Because the pill works faster than other antidepressants and is taken for only two weeks, it may encourage more treatment of the debilitating condition.The Food and Drug Administration on Friday approved the first pill for postpartum depression, a milestone considered likely to increase recognition and treatment of a debilitating condition that afflicts about a half-million women in the United States every year.Clinical trial data show the pill works quickly, beginning to ease depression in as little as three days, significantly faster than general antidepressants, which can take two weeks or longer to have an effect. That — along with the fact that it is taken for just two weeks, not for months — may encourage more patients to accept treatment, maternal mental health experts said.The most significant aspect of the approval may not be the features of the drug, but that it is explicitly designated for postpartum depression. Several doctors and other experts said that while there were other antidepressants that are effective in treating the condition, the availability of one specifically shown to address it could help reduce the stigma of postpartum depression by underscoring that it has biological underpinnings and is not something women should blame themselves for.The hope is that it will encourage more women to seek help and prompt more obstetricians and family doctors to screen for symptoms and suggest counseling or treatment.“This is a patient population that just so often falls through the cracks,” said Dr. Ruta Nunacs, a psychiatrist with the Center for Women’s Mental Health at Massachusetts General Hospital. “When women are told, ‘You have postpartum depression,’ it’s embarrassing, it is demeaning, it makes them feel like a bad mom.”She added, “There’s also a lot of stigma about taking antidepressant medication, so that might make this treatment more appealing because it’s really a treatment specific for postpartum depression.”An estimated 10 to 15 percent of women who give birth in the United States experience depression during pregnancy or in the year afterward. The condition can be accompanied by intense anxiety, shame, guilt, impaired sleep, panic attacks and suicidal thoughts or attempts. And it can make it difficult for mothers to provide their babies with the care, bonding and nurturing that is crucial for healthy development.“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” Dr. Tiffany R. Farchione, the director of the F.D.A. division responsible for the approval, said in a statement.The pill, zuranolone, which will be marketed under the brand name Zurzuvae, was developed by Sage Therapeutics, a Massachusetts company that produces it in partnership with Biogen. It is expected to be available after the Drug Enforcement Administration completes a 90-day review required for drugs affecting the central nervous system, Sage said. The companies have not announced a price for the pill.The only other drug approved for postpartum depression is brexanolone, also developed by Sage and marketed as Zulresso. But brexanolone, approved in 2019, requires a 60-hour intravenous infusion in a hospital, carries risks of loss of consciousness and costs $34,000. Sage says only about 1,000 patients have received it so far.Taking a pill for two weeks is much easier, not requiring a mother to leave her baby for several days. However, the F.D.A. did require the label to include warnings about possible suicidal thoughts and behavior, sleepiness and confusion. The label will also include a so-called “black box warning” that patients should not drive or operate heavy machinery for at least 12 hours after taking the pill. The pill should be taken in the evening “with a fatty meal,” the agency’s announcement said. Doctors said Zurzuvae would not be appropriate for everyone experiencing postpartum depression. For those with mild to moderate depression, talk therapy can work well. Dr. Kimberly Yonkers, chairwoman of the psychiatry department at University of Massachusetts Chan Medical School, said she would probably not recommend Zurzuvae for patients with longstanding recurrent depression or for “somebody who has a severe episode with a suicidal attempt or hospitalization because you don’t give them a treatment for two weeks and then stop it.”Appropriate patients, she said, might include “people who have not had a complete response to another antidepressant.”Dr. Alison Reminick, director of the women’s reproductive mental health program at the University of California, San Diego, said about 10 percent of her patients would be likely candidates. Those would include women experiencing depression for the first time. Such patients are at higher risk of developing bipolar disorder, she said. Although drugs such as Lexapro, Zoloft and other selective serotonin reuptake inhibitors (S.S.R.I.s) work, they can cause mania in those patients, she said.She would also offer Zurzuvae to women whose depression was accompanied by anxiety or insomnia because studies suggest it may ease those symptoms.“I’m a huge fan of S.S.R.I.s,” Dr. Reminick said, but noted that many patients resisted trying medication. “I think this will be much easier to get them to just try this for two weeks.”Data submitted to the F.D.A. came from two company-funded clinical trials involving about 350 patients. A majority of those receiving Zurzuvae (72 percent in one trial, 57 percent in another) clinically responded to the treatment after the two-week course, meaning that their scores on a standard depression scale improved by 50 percent or more.Depression also improved in women receiving the placebo, a common phenomenon in studies of depression treatments, possibly because interacting with medical teams in a trial is itself helpful. But in the group receiving Zurzuvae, the improvement was consistently greater, by several points, beginning three days after starting the medication. Fifteen days after taking the first pill, Zurzuvae patients were significantly more likely to have a low enough depression score to be considered in remission.The effect continued after the patients stopped taking the medicine, throughout the 45 days that they were monitored in the trials. But several maternal mental health experts said longer-term data was needed to determine if patients relapse.The main side effects of Zurzuvae were sleepiness and dizziness. Importantly, the trials found no evidence of increased suicidality or withdrawal symptoms after patients stopped taking the drug.Amy Bingham, 33, of Gibsonville, N.C., received Zurzuvae in a clinical trial in 2018, about six months after giving birth to her son Benjamin.“I did start to feel calmer — I wasn’t having as many days where I was feeling as tearful,” said Ms. Bingham. Eventually, “I felt that I could enjoy my time with my son.”Kate Medley for The New York TimesMs. Bingham, who works from home for a call center, had experienced depression as a teenager, but her postpartum depression symptoms were different, including panic attacks, tears and shortness of breath.“I was very anxious that I would do something wrong, that Ben would get hurt because of a mistake I would make,” she said, “that I wasn’t able to respond to his needs effectively and that because I wasn’t able to, he would be an unhappy baby.”Sometimes, she said, “I would think I was a terrible mother because I couldn’t soothe my own child.”Her depression scores recorded in the trial improved by the third day on the medicine and reached remission levels by Day 15, according to data shared with The New York Times.Under standard procedure in such trials, Ms. Bingham did not know if the pill she took for two weeks was Zurzuvae or placebo. She said: “I didn’t feel a lot of improvement at first. It did take about a month for me to start feeling some of the benefits.”But gradually, she said, “I did start to feel calmer.”“I wasn’t having as many days where I was feeling as tearful,” she continued. Eventually, “I felt that I could enjoy my time with my son.”Zurzuvae contains a synthetic version of a neurosteroid or brain hormone called allopregnanolone, which is produced by progesterone and helps regulate a mood-related neurotransmitter, said Dr. Samantha Meltzer-Brody, director of the Center for Women’s Mood Disorders at the University of North Carolina at Chapel Hill and a lead investigator for the trials of Zurzuvae for postpartum depression.During pregnancy, “levels of estrogen and progesterone rise many-fold and then they fall precipitously at the time of childbirth,” she said. She added that, for genetic or other reasons, women who develop postpartum depression seem especially sensitive to that surge and drop-off, which also lowers allopregnanolone levels.Typically, “increases in allopregnanolone help deal with acute stress,” said Amy VandenBerg, a psychiatric pharmacist at the University of Michigan. Zurzuvae might address postpartum depression by essentially replenishing depleted allopregnanolone and targeting the same neurotransmitters to stabilize mood, she said.Although many cases of maternal depression begin in pregnancy, the pill is not being recommended until after childbirth because it operates on a hormonal pathway and wasn’t tested in pregnant women, Dr. Meltzer-Brody said. The warning label says the drug could cause harm to a fetus.The pill was not tested in women who were breastfeeding their babies. Several doctors said they would inform patients who were considering taking it that there was little data about the drug’s effect on lactating. Some women might be able to pump milk for the two weeks they plan to take Zurzuvae and resume nursing afterward. Some S.S.R.I.s and other antidepressants have been found to be safe for breastfeeding.About 15 to 20 percent of women in the trials continued taking other antidepressants they had been on for a while. Experts said it was possible that for some patients Zurzuvae would be an adjunct medication or would be used as a bridge to longer-term antidepressants.“It’s not the only treatment that’s helpful for postpartum depression, but the innovation and the excitement about this is that it’s specific, designed to target postpartum depression based on potential biological causes,” said Wendy Davis, executive director of Postpartum Support International, a nonprofit that raises awareness and provides resources for those experiencing maternal mental health issues. “It gives the understanding that there is a biological reason for what you’re feeling right now,” she said, adding “It is not your fault.”The fact that there’s a medication prescribed for a mother’s depression might prompt family members to “give recognition to it and increase how much help they give mom,” Dr. Reminick said.“If it gets more people into treatment, that’s wonderful,” Dr. Nunacs said. “If it doesn’t work, they’re connected with providers and we can try other things. So it opens a door for treatment that has been hard to open in the past.”

