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☆ Appeals Court Upholds Abortion Pill Restrictions
▼ + stars: | 2023-08-16 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: 1 min

A federal appeals court panel said Wednesday that it would impose restrictions on the abortion pill mifepristone that would prevent the drug from being prescribed by telemedicine or dispensed through the mail. But the decision — the latest development in a closely watched lawsuit filed by abortion opponents seeking to block access to abortion pills — will not take effect until the Supreme Court ultimately decides the case. In a ruling this spring, the high court said mifepristone should remain available under the current rules until the appeals process concludes. In its ruling, a three-judge panel of the U.S. Court of Appeals for the Fifth Circuit upheld part of a decision issued in April by a federal judge in Texas. That decision, by Judge Matthew J. Kacsmaryk, had nullified the Food and Drug Administration’s approval of the pill 23 years ago.

Persons: mifepristone, Judge Matthew J, Kacsmaryk Organizations: U.S ., Appeals, Fifth Locations: Texas

☆ For the First Time, There’s a Pill for Postpartum Depression
▼ + stars: | 2023-08-04 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

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. 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.

Organizations: Drug Administration Locations: United States

Last week, for the first time in U.S. history, federal regulators approved the sale of a birth control pill without a prescription. Pam Belluck, a health and science correspondent for The Times, explains why, after decades of brutal battles over contraception, this decision played out so differently.

Persons: Pam Belluck Organizations: The Times

☆ Treating Alzheimer’s Very Early Offers Better Hope of Slowing Decline, Study Finds
▼ + stars: | 2023-07-17 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

Treating Alzheimer’s patients as early as possible — when symptoms and brain pathology are mildest — provides a better chance of slowing cognitive decline, a large study of an experimental Alzheimer’s drug presented Monday suggests. The study of 1,736 patients reported that the drug, donanemab, made by Eli Lilly, can modestly slow the progression of memory and thinking problems in early stages of Alzheimer’s, and that the slowing was greatest for early-stage patients when they had less of a protein that creates tangles in the brain. For people at that earlier stage, donanemab appeared to slow decline in memory and thinking by about four and a half to seven and a half months over an 18-month period compared with those taking a placebo, according to the study, published in the journal JAMA. Among people with less of the protein, called tau, slowing was most pronounced in those younger than 75 and those who did not yet have Alzheimer’s but had a pre-Alzheimer’s condition called mild cognitive impairment, according to data presented Monday at the Alzheimer’s Association International Conference in Amsterdam. “The earlier you can get in there, the more you can impact it before they’ve already declined and they’re on this fast slope,” Dr. Daniel Skovronsky, Eli Lilly’s chief medical and scientific officer, said in an interview.

Persons: Eli Lilly, donanemab, “, they’ve, Dr, Daniel Skovronsky, Eli Lilly’s Organizations: Alzheimer’s Association International Locations: Amsterdam

☆ F.D.A. Approves First U.S. Over-the-Counter Birth Control Pill
▼ + stars: | 2023-07-13 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

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 step 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.

Persons: Opill, Ms, Welgryn Organizations: Drug Administration, Perrigo Locations: United States, Dublin

☆ What to Know if You’re Considering the Alzheimer’s Drug Leqembi
▼ + stars: | 2023-07-06 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

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. Leqembi is not a cure for Alzheimer’s, and the drug doesn’t improve patients’ memories or cognitive abilities. 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.

Persons: ” Organizations: Food and Drug Administration, Medicare

☆ New Federal Decisions Make Alzheimer’s Drug Leqembi Widely Accessible
▼ + stars: | 2023-07-06 | by ( Pam Belluck | More About Pam Belluck | ) www.nytimes.com time to read: +1 min

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 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.

Persons: Alzheimer’s Organizations: Drug Administration, Medicare

☆ Religious Freedom Arguments Underpin Wave of Challenges to Abortion Bans
▼ + stars: | 2023-06-28 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

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. 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. “We’re in a completely new landscape,” Ms. Platt said.

Persons: Mikayla, “, ”, Elizabeth Reiner Platt, ” Ms, Platt, Josh Blackman, Ms, Adria Malcolm Organizations: Law, Columbia University, South Texas College of Law Houston Locations: Albuquerque

☆ Wyoming Judge Temporarily Blocks State’s Ban on Abortion Pills
▼ + stars: | 2023-06-22 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

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. 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.

Persons: Melissa Owens, Judge Owens Locations: Wyoming, Teton County

☆ New York Passes Bill to Shield Abortion Providers Sending Pills to States With Bans
▼ + stars: | 2023-06-20 | by ( Pam Belluck | Emily Bazelon | ) www.nytimes.com time to read: +1 min

The New York State Legislature gave final approval on Tuesday to legislation that provides legal protection for New York doctors to prescribe and send abortion pills to patients in states that have outlawed abortion. The measure, along with similar new laws in several other states controlled by Democrats, could significantly expand medication abortion access by allowing more patients in states that restrict abortion to end pregnancies at home, without traveling to states where abortion is legal. The New York bill now goes to the desk of Gov. Since the Supreme Court ended the nationwide right to an abortion last year, legislation known as telemedicine abortion shield laws have been enacted in Massachusetts, Colorado, Vermont and Washington. Several providers in New York say they plan to send abortion pills to patients in all restrictive states, and a few providers are speaking publicly, which those in other states with shield laws have so far not done.

