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Texas Judge Questions Safety of FDA-Approved Abortion Drug



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AMARILLO, Texas. — A federal judge who could overturn access to a key abortion drug seemed open to an argument on Wednesday that the drug was not properly tested and may not be safe, says the Food and Drug Administration and presenters healthcare organizations.

While an anti-abortion group contesting the drug has acknowledged that there is no precedent for a court to suspend a long-approved drug, U.S. District Judge Matthew Kaczmarik has questioned mifepristone’s compliance with the stringent federal standards required for prescribing to patients in the United States. .

He asked the group’s lawyer if the court could unilaterally revoke the FDA’s approval for the drug, and contacted attorneys for both sides about whether the pills should be banned from mailing due to 19th century law which prohibits the submission of articles “for any obscene or immoral use” through the Postal Service.

At the end of the four-hour hearing, Kaczmarik said he would make his decision as soon as possible, which could lead to disruption of access to mifepristone even in states where abortion is legal and protected by law. His decision is likely to be appealed to the conservative US Court of Appeals for the Fifth Circuit, and the case could eventually go to the Supreme Court.

Medical abortion, which accounts for more than half of all abortions in the United States, has become increasingly controversial since the Supreme Court’s conservative majority rejected it. Row vs Calf in June, abolishing the constitutional right to terminate a pregnancy.

In a two-stage medical abortion, the patient first takes one tablet of mifepristone, which terminates the pregnancy, then takes a second drug, misoprostol, to expel the embryo or fetus. While misoprostol is widely used by itself for abortions around the world – and many U.S. abortion providers say they will do the same if mifepristone is withdrawn from sale – studies show it is less effective than the two-step regimen. , and usually causes more cramping and bleeding.

The abortion pill actually consists of two pills – mifepristone and misoprostol. Here’s how it works. (Video: Washington Post)

The lawsuit was filed by the conservative legal group, the Alliance for Freedom, on behalf of anti-abortion medical organizations and four doctors who claim to have treated patients with mifepristone. The complaint accuses the FDA of approving an “unsafe drug regimen” without sufficient scrutiny and objects to recent moves to make it easier to get the drug.

Public health professionals and lawyers condemned the lawsuit as unsupported by scientific evidence and said it could overturn the FDA’s overall drug approval process. The agency has repeatedly stated that the two-stage medical abortion protocol is a safe and effective alternative to surgical abortion.

The plaintiffs have asked Kaczmarik to issue a preliminary injunction ordering the FDA to withdraw or suspend its approval of mifepristone.

Justice Department lawyers object to the court’s questioning the FDA’s technical expertise and called the request for an injunction “extraordinary and unprecedented.” The lawsuit, the government said in court documents, is based on false claims that the drug causes serious complications and “does not recognize that the alternatives to mifepristone – surgical abortion or pregnancy maintenance – also have a complication rate, with birth rates significantly higher than mifepristone”.

A court in Texas held a March 15 hearing in a lawsuit filed by anti-abortion groups challenging the FDA’s approval of the widely used abortion pill mifepristone (Video: The Washington Post)

Wednesday’s hearing was the first time Kaczmarik spoke directly with DOJ lawyers representing the FDA; the company that manufactures and distributes the drug; and an anti-abortion group challenging the drug.

The judge left his toughest questions to state attorneys. He expressed skepticism about what he described as an accelerated government approval process for mifepristone and questioned the safety of a more recent FDA decision to allow the drug to be dispensed by mail rather than in person by a doctor. Kaczmarik noted that the accelerated process is commonly used for drugs that treat life-threatening diseases such as HIV and cancer. In response, Justice Department lawyers opposed accusations that the approval process was flawed and said there was strong evidence that the pill was safe even if it was not administered by a doctor.

It took more than four years for the abortion pill to receive FDA approval in 2000.

Kaczmarik approached Eric Baptist, a lawyer at Alliance Defending Freedom, asking if he could come up with a “counterpart where the courts intervene in this way” so many years after the drug was approved.

“No, I can’t,” Baptiste said. He then noted that people had been trying for years to challenge the approval of the drug internally through the FDA.

Kaczmarik also reached out to Baptist for advice on how a potential solution could be implemented, asking if the conservative group thinks a judge can unilaterally direct the FDA to withdraw its approval or has the power to just start the process.

According to Baptiste, the court may “at its own discretion” order the FDA to withdraw.

Kaczmarik could issue a broad ruling directing the government to withdraw approval of the drug, or a narrower resolution, such as requiring the FDA to reintroduce restrictions on the distribution of mifepristone.

