The New Order in the U.S. Supreme Court Revival of the Medical Approval of the Abortion Pill and Its Consequences for Medicine Discovery and Development

A split 5th Circuit panel said in its new order that it was reinstating the approval of the drug because of certain procedural obstacles the plaintiffs face in challenging it. The abortion pill’s defenders did not show that they were going to be successful in the case, according to the appeals court.

He wrote that the associations’ members have standing because they alleged that adverse events from abortion drugs could overwhelm the medical system and place enormous pressure on doctors during emergencies.

“Vague speculation that someday, somewhere, some unspecified doctor will be overwhelmed by an onslaught of patients coming into the ER after taking mifepristone does not establish that these particular doctors face an imminent risk of a concrete and particularized harm,” Adam Unikowsky, a lawyer and former clerk of conservative Justice Antonin Scalia, wrote in his newsletter.

“The vice president will also point out that this unprecedented decision is not only an attack on women’s freedom to make decisions about her own body, but it also threatens our nation’s system of drug approvals and the rights of Americans across the country who expect that a medication approved by the FDA and prescribed by their doctor will be available to them when they need it,” the official continued.

Andrew Pincus told the Supreme Court that there are some questions that need to be answered about the kind of real-world injury that is needed for a case to go to court.

“There are serious questions on whether the Supreme Court is willing to endorse the district’s court’s very broad approach to those questions,” he said.

The case might be more about the authority of a federal agency to assess public health than it is about abortion.

“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. “The one place where they have been less skeptical though, has been an agency’s authority, which is predicated on long settled and well developed technical and scientific expertise” he added.

The companies stated that they rely on the FDA’s authority to bring new medicines to patients under a reliable regulatory process. “Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry,” they said.

Justice Department Benchmark on Alito’s Decision to revoke the FDA’s approval of mifepristone: A Commentary by Jeffrey Kacsmaryk

Justice Samuel Alito announced that the Constitution doesn’t prohibit citizens of each State from regulating abortion. They arrogated that authority. The authority to make those decisions is back to the elected representatives of the people.

Kacsmaryk chooses, instead, to use the word “unborn human.” He also referred to it as “chemical abortion”, which is favored by opponents of abortion rights.

At other times his language is graphic. In his article, he writes that it starves the unborn human until death and that ithalts nutrition.

She wrote that the health of people who are mothers, sister, daughters, wives and friends is at risk because of restricted access to this safe therapeutic.

A study about the experience of women who have had abortions felt shame, regret, anxiety, and depression, without mentioning other studies holding the opposite.

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.”

A panel of three judges narrowed the decision of a lower court judge in Texas that blocked the FDA’s approval of the drug following the lawsuit by its opponents.

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.

Last Friday, Kacsmaryk issued a ruling that would have halted the FDA’s 23-year-old approval of the drug, mifepristone. Under the appeals court’s new order, the approval will stay in effect and the drug will remain on the market while an expedited appeal plays out.

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. Kacsmaryk and the challengers were rebuked by the Justice Department for relying on anonymous posts to claim that it’s unsafe.

Mifepristone and the New York Department of Health: It’s a bad place to get an abortion, but it’s bad for the U.S.

Mifepristone was approved by the FDA in 2000 and is used in combination with another drug in nearly all medication abortions in the United States. Mifepristone was initially approved for medication abortion through seven weeks of pregnancy, but in 2016, the FDA expanded that to 10 weeks.

The New York Gov. announced that the Department of Health would buy a certain quantity of medication abortion drugs.

“Anti-choice extremists have shown that they are not stopping at overturning Roe, and they are working to entirely dismantle our country’s reproductive health care system, including medication abortion and contraception,” Hochul said. New York will always be a good place to get an abortion because it is a safe harbor and I am taking action to protect it.

There is a nonpartisan group of 21 governors who are committed to protecting reproductive rights, and who may also be interested in taking such action that California shared with other members of the Reproductive Freedom Alliance.

The Department of Corrections has a pharmacy license and was directed by the state to purchase the drug last month, he said. The University of Washington had purchased a certain number of doses.

“This Texas lawsuit is a clear and present danger to patients and providers all across the country. Washington will not sit by and wait for the right time to act. “Washington is a pro-choice state, and no Texas judge will order us otherwise.”

An Oregon Health Authority Rule Proposed to Protect Privacy in Abortion and Reproductive Health Care: Public Hearing from the Biden Administration on Mifepristone

The governor’s office said last week that the university bought 15,000 of the contraceptives and they will be arriving this week. The government is setting aside $1 million to pay for the doses that health care providers have agreed to buy.

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.”

This NPRM would prohibit the use or disclosure of protected health information by regulated entities, such as health insurance plans, providers and others, if a criminal, civil or administrative investigation is instituted against a person in connection with seeking, acquiring, providing or facilitating.

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 Health and Human Services Secretary will be there as well.

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 said that it is a step further than previous guidance given after the US Supreme Court ruled last year that the right to an abortion was dead in the US. The current guidance, still in effect, protects HIPAA privacy rights by not requiring the disclosure of patient information under certain circumstances. Some providers would be worried about complying with subpoenas, even though officials found that they would still get fearful.

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.

Those rulings prompted a fresh scramble from administration officials, who had been bracing for the Texas ruling to come down, and officials convening behind closed doors to work through a response. After the decision dropped Friday, a senior administration official said the White House immediately began engaging allies on the next steps.

“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’ve also been in close contact, of course, with allies on the state level, state legislators, attorneys general etc. We will continue to do that.

The administration is committed to protecting reproductive rights in the midst of a health care crisis, according to a third senior administration official.

Harris was leading the administration’s response to abortion rights. She has hosted dozens of Roundtable discussions about reproductive rights, including access to contraceptives, and met with legislators across the country since the Supreme Court overturned the Wade decision.

Mifepristone, the Drugmaker’s Advocate, and the Courts in the 5th Circuit: When Does the FDA Come to the High Court?

It is not known if the justice department or the drug company 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.

In November, anti-abortion doctors and plaintiffs brought the lawsuit challenging the FDA’s 2000 approval of the drug and targeting how the agency has since changed the rules around its use in ways that have made the pill easier to obtain.

The judges who gave the order were from the Circuit Judges, ie the George W. Bush and Donald Trump nominees. Some aspects of the order were not signed on by Haynes.

Mifepristone was approved to be used to end pregnancies for seven weeks. In 2016 the agency loosened some of the safety restrictions it had put in place in 2015, then approved a generic version in 2019. Mail will be the place to get the drug that is only available by prescription.

But changes made by the FDA since 2016 relaxing the rules for prescribing and dispensing mifepristone would be placed on hold. Those include extending the period of pregnancy when the drug can be used and also allowing it to be dispensed by mail, without any need to visit a doctor’s office.

Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than problems in wisdom teeth removal, colonoscopies and other routine procedures, medical groups have recently noted.

An appellate panel ruling on a federal drug ban from the U.S. Court of Appeals for a nationwide Roe v. Wade injunction

Since it became clear in 2022 that the US Supreme Court would overturn Roe v. Wade, experts have predicted that conflicts would arise between states and the federal agency over which drugs are allowed in which states, and if they can be shipped there by mail—thus  undermining the longstanding agreement that federal regulations should supersede the wishes of individual states.

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 is trying to get some kind of emergency relief from the Supreme Court.

He stayed the injunction for seven days so that the appeals court would have time to consider it. The FDA is waiting for the Fifth Circuit Court of Appeals to rule on its request for an emergency stay.

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.

The panel found that the statute of limitations for a challenge to the FDA’s original approval had likely passed in the past two decades.