Abortion rights advocates gather in front of the J Marvin Jones Federal Court Building and Court in Amarillo, Texas, on March 15, 2023.
Moises Avila | AFP | beautiful pictures
A federal judge in Texas on Friday suspended the Food and Drug Administration’s nationwide approval of the abortion drug mifepristone, but delayed the ruling by a week to give the Biden administration time appeal.
But minutes after the Texas decision was announced, a federal judge in Washington state issued a preliminary order to the contrary.
The seemingly contradictory federal court rulings for Texas and Washington mean the Supreme Court could finally weigh in on the legality of mifepristone in the United States, which has been approved by the FDA for more than two years. decade ago in 2000.
Used in combination with another drug called misoprostol, mifepristone is the most common method of termination of pregnancy in the United States, accounting for about half of all abortions.
U.S. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas held a key hearing on the case a few weeks ago in Amarillo, but news of the decision could hinder access to the drug. The important pregnancy is only given late on Friday when many Americans are on holiday. religious rites.
Kacsmaryk endorsed nearly all of the plaintiffs’ arguments for their right to sue, which called for the removal of FDA approval of the drug. He argued that mifepristone had serious safety problems, rebutting the FDA’s long-standing decision that the drug was safe and effective.
“The court did not take FDA decision making lightly,” Kacsmaryk wrote. “But here, the FDA agreed to its legitimate safety concerns – a violation of a statutory obligation – on the grounds that it was clearly unfounded and the studies did not support the conclusion of the study. It.”
But in a dramatic turn, U.S. District Judge Thomas Owen Rice for the Eastern District of Washington essentially opposed Texas’ decision, when he barred the FDA from “changing the status quo and the rights related to availability of mifepristone” in 17 states and DC sued to keep the drug on the market there.
Canisters of Mifepristone for medical abortion are prepared for patients at Planned Parenthood medical center in Birmingham, Alabama, March 14, 2022.
Evelyn Hockstein | Reuters
US Attorney General Merrick Garland said Kacsmaryk’s ruling in Texas “overturns the FDA’s expert judgment, made more than two decades ago, that mifepristone is safe and effective.” Garland said the Justice Department will appeal the Texas ruling and defend FDA approval.
In response to the Texas ruling, President Joe Biden said in a statement: “My administration will fight this ruling.”
“If this ruling goes into effect, then virtually no prescription drug, approved by the FDA, will be safe from these kinds of political, ideological attacks,” the president said.
The case will be brought to the US Fifth Circuit Court of Appeals. If the Biden administration fails to convince that court to overturn Kacsmaryk’s ruling, access to mifepristone will be in jeopardy across the US.
But the Washington state exclusion could preserve access at least in Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania , Washington state and DC
Kacsmaryk’s decision will not affect access to misoprostol, which is commonly used as a stand-alone abortion pill in other parts of the world. Some abortion providers have said they plan to use misoprostol as an alternative to a two-drug regimen if mifepristone is withdrawn from the market.
How it started
A coalition of doctors who oppose abortion, known as the Hippocratic Alliance of Medicine, sued the FDA in November over its approval of mifepristone. The group argues that the FDA abused its authority by approving mifepristone through an expedited process for new drugs that help patients with more serious or life-threatening illnesses than existing ones. on the market.
Kacsmaryk accepted the group’s statement Friday, arguing that pregnancy is not a disease and that mifepristone offers no meaningful therapeutic benefit over surgical abortion.
The anti-abortion doctors are represented by attorneys from the Alliance for Defense of Freedom, an organization that worked with Mississippi lawmakers to draft legislation at the center of Dobbs v. Jackson Women’s Health Organization . That case eventually led to the Supreme Court overturning Roe v. Wade.
Kacsmaryk joined the court in 2019 after being appointed by former President Donald Trump. Kacsmaryk’s nomination was unanimously opposed by Senate Democrats as well as Republican Susan Collins of Maine, abortion rights advocates.
His nomination was also opposed by abortion and LGBTQ rights organizations such as Planned Parenthood and the Human Rights Campaign.
The FDA called the incident “unusual and unprecedented” in its January response to the lawsuit. The agency’s attorneys said they could not find any previous examples of a court second-guessing an FDA’s decision to approve a drug.
The agency also said mifepristone is not approved under the expedited route. It took more than four years from the initial application until the pill was approved.
The agency’s attorneys have approved mifepristone as a safe and effective method for early pregnancy termination based on extensive scientific evidence. The lawyers argue that decades of experience with thousands of women have confirmed that a drug regimen is the safest option for many patients over surgical abortion or childbirth.
The FDA warned that withdrawing mifepristone from the US market would jeopardize women’s health if they cannot access safe birth control pills. It would also undermine FDA’s authority to approve federal drugs and hinder drug development by creating regulatory uncertainty in the marketplace. government attorney said.
“If long-standing FDA drug approvals were easily forced, even decades after they were issued, pharmaceutical companies would not be able to confidently rely on FDA approval decisions to develop a pharmaceutical infrastructure that Americans depend on to treat a variety of health conditions,” the report said. Attorneys for the Biden administration wrote.
Mifepristone has been subject to FDA restrictions since its approval in 2000 to monitor the pill’s safety and effectiveness. These restrictions have come under criticism and litigation from medical associations such as the American College of Obstetricians and Gynecologists and more recently. from attorney generals in Democratic-led states.
The FDA has gradually relaxed restrictions on mifepristone over the years as more evidence becomes available. The agency has dropped previous regulations requiring medical professionals to visit in person, allowing drug delivery by mail. FDA recently authorized retail pharmacy dispensing mifepristone when the patient has a prescription from an approved healthcare provider under the agency’s surveillance program.
Misoprostol, which is used together with mifepristone, is recommended by the World Health Organization as an independent method for terminating a pregnancy. But the FDA has not approved misoprostol as an abortion drug.
The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative to early abortion if mifepristone is not available, although it is not as effective as a two-drug regimen. by organization.
