Will Texas be able to ban medical abortion in the United States?
Voluntarily interrupting a pregnancy in the United States could become even more difficult and the sentence by a Texas judge against mifepristone, one of the two drugs used for medical abortion, risks creating a significant historical precedent. Here's why and what's happening
23 years after its approval by the Food and Drug Administration (Fda), Matthew Kacsmaryk, Texas federal judge chosen by Donald Trump when he was president, has asked the government agency that deals with the regulation of food and pharmaceutical products to block throughout the United States the distribution of mifepristone, one of the two drugs used for two-stage medical abortion.
President Joe Biden promises battle and hundreds of pharmaceutical executives have signed a letter criticizing the ruling.
THE CASE BRING TO COURT BY THE ANTI-ABORTISTS
The lawsuit against one of Italy's key medical abortion drugs, known as RU486, was filed by a coalition of anti-abortion groups and doctors who aim to revoke access to abortion nationwide.
Proponents say that when the FDA approved mifepristone in 2000 it "did not adequately review the scientific evidence" and that it has since "ignored the drug's safety risks."
The claims are unsubstantiated because, as the New York Times states, "the FDA has regulated mifepristone more strictly than many other drugs and has regularly reviewed the evidence of its safety and efficacy". Indeed, for more than 10 years "the agency has imposed an additional framework of restrictions and monitoring for the drug" through the Risk Evaluation and Mitigation Strategy and in recent years it has examined the new data in depth.
THE JUDGMENT OF TEXAS
Kacsmaryk, whose anti-abortion positions are known, therefore blocked the approval of mifepristone on Friday.
"In the 67-page sentence – writes the NYT – Judge Kacsmaryk appeared to agree with almost all the statements of the anti-abortion groups and repeatedly used the language of the opponents of abortion, calling medical abortion 'chemical abortion' and referring to the fetus as 'human' or 'unborn' child'”.
AN OPPOSING JUDGMENT
But less than an hour later, a Washington state judge issued a ruling in another lawsuit, contradicting Kacsmaryk's decision and ordering the FDA not to make any changes to the availability of mifepristone in the 18 Democratic states that had filed the lawsuit. cause.
"Conflicting orders from two federal judges, both preliminary injunctions issued before the hearing of full cases, appear to create a legal deadlock that could escalate all the way to the Supreme Court," the NYT said.
WHAT HAPPENS NOW
The drug will continue to be available in the short term in states where it is legal and the FDA will have until next Friday to appeal Kacsmaryk's sentence by requesting the intervention of the Court of Appeals.
This, if the Texas judge were to agree, would make mifepristone illegal and it would therefore be forbidden to manufacture, market and distribute it unless an even higher court, such as the Supreme Court, rules, which however has a conservative majority.
However, according to legal experts cited by the NYT , even if the Texas ruling is upheld, there are several legal options that could continue to allow the drug to be used.
THE RISKY CONSEQUENCES
In addition to jeopardizing access to abortion, already undermined last June by the Supreme Court's ruling which overturned the famous Roe v. Wade in 1973, Kacsmaryk's request creates a dangerous historical precedent because it questions the FDA's authority over drug approval and creates uncertainty for the entire pharmaceutical industry.
It is in fact the first time that a court has ordered the FDA to remove a drug from the market. As Biden stated , “if this ruling is upheld, there will be virtually no prescription, approved by the FDA, that will be safe from this kind of political and ideological attack.”
Although the Texas court states that “the Court does not judge FDA decision-making lightly,” it also adds that “in this case, the FDA has renounced its legitimate safety concerns — in violation of its statutory duty — relying on patently unsubstantiated reasoning and studies that did not support his conclusions.”
THE BATTLE OF THE PHARMACEUTICAL MANUFACTURERS…
Heavy accusations which obviously were opposed by about 400 pharmaceutical executives, including Pfizer CEO Albert Bourla and the heads of Novartis, Biogen and Merck, who write in a letter that "[Kacsmaryk's] decision ignores decades of scientific evidence and of legal precedents".
Major US manufacturers of mifepristone include GenBioPro and Danco Laboratories , and drug chains that distribute these pills include Walgreens Boots Alliance, CVS Health, and Rite Aid.
…AND CLINICS AGAINST THE TEXAS JUDGMENT
More than half of abortions in the United States are performed medically, but if mifepristone becomes illegal, abortion facilities will continue to offer surgical abortions and doctors will still be able to prescribe misoprostol, the second drug administered after mifepristone.
As the Washington Post clarifies, two-stage medical abortion involves first the mifepristone pill, which terminates the pregnancy, and about 24 hours later misoprostol, which softens the cervix and causes contractions that expel the embryo or fetus. However, the latter alone is less effective and usually causes more cramping and bleeding.
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/il-texas-riuscira-a-mettere-al-bando-aborto-farmacologico-negli-stati-uniti/ on Tue, 11 Apr 2023 09:37:30 +0000.