High court temporarily blocks restrictions on abortion pill

WASHINGTON (AP) — The Supreme Court said Friday it was temporarily keeping in place federal rules for use of an abortion drug, while it takes time to more fully consider the issues raised in a court challenge.

In an order signed by Justice Samuel Alito, the court put a five-day pause on the fast-moving case so the justices can decide whether lower court rulings restricting the Food and Drug Administration’s approval of the drug, mifepristone, should be allowed to take effect in the short term.

The justices are being asked at this point only to determine what parts of an April 7 ruling by U.S. District Judge Matthew Kacsmaryk in Texas, as modified by an appellate ruling Wednesday, can be in force while the case continues. The order expires late Wednesday, suggesting the court will decide that issue by then.

The court finds itself immersed in a new fight involving abortion less than a year after conservative justices reversed Roe v. Wade and allowed more than a dozen states to effectively ban abortion outright.

President Joe Biden’s administration and New York-based Danco Laboratories, the maker of the pill, asked the justices to intervene.

A lawyer for the anti-abortion doctors and medical organizations suing over mifepristone said the court’s action Friday was “standard operating procedure” and urged the justices to allow the appeals court-ordered changes to take effect by the middle of next week.

The type of order issued by the court Friday, an administrative stay, ordinarily is not an indication of what the justices will do going forward. It was signed by Alito because he handles emergency filings from Texas. Alito also is the author of last year’s opinion overturning Roe v. Wade.

The Justice Department and Danco both warned of “regulatory chaos” and harm to women if the high court doesn’t block the lower-court rulings that had the effect of tightening FDA rules under which the drug, mifepristone, can be prescribed and dispensed.

The new limits would have taken effect Saturday if the court hadn’t acted.

“This application concerns unprecedented lower court orders countermanding FDA’s scientific judgment and unleashing regulatory chaos by suspending the existing FDA-approved conditions of use for mifepristone,” Solicitor General Elizabeth Prelogar, the Biden administration’s top Supreme Court lawyer, wrote Friday, less than two days after the appellate ruling.

The Biden administration and Danco now want a more lasting order that would keep the current rules in place as long as the legal fight over mifepristone continues. As a fallback, they asked the court to take up the issue, hear arguments and decide by early summer a legal challenge to mifepristone that anti-abortion doctors and medical organizations filed last year.

The court rarely acts so quickly to grant full review of cases before at least one appeals court has thoroughly examined the legal issues involved.

A ruling from the 5th U.S. Circuit Court of Appeals late Wednesday would prevent the pill, used in the most common abortion method, from being mailed or prescribed without an in-person visit to a doctor. It also would withdraw the Food and Drug Administration’s approval of mifepristone for use beyond the seventh week of pregnancy. The FDA says it’s safe through 10 weeks.

Still, the appeals court did not entirely withdraw FDA approval of mifepristone while the fight over it continues. The 5th circuit narrowed an April 7 ruling by U.S. District Judge Matthew Kacsmaryk, whose far-reaching and virtually unprecedented order would have blocked FDA approval of the pill. He gave the administration a week to appeal.

“To the government’s knowledge, this is the first time any court has abrogated FDA’s conditions on a drug’s approval based on a disagreement with the agency’s judgment about safety — much less done so after those conditions have been in effect for years,” Prelogar wrote.

Erin Hawley, a lawyer for the challengers, said in a statement that the FDA has put politics ahead of health concerns in its actions on medication abortion.

“The 5th Circuit rightly required the agency to prioritize women’s health by restoring critical safeguards, and we’ll urge the Supreme Court to keep that accountability in place,” said Hawley, a senior counsel with Alliance Defending Freedom, a conservative legal group that also argued to overturn Roe v. Wade.

Mifepristone was approved by the FDA more than two decades ago and is used in combination with a second drug, misoprostol.

Adding to the uncertainty, a separate federal judge in Washington on Thursday clarified his own order from last week to make clear that the FDA is not to do anything that might block mifepristone’s availability in 17 Democrat-led states suing to keep it on the market.

It’s unclear how the FDA can comply with court orders in both cases, a situation that Prelogar described Friday as untenable.

Use of medication abortion jumped significantly after the FDA’s 2016 rule expansion, according to data gathered by the Guttmacher Institute, a research group that supports abortion rights. In 2017, medication abortion accounted for 39% percent of abortions, but by 2020 it had increased to become the most common method, accounting for 53% of all abortions.

Experts have said the use of medication abortion has increased since the court overturned Roe.

When the drug was initially approved, the FDA limited its use to up to seven weeks of pregnancy. It also required three in-person office visits: the first to administer mifepristone, the next to administer the second drug, misoprostol, and the third to address any complications. It also required a doctor’s supervision and a reporting system for any serious consequences of the drug.

If the appeals court’s action stands, those would again be the terms under which mifepristone could be dispensed for now.

