Appeals court can rule on the issue at any time
Medical Associations and the Courts of First and Fourth Circuits: A Reply to the High Court’s Critique of Abortion in the United States
Pharmaceutical executives this week also signed a letter that condemned the Texas ruling and warned that FDA approval of other drugs could be at risk if U.S. District Judge Matthew Kacsmaryk’s decision stands. There is no precedent for a judge to overturn the medical recommendations of the FDA.
“Here, the associations’ members have standing because they allege adverse events from chemical abortion drugs can overwhelm the medical system and place enormous pressure and stress on doctors during emergencies and complications,” he wrote.
The American Medical Association is one organization that recommends that courts not allow access to the drug.
It was part of the 5th Circuit order to analyze procedural issues in bringing a case. The appeals court sympathized with a lot of the claims that the drug safety has been questioned by leading medical associations.
“These questions of whether the plaintiffs have the kind of real-world injury that is necessary to get into court, and whether their claim was timely or filed too late apply across the board in federal lawsuits,” said Supreme Court litigator Andrew Pincus.
He said that there were serious questions on whether the Supreme Court would endorse the district court’s approach to those questions.
Some of the members of the high court could see this case as less about abortion, and more about the authority of a federal agency to assess public health and the regulatory landscape in general.
“The current conservative majority has generally been very skeptical of how much authority various agencies exercise,” said CNN Supreme Court analyst Steve Vladeck who is a professor at the University of Texas School of Law. Agency authority is predicated on long settled technical and scientific expertise and has been one place where they have been less skeptical.
In a statement released Monday, the companies made it clear that they rely on the FDA’s authority to bring new medicines to patients. The risk of discovering and developing new medicines is inherently risky and there is likely to be less incentive for investment if regulatory uncertainty is added.
Justice Department and Legal Challengers Revisited Kacsmaryk’s ruling on Mifepristone in the Emergency Mediation Case
The Constitution doesn’t prohibit the citizens of each State from regulating or prohibiting abortion, according to Justice Samuel Alito who wrote for the majority. Roe and Casey arrogated that authority. We have reverted the authority of those decisions to the people and their elected representatives.
The word “unborn human” was chosen by Kacsmaryk. He uses the term “chemical abortion” to refer to medication abortion.
At other times his language is graphic. In his book, Kacsmaryk writes that Mifepistone ends nutrition, and starves the unborn human until death.
She wrote that the health of real people, who are mothers, sisters, daughters, wives and friends, is at risk because of restricted access to safe therapeutic.
A judge cites a study about women who have abortions who feel “shame, regret, anxiety and depression” without mentioning other studies showing the opposite.
For that reason, even some conservatives criticized the decision. My colleague Adam Liptak wrote that the legal scholars he interviewed described Kacsmaryk’s decision as being of “poor quality” and “breathtaking sweep.”
In that decision, also issued Friday shortly after Kacsmaryk released his ruling, U.S. District Judge Thomas O. Rice said the FDA was prohibited from “altering the status quo and rights as it relates to the availability of Mifepristone.”
But the court only partially granted the request by the Justice Department and the drug’s manufacturer to put US District Judge Matthew Kacsmaryk’s ruling on hold, with the panel effectively making the drug harder to obtain.
Mifepristone has been approved by the FDA for terminating pregnancies for nearly 23 years. Leading medical associations have rebuked the claims by the approval’s legal challengers and by the judge that the drug is unsafe.
The Justice Department filing pushed back on the assertions by the challengers, made in their filing overnight in the emergency dispute, that the 5th Circuit did not have the authority to hear the appeal of Kacsmaryk’s ruling. The Justice Department expressed their displeasure with Kacsmaryk for relying on anonymous blog posts to state that Mifepristone is unsafe.
New York City will be able to buy Misoprostol off-label for an abortion without a mifepristone
Misoprostol can be used off-label for an abortion, without mifepristone, but patients often have to use more of it. It would not be covered by the court case, and if Kacsmaryk’s decision stands, the New York City’s Health Department tweeted, it will change to using this medication only.
The New York Gov. Kathy Hochul announced on Tuesday that her state would purchase 150,000 of the drugs used in abortions.
Anti-choice extremists are not stopping at undoing the law of Roe and they are going to destroy the reproductive health care system in this country, Hochul said. I am taking action to protect abortion access in our state and I will continue to lead the nation in defending the right to reproductive autonomy.
The terms of the purchase agreement between California and the Reproductive Freedom Alliance were shared by other members of the coalition who are also interested in protecting reproductive rights.
The state Department ofCorrections, which has a pharmacy license and is able to buy medications, was ordered to purchase the drug by Inslee and it was delivered on March 31. The University of Washington also bought lots of vaccine.
There is a threat to patients and providers across the country due to the Texas lawsuit. Washington will not be passive and risk the devastating consequences of not taking action. “Washington is a pro-choice state, and no Texas judge will order us otherwise.”
