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☆ 5 things the Supreme Court will take into account in medication abortion case
▼ + stars: | 2023-04-12 | by ( Ariane De Vogue | ) edition.cnn.com time to read: +10 min

CNN —As the Supreme Court prepares for yet another controversial abortion case to come its way, the justices will pore over District Court Judge Matthew Kacsmaryk’s ruling last week to block the government’s approval of the key medication abortion drug at issue. “There are serious questions on whether the Supreme Court is willing to endorse the district’s court’s very broad approach to those questions,” he said. As he often does, Supreme Court Justice Brett Kavanaugh wrote separately last June to explain his thinking in voting to overturn Roe v. Wade. The Supreme Court might also take issue with the relief that Kacsmaryk ordered. None other than the liberals on the Supreme Court who dissented in Dobbs.

[1/4] A pack of birth control pills is displayed in this illustration picture taken in Philadelphia, Pennsylvania, U.S., July 11, 2022. REUTERS/Hannah Beier/IllustrationApril 10 (Reuters) - Over 300 biotech and pharmaceutical industry executives, including Pfizer Inc (PFE.N) CEO Albert Bourla, signed an open letter on Monday calling for reversal of a federal judge's decision to suspend sales of the abortion pill mifepristone. Last week's ruling by Judge Matthew Kacsmaryk undermines the FDA's authority, the letter's authors wrote, adding that it ignores decades of scientific evidence and legal precedent. The ruling could open the possibility to the banning of vaccines and contraception for women, said Levin. "It's the single worst threat to the industry in over 50 years."

☆ Drug Company Leaders Condemn Ruling Invalidating F.D.A. Approval of Abortion Pill
▼ + stars: | 2023-04-10 | by ( Christina Jewett | ) www.nytimes.com time to read: +1 min

Senior executives of more than 250 pharmaceutical and biotech companies on Monday issued a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s 23-year-old approval of the abortion pill mifepristone, and they called for the decision to be reversed. “The decision ignores decades of scientific evidence and legal precedent,” said the letter, which was signed by leaders of some of the industry’s most prominent companies, including Albert Bourla, chief executive of Pfizer, and Alisha Alaimo, president of Biogen. The ruling, by Judge Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas, “has set a precedent for diminishing F.D.A.’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry,” the letter argues. The letter also said that pharmaceutical companies rely on the F.D.A.’s autonomy to bring products to market under a “reliable regulatory process for drug evaluation and approval.”

☆ DOJ asks judge to clarify legality of abortion pill mifepristone after dueling court rulings
▼ + stars: | 2023-04-10 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Rice's decision came just 20 minutes after U.S. District Judge Matthew Kacsmaryk of the U.S. Northern District of Texas suspended the FDA's approval of mifepristone nationwide. The Justice Department on Monday asked the 5th Circuit Court of Appeals to block Kacsmaryk's decision from taking effect as litigation plays out. The government's lawyers indicated they may ask the Supreme Court to get involved. The Justice Department asked Rice to clarify its obligations on the legality of mifepristone by Friday. Kacsmaryk's decision goes into effect at midnight CT on Saturday if the 5th Circuit doesn't block the order out of Texas.

WASHINGTON, April 10 (Reuters) - A federal judge's decision last week to suspend the U.S. Food and Drug Administration's (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said. The FDA approved mifepristone, part of a two-drug regimen that accounts for more than half of U.S. abortions, over 20 years ago. Banning its sale calls into question the FDA's power to regulate all drugs nationwide, the experts said. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before Kacsmaryk, who is himself a conservative former Christian activist. Plaintiffs are arguing that the FDA in its 2000 approval did not adequately consider the drug's safety when used by girls under age 18 to terminate a pregnancy.

April 7 (Reuters) - The federal judge who on Friday suspended approval of the abortion pill mifepristone is a former Christian legal activist whose small courthouse in Amarillo, Texas, has become a go-to destination for conservatives challenging Biden administration policies. U.S. District Judge Matthew Kacsmaryk, an appointee of former Republican President Donald Trump, had a long track record of opposing abortion and LGBTQ rights before the U.S. Senate confirmed him in 2019 to a life-tenured position as a federal judge. FAVORED VENUESince then, his courthouse has become a favored venue for conservative legal activists and Republican state attorneys general pursuing lawsuits seeking to halt aspects of Democratic President Joe Biden's agenda - often with success. In October, Kacsmaryk vacated Biden administration guidance requiring employers to allow transgender workers to dress and use bathrooms consistent with their gender identities. Reporting by Nate Raymond in Boston, Editing by Alexia Garamfalvi, Bill Berkrot and Diane CraftOur Standards: The Thomson Reuters Trust Principles.