The price of the pill, which has not been announced, will determine how affordable it will be when it becomes available in early 2024.The Food and Drug Administration on Thursday approved a birth control pill to be sold without a prescription for the first time in the United States, a milestone that could significantly expand access to contraception.The medication, called Opill, will become the most effective birth control method available over the counter — more effective at preventing pregnancy than condoms, spermicides and other nonprescription methods. Experts in reproductive health said its availability could be especially useful for young women, teenagers and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor to obtain a prescription.The pill’s manufacturer, Perrigo Company, based in Dublin, said Opill would most likely become available from stores and online retailers in the United States in early 2024.The company did not say how much the medication would cost — a key question that will help determine how many people will use the pill — but Frédérique Welgryn, Perrigo’s global vice president for women’s health, said in a statement that the company was committed to making the pill “accessible and affordable to women and people of all ages.” Ms. Welgryn has also said the company would have a consumer assistance program to provide the pill at no cost to some women.Since the Supreme Court overturned the national right to an abortion last year, the accessibility of contraception has become an increasingly urgent issue. But long before that, the move to make a nonprescription pill available for all ages had received widespread support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.In a survey last year by the health care research organization KFF, more than three-quarters of women of reproductive age said they favored an over-the-counter pill, primarily because of convenience. Nearly 40 percent said they would be likely to use it. Those most likely to opt for the product included women already taking birth control pills, women without health insurance and Hispanic women, the survey found.And strikingly, at a time of fierce divisions over abortion, many anti-abortion groups have declined to criticize over-the-counter birth control. Opposition appears to come primarily from some Catholic organizations and Students for Life Action.In May, a panel of 17 independent scientific advisers to the F.D.A. — including obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy — voted unanimously that the benefits of making a birth control pill available without a prescription vastly outweighed the risks. The panel cited the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago. The over-the-counter pill will be identical to the prescription version, which is 93 percent effective at preventing pregnancy with typical use. Several panelists said there was a pressing public health need for an over-the-counter option in a country where nearly half of all pregnancies are unintended.“The evidence demonstrates that the benefits clearly exceed the risks,” said one advisory committee member, Kathryn Curtis, a health scientist with the Centers for Disease Control and Prevention’s division of reproductive health. She added: “I think Opill has the potential to have a huge positive public health impact.”For proponents of over-the-counter pills, the main issue is affordability.The Affordable Care Act requires heath insurance plans to pay for prescription contraception, but not over-the-counter methods. Some states have laws mandating coverage of over-the-counter birth control, but most states do not. The KFF survey found that 10 percent of women would not be able or willing to pay any out-of-pocket cost for contraception. About 40 percent would pay $10 or less per month, and about a third would pay $20 or less.Under a recent executive order by President Biden, the federal government could soon take steps toward requiring insurers to cover over-the-counter birth control. And Senate Democrats have reintroduced legislation to require such coverage.“We need to make it affordable and available,” Senator Patty Murray, a Democrat from Washington State and a co-sponsor of the bill, said in an interview in May. “Let’s provide women what they need and make sure it’s affordable so there’s equity, and women who are low-income, women who for whatever reason are struggling don’t have to be forced to not have any birth control simply because they can’t afford it today,” she added.Opill is known as a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the F.D.A. about applying for over-the-counter status.The F.D.A. analysts who evaluated the data Perrigo submitted in its application for a nonprescription Opill had raised concerns about whether women with medical conditions that should preclude them from taking birth control pills — primarily breast cancer and undiagnosed vaginal bleeding — would follow the warnings and avoid the product. The F.D.A. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.Several advisory committee members said patients with breast cancer, the main medical condition that precludes taking hormonal contraception, typically have doctors who would advise them to avoid birth control pills. They also said that Opill might actually be safest for adolescents because they are very unlikely to have breast cancer. And because young people often start off with contraception they can buy over-the-counter, it is especially important for them to have easy access to a method more effective than condoms and other birth control products available in retail stores, the panelists said. Perrigo reported that participants in a study took Opill on 92.5 percent of the days they were supposed to take it. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps, such as abstaining from sex or using a condom, Dr. Stephanie Sober, the company’s U.S. medical liaison, said at the advisory committee hearing. She said that among 955 participants, only six became pregnant while using Opill.Most people who said they had missed doses attributed that to running out of pills before they could get to one of the study’s resupply sites, results that, Dr. Sober said, “illustrate precisely the barriers to adherence that could be lessened” by making the pill available over the counter.