Persons: Kathy Hochul Organizations: New, Democrats, The New, Assembly Locations: New York, The New York, York, Massachusetts , Colorado , Vermont, Washington, But

Sixteen months after his infection, Mr. Muñoz’s lungs have recovered somewhat, but not completely. Tap to enableA 3-D visualization comparing a healthy set of lungs with Ms. Rodríguez’s lungs 14 months after her infection. Tilt your device to rotate lungs Slide to rotate lungs Slide to rotate lungsHealthy lungs are filled with millions of tiny air sacs called alveoli. Lung tissue with chronic damage shows scarred, thickened areas and collapsed sections with reduced airflow. Ms. Rodríguez has come closer to recovering, most likely helped by her youth and previous good health.

Persons: Andy Muñoz, Covid, ”, Howard Huang, It’s, Dr, Huang, Tom Kennedy, Kennedy, “, Marlene Rodríguez, Rodríguez, David Sayah, Sayah, “ She’s, ” Meridith Kohut, “ Covid, Mr, Muñoz, Meridith Kohut, ” Dr, Kennedy’s, Muñoz’s, Rodríguez’s, Melissa Raymundo, Ms, Raymundo, Gayle, Rodríguez didn’t, Vianney, José, it’s, “ We’re Organizations: New York Times, Houston Methodist Hospital, Covid, Medical Center, ”, The New York Times, USA Locations: La Porte , Texas, Houston, Atwater, Calif

☆ Fifth Circuit Judges Are Hearing Arguments in Abortion Pill Case
▼ + stars: | 2023-05-17 | by ( Abbie Vansickle | Pam Belluck | ) www.nytimes.com time to read: +1 min

A federal appeals court is hearing arguments on Wednesday in a case that could determine the availability of a medication used in a majority of abortions in the country. As the hearing began in New Orleans, the three Republican-appointed judges on the U.S. Court of Appeals for the Fifth Circuit interjected questions and comments as lawyers from both sides presented their cases. Although the case is still in its early stages and any decision is likely to be appealed, it could ultimately have profound implications. If the initial judge’s ruling is upheld, access to medication abortion would be upended in states where abortion is legal, not just in states where bans and restrictions are in force. The F.D.A.’s regulatory authority over other drugs could be challenged with other lawsuits, and pharmaceutical companies say that uncertainty about the F.D.A.’s role could chill drug development in the United States.

☆ What to Know About the Comstock Act
▼ + stars: | 2023-05-16 | by ( Luke Vander Ploeg | Pam Belluck | ) www.nytimes.com time to read: +1 min

As the legal battle over abortion pills winds through the federal courts, anti-abortion activists are citing a 150-year-old law, the Comstock Act of 1873, to bolster their case. Here is how the Comstock Act came to be and how it is being viewed today. What does the Comstock Act say? Among other things, the Comstock Act prohibits the mailing of “obscene, lewd, or lascivious” materials, like pornography, or any article or thing “intended for the prevention of conception or procuring of abortion.” It also prohibits shipping those things by way of express common carriers, meaning services like FedEx or UPS. The act’s namesake, Anthony Comstock, was a deeply religious Civil War veteran turned anti-vice crusader from New York who was obsessed with combating what he saw as a culture of sexual impurity.

☆ F.D.A. Advisers Say Benefits of Over-the-Counter Birth Control Pill Outweigh Risks
▼ + stars: | 2023-05-10 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

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. analysts also raised questions about whether younger adolescents and people with limited literacy could follow the directions.

☆ F.D.A. Advisers Weigh Allowing First U.S. Over-the-Counter Birth Control Pill
▼ + stars: | 2023-05-09 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

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. 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. “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, said after both sides had made presentations.

☆ Supreme Court Is Expected to Decide on Access to Abortion Pill as Appeal Moves Forward
▼ + stars: | 2023-04-21 | by ( Abbie Vansickle | Pam Belluck | ) www.nytimes.com time to read: +1 min

At issue is the availability of mifepristone, part of a two-drug regimen that now accounts for more than half of the abortions in the United States. More than five million women have used mifepristone to terminate their pregnancies in the United States, and dozens of other countries have approved the drug for use. added a series of guidelines that eased access to the pill. The restrictions would include blocking patients from receiving the drug by mail. The case could also pave the way for all sorts of challenges to the F.D.A.’s approval of medications.

☆ Court Says Abortion Pill Can Remain Available but Imposes Temporary Restrictions
▼ + stars: | 2023-04-13 | by ( Pam Belluck | ) www.nytimes.com time to read: +1 min

Last week’s ruling by Judge Matthew J. Kacsmaryk, of the U.S. District Court for the Northern District of Texas, was a preliminary injunction saying that the F.D.A. Judge Kacsmaryk, a Trump appointee who has written critically of the Roe v. Wade decision, had stayed his order for seven days to give the F.D.A. The F.D.A had asked the appeals court to extend the stay beyond that seven days. In the decision, two Trump-appointed judges voted to reimpose some of the restrictions that the F.D.A. The third judge, appointed by President George W. Bush, said she would essentially have granted the full request.

☆ With Dueling Rulings, Abortion Pill Cases Appear Headed to the Supreme Court
▼ + stars: | 2023-04-08 | by ( Abbie Vansickle | Pam Belluck | ) www.nytimes.com time to read: +1 min

WASHINGTON — The dramatic dueling rulings by two federal district judges on Friday about access to a widely used abortion pill set up a lower court conflict that legal experts say will almost certainly send the dispute to the Supreme Court. “It really turbocharges the imperative for the Supreme Court to step in and to do so sooner rather than later,” said Stephen I. Vladeck, a law professor at the University of Texas at Austin. A federal judge in Texas issued a preliminary ruling on Friday invalidating the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, which could make it more difficult for patients across the country to access the medication. Less than an hour later, a federal judge in Washington State issued a ruling in another case that contradicted the Texas judge by ordering the F.D.A. The Texas judge, Matthew J. Kacsmaryk, an appointee of President Donald J. Trump, stayed his order for seven days to allow the F.D.A.

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