Republicans need to take away mifepristone from the US market

Democratic and Republican attorneys general faced off Friday over an anti-abortion attempt to take the abortion pill mifepristone off the US market.

New York led a coalition of 22 state attorneys general who argued that going off the pill would have “devastating consequences” for women. Mississippi led 22 Republican attorneys general who argued that the Food and Drug Administration’s approval of mifepristone was “deeply flawed.”

The dueling arguments are part of an escalating Texas federal court battle over a lawsuit filed by anti-abortion advocates last November seeking to overturn the FDA’s more than two-decade-old approval of mifepristone.

When combined with misoprostol, mifepristone is the most common method of abortion in the United States, accounting for about half of all abortions.

Abortion rights group NARAL Pro-Choice America said in an analysis released Friday that 40 million women would lose access to the abortion pill if the court overturned the FDA’s approval.

The New York-led coalition argued that repealing FDA approval would make the pill largely inaccessible, forcing women to either undergo more invasive surgery or forego an abortion altogether.

Surgical abortions are more expensive and more difficult to obtain, they argued, which would disproportionately affect women on lower incomes, underserved women or women living in rural communities where there may not be access to a clinic.

“It would be devastating,” said Attorney General Judge Matthew Kacsmaryk, who is presiding over the case in the US District Court in North Texas.

The Mississippi-led coalition backed the anti-abortion doctors’ claims and called the FDA’s actions on mifepristone “deeply flawed.”

“For two decades, the U.S. Food and Drug Administration has worked to establish a statewide regime of on-demand abortion by authorizing widespread access to chemical abortion drugs – in violation of federal and state laws protecting life, health and security,” said Republican attorneys general argued.

Later Friday, 67 Republican congressmen filed a brief calling the FDA’s approval of mifepristone “unlawful” and arguing it should be overturned. They claimed that the agency’s actions had undermined Congressional protections for patients. However, the FDA has had regulations monitoring the safety of mifepristone for years, which it has gradually relaxed as more evidence came in.

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

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

Kacsmaryk extended an important deadline in the case on Thursday. He directed one of the abortion pill makers, Danco Laboratories, to fight the lawsuit. The anti-abortion advocates who brought the case then have until February 24 to respond.

“Forcing the FDA to withdraw a long-standing approval would upset the government’s agency of determining whether drugs are safe and effective and would directly and immediately harm Danco by shutting down its business,” attorneys for Danco Laboratories said in court Friday.

Mifepristone has become a central issue in the battle for access to abortion since the Supreme Court Roe v. Wade lifted last June.

The FDA changed its rules last month to allow certified retail pharmacies to dispense mifepristone. CV And Walgreensthe country’s two largest drugstore chains, have said they will be certified to dispense prescription drugs in states where it’s legal.

Republican attorneys general have warned companies not to mail the pill in their states, saying they would face legal action.

There are also lawsuits aimed at overturning government restrictions on mifepristone on the grounds that they conflict with FDA regulations. GenBioPro, the other abortion pill maker, is suing to get West Virginia’s ban overturned. A doctor in North Carolina questions that state’s restrictions.

The New York-led coalition of attorney generals arguing to keep mifepristone on the market includes: California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico , North Carolina, Oregon, Pennsylvania, Rhode Island, Washington, Wisconsin and Washington, DC

The Mississippi-led coalition arguing against FDA approval of mifepristone includes: Alabama, Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana, Nebraska, Ohio, Oklahoma, South Carolina , South Dakota, Tennessee , Texas, Utah and Wyoming.

The US Covid emergency ends on Could 11th. HHS officers say what to anticipate

People walk past a walk-in COVID-19 testing site on July 28, 2022 in New York City.

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The Department of Health and Human Services on Thursday laid out what will change and what will remain the same when the three-year Covid public health emergency ends in May.

Health Secretary Xavier Becerra formally told state governors on Thursday that he was renewing the declaration one final time but planning to let the state of emergency expire on May 11. The White House informed Congress of these plans last week.