Pool via REUTERSApril 8 (Reuters) - The federal judge who on Friday suspended approval of the abortion pill mifepristone is a former Christian legal activist whose small courthouse in Amarillo, Texas, has become a go-to destination for conservatives challenging Biden administration policies. U.S. District Judge Matthew Kacsmaryk, an appointee of former Republican President Donald Trump, had a long track record of opposing abortion and LGBTQ rights before the U.S. Senate confirmed him in 2019 to a life-tenured position as a federal judge. When anti-abortion groups in November filed a lawsuit challenging the U.S. Food and Drug Administration's more than two-decade old approval of the abortion pill mifepristone, they filed in Amarillo, guaranteeing the case would be heard by Kacsmaryk. FAVORED VENUESince then, his courthouse has become a favored venue for conservative legal activists and Republican state attorneys general pursuing lawsuits seeking to halt aspects of Democratic President Joe Biden's agenda - often with success. While the district's chief judge could order cases be reallocated, he has not.

☆ Federal judge stays FDA abortion pill approval, gives Biden administration time to appeal
▼ + stars: | 2023-04-07 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15, 2023. A federal judge in Texas on Friday stayed the Food and Drug Administration's approval of the abortion pill mifepristone, but delayed the ruling taking effect for a week, giving the Biden administration time to appeal. The Food and Drug Administration, abortion pill maker Danco Laboratories and the anti-abortion group Alliance Defending Freedom presented their arguments before the court. The alliance represents a coalition of physicians opposed to abortion called the Alliance for Hippocratic Medicine, which sued the FDA in November over its approval of mifepristone. It took more than four years from the filing of the initial application until the pill was approved.

Any impact on the FDA will depend on details of the judge's ruling in the case known as Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The challenge was brought by a coalition of anti-abortion groups and doctors seeking withdrawal of the FDA's mifepristone approval before U.S. District Judge Matthew Kacsmaryk of the Northern District of Texas, a conservative former Christian activist. The court could order mifepristone pulled from the market while it considers a final ruling. It would call into question the entire drug approval process, said Laurie Sobel, associate director for Women's Health Policy at the Kaiser Family Foundation. 'SO MUCH UNCERTAINTY'The possibility of its approvals being overruled would likely see the FDA become more cautious, Lee said.

☆ Judge Strikes Down Some Affordable Care Act Rules on Preventive Health Services
▼ + stars: | 2023-03-30 | by ( Stephanie Armour | ) www.wsj.com time to read: 1 min

Under the ACA, health plans must generally provide access to no-cost preventive care. WASHINGTON—A federal judge in Texas struck down a major part of the Affordable Care Act’s requirement that most insurers cover certain preventive health services, in a ruling that applies nationwide and will likely be appealed. Judge Reed O’Connor of the U.S. District Court for the Northern District of Texas issued on Thursday a nationwide injunction striking down the requirement that most commercial insurers fully cover dozens of preventive-care services and screenings recommended by a federal task force with no out-of-pocket consumer costs.

☆ Judge strikes down Obamacare coverage of preventive care for cancers, diabetes, HIV and other conditions
▼ + stars: | 2023-03-30 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

A federal judge on Thursday struck down an Obamacare mandate that required most private health insurance plans to cover preventive care such as certain cancer screenings and HIV prevention drugs. You can find the full list of covered preventive services the judge struck down here. Judge Reed O'Connor in U.S. Northern District of Texas struck down those coverage requirements and blocked the federal government from enforcing them. The Affordable Care Act mandated free coverage of health services recommended by an independent panel of experts called the Preventive Services Task Force. They had also sought to overturn the federal mandate that requires Obamacare compliant plans to cover birth control with no out-of-pocket costs.

☆ Abortion pill mifepristone ruling in Texas case could hinge on 1873 Comstock Act
▼ + stars: | 2023-03-21 | by ( Spencer Kimball | ) www.cnbc.com time to read: +6 min

A federal judge in Texas may try to invoke an obscure 19th-century law called the Comstock Act to roll back mail delivery of the abortion pill mifepristone. His rationale could hinge in part on the Comstock Act. The anti-abortion group's attorneys argued that the Comstock Act and other laws ban mail delivery of mifepristone. The Comstock Act has not been enforced in decades, said Rachel Rebouche, an expert on reproductive health law at Temple University. Congress passed the Comstock Act in 1873 after an anti-vice crusader named Anthony Comstock successfully lobbied lawmakers to declare "obscene" materials as not mailable.

☆ U.S. judge in Texas will soon rule on the abortion pill mifepristone. Here's what could happen
▼ + stars: | 2023-03-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify the FDA's medical approval of mifepristone, which would effectively ban the abortion pill across the US. Senate Judiciary Committee | YouTubeA Texas judge will soon issue a pivotal ruling in a closely watched case challenging the Food and Drug Administration's approval of the abortion pill mifepristone. It's also possible that Kacsmaryk could order the agency to impose tighter restrictions on access to mifepristone but stop short of completely halting sales. Abortion rights groups and legal experts expect the judge will rule against the FDA in some form. Possible injunctionIf Kacsmaryk issues an order to withdraw mifepristone from the market, there are several ways such a ruling could be drafted.