The F.D.A. gave full approval to the drug, but added a black-box warning about safety risks. Medicare said it would cover most of the high cost.The Food and Drug Administration on Thursday gave full approval to the Alzheimer’s drug Leqembi, and Medicare said it would cover much of its high cost, laying the foundation for widespread use of a medication that can modestly slow cognitive decline in the early stages of the disease but also carries significant safety risks.The F.D.A.’s decision marks the first time in two decades that a drug for Alzheimer’s has received full approval, meaning that the agency concluded there is solid evidence of potential benefit. But the agency also added a so-called black-box warning — the most urgent level — on the drug’s label, stating that in rare cases the drug can cause “serious and life-threatening events” and that there have been cases of brain bleeding, “some of which have been fatal.”Leqembi cannot repair cognitive damage, reverse the course of the disease or stop it from getting worse. But data from a large clinical trial suggests that the drug — administered every two weeks as an intravenous infusion — may slow decline by about five months over about 18 months for people with mild symptoms.Still, some Alzheimer’s experts have said it is unclear from the medical evidence whether Leqembi’s ability to delay erosion of memory and cognition would be enough to be noticeable or meaningful for patients and their families. And while most cases of brain swelling and bleeding have been mild or moderate and have resolved, there have been some serious cases.“The risks are very vivid,” said Dr. Jason Karlawish, a co-director of the University of Pennsylvania’s Penn Memory Center, who said he will prescribe Leqembi after carefully evaluating patients and explaining the potential pros and cons. “Within the first few months, you may have small bleeds or swelling in your brain, which may or may not be symptomatic and if not detected in time can cause disability.”“In contrast,” Dr. Karlawish continued, “the benefits of slowing are subtle. You’re not going to experience the perception of changes in your cognition or function in the same amount of time.”Though Medicare will cover 80 percent of Leqembi’s $26,500 cost, patients could still shoulder thousands of dollars in co-payments.Eisai, a Japanese pharmaceutical company, led the development and testing of Leqembi (pronounced le-KEM-bee). Eisai is partnering and splitting profits with the American company Biogen, the maker of the controversial Alzheimer’s drug Aduhelm, for its commercialization and marketing.The F.D.A.’s approval of Aduhelm was severely criticized because the evidence of potential benefit was inconclusive, with one trial showing modest slowing of decline but another showing no slowing. Before that approval, a committee of independent advisers and an F.D.A. council of senior officials said there was not enough evidence that it worked. Many medical centers declined to prescribe Aduhelm, and Medicare has covered it only for clinical trial participants, sharply restricting its availability.Evidence supporting Leqembi is much clearer, Alzheimer’s experts said.Leqembi will be available for people with mild dementia or a pre-Alzheimer’s condition called mild cognitive impairment. The F.D.A. label instructs doctors not to treat patients without testing to confirm they have an accumulation of the protein amyloid, a hallmark of Alzheimer’s that Leqembi attacks.About 1.5 million people in the United States are estimated to be in the beginning phases of Alzheimer’s. Many more — about five million — have progressed too far to be eligible for Leqembi. Alex Scott, Eisai’s executive vice president of integrity, said the company recommends patients stop using Leqembi once they develop moderate Alzheimer’s disease.Alzheimer’s experts said they would inform some patients that they had greater risk for brain swelling and bleeding — including those taking blood thinners, those with more than four microscopic bleeds in the brain and those with an Alzheimer’s-linked gene mutation called APOE4.The risk to people with two copies of the APOE4 mutation — about 15 percent of people with Alzheimer’s — is so high that the F.D.A.’s black-box warning recommends that all patients be genetically tested to assess their safety risk and spells out that those with two APOE4 copies are more vulnerable to developing “symptomatic, serious and severe” brain bleeding or swelling.The black-box warning will apply to all drugs that, like Leqembi, are monoclonal antibodies that attack amyloid. Leqembi is the first to get full approval, but others are in various stages of development.The warning does not mention patients who are taking blood thinners, but Leqembi’s label says that “additional caution should be exercised” when considering whether to give blood thinners to Leqembi patients. The F.D.A. greenlighted Aduhelm under a program called “accelerated approval,” which can be given to drugs with uncertain benefit under specific criteria, including that the company conduct another clinical trial. Leqembi received accelerated approval in January, but that status meant Medicare would only cover the drug in limited circumstances.The F.D.A. decision granting full approval to Leqembi means that Medicare will cover it for eligible patients.Still, some patients will be unable to afford the 20 percent Medicare does not cover, possibly about $6,600 a year. Including costs of medical visits and required regular brain scans, some of which will receive Medicare reimbursement, the treatment could run to about $90,000 a year, some experts estimate.A recent study estimated that covering the drug and necessary services for about 85,000 patients would cost Medicare $2 billion a year and would climb to $5.1 billion if the number of patients reached about 216,000. That could lead to an increase in premiums for all Medicare beneficiaries, not just those receiving Leqembi, the study said.In interviews, Ivan Cheung, the chairman and chief executive of Eisai’s United States operations, estimated that in the first three years, about 100,000 patients would be receiving the drug.The Medicare agency is adding a requirement that doctors prescribing Leqembi submit medical information about each patient before and while they are being treated with the drug. The information will be kept in patient registries and evaluated to learn more about Leqembi’s benefits or harms, the agency said.“With F.D.A.’s decision, C.M.S. will cover this medication broadly while continuing to gather data that will help us understand how the drug works,” the administrator of the Centers for Medicare and Medicaid Services, Chiquita Brooks-LaSure, said in a statement.Some advocacy groups, like the Alzheimer’s Association, have criticized the registry requirement, calling it an unnecessary barrier to access. But medical experts say registry programs are common and easy to comply with. Their concern is that the registry won’t be comparing Leqembi patients with others, so it won’t be able to say if Leqembi slows cognitive decline.The F.D.A.’s approval on Thursday was based on a large trial indicating that patients receiving Leqembi declined 27 percent more slowly over 18 months than patients receiving a placebo. The difference between those receiving drug and placebo was small — less than half a point, on an 18-point cognitive scale that assesses functions like memory and problem-solving. Some Alzheimer’s experts say that for slowing of decline to be clinically meaningful, or noticeable to patients and families, the difference between the groups must be at least one point.Leqembi patients also declined more slowly on three secondary measures of cognition and daily function, and data on biological markers was generally stronger for Leqembi than for the placebo. All these measures moving in the same direction strengthens the idea that the drug can benefit patients, experts say.Still, a report on the data, published in The New England Journal of Medicine and co-written by scientists from Eisai, concluded that “longer trials are warranted to determine the efficacy and safety.”Concerns about safety have been stoked by reports of deaths of three clinical trial participants who experienced brain swelling and brain bleeding, two of whom were being treated with blood thinners. Eisai has said it is unclear if Leqembi contributed to their deaths because the patients had complex medical issues.“You’ve got small benefits and a certain risk for serious adverse events, and that has to be balanced,” said Dr. Lon Schneider, director of the California Alzheimer’s Disease Center at the University of Southern California, who said he will prescribe Leqembi to carefully evaluated patients.“If its efficacy were greater, we would not be talking about adverse events as much because we would see a clear benefit,” he said, adding, “I think many people will see this and say it’s not worth the effort, it’s not worth twice-a-month infusions.”Dr. Karlawish said the decisions facing patients and families will be complicated. Because eligible patients have only mild symptoms of cognitive decline, some might opt to take any medication that might prolong that relatively functional stage, while others might only consider the risks of the drug worthwhile if they were much more impaired.Dr. Karlawish said one recent patient declined to get evaluated for potential treatment, indicating that “‘I want more benefits, I don’t see the value.’” But, he said, “I have other patients, though, who would say, You mean you can give me a drug that could slow the disease?”In the trial, nearly 13 percent of patients receiving Leqembi experienced brain swelling, which was mostly mild or moderate, while less than 2 percent of patients receiving the placebo experienced such swelling. Most brain swelling did not cause any symptoms, generally emerged soon after use began and resolved within a few months. About 17 percent of Leqembi patients experienced brain bleeding, compared with 9 percent of patients receiving a placebo. The most common symptom from brain bleeds was dizziness.Overall, the results suggest the risk of brain bleeding and swelling was significantly lower than for patients in trials of Aduhelm.Dr. Jerry Avorn, a professor of medicine at Harvard Medical School who studies medication regulation and use, said doctors will feel pressure to prescribe Leqembi from patients, families and advocacy organizations. Medical institutions will also have an “enormous financial incentive” because of the Medicare reimbursement that “they could then spend on social workers and all the other things that Medicare will not reimburse,” he said, adding “any economically self-respecting memory center is going to see this as an economic windfall.”

