This case and a case in Washington state are likely to be appealed to the Supreme Court.
The American Medical Association and several other healthcare and advocacy groups criticized a federal court judge ruling in Texas that would halt the distribution of medication abortion drug mifepristone. The Biden Administration has appealed the ruling and a bill introduced in the U.S. House today would clarify that FDA’s medication abortion policies supersede any state law.
In the case of Alliance for Hippocratic Medicine v. FDA, District Court Judge Matthew Kacsmaryk ruled that the approval of mifepristone more than two decades ago was “improperly rushed and allowed an unsafe drug regimen to reach the market.
Kacsmaryk issued a stay that effectively shuts down the prescribing and distribution of mifepristone in seven days. But his ruling is being appealed and there is a strong likelihood the case will be decided by the Supreme Court.
Mifepristone is manufactured by Danco Laboratories and is sold under the brand name Mifeprex. A generic version is sold by GenBioPro Inc.
Mifepristone, which had been known as RU-486, blocks progesterone, a hormone that thickens the lining of the uterus and is needed for a pregnancy to continue. In the U.S., mifepristone is the first of two drugs used in nonsurgical “medication” abortions. A second drug, misoprostol, causes the uterus to empty.
On the same day that Kacsmaryk, a Trump appointee, issued his controversial ruling, a District Court judge in Washington state, Judge Thomas O. Rice, an Obama appointee, issued a contradictory ruling that would block the FDA from restricting access to mifepristrone further in the states that brought the case in his court.
The court rulings triggered political and legislative reactions. In the House, Reps. Pat Ryan, a New York Democrat, and Lizzie Fletcher, a Texas Democrat, reintroduced today the Protecting Reproductive Freedom Act, which would reaffirm that the FDA — “not extremist courts — has clear and pre-emptive authority to regulate abortion medication,” the representatives said. The bill would also protect medication abortion via telehealth for patients across the country.
“Mifepristone is a safe and effective medication that has been prescribed by doctors during the over two decades since the FDA approved it. However, the Texas decision has nothing to do with science or medicine and everything to do with radical groups whose only goal is a national abortion ban,” Ryan said.
Medical and healthcare groups also roundly criticized Kacsmaryk’s ruling.
The ruling “flies in the face of science and evidence and threatens to upend access to a safe and effective drug that has been used by millions of people for more than 20 years,” said Jack Resneck Jr., M.D., president of the American Medical Association, in a. prepared statement. “The court’s disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation. By rejecting medical facts, the court has intruded into the exam room and has intervened in decisions that belong to patients and physicians.”
In addition to its use for voluntary termination of pregnancy, mifepristone is regularly used, in combination with misoprostol, “as one of the most effective regimens for medication management of miscarriage – a use this decision ends for countless patients already struggling with the loss of a pregnancy,” Resneck explained. “Prohibiting access to mifepristone would force patients to consider using a higher dosage of misoprostol on its own, which is a less effective treatment.”
There is no evidence that people are harmed by having access to the safe and effective medication, Resneck added. "To the contrary, there is substantial evidence that the denial of needed abortion care without justification carries a psychological, physical and economic toll. For people who do not have access to procedural abortion or adequate medical facilities, there may be no other options to obtain critically needed care,” he said.
Data show an association between restricted access to safe and legal abortion and higher rates of maternal morbidity and mortality, with already vulnerable populations experiencing the greatest burden, according to Resneck. “Reduced access to mifepristone will almost certainly exacerbate the maternal mortality crisis in places that do not have access to this medication.”
State legislatures have also made efforts to limit access mifepristone, and the AMA believes that FDA regulations should supersede state law.
Ilisa Bernstein, Pharm.D., J.D., interim executive vice president and CEO of the American Pharmacists Association, said the nation’s pharmacists “stand behind the FDA review and approval process that relies on evidence-based expert review to establish the safety and efficacy of marketed drugs.”
“The FDA gold standard for approval has been in place for nearly 120 years and is the basis for pharmacists’ trust and confidence in the medicines they recommend and dispense to patients. The Texas decision does not change this gold standard” Bernstein said in a press release on Friday. In addition, the ruling “only adds more confusion and complexity to an already complicated state and federal legal and regulatory landscape for pharmacists and patients related to mifepristone.”
Deirdre Schifeling, national political director of the American Civil Liberties Union, warned that the “devastating decision has the potential to compromise the ability of people to get abortion care in every state across the country.”
“Getting a judge to withdraw approval of mifepristone is just the next step in their larger plan to ban abortion in every state. If this decision is allowed to stand, it has frightening implications even beyond abortion and miscarriage care, including the ability of Americans to access any medication that some fringe group opposes on political grounds,” Schifeling added.