☆ Abortion pill fight: Read the transcript of Texas court hearing on fate of mifepristone
▼ + stars: | 2023-03-17 | by ( Spencer Kimball | ) www.cnbc.com time to read: +1 min

Abortion rights advocates gather in front of the J Marvin Jones Federal Building and Courthouse in Amarillo, Texas, on March 15, 2023. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas in Amarillo heard four hours of arguments. The anti-abortion group that filed the lawsuit, the Alliance Defending Freedom, presented their case against the FDA first. They were followed by Justice Department attorneys defending the FDA and then the abortion pill maker Danco Laboratories. The Alliance Defending Freedom argued that mifepristone is unsafe and the FDA did not properly follow its approval process when it cleared mifepristone for use in 2000.

☆ Citing 'death threats,' Texas judge asked attorneys to keep news of hearing on legality of abortion pill quiet
▼ + stars: | 2023-03-14 | by ( Spencer Kimball | ) www.cnbc.com time to read: +4 min

The Alliance For Hippocratic Medicine wants Judge Kacsmaryk to nullify the FDA's medical approval of mifepristone, which would effectively ban the abortion pill across the US. But Kacsmaryk asked the attorneys to not to publicize the hearing, citing security concerns. Those present at the Friday conference call included lawyers from the Justice Department, the abortion pill maker Danco Laboratories, and a group that opposes abortion called the Alliance Defending Freedom. A group of physicians who oppose abortion called the Alliance for Hippocratic Medicine asked Kacsmaryk in November to order the Food and Drug Administration to withdraw its approval of the abortion pill mifepristone. The abortion pill has become the central flashpoint in the legal battle over access to abortion in the wake of the Supreme Court's ruling that overturned Roe v. Wade last June.

☆ Judge shares date of abortion pill hearing after media outlets criticize him for secrecy
▼ + stars: | 2023-03-13 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

A federal judge in Texas publicly disclosed that he scheduled a hearing in a case seeking to overturn the Food and Drug Administration's approval of the abortion pill mifepristone, after media outlets criticized him for attempting to keep the proceedings secret until the last minute. The hearing will take place in Amarillo, Texas. Media outlets filed a letter on Monday urging Kacsmaryk to disclose the date of the hearing immediately. The outlets included NBCUniversal News Group, of which CNBC is a part, The Washington Post, ProPublica, the Texas Press Association and Gannett, among others. They argued that the way the FDA approved mifepristone violated federal law.

☆ 3D printer company to pay U.S. up to $27 mln for violating export curbs to China
▼ + stars: | 2023-02-27 | by ( Karen Freifeld | ) www.reuters.com time to read: +2 min

WASHINGTON, Feb 27 (Reuters) - 3D Systems Corp on Monday agreed to pay up to $27 million to settle with the U.S. for illegally exporting to China controlled design drawings for military electronics and spacecraft, among other violations. Besides the Commerce Department, the company also settled with the U.S. Department of Justice and the U.S. Department of State. The Commerce Department penalty is for $2.8 million. In addition to the aerospace documents, the Commerce Department said, 3D Systems exported metal alloy powder to China without a license, although it is restricted for national security and nuclear nonproliferation reasons. "The company is pleased to have reached a settlement with the agencies and remains committed to continuing to enhance its export controls program," 3D Systems said in a statement.

☆ Who is Matthew Kacsmaryk, the Trump-appointed Texas judge who could ban abortion pills?
▼ + stars: | 2023-02-26 | by ( Lloyd Lee | ) www.businessinsider.com time to read: +8 min

Matthew Kacsmaryk is a Texas federal judge who was nominated by Donald Trump in 2017. Kacsmaryk graduated from Abilene Christian University in 1999 and received his law degree from the University of Texas School of Law in 2003. The Post reported that it was during law school when Kacsmaryk focused on abortion rights. Kacsmaryk also served as the executive editor of the Texas Review of Law & Politics and received two Dean's Achievement Awards, according to the questionnaire. During his undergraduate years, studying political science, Kacsmaryk was outspoken about his conservative views and stances on abortion.

☆ Childbirth is far more dangerous for women than the abortion pill, American Medical Association tells the Texas judge weighing mifepristone ban
▼ + stars: | 2023-02-16 | by ( Charles R. Davis | ) www.businessinsider.com time to read: +5 min

The American Medical Association is urging a Texas judge to reject an effort to ban mifepristone. This is not an opinion — it is a fact based on hundreds of medical studies and vast amounts of data amassed over the course of two decades," the brief states. But pregnant teenagers, the medical groups note, have levels of progesterone far greater than their non-pregnant peers. "There is no reason to think, nor is there evidence to show, that preventing the absorption of progesterone for a brief window would have any effects on adolescent development," the brief states. Republican attorneys general also submitted a brief arguing that the availability of the drug infringes on the right of states to regulate abortion.

