Abortion rights supporters gather outside the Federal Constructing and the J Marvin Jones Courthouse in Amarillo, Texas, March 15, 2023.
Moises Avila | AFP | Getty Images
A federal judge in Texas on Friday suspended the Food and Drug Administration’s nationwide approval of the mifepristone abortion pill, but delayed the ruling’s entry into force every week to give the Biden administration time to appeal.
But minutes after the decision was announced in Texas, a federal judge in Washington state issued a preliminary injunction that principally said the opposite.
Seemingly conflicting rulings by federal courts in Texas and Washington state mean that the Supreme Court may ultimately weigh on the legality of mifepristone in the US, which was approved by the FDA greater than 20 years ago in 2000.
Used together with one other drug called misoprostol, mifepristone is the most typical approach to abortion in the United States, accounting for about half of all abortions.
U.S. Judge Matthew Kacsmaryk of the Northern District of Texas held a key hearing on the case a number of weeks ago in Amarillo, but news of the decision, which could subvert access to a key abortion drug, didn’t come until late Friday when many Americans were on vacation. religious rites.
Kacsmaryk supported nearly all of the plaintiffs’ arguments regarding their right to sue, which called for the FDA’s approval of the drug to be revoked. He argued that mifepristone has serious questions of safety, which brushes aside the FDA’s longstanding determination that the drug is protected and effective.
“The court doesn’t disregard the FDA’s decision,” wrote Kacsmaryk. “But here the FDA agreed with its legitimate safety concerns – in violation of its statutory duty – based on clearly faulty reasoning and research that failed to support its conclusions.”
But in a dramatic twist, Judge Thomas Owen Rice of the U.S. District for the Eastern District of Washington fundamentally opposed the Texas decision when he banned the FDA from “changing the establishment and laws related to the availability of mifepristone” in 17 states and DC filed a lawsuit to keep the pill on the market.
Boxes of the drug Mifepristone used to induce medical abortion are prepared for patients at the Planned Parenthood Health Center in Birmingham, Alabama, March 14, 2022.
Evelyn Hockstein | Reuters
US Attorney General Merrick Garland said the Kacsmaryk Texas ruling “refutes the FDA’s expertise, issued greater than 20 years ago, that mifepristone is protected and effective.” Garland said the Justice Department would appeal the Texas ruling and defend the FDA’s approval.
Responding to the Texas ruling, President Joe Biden said in a press release, “My administration will fight this ruling.”
“If this ruling were to hold, there could be virtually no FDA-approved prescription protected from these sorts of political, ideological attacks,” the president said.
The case will go to the fifth US Circuit Court of Appeals. If the Biden administration fails to persuade this court to overturn Kacsmaryk’s ruling, access to mifepristone shall be in danger across the US
But the Washington state exclusion can protect access in a minimum of Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, Recent Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington State, and DC
Kacsmaryk’s decision is not going to affect access to misoprostol, which is widely used as a standalone abortion drug in other parts of the world. Some abortion providers have said they plan to use misoprostol instead to the two-drug regimen if mifepristone is withdrawn from the market.
The way it began
A coalition of doctors opposed to abortion, called the Alliance for Hippocratic Medicine, sued the FDA in November over the approval of mifepristone. The group argued that the FDA abused its authority by approving mifepristone in an accelerated process for brand spanking new drugs that help patients with serious or life-threatening illnesses greater than what’s on the market.
Kacsmaryk accepted the group’s claims on Friday, arguing that pregnancy will not be a disease and that mifepristone doesn’t provide a major therapeutic profit over surgical abortion.
Anti-abortion doctors were represented by lawyers from Alliance Defending Freedom, a company that worked with Mississippi lawmakers on the bill at the Dobbs v. Jackson Women’s Health Organization center. This case ultimately led to the Supreme Court overturning Roe v. Wade.
Kacsmaryk joined the court in 2019 after being nominated by former President Donald Trump. Kacsmaryk’s nomination was unanimously opposed by Senate Democrats in addition to Republican Susan Collins of Maine, who supports abortion rights.
His appointment was also opposed by abortion and LGBTQ rights groups equivalent to Planned Parenthood and the Human Rights Campaign.
The FDA called the case “extraordinary and unprecedented” in its January response to the lawsuit. The agency’s lawyers said they may not find any previous example of a court guessing the FDA’s decision to approve the drug.
The agency also said that mifepristone was not approved on an accelerated basis. Greater than 4 years passed from the initial application to the approval of the pill.
The FDA has approved mifepristone as a protected and effective approach to terminating early pregnancy based on extensive scientific evidence, the agency’s lawyers wrote. Many years of experience from hundreds of girls have confirmed that a drug treatment regimen is the safest option for a lot of patients compared to surgical abortion or childbirth, lawyers argued.
The FDA has warned that withdrawing mifepristone from the U.S. market would put women’s health in danger if they can’t access the pill to safely terminate a pregnancy. It might also weaken the FDA’s federal drug approval powers and make drug development harder, creating regulatory uncertainty in the marketplace, government lawyers said.
“If it were really easy to obtain FDA approvals for long-term drugs, even many years after they were released, pharmaceutical corporations would definitely not have the option to depend on FDA approval decisions to develop the pharmaceutical-drug infrastructure that Americans depend on to treat quite a lot of medical conditions. Biden administration lawyers wrote.
Mifepristone has been subject to FDA restrictions since its approval in 2000 to monitor the pill’s safety and effectiveness. These restrictions have been the subject of criticism and litigation from medical associations equivalent to the American College of Obstetricians and Gynecologists and more recently from attorney generals in Democratic-led states.
The FDA has regularly relaxed restrictions on mifepristone over the years as increasingly evidence emerges. The agency dropped previous rules that required in-person visits to doctors, allowing pills to be delivered by mail. The FDA recently allowed certified retail pharmacies to dispense mifepristone when a patient has a prescription from a healthcare provider that has been approved under the agency’s monitoring program.
Misoprostol, a drug used with mifepristone, is beneficial by the World Health Organization as a standalone approach to terminating pregnancy. But the FDA has not approved misoprostol alone as an abortion drug.
The American College of Obstetricians and Gynecologists recommends misoprostol instead to early abortions if mifepristone will not be available, even though it will not be as effective as the two-drug regimen, by organization.