The U.S. appeals court still gives partial access to the abortion pill

The U.S. Food and Drug Administration Cannot Continue to Approval Medication Abortion: A Second Circuit Circuit Court Decision Begins at 9:00 AM ET

A federal appeals court late Wednesday night froze parts of a Texas judge’s order that would have suspended the US Food and Drug Administration’s approval of a medication abortion drug.

Kacsmaryk had issued a broad ruling last week that stopped the FDA from approving the drug in 2000, as well as changes the FDA made in subsequent years to make it more accessible.

The FDA loosened some provisions in the year 2016 in order to allow patients to take the drug up until 10 weeks of pregnancy, reduce requirements for in-person visit, and allow clinicians other than physicians to prescribe and administer it. Then in 2021, during the pandemic, the FDA announced that it would use its “enforcement discretion” to temporarily allow mifepristone to be dispensed through the mail or a mail-order pharmacy. In January, the FDA lifted the in-person dispensing requirement entirely. The rules that were in place in 2000 are no longer valid after the circuit court decision.

Medication abortion, which makes up the majority of abortions obtained in the United States, has emerged a particularly heated flashpoint in the abortion legal battle since the Supreme Court last year overturned Roe v. Wade precedent that protected abortion rights nationally.

Danco, a manufacturer of the drug, also asked the justices to step in on an emergency basis before Friday, with an attorney for the company saying in its filing that leaving the lower court opinion in play will “irreparably harm Danco, which will be unable to both conduct its business nationwide and comply with its legal obligations under the FDCA nationwide.”

The judges who handed the order down were Circuit Judges for both George W. Bush and Donald Trump. Haynes, however, did not sign on to some aspects of the order.

The judge states that she would have given the expedited appeal and issued an administrative stay on the ruling, but would have put it on hold for a short period of time.

A U.S. Appeals Court ruling against the FDA’s 2003 decision to ban the use of mifepristone, an opioid-based oral tablet

The plaintiffs argued that the FDA based its original decision on “transparently false conclusions” about the drug’s benefits and risks. Then, they contend that the FDA “failed to satisfy … When it expanded access to the drug, it had rigorous scientific standards.

“Even though this softens the blow of Judge Kacsmaryk’s ruling, it is just as problematic and concerning,” says David Cohen, a professor of law at Drexel University, referring to the restrictions that the appeals court placed on the pill. He believes that the courts are still trying to influence how an approved drug can be used. It is a lawless opinion without respect for the authority of the FDA.

Over the past 23 years, millions of women have been prescribed mifepri stone, and the medication has not been found to cause problems like wisdom teeth removal or colonoscopies.

It’s unclear how the latest decision will interact with a ruling in a separate federal case in Washington state, filed by attorneys general from 17 states and the District of Columbia who are seeking to preserve access to the pills.

Washington state Attorney General Bob Ferguson, one of the leaders of that effort, told NPR he believes it will preserve access to mifepristone for people in those 17 states and D.C., unless a higher court says otherwise.

The Justice Department filed a motion Monday asking Rice to clarify the meaning of his ruling, given there is tension with Kacsmaryk’s nationwide injunction.

Why do so many pharmaceutical companies want to stay in the US? An open letter against the decision by the U.S. Supreme Court on a case against misoprostol

There are back-up plans in place if a drug is unavailable. Medication abortions typically consist of two pills: mifepristone and misoprostol. Mifepristone works by blocking the hormone progesterone, which is necessary for pregnancies to continue. Mifepristone is actually an abortion pill that stimulates the uterus to expel fetal tissue. And as misoprostol is not subject to the recent rulings, there is a possibility that these companies will begin offering misoprostol on its own if manufacturers cut off access to mifepristone. This is not ideal, as the combination of pills produces the best results; misoprostol on its own can cause additional cramping and nausea. But for providers determined to keep helping patients, it’s better than nothing.

The Justice Department wants the Supreme Court to block a federal appeals court decision that limits access to an abortion drug.

Vice President Kamala Harris criticized the Fifth Circuit’s decision on Tuesday. She said the agency’s medical experts were second-guessed. “If this decision stands, no medication — from chemotherapy drugs, to asthma medicine, to blood pressure pills, to insulin — would be safe from attacks.”

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.

Both U.S. based providers and overseas sellers of pill-by-mail say that they still want to stay in the US after conflicting legal rulings caused a lot of uncertainty about the future.