In a call with reporters, HHS officials laid out what the public can expect when the emergency ends.

Immediate Changes:

  • Those with private health insurance may have to pay for Covid testing, both at the counter and in the lab, depending on the plan.
  • Seniors on Medicare Part B pay for over-the-counter testing, although the program covers lab testing.
  • Hospitals will lose flexibility to expand capacity in response to surges.
  • The federal government can no longer require laboratories to report Covid test results to the Centers for Disease Control and Prevention.

longer-term changes

  • Covid vaccines and antivirals like Paxlovid will remain free for everyone, regardless of insurance status, until the current federal stockpile is exhausted.
  • Extended telemedicine through Medicare will also remain in place through December 2024 under federal spending laws passed in December. But it will end thereafter without congressional intervention.

The Food and Drug Administration will continue to have the power to quickly approve Covid vaccines, tests and treatments through its separate emergency powers.

Millions of people are also at risk of losing their Medicaid health coverage this year as the federal protections that have kept people covered during the pandemic come to an end. These safeguards were once tied to the public health emergency, but Congress then decided to phase them out separately.

In short, states can begin throwing people out of Medicaid as early as April if they no longer meet eligibility requirements for the public health insurance program. HHS plans to open a special enrollment phase to allow these individuals to apply for coverage under the Affordable Care Act.

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Although Covid vaccines and treatments will remain free for everyone after the public health emergency ends, this may change for uninsured adults when federal supplies run out.

The Biden administration plans to stop buying vaccines and treatments for the public as early as this fall, in part because Congress failed to allocate additional funding. If the federal government pulls out, vaccines and treatments will be bought and distributed through the private market.

That means Pfizer And Modern sells the syringes directly to healthcare providers and whether you pay depends on whether you have insurance.

Those covered by the Affordable Care Act and Medicare will continue to receive the recordings free of charge. Those receiving Medicaid will receive the shots for free until September 2024, after which coverage will vary from state to state.

Adults who aren’t insured will likely have to pay for the shots when supplies run out, although the White House has said it is developing plans to help them.

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Adidas Splits Tank After Warning About Unsold Yeezy Inventory

“The numbers speak for themselves. We are currently not performing as we should,” said Adidas CEO Bjørn Gulden in a press release.

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Adidas could lose around €1.2 billion ($1.3 billion) in revenue in 2023 if it’s unable to sell its existing Yeezy stock.

The German sportswear company canceled its partnership with rapper and fashion designer Ye, formerly known as Kanye West, the face of Yeezy, in October after he made a series of anti-Semitic comments.

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The company said late Thursday it was reviewing what to do with the inventory, adding it had already considered the “significant negative impact” of not selling the products.

Operating profit would fall by around 500 million euros if the company doesn’t switch products, and Adidas expects sales to fall in the high single digits in 2023. Adidas could choose to write off its remaining Yeezy products.

Shares fell 9.5% on Friday morning as traders reacted to the announcements.

The company also forecast one-off costs of up to 200 million euros, leaving Adidas’ worst-case scenario for the year at a loss of 700 million euros for 2023.

“The numbers speak for themselves. We are not currently performing as we should,” Adidas CEO Bjørn Gulden said in a press release.

Adidas’ revenues increased by 1% in 2022 based on unaudited figures, while operating profit fell to 669 million euros in 2022 from almost 2 billion euros in 2021.

Adidas Employees Raised Concerns About Working With Kanye West: WSJ

Debbie Wasserman Schultz mops the ground with Jonathan Turley throughout the choose committee listening to

Republicans on the special committee tried to sell Jonathan Turley as a Twitter expert, but Rep. Debbie Wasserman Schultz (D-FL) picked him up.