It is unusual for the FDA to order a drug from the market for safety reasons. The multi-step process can take years because the manufacturer, if they disagree with the agency, has the right to present their case and can request a hearing.

At the hearing, Kaczmarik also questioned whether anti-abortion groups and individual doctors challenging the drug have sufficient legal grounds or standing to file a lawsuit. The Department of Justice described as speculative doctors’ claims that they were directly harmed because they treated patients who claimed they had complications from their medications.

Much of Wednesday’s hearing focused on federal regulations and FDA processes. He didn’t delve into the legality of abortion or when life begins.

During the hearing, lawyers for the anti-abortion group argued that the FDA’s decision to allow mail-order abortion pills violated a 150-year-old law. The Comstock Act, they say, prohibits the mailing of any drugs used “to produce abortions.”

These arguments seem to have resonated with Kaczmarik, who asked government lawyers if there was “any dispute” that the law prohibits mail-order abortion drugs.

The Justice Department argued that modern interpretation of the law has never prevented abortion pills from being mailed, partly because the drugs have other uses and because abortion remains legal in many cases.

Minutes before the adjournment of the hearing, Kaczmarik requested confirmation that the plaintiffs also did not contest the FDA’s approval of misoprostol.

“Right,” Baptiste said, adding that misoprostol has a number of approved uses beyond abortion. At the same time, he argued that a decision based on Comstock’s Law may also affect misoprostol.

Jenny Ma, senior adviser for the Center for Reproductive Rights, said in a recent interview that if Kaczmarik invokes the law in his decision, he could ban all forms of medical abortion by mail, including the two-stage regimen with mifepristone and the misoprostol-only alternative.

Even if access to misoprostol is not restricted, some providers say they will only do surgical abortions if mifepristone is taken off the market. Service providers said either scenario would lead to widespread upheaval as they attempt to introduce new procedures that some clinic owners fear could create legal hurdles.

Some stockpiled mifepristone pending a decision, hoping that they would still be allowed to distribute the pills they already have, regardless of Kaczmarik’s decision. Organizations that ship abortion drugs to clients in the US from overseas will not be directly affected by the judge’s decision.

Kachmarik, candidate for President Donald Trump draws criticism from abortion rights advocates due to his longtime anti-abortion views. Previously, he was a lawyer for the conservative legal organization First Liberty.

A devout Christian, Kaczmarik usually begins a trial in the courtroom by saying: “Let’s pray.” Wednesday’s hearing also opened in this way.

The scheduling of the hearing itself became a source of controversy after the judge deliberately delayed public notice and asked the parties’ lawyers to remain silent about the scheduled hearing, steps he said he took to try to minimize disruptions, security threats and protests. Kaczmarik said he could wait until late Tuesday to announce the hearing, which would normally be published in court records shortly after the call.

After The Washington Post informed lawyers of the judge’s directive, a coalition of media organizations criticized the decision, and on Monday the judge officially released a notice of the hearing.

Marimov reported from Washington. Laurie McGinley of Washington contributed to this report.

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For Trump and his potential 2024 GOP rivals, it’s all about Iowa



DEMOINES, Iowa — Donald Trump was in Iowa on Monday. Government Ron DeSantis of Florida made his first visit last week. Nikki Haley and Senator Tim Scott of South Carolina made recent trips. And on Saturday, former Vice President Mike Pence will speak.

Despite Democrats choosing to snub Iowa in 2024, the state has never been seen by Republicans as significant in the presidential race. For one Republican, it was a do-or-die feeling — the first real test of Mr. Trump’s strength or vulnerability.

In modern times, no former president has sought to reclaim the White House. Mr. Trump’s loss or even less-than-convincing victory in the state caucuses, the Republican kick-off contest early next year, would signal near-fatal weakness in his campaign, according to GOP strategists inside and outside the state. . For this reason, both his rivals and Trump himself are paying increased attention to Iowa.

“I don’t see a formula where Trump loses Iowa and it doesn’t really hurt him and his chances as a candidate,” said Terry Sullivan, who ran Senator Marco Rubio’s 2016 presidential campaign.

Despite Mr. Trump handily winning Iowa’s 2016 and 2020 general elections, Republican activists in the state have said he is not guaranteed a 2024 caucus victory, although he remains the leader.

Last week a Des Moines Registration / Mediacom Iowa Poll found that Mr. Trump’s appeal is waning: if he becomes a candidate in 2024, only 47 percent of Republicans in Iowa would definitely support him in the general election. That’s a double-digit decline from the 69 percent who in 2021 said they would definitely support it.

