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Abortion rights supporters gather in front of the J Marvin Jones Federal Building and Courthouse on March 15, 2023 in Amarillo, Texas.

Moises Avila | AFP | Getty Images

A federal judge in Texas on Friday suspended Food and Drug Administration approval for the abortion pill mifepristone statewide but delayed the ruling’s effective date by a week to give the Biden administration time to appeal.

But minutes after the Texas decision was announced, a Washington state federal judge issued an injunction that said essentially the opposite.

The seemingly conflicting rulings of the federal courts in the states of Texas and Washington mean the Supreme Court could ultimately weigh the legality of mifepristone in the US, which was approved by the FDA more than two decades ago in 2000.

When combined with another drug called misoprostol, mifepristone is the most common method of terminating a pregnancy in the United States, accounting for about half of all abortions.

US Judge Matthew Kacsmaryk of the US Northern District of Texas held a key hearing in the case weeks ago in Amarillo, but news of the decision, which could turn access to the key abortion drug, came late in the day Friday when many Americans were away religious observances.

Kacsmaryk supported almost all of the plaintiffs’ arguments in their right to sue, seeking to overturn the FDA’s approval of the drug. He argued that mifepristone had serious safety issues, overriding the FDA’s longstanding finding that the drug was safe and effective.

“The court does not lightly challenge FDA’s decision-making,” Kacsmaryk wrote. “But here the FDA has acknowledged its legitimate safety concerns – in breach of its legal duty – on the basis of patently unsound arguments and studies that did not support its conclusions.”

But in a dramatic twist, US District Judge Thomas Owen Rice for the Eastern District of Washington essentially countered the Texas decision when he barred the FDA from “changing the status quo and rights regarding the availability of mifepristone.” 17 states and DC that have sued to keep the pill on the market there.

Boxes of the drug mifepristone, used to induce a medical abortion, are prepared for patients at the Planned Parenthood Health Center in Birmingham, Alabama March 14, 2022.

Evelyn Hockstein Reuters

US Attorney General Merrick Garland said Kacsmaryk’s Texas ruling “overturns the FDA’s expert judgment, made more than two decades ago, that mifepristone is safe and effective.” Garland said the Justice Department will appeal the Texas ruling and defend the FDA approval.

In response to the Texas ruling, President Joe Biden said in a statement, “My administration will fight this ruling.”

“If this ruling stands, there will be virtually no FDA-approved prescription that would be safe from such political, ideological attack,” the president said.

The case goes to the US 5th Circuit Court of Appeals. If the Biden administration fails to persuade this court to overturn Kacsmaryk’s ruling, access to mifepristone across the United States would be jeopardized

But Washington State’s exclusion can protect access in at least Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, and Washington State direct current

Kacsmaryk’s decision will not affect access to misoprostol, which is widely used as a standalone abortion drug in other parts of the world. Some abortion providers have announced they will use misoprostol as an alternative to two-drug therapy if mifepristone is withdrawn from the market.

how it started

A coalition of anti-abortion doctors called the Alliance for Hippocratic Medicine sued the FDA in November over the approval of mifepristone. The group argued that the FDA abused its authority by fast-tracking mifepristone for new drugs that help patients with serious or life-threatening illnesses more than what is otherwise available on the market.

Kacsmaryk welcomed the group’s claims on Friday, arguing that pregnancy is not a disease and mifepristone offers no significant therapeutic benefit over surgical abortion.

The anti-abortion doctors were represented by attorneys from the Alliance Defending Freedom, an organization that worked with Mississippi lawmakers to draft the law at the center of the women’s health organization Dobbs v. Jackson. This case eventually led to the Supreme Court ruling Roe v. Wade picked up.

Kacsmaryk joined the court in 2019 after being appointed by former President Donald Trump. Kacsmaryk’s nomination was unanimously rejected by Senate Democrats and Maine Republican Susan Collins, who supports abortion rights.

His nomination was also rejected by abortion and LGBTQ rights organizations such as Planned Parenthood and the Human Rights Campaign.

The FDA called the case “extraordinary and unprecedented” in its January response to the lawsuit. Lawyers for the agency said they could not find any previous example of a court guessing after the fact of an FDA decision approving a drug.

The agency also said mifepristone was not approved through an accelerated route. It took more than four years from the initial application to the approval of the pill.

