MONDAY, April 10, 2023 (HealthDay News) -- A Texas federal judge has issued a preliminary ruling that invalidates the U.S. Food and Drug Administration approval in 2000 of mifepristone, the first of two drugs most commonly taken during a medical abortion.
Judge Matthew Kacsmaryk added a seven-day stay to his order, issued Friday, to give the FDA time to mount an appeal.
About an hour later, Washington state federal judge Thomas Rice issued a countering decision in a case filed there, ordering a halt to “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”
The two opposing rulings would suggest that any final decision on the availability of mifepristone, which is typically given alongside misoprostol to cause an abortion, may end up at the Supreme Court.
The Washington state lawsuit originated with Democratic attorneys general who were challenging restrictions in place that made it difficult to obtain mifepristone.
The Texas decision involves a lawsuit filed by a coalition made up of doctors and anti-abortion groups who sought an end to the use of mifepristone, claiming that the FDA's decision 23 years ago to approve the drug was made hastily and without proper regard for its overall safety.
In his decision, Kacsmaryk said that, ”The court does not second-guess [the] FDA’s decision-making lightly. 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. There is also evidence indicating FDA faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased ‘access’ to chemical abortion.”
'Not just Texas'
In a statement, President Joe Biden warned that Kacsmaryk's ruling could affect medicines beyond mifepristone and affect Americans nationwide.
"If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks," he said.
Biden added that the ruling "does not just affect women in Texas – if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state."
He said the Justice Department had already filed an appeal and will seek an "immediate stay" of the decision.
Medical abortion now accounts for about half of all abortions in the United States. With the overturning of Roe v. Wade last June, obtaining mifepristone and misoprostol for a medical abortion has been seen as a viable option for women who live in states affected by bans who might still want to obtain an abortion.
Mifeprostol work by suppressing a hormone that's necessary for pregnancy to continue. The second drug, misoprostol, induces contractions similar to those seen in a miscarriage. In countries where mifepristone is hard to obtain, medical abortions often involve the use of misoprostol alone, although experts believe the efficacy of misoprostol alone is less than the two-drug combo, and side effects such as nausea become more common.
Doctors' groups concerned
Reaction from abortion rights proponents and opponents was swift.
The America College of Obstetricians and Gynecologists (ACOG) condemned the Texas ruling. In a joint statement, ACOG president Dr. Iffath Abbasi Hoskins and CEO Dr. Maureen Phipps called the decision " a grievous legal overstep into America’s well-established regulatory system."
"“Mifepristone has been used safely and effectively for medication abortion for more than two decades," Hoskins and Phipps said. "That safety and efficacy is backed up by robust, evidence-based, clinical data and its observed use by millions of people with support from clinicians, including obstetrician-gynecologists. Regardless of the opinion of one judge on this matter, mifepristone is a safe, effective part of comprehensive health care."
“Today’s decision is clearly a transparent effort to make it harder for people to access medication abortion," they added. "It will force people to turn to other means of accessing abortion care; it will force clinicians to prescribe less safe, less effective regimens for medication abortion; and it will impose greater harm on those who already struggle to access needed reproductive health care, thus increasing health inequities."
The American Medical Association (AMA) issued a similar statement.
"There is no evidence that people are harmed by having access to this safe and effective medication," said AMA president Dr. Jack Resneck Jr. "To the contrary, there is substantial evidence that the denial of needed abortion care without justification carries a psychological, physical and economic toll."
Resneck added that any decision by the courts to rescind FDA approval of mifepristone could set a dangerous precedent for other medications Americans use every day.
"This decision introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration [FDA]. Doing so goes against the established scientific process that leads to those decisions and puts other drugs at risk of being subject to similar efforts," he said.
“This decision shines a light on something that the Biden Administration wants to sweep under the rug -- that these drugs do not treat or cure disease but kill unborn children and expose their mothers to dangerous side effects. The FDA should be in the business of ensuring safety, not in taking lives,” she said.
For its part, Danco Laboratories, one of two companies that make mifepristol, said it will fight to provide its drug (brand name Mifeprex) to women.
"Danco affirmatively joined the case as a defendant to protect the availability of Mifeprex for pregnant women and the company’s only product, recognizing the importance of mifepristone as the only drug approved for medication abortion," the company said in a statement.
The company estimates that over 5 million women have used Mifeprex to undergo medical abortion since its approval in 2000, noting that it is 97% effective in terminating early pregnancy.
Even if the decision to rescind mifepristone's FDA approval is ultimately upheld, experts believe most American women could still access medical abortion, since misoprostol would still remain legal.
The FDA has for a dozen years placed mifepristol under strict safety monitoring protocols known as the Risk Evaluation and Mitigation Strategy (REMS), which currently cover about 60 drugs. REMS involves periodic review of the latest safety data of medicines.
In recent years that review resulted in the agency lifting the restriction that mifepristone could only be obtained in person from a provider. That opened the door to mail-order access for the mifepristone/misoprostol combination needed for medical abortion.
Find out more about medical abortion at the Cleveland Clinic.
SOURCES: White House, news release, April 7, 2023; American College of Obstetricians and Gynecologists, statement, April 7,2023, American Medical Association, National Right to Life, statement, April 7, 2023; Danco Laboratories, news release, April 7, 2023
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