Abortion Pill to Be Blocked Nationwide Under Judge’s Order (3)

A Republican-appointed federal judge in Texas issued an order suspending the US government’s decades-old approval of a key drug used in medication abortion, initiating a process that could block access to the pill nationwide in a week.

But his order Friday was almost immediately contradicted by a Democratic-appointed judge in Washington state who affirmed the US Food and Drug Administration’s approval of mifepristone and blocked the government from restricting access.

The competing orders just minutes apart signal the issue is almost certainly bound for the US Supreme Court, potentially setting up another politically seismic ruling a year after the high court’s conservative majority overturned Roe v. Wade.

The decision out of Texas from US District Judge Matthew Kacsmaryk, who was appointed by President Donald Trump, could soon end the sale and distribution of mifepristone — used as part of a two-pill regimen to terminate a pregnancy within the first 10 weeks — while a lawsuit seeking a more permanent ban on the drug proceeds.

Kacsmaryk’s order will not go into effect for seven days, giving the Biden administration time to appeal his decision to the New Orleans-based 5th US Circuit Court of Appeals, which is considered one of the most conservative courts in the country.

The Justice Department, which argued the FDA’s approval was proper and that the pill has been proved safe, filed a notice of appeal late Friday. Attorney General Merrick Garland said in an emailed statement the department will seek a stay on the order while it pursues the challenge.

Possible ‘Chaos’

Steve Vladeck, a law professor at the University of Texas, said the opposing rulings in Washington and Texas will step up pressure for a federal appeals court and possibly the Supreme Court to act quickly before Kacsmaryk’s ruling goes into effect.

“Presumably, someone has to rule by next Friday, or else Saturday we have chaos,” he said.

The ruling in Washington came from US District Judge Thomas Rice, an appointee of President Barack Obama, who granted a request by several Democratic-leaning states for an order affirming the FDA approval of the pill.

Both decisions are sure to further elevate abortion access as a potent political issue heading into the the 2024 US elections. Medication abortion has become the most common method in the country as states across the nation grapple with how to legislate reproductive rights during the past year.

The initial plan for Democrats who control the Senate is to fight the Texas decision in the courts, Senate Majority Leader Chuck Schumer and Senate Health committee Chair Patty Murray told reporters on a Saturday call. Legislatively, they only said they continue to push for legislation that would codify the 1973 Roe v. Wade decision that protects a woman’s right to abortion access — a measure that was blocked by Senate Republicans last year.

“We will fight this in the courts and we will work right alongside the administration to pursue every avenue available to make sure women in this country can make their own health care decisions for themselves,” Murray said.

Vice President Kamala Harris told reporters Saturday she’s still reviewing the decision, but that she and President Joe Biden are going to do “everything we can to ensure that women have the ability to make decisions about their healthcare.”

Religious groups and anti-abortion advocates targeted the FDA in a November lawsuit in Texas claiming the agency fast-tracked approval of mifepristone in 2000 without sufficient scientific evidence.

Safer Than Tylenol

Medical groups have defended the medication, arguing that studies show it is safer than Tylenol and Viagra and sends fewer people to the emergency room than those drugs. Abortion rights supporters have decried the lawsuit as politically motivated and not based in science.

Kacsmaryk, who sits in Amarillo, Texas, said it was clear that the FDA overstepped its authority when it first approved mifepristone for use and suggested that the agency “faced significant political pressure” to advance the drug.

“The Court does not second-guess FDA’s decision-making lightly,” Kacsmaryk said in his decision. “But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions.”

The judge said the FDA’s stance had likely led to death and injury among women taking the drug. “Whatever the numbers are, they likely would be considerably lower had FDA not acquiesced to the pressure to increase access to chemical abortion at the expense of women’s safety,” Kacsmaryk wrote.

Read More: Abortion Providers Gear Up for Judge’s Ruling Over Pill Approval

If the ruling is not blocked by the 5th Circuit, women seeking to end pregnancies will be left with two options: surgical abortion or a single pill called misoprostol, which is less effective when not used in combination with mifepristone. The latest data shows that 98% of medication abortions that occur in the US use the two-pill method, according to the Guttmacher Institute.

Evan Masingill, the chief executive officer of GenBioPro, the manufacturer of the generic version of mifepristone, said in a statement that the drug maker is reviewing both court orders but “will take any steps necessary to lawfully make mifepristone available and accessible to as many people as possible.” He added, “The bottom line is, we are confident in the legality of mifepristone’s approval.”

The high-profile Amarillo case has drawn focus from advocates on both sides of the issue, as well as health professionals and medical associations who have been bracing for a ruling on the temporary order for weeks. Dozens of states and advocacy organizations have filed briefs with the court, arguing for or against the order.

The abortion pill ruling isn’t Kacsmaryk’s final word on the case, with many court filings and a possible trial to come. But the injunction reflects his judgment that the plaintiffs are likely to succeed on the merits, among other factors.

Texas Judge

Anti-abortion groups expected Kacsmaryk to be favorable to their case. Lawyers for the conservative religious-rights groups suing FDA chose to sue in Amarillo, where they were all but assured to get Kacsmaryk, who is assigned all civil and criminal cases.

In December, Kacsmaryk tossed out a federal rule that aimed to expand teen access to birth control. In November, he rejected a federal policy that stopped doctors from discriminating against people based on their sexual orientation or gender identity.

The conservative group behind the lawsuit argues that the agency didn’t follow the appropriate protocol when it first authorized the use of mifepristone in 2000 and failed to study the safety of the drugs as required, putting “politics over science.”

FDA officials have refuted that characterization in public statements and court filings, arguing that the agency followed procedure when approving the medication and “extensively reviewed” the scientific evidence at hand to determine its safety and efficacy.

Mifepristone was first approved in 2000 for use through the first seven weeks of pregnancy. In 2016, the FDA extended that window to 10 weeks. It is the first pill used in the two-drug regimen most used to terminate a pregnancy and blocks a hormone called progesterone that is needed to support a pregnancy. It is followed by misoprostol, which prompts contractions that expel the contents of the uterus.

Kacsmaryk’s decision comes as the federal government has taken steps to loosen restrictions on abortion pills, allowing authorized pharmacies to dispense the pills instead of limiting their distribution to doctor’s offices. But Republican leaders of states with abortion restrictions have push backed against the new regulations, filing lawsuits and drafting letters to major drugstore chains to ensure the drugs cannot be dispensed at stores in their states or mailed to their residents.

With Roe Fallen, Drugstore Chains Are Abortion Foes’ Next Target

The case is Alliance for Hippocratic Medicine v. US Food and Drug Administration, 2:22-cv-00223, US District Court, Northern District of Texas (Amarillo).

(Updates with comments from Senate Democrats in paragraphs 11-12, Harris in paragraph 13.)

--With assistance from Laura Litvan.

To contact the reporter on this story:
Madlin Mekelburg in Austin at mmekelburg@bloomberg.net

To contact the editors responsible for this story:
Anthony Lin at alin364@bloomberg.net

Steve Stroth, Ian Fisher

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