2022, the U.S. Supreme Court overturned the fundamental right to abortion established in the 1973 Roe v. Wade decision.
Justice Samuel A. Alito Jr. wrote for the conservative majority. “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”
That left it up to each state to decide their own abortion policy until such times as Congress approved a national abortion policy.
But anti-abortion zealots were not content unless they could impose their forced-birther policies on the entire nation. Kacsmaryk’s ruling poses a challenge to SCOTUS because it puts to a lie their states’ rights contention in last year’s Dobbs v. Jackson Women’s Health Organization overturning Roe.
Here is some more reaction to the ruling:
Sen. Ron Wyden (D-Ore.) said President Biden and the FDA should ignore any court-imposed ban on mifepristone.i
Here is some more reaction to Judge Kacsmaryk’s decision compiled by CNN:
The American Medical Association blasted Kacsmaryk's decision, saying it "flies in the face of science and evidence."
"The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation. By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians," said Jack Resneck, Jr., M.D., the group’s president, in a statement.
Planned Parenthood called Kacsmaryk's decision a "deeply harmful move."
"The judge's decision in Texas today blocking the FDA’s approval of mifepristone is an outrage and exposes the weaponization of our judicial system to further restrict abortion nationwide," Alexis McGill Johnson, president and CEO of Planned Parenthood, said in a statement. "However, I want to be clear that access to mifepristone remains safe for now."
"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," Johnson added. "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."
California Gov. Gavin Newsom issued a statement in which he said:
“Today’s ruling, by an extremist judge pursuing a radical political agenda, ignores facts, science, and the law – putting the health of millions of women and girls at risk. Abortion is still legal and accessible here in California and we won’t stand by as fundamental freedoms are stripped away.”