The two largest pharmacy chains in the US – CVS and Walgreens – are to begin selling the abortion drug, mifepristone, via prescription in certain states, including New York, Pennsylvania, Massachusetts, California, Illinois, and Rhode Island later this month. Both pharmacies have received certification to dispense the drug under FDA guidelines; mail order prescription will not be available. Expansion to other states where the drug is legal is also anticipated.
In a statement, President Biden said that he encourages other interested pharmacies to seek certification to dispense the drug.
Vice President Kamala Harris also praised the announcement as an important step forward for women’s health, adding that the administration would “not waver in our dedication to preserving access to essential medication and defending the FDA’s independent, evidence-based approval and regulation of safe and effective drugs.”
Harris’s comment refers to the ongoing court cases around mifepristone. In April 2023, a court in Texas moved to suspend FDA approval of the drug – the first time a court has ever intervened in a drug approval. The lawsuit was initiated by the Alliance for Hippocratic Medicine (AHM), which was formed in 2022 and seems to mainly consist of anti-abortion groups. Journalists looking into the AHM’s origins have described the paper trail behind the alliance as “ambiguous.” Others claim that the case was orchestrated so that it would land in front of an anti-abortion activist judge.
An hour after the ruling in Texas, however, a court in Washington ruled (in a lawsuit brought about by 18 other states) that the FDA was to make no change to the approval. Because of the conflict in opinions, the US government appealed to the Fifth Circuit Court of Appeals in New Orleans – which decided that the drug could stay on the market, but with restricted access. The appeals court ordered the FDA to roll back efforts to expand access to the drug, including telemedicine and increasing the use window from the first seven weeks of pregnancy to the first 10.
But the restrictions won’t take effect until the court case is complete. The US government and Danco Laboratories (manufacturer of mifepristone) have asked the Supreme Court to hear their arguments. They are looking to restore access – and have also asked the court to consider whether the AHM had the legal right to bring about the case in the first place. Oral arguments will be heard on March 26.
AHM also asked the Supreme Court to consider reviewing the FDA’s initial mifepristone approval in 2000; this was denied, which suggests that a full ban on mifepristone will be unlikely. But the stakes are still high.
A number of stakeholders have submitted information in support of the case. The Center for Reproductive Rights said in a statement: “The Center for Reproductive Rights and its movement partners have submitted amicus briefs in this case supporting the FDA’s approval of the medication. Leading pharmaceutical companies, medical and health organizations, members of Congress, government officials, rights and justice groups, and other experts have also submitted amicus briefs in support of the FDA.”
We all have our own moral codes and beliefs when it comes to abortion, but I agree with the Biden administration when they say: “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.”
Other industry stakeholders also believe that a court overturning an FDA approval would set a dangerous precedent. A statement from The Biotechnology Innovation Organization said: “The preliminary ruling by a federal judge in Texas is an assault on science and the FDA’s long-standing role as the authority to make decisions on the safety and efficacy of medicines. For a court to invalidate the approval of a drug that was reviewed and approved more than two decades ago is without precedent. As legal scholars have noted, the courts do not have the medical expertise to make these types of scientific determinations.
“This decision has ramifications that extend well beyond this case, setting a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies.”
According to Danco, the AHM’s “real disagreement with FDA is that they oppose all forms of abortion.”
Newsletters
Receive the latest analytical science news, personalities, education, and career development – weekly to your inbox.