Video:

😬 that didn’t go so well for Turley pic.twitter.com/YUfjmy1zz0

— Acyn (@Acyn) February 9, 2023

When it came time for their question and answer session, Wasserman asked Schultz Turley if he had ever worked for Twitter, and he said no. She asked if he had any ties to Twitter, and he said no. She asked him if he knew anything about the inner workings of Twitter. Turley answered no.

Wasserman Schultz then said that Turley’s answers were conjecture and opinion. Turley said he was going by what he read in the Twitter files. Wasserman Schultz again asked if he had any unique knowledge. Turley said no, but added that he offers legal analysis. Wasserman Schultz reclaimed her time, saying that legal analysis was another word for opinion.

By the end of the conversation, Turley had to admit that everything he offered was essentially his opinion. Another Republican star witness was dismantled.

The hearing itself was an insult to error.

The special counsel is nothing more than a laundering operation for right-wing conspiracy theories and talking points that Democrats on the committee dismantle with ease.
The special committee tasked with helping Trump get re-elected looks like a dud.

Jason is the managing editor. He is also a White House press pool and congressional correspondent for PoliticusUSA. Jason has a bachelor’s degree in political science. His thesis focused on public policy with a specialization in social reform movements.

Awards and professional memberships

Member of the Society of Professional Journalists and the American Political Science Association

Biden’s proposal to cap all insulin costs at $35 a month has little likelihood of passing Congress

President Joe Biden delivers the State of the Union address before a joint session of Congress on February 7, 2023

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President Joe Biden used the pulpit during his State of the Union address this week to call for a universal price cap on insulin for all diabetes patients, but the proposal is highly unlikely to pass the current Congress.

Biden’s signature legislative achievement, the Inflation Reduction Act, capped insulin prices for Medicare beneficiaries at $35 a month, but the law doesn’t protect younger diabetic patients with private insurance or no insurance from higher prices.

“Let’s finish the work this time. Let’s cap insulin costs to $35 for everyone,” Biden told Congress Tuesday night.

As the President spoke, Sen. Jeanne Shaheen, DN.H., called on Congress to pass the Insulin Act that would extend the $35 price cap to those with private insurance. Shaheen co-sponsored the bipartisan legislation with Sen. Susan Collins, R-Maine, last July.

According to a report by Rand Corp. from 2021, the average price of insulin in the US in 2018 was 10 times higher than the average price in other wealthy countries.

While there is some bipartisan support for a universal price cap on insulin, the proposal will face an uphill battle and is unlikely to pass in a tightly divided Congress, where Democrats hold a slim majority in the Senate and Republicans weakly hold the House of Representatives represent.

Even when Democrats controlled both houses last summer, Senate Republicans managed to stop a measure that would have capped insulin prices for people with private insurance at $35 a month. Should the Senate pass the insulin bill, it would still face a House that is now in the hands of the GOP.

Rep. Cathy Rodgers of Washington, the Republican chair of the House Energy and Commerce Committee, wasted no time in real-time rejecting Biden’s proposal and sweepingly condemning state insulin price caps as “socialist” and a “federal mandate” that encourages competition harms .

“It’s time for the president to abandon his socialist pricing schemes and work to make insulin products more affordable without jeopardizing insulin competition and innovation,” Rodgers said in a statement released during the president’s address Tuesday night.

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Lisa Murdock, chief policy officer at the American Diabetes Association, acknowledged that extending the insulin price cap to those with private insurance will be an uphill battle in the ongoing Congress. However, Murdock noted that in the previous Senate, seven Republicans had voted for the cap.

“We’ve seen Republicans come forward and champion this measure, so I don’t want to say we think it’s out of reach — we’re still very committed to working with members on both sides of the aisle to do so.” that,” Murdock said.

The insulin market is dominated by Eli Lilli, Novo Nordisk And Sanofi. Industry reaction to Biden’s proposal was mixed.

Lilly supports expanding the $35 price cap to all Americans, spokeswoman Kristiane Bello said. The company has a program to provide insulin to patients regardless of their insurance status for $35 or less a month, Bello said.

