The mifepristone case before the Supreme Court: Amicus briefs asking the court to hear it again or it refuses to hear the appeal
The Fifth Circuit’s ruling could be final soon and it is certain to be appealed back to the Supreme Court. Under the emergency stay issued last month, mifepristone will continue to be available until the Supreme Court rules again or it refuses to hear the appeal.
The case has drawn national attention. Many groups, including pharmaceutical companies, sexual assault survivors, local governments, legal scholars, and lawmakers, have filed amicus briefs, asking the court to either side in the case.
In their appeal, lawyers representing Danco wrote that Kacsmaryk’s decision was “an unprecedented judicial assault on a careful regulatory process that has served the public for decades.”
The lawsuit was originally filed in the Northern District of Texas, a venue that guaranteed it would be heard by Kacsmaryk, a Trump appointee who was a vocal abortion opponent before becoming a federal judge. He gave money to the Senate campaign of Josh’s husband. (Sen. Josh Hawley is a Republican representing Missouri.)
“You think the mail issue is not a dramatic change? Going from seven to ten weeks isn’t a dramatic change, do you think? Isn’t going from 3 visits to just one without a doctor a big deal? Ho asked the Danco lawyer a question. “We can’t deny this is a big-stakes issue.”
Source: https://www.npr.org/sections/health-shots/2023/05/17/1176763079/mifepristone-hearing-federal-appeals-court
Interfering doctors, the public, and the FDA: Why did the FDA let mifepristone go without asking a doctor?
Generally, a six-year statute of limitations applies to agency actions. The FDA’s later decisions to expand access to the drug have been argued to restart the clock and reopen the door to challenge the approval.
Only two of the cases described in the doctors’ declarations “might show” instances in which the use of mifepristone had followed the FDA-approved regimen, argued Jessica Ellsworth, a lawyer representing Danco. She said that the cases took place in Texas and Indiana, two states with legislation banning abortion.
Fewer than 1% of patients who use mifepristone require a visit to the emergency room, a lawyer for the federal government said. The higher emergency room care rate was needed by women who had used the medicines, according to Hawley.
“Even if they alleged one patient that they actually cared for at some time in the past, we now live in a world where the availability of abortion in Texas and Indiana is quite different from when it was prior to Dobbs,” Ellsworth said.
Ending a fetus’s life with medication is unsafe, as claimed by a lawyer for the plaintiffs, who used an anti- abortion term.
Lawyers for Danco Laboratories argued that a group who brought the lawsuit did not have the right to do so.
The federal government believes that the FDA acted appropriately and within their authority when they did not like the results of a clinical trial.
On Wednesday, a three-judge panel in New Orleans questioned lawyers associated with the federal government, the manufacturer of medication used for contraception, and the individuals who oppose abortion. All three judges were appointed by Republicans: Circuit Judges James Ho and Cory Wilson were tapped by Donald Trump, while Circuit Judge Jennifer Walker Elrod was appointed by George W. Bush.
The appeals court had received friend-of-the-court briefs from women who said that if you don’t give them the pill by mail, they will never get away.
Judge Wilson did not think he was right. “It just strikes me,” he said, “that what the F.D.A. has done in making this more available and doing it by mail order and removing the doctor visits as well as the requirement that the prescriber be a doctor is you’ve made it much more likely that patients are going to go to emergency care or a medical clinic where one of these doctors is a member. I don’t see how you square that circle.”
Judge Wilson asked Ms. Harrington: “You’re not disputing the idea that in the future because of the F.D.A.’s actions, more women will turn up in emergency rooms needing emergency care?”