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File photo of a patient preparing to take mifepristone, the first pill given in a medical abortion, in Santa Teresa, U.S.
| Photo Credit: Reuters
Access to the most commonly used method of abortion in the U.S. plunged into uncertainty Friday following conflicting court rulings over the legality of the abortion medication mifepristone that has been widely available for more than 20 years.
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For now, the drug the Food and Drug Administration approved in 2000 appeared to remain at least immediately available in wake of two separate rulings that were issued in quick succession by federal judges in Texas and Washington.
U.S. District Judge Matthew Kacsmaryk ordered a hold on federal approval of mifepristone. But that decision came at nearly same time that U.S. District Judge Thomas O. Rice directed U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states where Democrats sued in an effort to protect availability.
The extraordinary timing of the competing orders revealed the high stakes surrounding the drug nearly a year after the U.S. Supreme Court overturned Roe v. Wade and curtailed access to abortion across the country.
The Justice Department swiftly gave notice it would appeal the Texas ruling and said it was reviewing the decision from Washington.
The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court.
“FDA is under one order that says you can do nothing and another that says in seven days I’m going to require you to vacate the approval of mifepristone,” said Glenn Cohen of Harvard Law School.
Abortion providers slam ruling
Abortion providers slammed the Texas ruling, including Whole Woman’s Health, which operates six clinics in five states and said it would continue to dispense mifepristone in person and by mail over the next week as they review the rulings.
The abortion drug has been widely used in the U.S. since securing FDA approval and there is no precedent for a lone judge overruling the medical decisions of the Food and Drug Administration. Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.
Mr. Kacsmaryk signed an injunction directing the FDA to stay mifepristone’s approval while a lawsuit challenging the safety and approval of the drug continues. His 67-page order gave the government seven days to appeal.
“Today’s decision overturns the FDA’s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,” U.S. Attorney General Merrick Garland said. “The Department will continue to defend the FDA’s decision.”
Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.
Alliance Defending Freedom’s case
The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because it did not adequately review its safety risks.
Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically banning abortion medications.
Mr. Kacsmaryk sided with plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialised review process reserved for drugs to treat “serious or life-threatening illnesses.” The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”
His order also agreed with plaintiffs in invoking a controversial 19th century law that anti-abortion groups are now trying to revive to block sending abortion medications through the mail. Originally passed in 1873 and named for an “anti-vice crusader,” the Comstock Act was used to prohibit the mailing of contraceptives, “lewd” writings and “instruments” that could be used in an abortion. The law was seldom invoked in the 50 years after Roe established a federal right to abortion.
Mr. Kacsmaryk, though, agreed with plaintiffs that the law — as literally interpreted — prohibits mailing mifepristone.
His order, if upheld, would also dismantle a number of recent FDA actions intended to ease access to the drug.
In late 2021 the FDA — under the Biden administration — dropped a requirement that women pick up the drug in person, opening the door to delivery by mail-order pharmacies. In January the agency dropped another requirement that prevented most brick-and-mortar pharmacies from dispensing the pill.
Pro-life groups embraced the Texas ruling. “The court’s decision today is a major step forward for women and girls whose health and safety have been jeopardised for decades by the FDA’s rushed, flawed and politicised approval of these dangerous drugs,” said March for Life President Jeanne Mancini.
Legal experts warned that the ruling could upend decades of precedent, setting the stage for political groups to overturn other FDA approvals of controversial drugs and vaccines.
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