Medicare will cover much of the cost for patients in the early stages of the disease, but Leqembi has safety risks and can only modestly slow cognitive decline.On Thursday, the Food and Drug Administration gave full approval to the drug Leqembi for patients who are in the early stages of Alzheimer’s disease, and Medicare said it would cover 80 percent of the cost of the $26,500-per-year medication. The decisions by the two federal agencies will vastly increase access to the drug but also present a dilemma for patients and their families.There are many factors, both financial and medical, to weigh. Here are answers to some crucial questions:How well does the drug work?Leqembi is not a cure for Alzheimer’s, and the drug doesn’t improve patients’ memories or cognitive abilities. It also does not stop the disease from getting worse. What Leqembi can do is modestly slow down cognitive decline in patients who are in the early stages of the disease. Data from a large clinical trial suggested that the drug may slow decline by about five months over a period of 18 months for those patients.How the drug might affect a patient’s daily life is likely to vary widely. For some people, Leqembi might mean several additional months of being able to follow a recipe, balance a checkbook or accomplish other activities without help. For others, the impact might be much more subtle and barely noticeable.Are there risks from taking it?Yes. The drug can cause swelling or bleeding in the brain that is often mild or moderate and resolves on its own but can be serious and in very rare cases can be fatal. The F.D.A. was so concerned about these side effects that it is requiring a “black-box warning” — the most urgent level — on the drug’s label, saying that the medication can cause “serious and life-threatening events.”Patients who are at higher risk include those on blood thinners, those who have had more than four microscopic bleeds in the brain and those with an Alzheimer’s-linked gene mutation called APOE4 — especially if they have two copies of the mutation. They, along with their doctors, should consider whether the increased safety risk outweighs their desire for a medication that might modestly slow cognitive decline.A large clinical trial of the drug found that nearly 13 percent of patients receiving Leqembi experienced brain swelling, but most of those cases were mild or moderate. Less than 2 percent of patients receiving the placebo experienced such swelling. Most brain swelling did not cause any symptoms and generally resolved within a few months.About 17 percent of the patients receiving Leqembi experienced brain bleeding, compared with 9 percent of patients receiving the placebo. The most common symptom from brain bleeds was dizziness, the study said.Who is eligible to take Leqembi?Leqembi — which is administered by intravenous infusions in a doctor’s office or clinic every two weeks — will be available for people diagnosed as having early-stage Alzheimer’s and for those with a pre-Alzheimer’s condition called mild cognitive impairment. About 1.5 million people in the United States fit that description. An additional 5 million who have Alzheimer’s will not qualify for Leqembi because their disease has progressed too far.The F.D.A.-required label on the drug instructs doctors not to treat patients without testing to confirm that they have one of the hallmarks of Alzheimer’s: a buildup in the brain of the protein amyloid, which Leqembi attacks. Amyloid levels can be assessed with PET scans, spinal taps or newly available blood tests.How much will we have to pay?Most patients will be old enough for Medicare, which has said it will pay for 80 percent of the $26,500 annual cost of the drug. Patients would be left with about $6,600 in co-payments, which may put the drug out of financial reach for many. Some or all of that co-payment might be covered by the supplemental private insurance policies that many Medicare patients have.There are potentially tens of thousands of dollars of additional costs, however — including medical visits for the infusions and regular brain scans. Some Alzheimer’s experts have estimated that the total cost of taking Leqembi could run to about $90,000 a year. With 80 percent coverage, treatment could potentially leave patients saddled with $18,000 per year in out-of-pocket costs.How should people and their families decide?Talk to your doctor. If your doctor is not well-versed in Alzheimer’s treatments, consider talking with a specialist. The most important thing is to discuss the decision with medical experts who will carefully explain the risks for your specific situation.To learn those risks, ask for genetic testing to determine if you have the APOE4 gene mutation. People with two copies of that mutation — about 15 percent of Alzheimer’s patients — are at especially high risk of brain swelling and bleeding.There are other factors to consider too. Would going to a clinic for a drug infusion every two weeks pose a burden?And, importantly, how do you and your family perceive your current cognitive condition and how it affects your life? Because Leqembi is for people with mild symptoms, some people might be less inclined to take safety risks, but others might consider it especially important to try a drug that might keep them at this mild stage a bit longer.