“For a former president, winning the Iowa caucuses is everything,” said Bob Vander Platz, the state’s influential evangelical voter leader. “If he loses, it will mean a nomination” for everyone else, he said. “If he wins the Iowa caucuses, no one will stop him.”

After the Democrats decided that Iowa’s almost all-white, mostly rural population is not representative and replaced South Carolina as the starting state for their 2024 primaries, the Republicans are accepting the state’s traditional role as a testing ground.

The Trump campaign has hired seasoned state leaders and is planning to build Iowa’s caucuses infrastructure, signaling a desire to turn things around in 2016, when Mr. Trump was shocked to come second in the caucuses.

At the time, the politically inexperienced reality TV star believed that the large crowds at his rallies would easily escalate into a flood of rally attendees. Instead, he lost to Senator Ted Cruz of Texas. Mr. Trump was so angry that he flew out of Iowa without thanking his local staff. unreasonably tweet later that Mr. Cruz won due to “fraud” — a preview of his approach after losing re-election in 2020.

Trump advisers have said they do not intend to repeat the mistakes of 2016. “We have a major political operation in Iowa, run and coordinated by exceptionally competent professionals who know their stuff,” said Chris Lacivita, a senior Trump campaign adviser. “We are doing this because, firstly, we are serious, and secondly, we want to win.”

Mr. Trump has hired Marshall Moreau, who oversaw last year’s unsuccessful Republican Attorney General’s victory in Iowa, as his state director. He also hired Alex Latchman, former political director of the Iowa Republican Party, as his director of early voting states. Mr. Latchman witnessed Trump’s clumsy efforts in 2016.

“We have learned from this lesson,” Mr. Latchman said.

Unlike primaries, the caucus is a low-turnout caucus that requires voters to weather the usually cold winter night for hours-long speeches and voting in their local precincts.

In 2016, Mr. Trump’s Iowa staff, including a former Apprentice contestant, hired volunteer organizers but failed to teach them how to reach meeting participants or even provide literature to leave at the door. There were many dark nights at Trump’s headquarters in suburban Des Moines, when competitors had many volunteers on the phone.

Trump’s advisers said things would be different this time. They pointed to Mr. Trump’s first visit to Iowa on Monday as the 2024 nominee. The campaign said it was tracking the names and emails of thousands of people who signed up to participate and filled a packed 2,400-seat hall in Davenport, Iowa.

How Times reporters cover politics. We expect our journalists to be independent observers. Thus, while Times employees may vote, they are not permitted to support or campaign for candidates or for political reasons. This includes participating in marches or rallies in support of a movement, or donating or raising money for any political candidate or election campaign.

“The real work of a campaign starts when the president is on the move,” Mr. Latchman said. “We’re going to continue to consistently recruit these people every single day until February.”

Mr. Trump has also bowed to campaign traditions he once shunned. During his speech in Davenport, he answered unscripted questions from the audience for 20 minutes. Prior to the rally, he unannounced a visit to Machine Shed, a popular Iowa chain.

One of Mr. Trump’s rivals, Ms. Haley, a former United Nations ambassador to the Trump administration, has traveled to Iowa twice since entering the race last month, and on both visits, she spoke at length with voters, relying on a one-on-one basis. . campaign style that helped her win election as governor of South Carolina.

Restaurant visits are a not-so-subtle way that Trump’s advisers in 2024 intend to create a contrast with his likely archrival, Mr. DeSantis, who is battling the wooden man’s reputation.

“Big rallies have worked in the past,” said Mr. Lacivita, a senior Trump adviser. “This is definitely a different campaign than in 2016. Now is another time. We’re going to do a mixture of retail politics and large-scale rallies.”

One national Republican strategist, Kyle Plotkin, had an opposing view of Iowa’s importance to Trump, noting that even if he loses there, his diehard supporters are about 30 percent of Republicans. in national polls – it would be enough for him to defeat the contenders who divided the voices of the opposition on the field.

Iowa GOP activists said Mr. Trump had a hot base of supporters, but many Republicans were open to an alternative, especially one they saw as more electable.

“I think Trump is supportive, but I wouldn’t say it’s in the bag,” said Steve Sheffler, one of two members of the Iowa Republican National Committee.

Gloria Mazza, GOP chairman for Polk County, the largest county in the state, said of the GOP base, “Are they looking for someone else? They can be”.

And Mr. Vander Plaats, the leader of the evangelical voters who make up the large Republican bloc in Iowa, said many are open to an alternative to Mr. Trump. “My concern, along with the fears of many other people, is that we are concerned about how America has pretty much decided on Donald Trump,” he said. “I think it’s time to get behind the next leader who can win in 2024.”