The FDA has approved mifepristone as a safe and effective method of terminating an early pregnancy based on extensive scientific evidence, the agency’s attorneys wrote. Decades of experience from thousands of women have confirmed that drug therapy is the safest option for many patients compared to surgical abortion or childbirth, the lawyers argued.

The FDA warned that withdrawing mifepristone from the US market would put women’s health at risk if they don’t have access to the pill to safely terminate pregnancies. It would also weaken the FDA’s powers for federal drug approvals and hamper drug development by creating regulatory uncertainty in the marketplace, government lawyers said.

“If long-standing FDA drug approvals were so easily waived decades after they were granted, pharmaceutical companies could not confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure Americans depend on to treat a variety of health conditions,” he said the attorneys for the Biden administration wrote.

Mifepristone has been under FDA restrictions since its approval in 2000 to monitor the pill’s safety and effectiveness. These restrictions have been criticized and challenged by medical organizations such as the American College of Obstetricians and Gynecologists, and more recently by attorneys general in Democratic-ruled states.

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The FDA has gradually relaxed restrictions on mifepristone over the years as more and more evidence has been received. The agency dropped previous regulations that required in-person visits to healthcare professionals and allowed the pill to be delivered through the mail. The FDA recently allowed certified retail pharmacies to dispense mifepristone if the patient has a prescription from a healthcare provider approved under the agency’s surveillance program.

Misoprostol, the drug used with mifepristone, is recommended by the World Health Organization as a standalone method of abortion. But the FDA hasn’t approved misoprostol as the sole abortion drug.

The American College of Obstetricians and Gynecologists recommends misoprostol as an alternative for early abortions when mifepristone is unavailable, although it’s not as effective as the two-drug regimen, according to the organization.

Research at Biogen

Source: Biogenic

New research from Eisai shows that Alzheimer’s patients taking Leqembi retain the benefits of the treatment even after they stop taking it.

The Japanese drugmaker and its partner Biogen last week released an additional analysis of clinical trials of the monoclonal antibody drug, also known as lecanemab. Alzheimer’s disease progressed more slowly in patients taking Leqembi, even after they had stopped treatment for an average of two years, the analysis found.

The results come as drugmakers await a decision on full approval of Leqembi. The Food and Drug Administration accelerated approval of the treatment in January and is scheduled to make its final decision on July 6. The findings also come as Eisai and Biogen try to regain a foothold after last year’s polarizing approval and disastrous launch of its other therapy for Alzheimer’s disease, Aduhelm.

About 6.7 million Americans age 65 and older are living with Alzheimer’s, according to the Alzheimer’s Association. This group is projected to grow to nearly 13 million by 2050.

One in three seniors will die of Alzheimer’s or another form of dementia, which kills more people than breast cancer and prostate cancer combined, the association said. The neurodegenerative disease begins with mild memory loss but eventually affects a person’s ability to think and perform day-to-day activities.

There is a wealth of research on Alzheimer’s, but treating it is notoriously difficult. Several drugs targeting the disease have failed in trials. The sheer cost and length of this research further hampers drug development. And in recent years, scientists have sparked a debate about the true cause of the disease and the goal of the drugs.

In the analysis, Alzheimer’s patients stopped taking Leqembi after 18 months in a phase II clinical trial and later resumed treatment in an extension study. Patients stopped Leqembi for a gap period of nine to 59 months before restarting it.

The analysis compared these patients to a group receiving a placebo.

Leqembi reduced amyloid plaques in patients at 12 and 18 months during the clinical trial, the analysis said. Amyloid is a protein that accumulates in the brains of Alzheimer’s patients and disrupts cell function.

The analysis said the reduction in amyloid plaques was accompanied by a “consequent reduction in clinical regression” compared to patients receiving the placebo. This means that Alzheimer’s disease progressed more slowly in patients who received Leqembi than in those who took placebo during the clinical trial.

According to the analysis, the difference in disease progression rate between the Leqembi and placebo groups remained the same throughout the gap between treatments. In other words, the disease progressed more slowly in patients taking Leqembi than in the placebo group, even during the time they were not taking the drug.

“The benefit that was obtained from the treatment continued,” said Dr. David Russell, director of clinical research at the Institute for Neurodegenerative Diseases, told CNBC.

“The disease has been put on hold for a period of time,” he added. “People have another year before they reach a more moderate stage of the disease compared to people who have not received treatment.”

The research institute is involved in clinical trials for Leqembi and other investigational Alzheimer’s drugs, including Eli Lilly’s donanemab and Genentech and AC Immune’s semorinemab.