In lawsuits challenging state abortion bans, lawyers for abortion rights plaintiffs are employing religious liberty arguments the Christian right has used for decades.For years, conservative Christians have used the principle of religious freedom to prevail in legal battles on issues like contraceptive insurance mandates and pandemic restrictions. Now, abortion rights supporters are employing that argument to challenge one of the right’s most prized accomplishments: state bans on abortion.In the year since Roe v. Wade was overturned, clergy and members of various religions, including Christian and Jewish denominations, have filed about 15 lawsuits in eight states, saying abortion bans and restrictions infringe on their faiths.Many of those suing say that according to their religious beliefs, abortion should be allowed in at least some circumstances that the bans prohibit, and that the bans violate religious liberty guarantees and the separation of church and state. The suits, some seeking exemptions and others seeking to overturn the bans, often invoke state religious freedom restoration acts enacted and used by conservatives in some battles over social issues.The lawsuits show “religious liberty doesn’t operate in one direction,” said Elizabeth Sepper, a law professor at University of Texas at Austin.Aaron Kemper, a lawyer representing three Jewish women who are suing to overturn Kentucky’s abortion ban, said he studied and emulated federal and state religious liberty cases that conservatives won.“We were like, it works for them, so we thought we should use sections from those cases,” he said.Though most lawsuits have not yet yielded court rulings, there are signs the arguments may have some legal traction. In Indiana, a judge issued a preliminary injunction blocking the state’s abortion ban, saying it violated the state’s Religious Freedom Restoration Act adopted in 2015 under then-Gov. Mike Pence, an ardent abortion opponent who is now running for president.Recognizing a potential threat, Oklahoma and West Virginia recently amended their religious freedom restoration acts to explicitly prevent challenges to abortion bans under the acts.Some belief systems, including the United Church of Christ’s, support women making their own decisions in pregnancy. Some, including the Episcopal Church and many branches of Judaism have traditions that abortion should be supported in certain cases, especially where pregnancies threaten women’s physical or mental health or involve serious fetal abnormalities. Some faiths do not define life as beginning with conception.The Indiana case was filed by Hoosier Jews for Choice, three Jewish women and a woman with independent spiritual beliefs. Judge Heather Welch of Marion County Superior Court has certified it as a class-action lawsuit on behalf of “all persons in Indiana whose religious beliefs direct them to obtain abortions in situations prohibited by” the ban.The Rev. Dr. Laurie Hafner, a United Church of Christ pastor, is suing the state of Florida over its abortion bans, saying that according to her faith, “women have the ability and wherewithal to make the decision that’s right for them.”Sydney Walsh for The New York Times“The court has concluded that the plaintiffs’ religious exercise is being substantially burdened, that they are suffering irreparable harm,” Judge Welch wrote in blocking the ban.The state has appealed, arguing that “‘abortion access’ is not religious exercise.” Like other states fighting such lawsuits, Indiana said it has a “compelling interest” to prohibit abortions. “Plaintiffs identify no principle that makes abortion a religious act any more than countless other actions that they believe to affect their well-being,” Indiana’s attorney general wrote, adding, “Other acceptable means for plaintiffs to achieve such ends in the context of childbearing include sexual abstinence, contraceptives, IUDs and natural family planning, just to name a few.”Decades ago, some anti-abortion groups warned that religious freedom arguments might be used to bolster abortion rights. When Congress considered what became the 1993 Religious Freedom Restoration Act, the National Right to Life Committee and the U.S. Catholic Conference raised that concern.“The Act, if passed, will be used to seek access to abortions,” the Catholic Conference’s general counsel wrote in 1992.In Florida, lawsuits filed by Episcopal, Buddhist, Unitarian Universalist, Jewish and United Church of Christ clergy say abortion restrictions violate “clerical obligations and faith” and impose “severe barriers” on religious belief, speech and conduct.Mikayla took mifepristone, the first pill in a two-drug regimen to end a pregnancy.Adria Malcolm for The New York Times“We believe God is the source of all life and has caused us to share in the work of creation,” said one plaintiff, the Rev. Dr. Laurie Hafner, senior pastor of Coral Gables Congregational United Church of Christ. “The privileges and responsibilities of being part of co-creating,” she said, mean “women have the ability and wherewithal to make the decision that’s right for them.”Reverend Hafner said she had counseled parishioners deciding whether to terminate pregnancies, including a 14-year-old girl and a woman whose fetus was nonviable. Florida’s six-week abortion ban is currently on hold, but, she said, “what if it gets to that place where I can no longer sit at the bedside or in the living room or in my office with someone out of fear of what might happen?”Within any faith, there may be varying opinions on abortion. But many of those suing say abortion bans embed conservative Christian ideology into state law.One Kentucky plaintiff, Sarah Baron, a 38-year-old mother of two and a board member of a Louisville synagogue, said, “The Torah teaches us that the fetus does not have the same personhood status as the mother until its first breath.”Ms. Baron, who belongs to Judaism’s conservative denomination, said her age and previous fertility struggles raised risks of pregnancy complications or fetal abnormalities.Under Kentucky’s ban, she said, “I would be unable to make that extremely difficult decision of whether to continue carrying a fetus if the pregnancy is causing severe physical or psychological harm to me or the fetus is nonviable.”“It’s not only cruel,” she said, “but it represents a situation where Jewish law may require the pregnancy to be terminated.”Within Judaism, there are differing views, with some Orthodox Jews supporting only very limited circumstances for abortion. But Mr. Kemper, the Kentucky plaintiffs’ lawyer, said rabbis from every large Kentucky synagogue have supported the lawsuit.Sarah Baron, a Kentucky plaintiff, is a mother of two and a board member of a Louisville synagogue. “The Torah teaches us that the fetus does not have the same personhood status as the mother until its first breath,” she said.Andrew Cenci for The New York TimesThe lawsuits by members of widely known faiths follow a trail blazed by a less conventional religion, the Satanic Temple, which began filing abortion-related lawsuits after the Supreme Court’s 2014 Hobby Lobby decision exempting family-owned corporations from the Affordable Care Act’s mandate that insurance cover contraceptives. The temple, which is recognized by the I.R.S. as a religion and lists 46 American congregations, has lawsuits pending in Idaho, Texas and Indiana, and it recently started the first telemedicine abortion service operated by a religion, with a goal of using it to challenge abortion restrictions.A nontheistic religion that construes Satan not as a New Testament evildoer but as the English literary character who battles oppression, the Satanic Temple often employs a strategy of flamboyant provocation, said Joseph Laycock, a religion scholar at Texas State University and the author of a book about the temple. Its antics make some abortion rights supporters worry that it will stoke anti-abortion sentiment. But some courts have taken its religious freedom claims on various issues seriously, including in a recent preliminary ruling ordering a school district in Hellertown, Pa., to allow its After School Satan Club to meet.Marci Hamilton, a religious freedom expert at the University of Pennsylvania who represents clergy in abortion rights lawsuits in Florida, called the temple’s lawsuits “extremely helpful.”