Sanofi also supports a universal price cap of $35 for insulin and is already offering the drug at that price to the uninsured through a savings program, a company spokesman said.

Novo Nordisk fears that government drug price fixing will eventually limit patient access to new therapies, spokeswoman Nicole Araujo said.

Stephen Ubl, CEO of Pharmaceutical Research and Manufacturers of America, called insulin cost caps “a patch on a broken system that’s forcing people to pay more for drugs than health insurers and pharmacy benefit managers are paying.”

Last month, California sued insulin manufacturers and pharmacy service administrators CVS Caremark, Cigna’s Express scripts And Optum by United Health They claim they are using their market power to overcharge patients.

CNBC has reached out to pharmacy performance managers for comment on the president’s remarks.

According to the American Diabetes Association, about 40% of people with diabetes have private insurance and 5% have no insurance. One in five privately insured diabetes patients pays more than $35 a month for insulin, according to a survey by the Kaiser Family Foundation.

Although insulin prices vary depending on a patient’s insurance policy, in some cases, Murdock says, people pay hundreds of dollars a month for drugs they need to survive.

According to an analysis by the Health Care Cost Institute, about 9% of people taking insulin with insurance through their employer paid more than $200 out of pocket in 2019. According to the analysis, these people spent an average of $403 per month.

According to a Harvard study published in the Annals of Internal Medicine, an estimated 1.3 million US adults will have to ration their insulin due to price in 2021. Patients rationed by skipping doses, taking less insulin, or delaying the purchase of injections to save money.

States have taken matters into their own hands in the absence of a federal price cap on insulin in all forms of insurance. So far, 22 states and Washington, DC have capped the price of insulin. The cap ranges from $25 in Connecticut for a month’s supply to $100 in other states.

Two youngsters died after a metropolis bus crashed right into a daycare middle

A horrifying situation unfolded when a city bus crashed into a daycare center and two young children lost their lives as a result of the tragedy.

The ordeal happened Wednesday morning in Laval, Quebec — a Canadian city about an hour from Montreal.

According to CBC News, a bus on the city’s public transit system crashed into the daycare center around 8:30 a.m. Two children died as a result. Also, six children suffered injuries and were treated at nearby hospitals, although they are all reportedly in stable condition.

Witness believes crime was premeditated, says driver was ‘in another world’

A witness named Hamdi Ben Chaabane lives near the scene of the crime and he estimates the bus was going about 20 miles per hour when it crashed into the daycare.

Remarkably, he shared, “From what I’ve seen, it wasn’t an accident.”

The witness also talked about how the driver started acting like a fool after the collision.

“He opens the door. He took off all his clothes. He was completely naked. We don’t know why he did it. We fell for him. We tried to subdue him.”

Ben Chaabane went on to describe the driver as “in another world,” noting that the whole experience was “a nightmare.”

“It was a nightmare. It’s horrible. He wouldn’t stop screaming. He didn’t say a word.”

The driver had been employed by the city for 10 years prior to the daycare incident

Stéphane Boyer, the mayor of Laval, noted that the driver – identified as Pierre Ny St-Amand – had been employed by the city’s transport department for 10 years. She also pointed out that the investigation is ongoing.

“There is a hypothesis that this was a premeditated act, but it needs to be confirmed by the investigation.”

According to The Independent, Prime Minister Justin Trudeau said the tragedy was “the worst nightmare imaginable for any parent”.

The suspect was charged with first-degree muder

At present, Pierre Ny St-Amand is reportedly facing two counts of first-degree murder, attempted murder, aggravated assault and assault with a weapon.

There are no further updates at this time and we send our sincere prayers to the families affected by this incident.

Zelenskyi anticipated to hunt extra assist from EU leaders in Brussels

Ukrainian President Volodymyr Zelenskyy addresses parliamentarians at Westminster Hall in London, England on February 8, 2023.