Patients taking Leqembi also maintained low amyloid plaque levels during the gap period, the analysis found. The protein replenished only slightly after patients stopped taking the drug, with an average increase of about six centiloids. A centiloid is a unit used to measure amyloid in the brain.

This aligns with previous research from the National Institutes of Health showing that amyloid gradually builds up in the brain.

“It takes many decades for enough plaque to build up to damage the brain,” Russell said.

Other biomarkers of Alzheimer’s disease are still deteriorating

Alzheimer’s drug Leqembi can be seen in this undated handout picture obtained by Reuters on January 20, 2023.

Eisai | via Reuters

However, Russell emphasized that lower amyloid plaque levels in people taking Leqembi does not mean that the disease has stopped progressing. Leqembi and other Alzheimer’s drugs have shown an ability to slow cognitive decline, not stop the disease entirely.

“You don’t have to bring the plaque back to the level you had before treatment to start disease progression,” Russell said.

dr Lynn Kramer, Eisai’s chief clinical officer for Alzheimer’s and brain health, added that “plaque is just one component of the whole story and disease process.”

Blood tests in the analysis showed that other biomarkers of Alzheimer’s disease worsened when treatment was stopped, Kramer noted. For example, another protein called p-tau181 accumulated in the brain, a trend linked to cognitive decline.

“These biomarkers are indicative of ongoing brain injury and dysfunction,” Kramer said.

“Our data show that if you stop therapy after plaque removal, everyone will experience cognitive decline and biomarker disruption [monoclonal antibody] unless therapy continues,” he added.

Specifically, the analysis found that these disease biomarkers improved after patients resumed Leqembi during the extension study. Amyloid plaque also began to decrease just three months after restarting the drug.

These improvements were associated with a “greater slowdown” in cognitive decline after restarting treatment, the analysis said.

Brad Little, Governor of Idaho speaks on Day 2 of the CPAC (Conservative Political Action Conference) Conference in Washington, DC at the Gaylord National Harbor Resort & Convention.

Lev Radin | Light Rocket | Getty Images

Republican Idaho Gov. Brad Little has signed legislation prohibiting adults from helping a minor cross state lines to obtain an abortion without parental consent.

Under the law, any adult who helps a minor obtain an abortion pill or surgical procedure in Idaho or across state lines is “human trafficking,” punishable by up to five years in prison.

Abortion remains legal in Idaho’s neighboring states such as Washington, Oregon, Nevada and Montana.

The Idaho law, signed into law Wednesday, is the first to restrict interstate travel for an abortion since the Supreme Court’s Roe v. Wade lifted last June. The decision returned control of the procedure to the federal states.

Reproductive rights activists immediately condemned the law as a threat to the safety of young people.

“We have a responsibility to protect young people, and this law only puts them at risk,” Mini Timmaraju, president of NARAL Pro-Choice America, said in a statement.

“This is a clear and dangerous escalation in the push by anti-choice extremists to block all abortion treatment in every state, and our families will continue to suffer the consequences. Our children deserve better,” said Timmaraju.

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Idaho already has some of the toughest abortion laws in the United States. The state has outlawed performing an abortion as a crime punishable by up to five years in prison. Idaho law allows a doctor to perform an abortion if the person’s life is in danger or if they have been the victim of rape or incest.

But the doctor must present a “preponderance of evidence” that the abortion under the ban’s limited exceptions was necessary to avoid prosecution. In the case of rape or incest, the woman must provide the doctor with a police report.

After Roe’s ouster, one of the few options left for women and girls living in states with abortion bans is to cross state lines to places where the procedure is legal. But Idaho law would largely bar even that underage access, potentially putting children at risk in crisis situations.

In June, a 10-year-old girl who became pregnant after being raped by a 27-year-old man crossed the state lines from Ohio to Indiana to receive an abortion after her home state banned the procedure after six weeks. Gerson Fuentes was charged with double rape in July and allegedly confessed to sexually abusing the girl.

Indiana Republican Attorney General Todd Rokita asked the state medical licensing board to discipline the doctor who performed the abortion, claiming that they failed to report the girl’s abuse to authorities. The doctor, dr. Caitlin Bernard said she had complied with all reporting requirements.

In July, President Joe Biden condemned laws that force victims of sexual assault to cross state lines to obtain abortions as “horror.”

“A 10-year-old should be forced to give birth to a rapist’s child? I can’t think of anything more extreme,” said the President.