At the core of the Texas lawsuit is the allegation that the FDA’s initial approval of mifepristone was flawed because the agency did not adequately review safety risks.

Mifepristone has been used by millions of women over the past 23 years. While less drastic than completely overturning the drug’s approval, the latest ruling still represents a stark challenge to the FDA’s authority overseeing how prescription drugs are used in the U.S. The ruling late Wednesday overturned multiple decisions made by FDA regulators after years of scientific review.

Common side effects with mifepristone include cramping, bleeding, nausea, headache and diarrhea. In rare cases, women can experience excess bleeding that requires surgery to stop.

Still, in loosening restrictions on mifepristone, FDA regulators cited “exceedingly low rates of serious adverse events.”

More than 5.6 million women in the U.S. had used the drug as of June 2022, according to the FDA. In that period, the agency received 4,200 reports of complications in women, or less than one tenth of 1% of women who took the drug.

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Associated Press writers Paul Weber in Austin, Texas, and Lindsay Whitehurst in Washington contributed to this report.

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Harlem’s National Dance Institute Honors Ariana DeBose, Carmen, And Ray Debbane 

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Harlem-based National Dance Institute (NDI), a non-profit organization that has transformed the lives of millions of public school children through the arts. The event will held its 47th Annual Gala on Monday, April 17, 2023 at The Ziegfeld Ballroom in New York City. The event will honor Academy Award-Winning actress, dancer & singer Ariana DeBose as…

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Coping With Summer Anxiety- Self-Care Tips That Actually Work

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Summer is a great time for outdoor activities as you needn’t worry about freezing temperatures. Besides feeling inspired to jump out of bed and hit the gym, you can get a fair dose of relaxation during weekend trips and beach vacations. However, research suggests that high temperatures can elevate anxiety levels. You heard right- you…

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NYC is trying to introduce ‘tranquility’ at the foot of the Queensboro Bridge

NYC is trying to introduce ‘tranquility’ at the foot of the Queensboro Bridge

Anyone who lives in or near the Queensboro Bridge knows the area is a cacophonous symphony of car horns, subway train screeching and the constant whirr of traffic.

It’s not a particularly soothing or even a desired destination, but it’s a thoroughfare—an in-between space for many New Yorkers coming and going.

But NYC officials are hoping the $1.6 million renovation of a small park at the foot of the bridge (at East 59 Street, between First and Second Avenues) will bring a place of respite for New Yorkers passing through the area.

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Honey Locust Park, which was named after the line of honey locust trees once lining the block, has been a park since 1938 but has in recent years been a staging area for crews working on the bridge and tunnel. 

Starting in January 2022, the city began reconstructing the space with new benches, plaza space, pavements, landscaping, and water service to all provide a green space to “soften the imposing nature of the bridge and surrounding traffic,” according to a press release. 

The reconstruction still allows DOT access to perform maintenance and repairs to the bridge and retain stormwater within the property.

Note: A honey locust tree is mostly found along the eastern coast and its wood is heavy and durable, making it ideal material for railroad ties, fence posts, and agricultural implements, according to the parks department. Its fruit usually provides food for deer, rabbits, and squirrels. 

NYC Parks’ Honey Locust Park
Photograph: NYC Parks / Malcolm Pinckney

“Honey Locust Park provides much-needed green space and tranquility at the foot of the Queensboro Bridge,” said NYC DOT Commissioner Ydanis Rodriguez in a statement. “The Adams Administration is reimagining the use of public space by making our roads more inviting for pedestrians and cyclists while ensuring access to maintain our infrastructure. DOT is thrilled to have partnered with Commissioner Donoghue and NYC Parks to make this project a reality.” 

Manhattan Borough President Mark Levine said the park gives a “drab municipal equipment staging area a second life as a beautiful community gathering spot” and that it “perfectly embodies the paradox of New York City—this serene respite abuts and coexists with a major traffic artery.”

He said the value of the park to the community “cannot be overstated.”

Even if it’s at the foot of one of the city’s most-used bridges, any added public greenspace here in NYC is a win.

* This article was originally published here

Hooray, Union Settlement To Celebrate Nearly 130 Year Of Service To East Harlem

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Union Settlement (www.unionsettlement.org), East Harlem’s oldest and largest social service provider, will celebrate nearly 130 years of service in East Harlem. They will do this at its annual spring benefit fundraiser at Gotham Hall on April 19, 2023. The “Heart and Soul” Gala will bring together hundreds of New York City’s business, civic and community…

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Join The 1st Cannabis Community Forum At Columbia University In Harlem

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On Tuesday, April 18th, 9 AM to 1 PM , the public is invited to join the first Happy Munkey, Choose Happy Symposium event, at the Columbia Forum in partnership with Community Board 9. For the first time, Community Board 9 is partnering up with a legacy group to host an event at an Ivy League institution…

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