☆ There will be an 'unprecedented spike' in maternal mortality if a Trump-appointed judge bans the abortion pill, Democratic attorneys general argue
▼ + stars: | 2023-02-14 | by ( Charles R. Davis | ) www.businessinsider.com time to read: +7 min

Banning mifepristone will result in more women dying in pregnancy, Democratic attorneys general argued this month. The argument comes as a judge in Texas is considering a ban on the abortion pill. Republican attorneys general who have weighed in on the case also maintain that its approval infringed on state rights. In her brief, James noted that carrying a pregnancy to term poses significantly greater health risks than an early abortion. As Slate's Christina Cautertucci notes, mifepristone is only one of the two drugs used in a typical medication abortion.

"It's judge shopping on steroids," said Sarah Lipton-Lubet, executive director of the progressive legal advocacy group Take Back the Court. The Biden administration has called the lawsuit "unprecedented" and urged Kacsmaryk to not deprive women of a long-approved safe and effective drug. At least eight have led to rulings blocking Biden policies, with several more pending. The chief judges of Texas federal courts have the authority to reallocate cases to other judges, but have largely not done so, he said. Absent a change, litigants have every right to take advantage of that structure to seek a favorable judge, he said.

The states filed a complaint in a federal court in Amarillo, Texas, on Thursday arguing that the rule finalized in November will lead many retirement plans to focus on a social agenda rather than long-term financial stability for investors. The rule, which takes effect on Monday, reverses restrictions on socially conscious investing that were adopted by the Trump administration. The states in Thursday's lawsuit said the new rule fails to justify the departure from Trump-era regulations, in violation of the federal law governing rulemaking. And, the states said, it violates the U.S. law that regulates employee benefit plans by failing to protect retirement assets. The case is Utah v. Walsh, U.S. District Court for the Northern District of Texas, No.

☆ The FDA's power to approve drugs faces sweeping challenge in lawsuit seeking to pull abortion pill from U.S. market
▼ + stars: | 2023-01-24 | by ( Spencer Kimball | ) www.cnbc.com time to read: +7 min

The Alliance for Hippocratic Medicine asked a federal district court in Dallas late last year to declare the FDA approval unlawful and completely remove the abortion pill from the U.S. market. If the lawsuit prevails, women across the U.S. would lose access, at least temporarily, to the most commonly used abortion method. Judge Matthew Kacsmaryk is hearing the challenge to the FDA's approval of the abortion pill. Lawrence Gostin, an expert on public health law at Georgetown Law, said it would be "highly irresponsible" and "reckless" for a judge to overturn the FDA approval of mifepristone. Under federal law, lawsuits against the U.S. government must be filed within six years of an agency action.

☆ Federal judge temporarily blocks Biden from ending Trump-era 'Remain in Mexico' policy
▼ + stars: | 2022-12-16 | by ( Zoë Richards | Zoë Richards Is The Evening Politics Reporter For Nbc News. | ) www.nbcnews.com time to read: +1 min

A federal judge on Thursday temporarily blocked the Biden administration from ending a Trump-era policy designed to restrict immigration at the southern border. The Supreme Court said in a 5-4 ruling in June that the Biden administration had acted properly in seeking to end the policy, reversing a federal appeals court ruling that rejected a fresh attempt to end the policy in October 2021. The administration was previously forced to reinstate the policy after Texas and Missouri sued. Texas Attorney General Ken Paxton, who filed suit to block the policy from being lifted, praised the judge's order on Twitter. Immigrant rights groups and opponents of "Remain in Mexico," which is separate from another Trump-era border policy known as Title 42, say it denies people the right to seek protection in the U.S. and forces them to face potentially dangerous circumstances as they await asylum.

☆ Biden's student-loan forgiveness remains blocked after another federal court rejects the administration's attempt to revive its debt relief
▼ + stars: | 2022-12-01 | by ( Ayelet Sheffey | ) www.businessinsider.com time to read: +3 min

It was in response to Biden's appeal to the court after a Texas judge blocked the relief. Separately, the Supreme Court is expected to rule on an 8th Circuit decision also blocking relief. On Wednesday night, a three-judge panel in the 5th Circuit Court of Appeals ruled that it would not grant the Biden administration's request to pause a district court decision that blocked the implementation of student-loan forgiveness. The Supreme Court has not yet issued a decision on whether it will grant the Biden administration's request to revive debt relief for millions of borrowers. Now, the fate of student-debt relief appears to rest at the Supreme Court.

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