“They are saying, OK, courts, if you’re going to favor the religious right, we’re going to show you a faith whose rights are being violated,” she added.The temple created an abortion ritual, a recitation of tenets about individual control over one’s body and the importance of making decisions based on science. Its general counsel, Matthew Kezhaya, said the ritual strengthens legal claims by linking “abortion and the religion itself” and establishing a practice “interfered with by these particular laws.”The temple’s telemedicine service is currently available in New Mexico, where abortion is legal, but it plans to expand to states with bans and religious freedom laws, temple officials said. It has an intentionally inflammatory name, Samuel Alito’s Mom’s Satanic Abortion Clinic (after the Supreme Court justice who wrote the opinion overturning Roe), but it follows standard medical procedures, employs experienced reproductive health nurses and is listed by a national clearinghouse of legitimate medication abortion services.Mikayla, guided over Zoom by a Satanic Temple minister, participated in the abortion ritual, reciting tenets about autonomy over her body and the importance of science.Adria Malcolm for The New York TimesOne patient, Mikayla, 28, who asked to be identified by her first name to protect her privacy, drove from Texas to an Albuquerque airport hotel to use the service , and allowed The New York Times to observe. During video medical consultations, a nurse practitioner and patient care coordinator discussed effects like cramping and bleeding and urged her to call their 24-hour nurse hotline with questions or concerns.After she received the medication, the process took a different turn. Via Zoom, a minister prompted Mikayla to look in a mirror to reflect on self-empowerment and recite: “One’s body is inviolable, subject to one’s own will alone.” After swallowing the first pill in the two-drug regimen, Mikayla recited a tenet about prioritizing science. The minister advised that after the pregnancy tissue was eventually expelled, Mikayla could recite: “By my body, my blood. By my will, it is done.”Legal experts said some religious freedom lawsuits seeking abortion rights might succeed, given recent Supreme Court decisions that “supported religious exemptions even in cases where there are really strong health and safety issues,” said Elizabeth Reiner Platt, director of the Law, Rights and Religion Project at Columbia University. Arguments for exemptions might also be persuasive because most abortion bans have some exceptions, like rape, experts said.“These should be very strong, compelling cases, but I also acknowledge that this is a highly political issue,” Ms. Platt said.Josh Blackman, a professor at South Texas College of Law Houston who has criticized the lawsuits, questioned the plaintiffs’ legal standing, saying, “A lot of these women are sort of making prospective claims that, One day, I might be pregnant, and one day, I might have this problem and that might require me to have an abortion.”He said some plaintiffs could have religiously sincere “extenuating individual circumstances,” but that allowing widespread exemptions could undermine the law’s larger purpose.Whichever way courts rule could be groundbreaking.“We’re in a completely new landscape,” Ms. Platt said.Adria Malcolm

The law was to take effect on July 1. It is the only state law that specifically outlaws the most common abortion method in the country.A Wyoming judge on Thursday temporarily blocked the first state law specifically banning the use of pills for abortion, the most common method in the country.Just over a week before the ban was scheduled to take effect, Judge Melissa Owens of Teton County District Court granted a temporary restraining order, putting the law on hold pending further court proceedings.Ruling from the bench after a hearing that lasted about two hours, Judge Owens said that the plaintiffs, who include four health care providers, “have clearly shown probable success on the merits and that at least some of the plaintiffs will suffer possible irreparable injury” if the ban were to take effect.Medication abortion is already outlawed in states that have near-total bans, since those bans prohibit all forms of abortion. But Wyoming became the first state to outlaw the use of pills for abortion separate from an overall ban. The law was scheduled to take effect July 1.The ban, passed by the Legislature and signed by Gov. Mark Gordon in March, makes it illegal to “prescribe, dispense, distribute, sell or use any drug for the purpose of procuring or performing an abortion.”Doctors or anyone else found guilty of violating this law would be charged with a misdemeanor, punishable by up to six months in prison and a $9,000 fine. The law explicitly says that pregnant women would be exempt from charges and penalties.In the year since the Supreme Court overturned the national right to abortion, Wyoming’s Republican-controlled Legislature has been trying to ban abortions in the state.Last year, Judge Owens temporarily enjoined a near-total abortion ban, which she said appeared to contradict an amendment to Wyoming’s Constitution that guarantees adults the right to make their own health care decisions. An overwhelming majority of Wyoming citizens voted for that amendment in 2012.In March, the Legislature passed and the governor signed another near-total ban on abortions that tried to circumvent that constitutional amendment by declaring that abortion is not health care. Judge Owens temporarily blocked that law soon after it was signed, saying she questioned the state’s contention that abortion is not health care.The issue of whether abortion is health care was also a significant aspect of Thursday’s hearing on the medication abortion ban. Jay Jerde, a special assistant attorney general for Wyoming, argued that even though doctors and other health providers must be involved in abortions, there are many instances when “getting the abortion doesn’t implicate health care because it’s not restoring the woman’s body from pain, physical disease or sickness.”Judge Owens questioned Mr. Jerde’s argument. “Essentially the government under this law is making the decision for a woman,” she said, “rather than the woman making her own health care choice, which is what the overwhelming majority in Wyoming decided that we should get to do.”The plaintiffs in the case, who are challenging all of the bans in various lawsuits, include the only two abortion providers in Wyoming; an obstetrician-gynecologist who often treats high-risk pregnancies; an emergency room nurse; a fund that gives financing to abortion patients; and a woman who said her Jewish faith requires access to abortion if a pregnant woman’s physical or mental health or life is in danger.A ban on medication abortion would have a substantial impact because pills have been the method used in almost all recent abortions in the state, a lawyer for the plaintiffs, Marci Bramlet, told the court. Nationally, pills are now used in over half of abortions. Only one of Wyoming’s providers offers the other method, surgical abortions.“The ban seeks to only ban medication abortions, not all abortions, completely undermining the state’s stated goal of preserving prenatal life, and allows surgical abortions which are more invasive physically, financially and logistically,” Ms. Bramlet told the court. “The statute tells women, ‘You can have an abortion in Wyoming but not using the safe, effective, F.D.A.-approved medication available.’”

