A Texas District Court has issued a preliminary injunction halting sales of mifepristone in the United States. The ruling is part of a lawsuit by plaintiffs to overturn the Food & Drug Administration’s (FDA) approval of mifepristone in 2000 for reproductive health. The groups suing FDA to overturn mifepristone’s approval have argued that the agency used an improper process to evaluate the drug and failed to consider its safety in minors.
On the same day, the Washington District Court ruled on a similar case, finding that FDA’s approval of mifepristone was appropriate because the drug is safe and effective. The judge in the Washington state case further ruled that FDA should take no steps to reduce access to mifepristone in 17 states and the District of Columbia. These contrary rulings further complicate a complex patchwork of access to these medications based on state law.
ASHP is concerned about the Texas ruling’s potential impact on patient access to care as well as implications for the FDA approval of other drugs. The American Medical Association, the American College of Obstetricians and Gynecologists, and other medical societies submitted briefs opposing the removal of mifepristone from the market and supporting FDA’s approval process.
- Impact on Reproductive Healthcare Access: ASHP’s policy on reproductive health access asserts patients’ rights to access comprehensive reproductive healthcare services, including care for pre- conception, conception, post-conception, and termination of pregnancies. The policy also affirms that healthcare workers should be free to provide needed care guided by their individual beliefs without fear of retribution.
“Removing mifepristone from the market significantly narrows care options, which may result in more surgical abortions and increased wait times at clinics in states that still allow the procedure,” said Tom Kraus, ASHP vice president of government relations. “The sudden removal of mifepristone from the market may also trigger demand shortages for other medications utilized for termination of intrauterine or ectopic pregnancy.”
Although misoprostol alone can be used for termination of intrauterine or ectopic pregnancy, treatment with mifepristone and misoprostol has substantially lower rates of treatment failure than other medication options.
- Impact on Other FDA Approved Drugs: ASHP has long supported FDA’s approval process as the gold standard for determining medication safety and efficacy. This case sets a precedent allowing a court, rather than scientists and clinicians, the authority to disrupt the medication approval process. As a result, other clinically useful medications may also be subject to similar court challenges, even decades after approval.
“Patients and healthcare providers rely on FDA to make scientifically and clinically sound determinations about the safety and efficacy of medications,” said Kraus. “The Texas decision threatens to undermine public trust in the drug approval process.”
The Texas injunction does not take effect for seven days and the Biden administration has already appealed the ruling to the U.S. Court of Appeals for the 5th Circuit, asking for a stay, which would prevent the Texas ruling from taking effect. Similarly, the Washington state ruling has been appealed to the U.S. Court of Appeals for the 9th Circuit. A split decision at the Circuit Court level would increase the likelihood of the cases being appealed to the Supreme Court. ASHP will monitor developments and update members as more information becomes available.