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BRUSSELS – Ukrainian President Volodymyr Zelenskyy meets with European leaders on Thursday as he continues his second major trip abroad since Russia invaded Ukraine.

The Ukrainian leader is expected to address the European Parliament on Thursday morning and attend an extraordinary meeting of the 27 EU leaders later in the day.

The discussions in Brussels come after a surprise visit to the UK on Wednesday and a last-minute meeting with French and German leaders this evening in Paris. It is the second time Zelenskyy has left Ukraine since Russia invaded the country on February 24 last year.

The President is using his time abroad to thank allies for their support so far, while calling for further commitments at a time when Ukrainian authorities expect a full-scale Russian offensive.

Zelenskyy brought a helmet of a Ukrainian pilot with the inscription “We have freedom, give us wings to protect it” in London on Wednesday.

Last month, Zelenskyy requested fighter jets from Ukraine’s allies — a request that has yet to receive a green light from Western nations. However, Britain said Wednesday it would train Ukrainian pilots to fly fighter jets, and British Prime Minister Rishi Sunak said nothing was off the table when it came to helping Ukraine.

In Paris, too, Zelenskyy was very clear with his demands on the French and German heads of state. “The sooner we get long-range heavy weapons and our pilots get modern planes, Emmanuel, the sooner our pilots can get modern planes, Olaf, the more powerful our armored coalition will be,” Zelensky said.

What are one of the best resorts within the US, Europe or the Caribbean?

US News & World Report released its 13th annual ranking of the best hotels for travelers this week.

The ranking, released on Tuesday, is based on three factors: the number of travel industry awards, a hotel’s star rating and guest ratings from the travel website Tripadvisor.

According to the press release, more weight was given to recipients of “very selective” awards, as well as those with more travel reviews. This makes it harder for new hotels to break into the top tier of the annual list.

The report only ranks “luxury” hotels and resorts, which US News defines as those that consistently average 4- to 5-star ratings, although it now includes select 3.5-star hotels, the company said .

According to the announcement, hotels must also have at least 20 rooms to be considered.

The best hotels in the USA

These are the top rated hotels in the USA:

  1. Acqualina Resort & Residences – Miami, Florida
  2. The Canyon Suites at The Phoenician, a Luxury Collection Resort – Scottsdale, Arizona
  3. Pendry West Hollywood – Los Angeles, California
  4. The Sanctuary at Kiawah Island Golf Resort – Kiawah Island, South Carolina
  5. The Inn & Club at Harbor Town, Sea Pines Resort – Hilton Head Island, South Carolina

Acqualina Resort & Residences in Miami took first place in the United States for the first time. It features three pools, ocean views, and an award-winning spa.

US News also published additional hotel rankings searchable by state or city.

For example, travelers can search for the best hotels in California or explore hotel rankings in 46 different cities and locations, including La Jolla, Disneyland and Napa Valley.

You can then filter hotels by star rating, price, and amenities.

The best hotels in Europe

These are the top rated hotels in Europe:

  1. Waldorf Astoria Amsterdam — Amsterdam, Netherlands
  2. Grand Hotel Tremezzo — Tremezzo, Italy
  3. La Reserve Paris Hotel and Spa — Paris, France
  4. The Goring – London, United Kingdom
  5. The Connaught – London, United Kingdom

Last year’s #1 hotel, Le Bristol Paris, came in at #6 this year.

The Waldorf Astoria Amsterdam took first place in Europe for the first time. Consisting of six canal-side mansions, it houses a two-Michelin-star restaurant specializing in vegetarian cuisine.

The Waldorf Astoria Hotel in Amsterdam consists of six interconnected buildings next to the Herengracht.

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Europe’s second largest hotel, the Grand Hotel Tremezzo overlooks Italy’s famous Lake Como.

The US News & World Ranking also lists hotels in 39 European countries, from Albania to Wales.

Similar to the US rankings, visitors can narrow down this ranking by “popular regions” such as Capri, Cinque Terre and Venice in Italy.