These companies have been preparing for increased restrictions, and are now moving quickly to ensure they’re still able to legally operate without pause. Hey Jane and a few other places are now offering pills in mail in the states where they were previously located.

There was an open letter from more than 500 pharmaceutical executives and researchers which said that a decision to side with the conservative groups would result in “unsurety for the entire biopharma industry.” Among the signatories were Dr. Albert Bourla, the CEO of Pfizer, and executives from industry giants Bayer and Merck.

As the lawsuit was being considered in the lower court, the industry representatives had largely stayed away, declining to file amicus briefs detailing the industry’s fears even as the American Medical Association weighed in.

“Defendants have not shown that plaintiffs are unlikely to succeed on the merits of their timely challenges,” the three-judge panel wrote. The injunction is due to take effect this weekend, unless the Supreme Court intervenes.

He said in an interview that industry members are wondering, “what else can’t a judge do?” after the appeals court ruled in his favor.

The FDA’s first regulatory review: What does it take to prevent a drug from being approved for human use? A former law professor at the Georgia State University Law Professor Allison Whelan

It is time-Consuming to bring new drugs to market. To research and develop a new medical product can cost hundreds of millions of dollars and years of clinical trials.

Add to this the risk of litigation and the chance that an FDA approval could be revoked in part or in whole at any time by a judge and the risk of financial loss to invest in drugs that could be seen as politically controversial, like gender- equality, and it’s not worth the

Allison Whelan is a law professor at Georgia State University. She said it was not for safety and efficacy reasons, but for other reasons, that this was about stopping vaccines you disagree with.

Outside the courts there are concerns that the litigation could undermine the authority of the agency. There is skepticism about the claim that the FDAacted appropriately on the drug.

Beyond their public statements, Harvard’s Sarpatwari said he expected the pharmaceutical industry to be aggressive in lobbying Congress and taking other measures to preserve the FDA approval process. “I think that all cards are on the table in terms of what industry may do,” he said.

Joshua Sharfstein is a former deputy commissioner of the FDA who is now a vice dean at the Bloomberg School. This had the full support of the advisory committees. It had the full backing of major professional associations, and after millions of women received the treatment, it retained that support.

The drug was then approved in China, the United Kingdom and Sweden in the late 1980s and early 1990s. Then in 1999, nearly a dozen more countries approved mifepristone.

In July 1996, the FDA convened an advisory committee of outside experts to evaluate the drug. The advisers voted that the drug was safe but requested more data from the ongoing U.S. study, because it was different from the French health system.

The part used in the approval allowed the agency to add more safety restrictions, such as requiring that physicians providing the pill be able to diagnose ectopic pregnancies.

Henry Waxman said at the time there were people who wanted the drug to be removed from the market. “In fact, they didn’t want it to be approved. I don’t mind that they are against abortion by any means, whether it be through a medical procedure or by using the abortion pill RU-486. But that is not the issue of safety and it is not an issue of science and it is not an issue of data.”

Appeal of the Texas District Court’s Order Limiting the Use of the Drug ePharma to Prevent Abortion in the United States

The government requested an immediate administrative stay to preserve the status quo, while the court considers the request. The portions of the Texas district court’s order that limits the drug would take effect on Saturday at 1:00 a.m.

The Food and Drug Administration gave approval to the drug in 2000, which was the reason why anti-abortion groups sued in Texas.

The final ruling from the appellate panel led the DOJ to appeal even higher to the Supreme Court in hopes of ensuring access to the drug is fully restored.

Supreme Court Justice Samuel Alito gave the justices more time to consider the issue as he extended a hold on the lower court ruling that would have imposed restrictions on access to abortion drugs.

“The lack of emergency relief from this Court will also harm women, the healthcare system, the pharmaceutical industry, States’ sovereignty interests, and the separation-of-powers,” the attonrey, Jessica L. Ellsworth, told the justices.

The appeals court ordered a return to the stricter, pre-2016 FDA regime around the drug, which prevents mailing the pill to patients who obtained it through telehealth, or virtual visits with their providers rather than traveling to a clinic or hospital to obtain the drug in person.

The Supreme Court has given all parties until noon on April 18 to reply to the Department of Justice’s appeal of the Fifth Circuit decision.

On Thursday, April 13, US Attorney General Merrick Garland said the Justice Department sought “emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.” The Supreme Court received the appeal from the department Friday morning.