A New Rulemaking Proposal from the Biden Administration in Response to a Supreme Court Decision to Suspend the Approval of Mifepristone
The university purchased enough pills to cover the Commonwealth for about a year according to the governor’s office. The government has agreed to set aside $1 million for the vaccines, and local health care providers have agreed to buy more.
Danco Laboratories, the manufacturer of the brand-name version of mifepristone, says that orders for the drug have increased substantially in recent months and are significantly higher than they were at this time last year.
Oregon Gov. Tina Kotek’s office said in an email Wednesday that she has directed the Oregon Health Authority to “explore all available avenues for ensuring Oregon is prepared should Mifepristone become less available. That includes evaluating the supply of Mifepristone and Misoprostol and consulting with providers to better understand the potential impact on the provision of abortion and reproductive health care and what additional support might be necessary.”
A new rule will be proposed by the US Department of Health and Human Services, in an effort to protect the privacy of people who seek abortions.
The new rule proposal comes as Vice President Kamala Harris is set to convene an interagency taskforce meeting on reproductive rights at the White House. The Attorney General and the Health and Human Services Secretary will be in attendance.
In a call with reporters, senior administration officials previewed the notice of proposed rulemaking from the Biden administration, issued in response to a Texas federal judge’s ruling late last week to suspend the US Food and Drug Administration’s approval of medication abortion drug mifepristone.
The senior administration official called it a “step further” from existing guidance issued in the wake of the US Supreme Court’s ruling last summer that overturned Roe v. Wade and ended the right to an abortion nationwide. It is not required for the disclosure of patient information under certain circumstances according to the current guidance. Officials said some providers were still afraid of complying with the guidance when subpoenaed.
This proposed rule, they said, providers further cover “to not provide that information, if it’s not for the specific purpose articulated in the role.”
The US Department of Education is also issuing guidance to remind over 20,000 school officials of their obligations to student privacy, according to a statement from the White House, among other new administration efforts.
Administration officials had been preparing for the Texas ruling to come down, so they went out and worked through a response. A senior administration official said the White House immediately started reaching out to allies after the decision was dropped.
“We’ve had very close contact with the Hill with members both in the House and the Senate, and staff, with groups who are focused on abortion, women’s groups, health care providers,” a second senior official told CNN. We have been in constant contact with our allies on the state level. And we will continue to do all of that.”
The administration is dedicated to protecting reproductive rights in the midst of a health care crisis, something the vice president will highlight.
The administration responded to the issue of abortion rights. Since the Supreme Court overturned Roe v. Wade, she has hosted dozens of roundtable discussions about reproductive rights, including access to contraception and medication abortion, while meeting with state legislators across the country.
The lawsuit against the FDA over COVID-19 and the reversal of the 5th Circuit theta_5 ruling in Mifepristone
It is not known if the Justice Department or drug company Danco will ask the Supreme Court to intervene. Earlier this week, the DOJ indicated it would turn to the high court if the 5th Circuit did not act by noon CT on Thursday.
The Alliance Defending Freedom was involved in the Mississippi case that led to the reversal of the Wade decision. At the core of the lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.
The judges that handed down the order were Catharina Haynes, George W. Bush nominee and Kurt Engelhardt, Donald Trump nominee. Haynes, however, did not sign on to some aspects of the order.
Mifepristone can be used to end pregnancies after seven weeks. The agency expanded that to 10 weeks and loosened some other safety restrictions in 2016, then approved a generic version in 2019. Amid the COVID-19 pandemic in 2021, the FDA allowed the drug, which is available only by prescription, to be obtained by mail.
In 2016, the FDA loosened some of its earlier provisions, allowing patients to take the drug up until 10 weeks of pregnancy rather than seven, reducing requirements for an in-person visit with a doctor from three to one, and allowing clinicians other than physicians to prescribe and administer it. The FDA announced it would be able to temporarily allow the distribution of mifepristone in the mail or a mail order pharmacy during the Pandemic of 2021. In January, the FDA lifted the in-person dispensing requirement entirely. But the circuit court decision winds the clock back to the rules that existed in the year 2000.
In the past 23 years,millions of women have used Mifepristone and its low risk of serious side effects have been noted by medical groups.
The Ninth Circuit Circuit Circuit Court of Appeals erratum on a motion seeking a new mifepristone prescription drug
It’s not clear how the decision will affect a case in Washington state and others where attorneys general are seeking to preserve access to the pills.
The Justice Department also filed a motion Monday asking Rice to clarify the meaning of his ruling, given there appears to be “tension” with Kacsmaryk’s nationwide injunction.
The Justice Department wants the Supreme Court to allow limited access to the drug in the Texas case.
He stayed his injunction for seven days to allow the appeals court to make a decision. The Fifth Circuit Court of Appeals was asked to consider the FDA’s request by midday Thursday.
Late Wednesday night, just before midnight Eastern Time, the appellate panel issued a complicated ruling on the injunction, siding in part with the FDA and part with the anti-abortion coalition.
It would allow the FDA’s original approval of mifepristone to stand even though the statute of limitations had passed, the panel said.