“It is just a nuisance, but it is a problem,” says Gonzales after the Supreme Court ruling on mifepristone
A federal judge in Texas has taken a shocking and irresponsible action: invalidating the Food and Drug Administration’s approval of mifepristone, a medication used safely by hundreds of thousands of women each year to help terminate pregnancies as part of a two-pill regimen. After two decades, the full backing of major professional medical organizations, the court invalidated an agency’s drug approval, which was based upon extensive review of scientific evidence, earning the unanimous support of outside experts.
The Republicans and Democrats made a lot of noise during their speeches 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.
But Texas Republican Rep. Tony Gonzales told CNN’s Bash that his party could use its House majority to punish the FDA if the agency took such a step. “If the administration wants to … not live up to this ruling, then we’re going to have a problem,” he said. “It may come (to) a point where House Republicans on the appropriation side have to defund FDA programs that don’t make sense.”
It could cripple a vital part of the American health care system, and deepen acrimony surrounding the regulatory approval process, when conservatives objected to the Covid-19 vaccine.
Gonzales told Bash that it is important to have real discussions about women’s health care and to stop talking about abortion. “Women have a whole lot more other issues than just abortion. Let’s have those real conversations, and let’s talk about the other things that are happening in this world.”
The resurgence of the debate on abortion may be bad news for Republicans. The decision of the Supreme Court last year to overturn the reproductive health care law motivated Democrats in the elections. According to a CNN/SSRS poll conducted last July, after Roe v. Wade was overturned, nearly two-thirds of Americans disapproved of the decision. Last week, an election in Wisconsin handed control of the state Supreme Court to liberals, and abortion was one of the key issues.
Problems for the approval of future drugs or legal challenges for existing drugs could be created by Kacsmaryk’s ruling. It is another example of a prominent conservative substituting his lack of scientific expertise for that of doctors and rigorous clinical trials. According to the FDA there have been 5 deaths associated with the drug since it was approved for the US in 2000. The risk of death from the use of penicillin is four times greater.
The agency has authority under the Constitution to address threats, but it is challenged by consequential cases. 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, Tuesday, Wednesday, Thursday and Friday. Sometimes the weekends, too. The attorneys in the agency’s large stable of dedicated attorneys defend its actions. There are administrative matters such as the agency moving too fast or slow on a generic drug approval or the agency missing regulatory deadlines.