The agency is expected to decide this summer whether to allow the first nonprescription sales of an oral contraceptive in the United States.A panel of advisers to the Food and Drug Administration voted unanimously on Wednesday that the benefits of making a birth control pill available without a prescription outweigh the risks, a significant step in the decades-long push to make oral contraception obtainable over the counter in the United States.If the F.D.A. approves nonprescription sales of the medication, called Opill, this summer, it could significantly expand access to contraception, especially for young women and those who have difficulty dealing with the time, costs or logistical hurdles involved in visiting a doctor, reproductive health experts say. Approval is not a foregone conclusion, however. F.D.A. scientists who analyzed data submitted by the pill’s maker, HRA Pharma, have raised concerns about whether women with medical conditions that should preclude them from taking the pill — primarily breast cancer and undiagnosed vaginal bleeding — would avoid the product.The agency’s reviewers also questioned the reliability of the data from a company study that was intended to show that consumers would follow the label’s directions to take the pill at roughly the same time every day and use another form of contraception or abstain from sex if they happened to miss a dose. The F.D.A. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.“The F.D.A. has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting,” said Dr. Karen Murry, deputy director of the F.D.A.’s office of nonprescription drugs, during the advisory panel’s discussion session on Wednesday afternoon. “We can’t just approve it based on the experience in the prescription setting without the applicant doing adequate studies to look at what’s likely to happen in the nonprescription setting,” she said. “But I wanted to again emphasize that F.D.A. does realize how very important women’s health is and how important it is to try to increase access to effective contraception for U.S. women.”The advisory committee’s members overwhelmingly said that those concerns were vastly outweighed by the public health need and the long history of safety and efficacy of Opill, which was approved for prescription use 50 years ago. “The panel expresses confidence in the effectiveness, not only in the general population of females, but also in adolescent populations and those with limited literacy,” said Maria Coyle, the chairwoman of the committee, a pharmacist and an associate clinical professor at The Ohio State University. “The panel seems very comfortable with the limited number of risks from the medication itself.” The advisory committee’s members included a wide range of medical professionals: obstetrician-gynecologists, adolescent medicine specialists, a breast cancer specialist and experts in consumer health behavior and health literacy.The F.D.A. had originally scheduled the committee’s public hearing for last November, but postponed it until this spring after asking the company to submit additional information.The birth control medication Opill.Perrigo, via Associated PressSince the Supreme Court overturned the national right to an abortion almost a year ago, the accessibility of contraception has taken on more urgency. The move to make a nonprescription pill available for all ages has garnered a groundswell of support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.In a survey by the health care research organization KFF, more than three-quarters of women of reproductive age favored an over-the-counter pill, primarily because of convenience.While some Catholic organizations have spoken out against over-the-counter birth control, most anti-abortion groups have been quiet on the issue. Support was expressed in the vast majority of hundreds of comments submitted before the hearing, which began on Tuesday, and by most of the 37 people who spoke during the hearing’s public comment portion.Opill is known as a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. A company that makes a combination pill, Cadence Health, has also been in discussions with the F.D.A. about applying for over-the-counter status.Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, spoke in support of the over-the-counter effort in the advisory committee’s hearing on Tuesday. He said in an interview that both types of pills were safe and about 93 percent effective in preventing pregnancy with typical use. Combination pills have been more popular in the United States, but that may be because progestin-only pills, which are widely used in Europe, have not been marketed much in this country, he said.HRA Pharma, which was purchased last year by Perrigo, a Dublin-based maker of over-the-counter pharmaceuticals, already sells a nonprescription progestin-only pill in the United Kingdom.

The panel heard strong support from the company and many doctors but concern from F.D.A. scientists.It was like a tale of two birth control pills.At a hearing Tuesday to consider whether the Food and Drug Administration should authorize the country’s first over-the-counter birth control pill, a panel of independent medical experts advising the agency was left to reckon with two contradictory analyses of the medication called Opill.During the eight-hour session, the manufacturer of the pill, HRA Pharma, which is owned by Perrigo, and representatives of many medical organizations and reproductive health specialists said that data strongly supported approval. They said that Opill, approved as a prescription drug 50 years ago, was safe, effective and easy for women of all ages to use appropriately — and that over-the-counter availability was sorely needed to lower the country’s high rate of unintended pregnancies.In contrast, F.D.A. scientists questioned the reliability of company data that was intended to show that consumers would take the pill at roughly the same time every day and comply with directions to abstain from sex or temporarily use other birth control if they missed a dose. The agency seemed especially concerned about whether women with breast cancer or unexplained vaginal bleeding would correctly choose not to take Opill and whether adolescents and people with limited literacy would use it accurately.“I’m just really quite confused by the level of discrepancy,” one member of the advisory panel, Pamela Shaw, a senior investigator with Kaiser Permanente Washington, saidafter both sides had made presentations.On Wednesday, the panel will take a nonbinding vote on whether the risks of an over-the-counter pill would outweigh its benefits. The F.D.A. is expected to make a final decision this summer.The move to make a nonprescription pill available for all ages has garnered a groundswell of support from specialists in reproductive and adolescent health and groups like the American Medical Association, the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians.In a survey by the health care research organization KFF, more than three-quarters of women of reproductive age favored an over-the-counter pill, primarily because of convenience.Strikingly, at a time of fierce divisions over abortion, including abortion pills, many anti-abortion groups have declined to criticize over-the-counter birth control. Opposition appears to primarily come from some Catholic organizations. Support was expressed in the vast majority of hundreds of comments submitted before Tuesday’s hearing and by most of the 37 people who spoke during the hearing’s public comment portion.“As a teenager I was told by my doctor that I shouldn’t start the birth control pill because it would make me more likely to become sexually active,” said one speaker, Rebecca Heimbrock, a 20-year-old college sophomore. “Of course we know that this is not true, and young people without access to birth control simply have sex without being on birth control.”Opill is called a “mini pill” because it contains only one hormone, progestin, in contrast to “combination” pills, which contain both progestin and estrogen. Dr. Daniel Grossman, a professor of obstetrics, gynecology and reproductive sciences at the University of California, San Francisco, who spoke in support of the over-the-counter effort in public comments Tuesday, said both types of pills were safe and about 93 percent effective in preventing pregnancy with typical use. He said that compared to progestin-only pills, more medical conditions would preclude women from taking combination pills, which work by blocking the release of eggs from the ovaries and carry a risk of causing blood clots for some women.Progestin-only pills, which thicken cervical mucous to make it difficult for sperm to fertilize eggs and may also disrupt the release of eggs, have virtually no risk of causing blood clots. Data has suggested that it may be more important to take progestin-only pills within the same three-hour period each day, while combination pills allow somewhat greater flexibility, he said.Dr. Pamela Horn, director of an F.D.A. division for nonprescription drugs, said Tuesday that she “cares deeply about women’s health” and would “love to have unambiguous data” to support the application.But she said there were numerous concerns, concluding that “the evidence for likelihood of effectiveness in the nonprescription setting submitted by the applicant is mixed and has many limitations.”The F.D.A. highlighted the fact that about 30 percent of study participants reported taking more pills than they had received, a phenomenon called “overreporting” or “improbable dosing.” Dr. Jeena Jacob, an F.D.A. medical officer, said that raised concerns about those participants as well as the possibility that “other participants who are not part of the improbable dosing group may have incorrectly used or incorrectly reported use.”And Dr. Karen Murry, deputy director of the agency’s Office of Nonprescription Drugs, pushed back on a much-quoted figure that over 100 countries have over-the-counter pills. She said that pharmacists dispense such pills in most of those countries, so Americans’ experience might be different. Here, she said, “if this product is approved, people might get it in a pharmacy, but they also might get it in a gas station or a big box store with no health care professionals around.”Presentations supporting the company made a very different case.“Despite availability of a variety of contraceptive methods, nearly half of the pregnancies are unintended every year,” Dr. Carolyn Westhoff, an obstetrician-gynecologist at Columbia University’s Mailman School of Public Health, testified. She noted that other over-the-counter methods, such as condoms, were less effective than the pill and added, “We need more effective methods to be available without a prescription.”Dr. Westhoff suggested that for most women, there is no advantage to a doctor prescribing the pills because doctors don’t typically monitor patient adherence and often only see such patients once a year. She said it was especially important to make the pill available to adolescents because “these youngest women faced most significant barriers to accessing the more effective methods.”Other speakers, including some who spoke during the public comment session, emphasized that the product would also be helpful for women in low-income, rural and marginalized communities who didn’t have insurance or who found it difficult to see a doctor for a prescription because of the time, transportation or child care costs involved.Dr. Pamela Goodwin, a breast cancer oncologist at Sinai Health System in Toronto, testified that very few breast cancer patients would be at risk, because their doctors would advise them against using it. The company’s study found that 97 percent of breast cancer patients correctly opted not to take the pill.The study reported that participants had taken the pill on 92.5 percent of the days they were supposed to take it, Dr. Stephanie Sober, the U.S. medical liaison for the company. She said that nearly 85 percent of participants had taken a pill on at least 85 percent of the days. Most participants who missed a pill reported that they had followed the label’s directions to take mitigating steps such as abstaining from sex or using a condom, Dr. Sober said, adding that among 955 participants, only six women had become pregnant while using Opill.“Let’s face it — the instructions for Opill use are extremely simple: Take one pill, at the same time every day,” said Dr. Anna Glasier, a British reproductive health expert who testified for the company. “The vast majority of women did just that. And if they made a mistake, most took the appropriate mitigating action. And let’s remember that the women who did miss pills often did so because they could only get a supply from the site where they had enrolled, while in the real world situation, they could have bought a pill from any drugstore.”

