A common abortion pill, mifepristone, is still in grave danger of being pulled off the market after the Supreme Court gave itself until Friday, April 21, to weigh in on a case that could decide access to the medication.
On April 19, Supreme Court Justice Samuel Alito extended a stay that keeps mifepristone accessible under a lower court’s new restrictions to give the high court more time to hear arguments in the case and decide how to proceed. The Supreme Court is reviewing a decision from the 5th Circuit Court, which ruled that mifepristone could remain on the market with restrictions. Alito previously delivered a stay that was set to expire at 11:59 PM on April 19.
The 5th Circuit Court’s decision came after U.S. District Judge Matthew Kacsmaryk ruled that mifepristone was unsafe and ordered that U.S. Food and Drug Administration (FDA) approval of the drug be suspended. The ruling was the first time a judge has ever ordered an FDA-approved drug off the market, and the implication of the ruling, if it is not overturned, suggests judges can interfere in the drug approval process in the United States.
Mifepristone was approved by the FDA in 2000 and has been used in the United States by more than 5 million people since. It is commonly referred to as being “safer than Tylenol” and its access has been expanded in recent years due to the COVID-19 pandemic and its widely-regarded safety. It is the most common care method for the treatment of miscarriage, as well.
The 5th Circuit Court, in an appeal, did decide that Kacsmaryk’s ruling went too far, but still imposed changes to mifepristone access beyond the FDA’s approval and recommendations. Specifically, the court stripped extensions of mifepristone access that have been expanded since 2016, including letting patients access the medication longer into pregnancy––from 49 days to 70 days––and prescribing the drug via telehealth and accessing it through the mail.
Alito’s April 19 decision keeps those 5th Circuit Court restrictions in place as justices decide what to do next. How the Supreme Court will act next is unknown, and the litigation upheaval has created chaos for healthcare providers, patients and the pharmaceutical industry. To further confuse legal experts, another federal judge based in Washington allowed 17 states that sued to keep full access to mifepristone. How these different rulings will shake out is largely unknown and unprecedented, according to healthcare and legal experts with Planned Parenthood Federal of America (PPFA) who spoke to reporters on a press call April 18.
Pharma industry makes its case
As the future of mifepristone is still being hotly contested, the pharmaceutical industry has voiced its opposition to judges interfering with the drug approval process. Hundreds of pharma and biopharma leaders signed a letter condemning the suspension of mifepristone, stating that the ruling created uncertainty for the industry and could have an enormous implications beyond abortion and miscarriage care. Of note, pharma leaders, including Pfizer CEO Albert Doula, stated in the letter that if judges can interfere with the drug approval process, companies will not be incentivized to research and develop new therapies.
In addition, the industry fears that if judges can make sweeping changes to what drugs the public has access to in the United States, they could come after vital vaccines next, PPFA experts said April 18.
Amid all the legal drama, GenBioPro, the drug maker of the generic version of the abortion pill mifepristone, launched a lawsuit on April 19 against the FDA to keep the drug on the market.
Danco Laboratories, the secretive drugmaker of the brand-name mifepristone––Mifeprex––issued a statement on April 14 applauding the Supreme Court for stepping in and granting a stay as it considers the case.
“It is temporary, but we look forward to the careful consideration we know the Court will give to these important issues,” Abby Long, Danco’s director of marketing and public affairs, said in the statement April 14.
The FDA and Danco Labs filed together to ask the Supreme Court to weigh in on the case.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."