The best hotels in the Caribbean

These are the top rated hotels in the Caribbean:

  1. Cap Juluca, a Belmond Hotel, Anguilla – Maundays Bay, Anguilla
  2. Jumby Bay Island, Oetker Collection — Jumby Bay Island, Antigua
  3. Jade Mountain Resort – Soufriere, St. Lucia
  4. Cheval Blanc St-Barth Island France — Saint Barthélemy
  5. Tortuga Bay Puntacana Resort & Club – Punta Cana, Dominican Republic

The Caribbean’s premier hotel, Cap Juluca features domed villas with ocean views and direct beach access.

Views of St. Lucia’s Pitons Mountains from Jade Mountain Resort, named 3rd Best Hotel in the Caribbean by US News & World Report in 2023.

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Hotel #2, Antigua’s Jumby Bay Island offers snorkeling expeditions and kayak tours for guests.

Other rankings

The US News & World Report also released new rankings for Canada, Mexico and Bermuda.

Separately, all-inclusive resorts in the Caribbean and Mexico are also listed, each topped by Jumby Bay Island, Oetker Collection, and Grand Velas Los Cabos.

GenBioPro is suing West Virginia, arguing that the FDA is forestalling a ban

Abortion pill maker GenBioPro sued Wednesday to overturn West Virginia’s abortion ban because it restricts access to a drug approved by the Food and Drug Administration.

The lawsuit, filed in federal court in West Virginia’s Southern District, argues that FDA regulations on drugs such as the abortion pill preempt state laws under the US Constitution.

Access to the pill, called mifepristone, has become a major legal battleground following the Supreme Court ruling overturning federal abortion rights last June. A dozen states, including West Virginia, have adopted near-total abortion bans that outright prohibit the use of mifepristone.

The FDA approved mifepristone as a safe and effective method of terminating an early pregnancy more than 20 years ago, despite the agency placing restrictions on how the pill is distributed and administered.

Mifepristone, when combined with misoprostol, is the most common method used to terminate a pregnancy in the United States, accounting for about half of all abortions nationwide in 2020.

The FDA has eased many of its restrictions to expand access to mifepristone. During the Covid-19 pandemic, the agency allowed patients to receive the pill in the mail. Earlier this month, the FDA allowed retail pharmacies to begin dispensing mifepristone for the first time, so long as they become certified to do so.

However, bans like the one in West Virginia conflict with FDA regulations on mifepristone, raising the question of whether federal or state laws take precedence. Although the FDA has a congressional mandate to approve drugs for use in the U.S. market, states generally license the pharmacies that dispense these drugs.

GenBioPro argues in its lawsuit that the West Virginia state ban is unconstitutional because it violates the primacy and trade clauses of the US Constitution, which give the FDA the power to regulate what drugs are sold across the country.

“The individual government regulation of mifepristone destroys the national common market and conflicts with the strong national interest in ensuring access to a government-approved drug to terminate a pregnancy, resulting in the kind of economic disruption that the Framers intended to prevent by the clause,” argued GenBioPro’s attorneys in the lawsuit.

“A state’s policing authority does not extend to the functional prohibition of an article of interstate commerce — the Constitution leaves that to Congress,” the company’s attorneys wrote.

In another case, a North Carolina doctor on Wednesday asked a federal court to overturn state restrictions on mifepristone because they go beyond FDA regulations. In North Carolina, patients must receive the pill in person from a doctor at a certified facility.

“North Carolina’s imposition of restrictions beyond those that the FDA believes to be warranted as part of its regulatory balance, including restrictions that the FDA has specifically rejected, thwarts the objectives of federal law,” the doctor’s attorneys wrote in the complaint.

Anti-abortion activists, on the other hand, are pushing for mifepristone to be completely removed from the US market. A coalition of anti-abortion doctors has asked a Texas federal court to overturn mifepristone’s more than two-decade-old approval as safe and effective.

A decision in this case could be made as early as February.