The suit by GenBioPro, the generic maker of mifepristone, is the latest strand in the intense legal battle over abortion pills.The company that makes a majority of the abortion pill mifepristone sold in the United States sued the Food and Drug Administration on Wednesday, a new legal volley in a string of recent court maneuverings over the fate of the drug.The lawsuit adds another strand to the intense legal battle underway over a case filed in federal court in Texas in which a consortium of anti-abortion groups are seeking to overturn the F.D.A.’s 23-year-old approval of mifepristone, the first pill used in a two-drug medication abortion regimen.In the new case, GenBioPro, which makes the generic version of mifepristone, seeks to block the F.D.A. from complying if the courts ultimately order mifepristone off the market. The case was filed in the U.S. District Court of Maryland.Earlier this month, the federal judge in the Texas case issued a preliminary ruling invalidating the approval of mifepristone. Last week a federal appeals court panel said the drug could remain on the market while the case was being litigated, but it ordered a reversal of all regulatory actions the F.D.A. has taken on mifepristone since 2016, which include the approval in 2019 of GenBioPro’s generic version of the exact same drug.That order has been briefly paused by the Supreme Court, which is expected to decide by midnight on Friday whether it will extend the stay until the full case can be heard.The GenBioPro lawsuit claims that the F.D.A. has repeatedly failed to stipulate that it would follow a regulatory process established by Congress and afford the drug company due process rights guaranteed by the Constitution if the agency was ordered to suspend or revoke its approval of GenBioPro’s product.By leaving open the possibility that it would immediately obey such a court order, the lawsuit argues, the F.D.A. has “left GenBioPro at risk of severe civil and criminal penalties if it does not cease shipments of mifepristone.”The F.D.A. issued a statement saying: “F.D.A. doesn’t comment on pending litigation.”In testimony Wednesday before the Senate Appropriations Committee, the F.D.A. commissioner, Dr. Robert M. Califf, fielding questions about the Texas lawsuit, said the agency was concerned about the potential implications of the case, “from the well-being of patients who need access to this drug, the pharmaceutical industry and our ability to implement our statutory authority.” He noted that the F.D.A. was fighting the case in court, adding “I’ll just say the FDA intends to comply with any court orders.”Evan Masingill, GenBioPro’s chief executive, said Wednesday that uncertainty about the outcome of the Texas case has led to fewer orders of mifepristone. “The market disruption is already pervasive, impacting orders that include tens of thousands of units,” he said.The case could also have implications for the broader drug industry. The suit claims that it would be unprecedented for the F.D.A. to follow a court order to immediately revoke the approval of a drug. A drug’s approval can only be revoked if the F.D.A. determines that it presents “an imminent hazard to the public health,” the lawsuit says. The F.D.A. has forcefully argued in court that mifepristone is very safe and cited scores of studies showing that serious complications are rare and that less than 1 percent of patients need hospitalization.“People develop drugs in this country and not in others because we’ve typically had a pretty predictable regulatory structure, and with the Texas lawsuit, is that becoming not the case?” said Skye Perryman, a lawyer for GenBioPro and president of Democracy Forward, a center-left legal advocacy organization. “That has industry wide implications.”GenBioPro says that it supplies about two-thirds of the drug sold in the United States and that it sold more than 850,000 units of the drug between 2017 and 2020. GenBioPro’s lawsuit cites filings the F.D.A. submitted to the Supreme Court, in which the agency said that if the appeals court decision were to take effect, “the generic version of the drug would cease to be approved altogether.”The company said in the lawsuit that such statements amounted to a policy decision by the federal agency and that “the F.D.A. decision is erroneous and unlawful.”The suit says that the F.D.A. has declined to say otherwise in response to three letters GenBioPro sent it in March and April. In those letters, GenBioPro asked the agency to clarify that it would adhere to the congressionally mandated process that typically involves a detailed and lengthy review before any decision about withdrawing a drug is made.The company said that the F.D.A. had responded to only the first letter, sent in March before any decision was announced in the anti-abortion groups’ lawsuit, and that it said only that the “F.D.A. will, of course, need to review the Court’s opinion and order before determining what steps may be necessary to comply with it.”“We are not challenging F.D.A.’s scientific or medical judgment,” Ms. Perryman said, “but F.D.A. has failed to confirm it will respect our clients’ rights and so we are seeking a court order.”Christina Jewett

The judges blocked the drug from being sent to patients through the mail and rolled back other steps the government had taken to ease access.A federal appeals court ruled late Wednesday that the abortion pill mifepristone could remain available, but the judges blocked the drug from being sent to patients through the mail and rolled back other steps the government had taken to ease access in recent years.The three-judge panel said its ruling would hold until the full case is heard on appeal.In its order, the U.S. Court of Appeals for the Fifth Circuit, said the Food and Drug Administration’s approval of mifepristone in 2000 could stand because too much time had passed for the plaintiffs, a consortium of groups and doctors opposed to abortion, to challenge that decision.But the court said that it was not too late for the plaintiffs to challenge a set of steps the F.D.A. took beginning in 2016 that lifted restrictions and made it easier for more patients to have access to the pill.Those steps included not requiring that the pill be prescribed only by doctors, approving the pill for use up to 10 weeks into pregnancy instead of seven weeks and allowing the pill to be mailed to patients instead of requiring it to be picked up from a health care provider in person.All of those restrictions were temporarily reinstated. The Justice Department is likely to appeal the order to the Supreme Court.Fifth Court of Appeals Order on Abortion Pill CaseRead Document 42 pagesMike Ives