There are more than 90 federal district courts in the USA, two of whom (in Texas and Washington state) have made rulings about the safety of mifepristone that contradict each other, and a third in a Louisiana court that is due to publish its opinion on 17 May. The Texas case, heard by a Donald Trump appointee, was tabled by anti-abortion activists to ban the use of mifepristone nationally, accusing the FDA of giving it a safety approval that they claimed was unwarranted.
The Washington state case was filed by 12 Democratic-led states in direct response, calling for the full FDA approval for mifepristone to date to be maintained. It sought to remove mifepristone from the FDA’s Risk Evaluation and Mitigation Strategy programme to further ease access to the pills. It called existing regulations on mifepristone “particularly burdensome”. The federal judge in that case, Thomas Rice, issued a preliminary injunction on any new restrictions on mifepristone, minutes after the Texas decision on 7 April.
The third, ongoing case is Danco Laboratories v. Alliance for Hippocratic Medicine, a lawsuit asking the federal judiciary to effectively ban mifepristone. Until this case is decided, no further lower courts can be approached to ban mifepristone, at least for the time being. Meanwhile, mifepristone remains available, and patients who live in states where abortion is legal may still obtain the abortion pills in the same way they would have obtained them if this lawsuit had never been filed. In this case, the court will examine various scientific evidence to determine if the original FDA approval was sound. The anti-abortion alliance will argue that it was not sound. However, groups with scientific and pharmaceutical expertise are already saying that some of the evidence submitted by the anti-abortion group is unsound or has not even been peer reviewed.
President Biden had also filed an emergency request to the Supreme Court to maintain the status quo with mifepristone. On 21 April, the Supreme Court ruled in favour of his request. One report thinks this “stay” could last up to a year as other cases proceed.
In response, Joe Biden said: “As a result of the Supreme Court’s stay, mifepristone remains available and approved for safe and effective use while we continue this fight in the courts. I continue to stand by FDA’s evidence-based approval of mifepristone, and my Administration will continue to defend FDA’s independent, expert authority to review, approve, and regulate a wide range of prescription drugs.” He also issued a statement calling on voters to take the issue of abortion access to the polls in the upcoming state and local elections in November.
A further case has been filed by GenBioPro, manufacturer of a generic version of mifepristone, in a federal court in Maryland. It too seeks to make restricting mifepristone more difficult by barring the FDA from potentially revoking the medication without a formal hearing.
Supreme Court Justice Alito dismissed concerns that “regulatory chaos” would ensue if the Supreme Court enforced the restrictions on mifepristone. His opinion, he added, did not “express any view” about “whether the FDA acted lawfully in any of its actions regarding mifepristone”, which is the central issue in the ongoing litigation. This was described by one report as “outrageous”. The same report also aptly called the anti-abortion activists “forced-birth advocates”.
Meanwhile, PBS News reports that some researchers are examining the rise of false online misinformation and disinformation about abortion being circulated, especially on social media, with a view to combating it. One researcher, Jenna Sherman, programme manager and researcher at Meedan Digital Health Lab, said: “Claims are circulating that exaggerate the harms of medical abortion, that use very shoddy and in many cases, non-rigorous science, and they do a lot of fear mongering and stigmatising around people who are considering using abortion pills in a manner that is unjustified based on the scientific literature.” She added: “And what’s really concerning to me, is that we are seeing many of those same claims in the actual legal appeals themselves, the ruling that the Texas judge put forth that I looked at, had at least 20 unique, false or misleading claims that were mis-aligned with scientific consensus. And that’s just an example of the cycle that we’re in where mis- and dis-information online gets baked into our legal and policy decisions, and then bolsters the disinformation online, and the cycle continues.”
SOURCES: AlJazeera, 24 February 2023 + PHOTO by Charlie Riedel/AP Photo ; FAQs: Court Information: US Courts ; Vox, by Ian Millhiser, 21 April 2023 ; Slate, by Mark Joseph Stern, 21 April 2023 ; Washington Post, by Jennifer Rubin, 22 April 2023 ; Scripps News, by staff, Stephanie Sandoval, 22 April 2023 ; The Guardian, by Poppy Noor, 21 April 2023 ; National Public Radio, 21 April 2023 ; Whitehouse.gov, 21 April 2023, PBS News, Jenna Sherman interviewed by John Yang, 22 April 2023