Mr. Vander Plaats said evangelicals had not forgotten that Mr. Trump blamed the significant Republican defeats in the 2022 midterm elections on the fact that candidates focused too much on the “abortion issue.”

“Putting the blame on the pro-life movement showed Trump’s character,” said Mr. Vander Plaats. “If you’re trying to win the Iowa caucuses, I wouldn’t put this base under a bus.”

If Mr. Pence enters the race, as many expected, the Trump campaign could run into trouble over the former vice president’s conversion to evangelical voters. And Mr. Pence may adopt a strategy of camping out in Iowa, spending most of his time in the state to put on a strong caucus.

“Mike Pence could do well in Iowa,” said Rick Tyler, Cruise’s top assistant in 2016. “I don’t think Trump has a chance in Iowa this time because he offended the evangelical base so much.”

Maggie Haberman made a report.

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GOP budget attack



Republican Senate budget planners have launched a multilateral attack on President Joe Biden’s fiscal year 2024 budget request, while Democrats have pointed to Congressional Budget Office analysis to say the GOP House budget plans are unrealistic. David Lerman, Peter Cohn, and Paul M. Kravzak of CQ Roll Call evaluate how the Biden draft was received on Capitol Hill and what it means for the appropriation process.

Show Notes:

The post-GOP budget attack first appeared on roll call.

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Twitter Files: Massive Censorship Project Rolled Out Against Politically Incorrect Speech About COVID-19



According to the latest release of “Twitter Files”, during the pandemic, the internet watchdog, the Stanford Internet Observatory, launched a sweeping effort to purge social media platforms of unwanted opinions related to COVID, whether or not the messages were true.

Internal emails released Friday by journalist Matt Taibbi show how the Stanford Internet Observatory Virality Project coordinated with several other academic institutions and publicly funded nonprofits to conduct a massive operation to monitor vaccine misinformation and shape platform policy to rid the web of from views that have disappeared. against the liberal mainstream.

Mr Taibbi said Twitter was one of six social media platforms that partnered with the Virality Project to monitor COVID-related posts during the pandemic.

In addition to the direct line for flagging posts, the collaboration also included a periodic roundup of vaccine misinformation spread across platforms, lists of repeat offenders, and lists of “truthful content that could contribute to mistrust of vaccines.”

The package of truthful information that the Virality Project wanted to ban included “viral posts by people expressing hesitancy about vaccines” and/or “stories of real vaccine side effects.”

The watchdog also took aim at discussions about vaccine passports, warning that such messages have “spurred a broader anti-vaccine narrative of loss of rights and freedoms.”

Mr. Taibbi said the project was an “Orwellian proof of concept” that “accelerated the evolution of digital censorship from true/false judgment to a new, more frightening model that openly focuses on political narrative at the expense of facts.” “.

The Stanford Internet Observatory did not respond to a request for comment.

The Twitter Files are the result of Elon Musk opening up the company’s email vault to select journalists after he took over Twitter in October 2022. It exposed the company’s politically biased behavior and partnerships with federal officials during the 2020 presidential campaign and throughout the COVID-19 pandemic. 19 pandemic.

In February 2021, the Virality Project emailed Twitter executives announcing the newly formed partnership and started a conversation about “how we can best collaborate with the Twitter team on this work.”

“Our goal is to connect with your team through which we can spread vaccine-related misinformation narratives that we flag either on Twitter or other platforms,” ​​a spokesperson for the Virality Project wrote in an email to executives. companies. .

The Virality project was given access to Twitter’s internal ticketing system to flag posts, and announced in a March 2021 email that it was “starting to expand” its notification process to other platforms.

Speaking before the federal government’s House Arms Subcommittee last week, Mr. Taibbi and fellow Twitter Files journalist Michael Shellenberger warned of an “industrial censorship complex” that is undermining Americans’ free speech.

In December, two journalists began revealing the extent of the federal government’s collaboration with Twitter executives to moderate content on the platform.

The Twitter files also revealed what Mr. Taibbi describes as a vast network of censorship that included online speech monitoring programs spearheaded by non-governmental organizations to suppress speech outside the mainstream.

“This is a serious threat to people of all political persuasions,” Mr. Taibbi said. “The First Amendment and the American population, accustomed to the right of speech, is the left’s best defense against the censorship industrial complex. If there’s anything the Twitter files show, it’s that we risk losing this most precious right, without which all democratic rights are impossible.”

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