The Texas judge ruling could harm the Republicans
The High-Tendering of Scientific Facts: Judge Matthew Kacsmaryk’s decision to suspend Food and Drug Administration approval of the drug mifepristone
US District Judge Matthew Kacsmaryk’s decision to suspend the Food and Drug Administration approval of the drug mifepristone, which has been used safely for more than 20 years, marked an extraordinary use of judicial power in the face of scientific data and is likely to force the Supreme Court to take up abortion again, a year after it overturned Roe v. Wade.
The intensity of the storm Kacsmaryk whipped up was evident in heated rhetoric between Republicans and Democrats on Sunday. Health and Human Services Secretary Xavier Becerra vowed that women would have safe and effective medication available after the administration launched a legal appeal to stop the suspension from going into force on Friday.
Kacsmaryk argued that the FDA had failed to consider psychological effects of the drug or long term medical consequences. Jack Res neck criticized the judge’s disregard for well-established scientific facts and speculative allegations in favor of ideological assertions that will cause harm to patients and undermines the health of the nation. He said that the court had intruded into the exam room by rejecting medical facts, and then intervening in decisions that belonged to patients and physicians.
The regulatory approval process for the Covid-19 vaccine was attacked by conservatives due to skepticism of the vaccine.
“It’s important that we have real discussions on women’s health care and … get off the abortion conversation,” Gonzales told Bash. There are many other issues women have that are more important than abortion. Let’s have those real conversations, and let’s talk about the other things that are happening in this world.”
The decision by Kacsmaryk, a long-time opponent of abortion rights, is the latest occasion where a high-profile member of the conservative movement has launched a daring application of power in a way that Democrats argue trashes legal and democratic convention. Previous examples include the Republican majority’s expulsion of two Black state legislators from the Tennessee state House last week after they joined a gun control protest in the chamber; attempts by some conservative states to curtail voting access; and even Trump’s bid to overturn the 2020 election.
The ruling threatens to create problems for the approval of new drugs or to allow legal challenges for existing drugs. This is another example of a prominent conservative person substituting his own lack of scientific expertise for that of doctors and the rigor of clinical trials. Since its approval in the US in 2000, there have been 5 deaths associated with mifepristone for every 1 million people who used it, according to the FDA. The risk of death from penicillin use is four times greater.
More consequential cases challenge whether the agency has the authority under statutes or the Constitution to address serious threats. For example, the Supreme Court struck down the agency’s initial attempt to regulate the marketing of tobacco products, leading Congress to later pass legislation permitting the agency to move forward. To the chagrin of many public health advocates, an expanding constitutional doctrine of corporate speech has led courts to limit the actions that the F.D.A. can take to protect the public.
There’s a name for the day of the week when the F.D.A. finds itself in court: Monday. Also Thursday, Friday and Tuesday. Sometimes on the weekends as well. The agency’s large stable of dedicated attorneys defends its actions on a multitude of issues. These include routine administrative matters such as whether the agency moved too fast or too slow on a generic drug approval or whether the agency has missed regulatory deadlines.
