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On Friday, two different US federal courts, one in Texas and one in Washington state, handed down openly conflicting rulings on mifepristone, one of the two drugs used for years for abortions. The first asked the Food and Drug Administration (FDA), the US government agency that deals with the regulation of food and pharmaceutical products, to block the distribution of mifepristone throughout the United States. The second prohibited the imposition of any restrictions on the distribution of the drug in 18 states.
At the moment, mifepristone continues to be available in states where it is legal, but within the next week the FDA will have to decide whether to grant the Texas judge’s request or appeal to another higher court. If not resolved within a lower court, the conflict between the two courts could require the intervention of the Supreme Court, which currently has a conservative majority and last year overturned the historic ruling that since 1973 had guaranteed access to abortion at the federal level.
The fight began when Texas Judge Matthew Kacsmaryk, hand-picked by Donald Trump when he was president, spoke out in recent days on a lawsuit brought by a conservative group alleging that the FDA did not have the authority to approve mephepristone when the did, in 2000. Kacsmaryk he questioned the safety of mifepristone and asked the FDA to pause its approval across the country until it speaks out. Now the FDA has until next Friday to appeal Kacsmaryk’s claim. If the Court of Appeals agrees with the judge, mifepristone will become an unapproved drug and will therefore be illegal to manufacture, market or distribute it, unless otherwise ruled by an even higher court, such as the Supreme Court.
Kacsmaryk’s sentence was immediately criticized because the judge, who had already been very active in criticizing abortion in the past, used language very similar to that of anti-abortion groups, saying among other things that mifepristone «makes you die of hunger for an unborn human being.”
Less than an hour after Kacsmaryk’s ruling, however, Washington state federal judge Thomas Rice barred the restriction of mifepristone’s distribution in 18 states, adding that it is dangerous for judges of their caliber to try to invalidate the rulings. FDA. Rice pointed out that there is a great deal of evidence that mifepristone is a safe drug for women, and basically ordered that the status quo be maintained.
In the United States, more than half of abortions occur with prescription medication after a remote doctor consultation. Patients who decide to terminate their pregnancy first take mifepristone (which in Italy is marketed under the name RU486), which blocks a hormone necessary for the development of pregnancy, and then a prostaglandin, another drug that helps to empty the uterus. Since it is also used for a number of other circumstances, the latter is not subject to particular restrictions on sale.
In 2021, the FDA lifted a restriction that required obtaining these drugs in person and from certified healthcare providers, making it possible to receive the drugs by mail and telemedicine. However, there are still several states that impose restrictions on the marketing and use of abortifacient drugs.
If the Texan case goes to the Supreme Court there could be repercussions that go far beyond just access to medical abortion: it is the opinion of many that such an event could “normalize” the possibility of seeking the opinion of the Supreme Court on many other drugs that are the subject of political controversies, even when they are considered safe from a medical-scientific point of view by the FDA, as is the case with mifepristone. “Several legal experts believe Judge Kacsmaryk’s decision is the first time a court has ordered the withdrawal of a drug’s approval despite the FDA’s objection,” they wrote on the New York Times Abbie VanSickle and Pam Belluck. “The ruling could also undermine the trust pharmaceutical companies place in the agency and influence companies’ decisions about which drugs to develop and commercialize.”
The same experts consulted by the New York Times they believe it probable that the Supreme Court, despite its strongly conservative leanings, will not confirm a ruling that undermines the FDA’s authority and impartiality, precisely because of the repercussions it would have on the credibility of the agency and on the commercial interests of the pharmaceutical sector.