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☆ 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.

April 7 (Reuters) - A federal judge on Friday halted federal regulators' approval of the abortion pill mifepristone while a legal challenge proceeds, partially granting a request by anti-abortion groups and dealing another setback to abortion rights in the United States. A White House official said they are reviewing the abortion ruling. Kacsmaryk's ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case before him continues. Some abortion providers have said that if mifepristone is unavailable, they would switch to a regimen using only misoprostol for a medication abortion. During the hearing in the case, the judge raised questions about the regulatory process used by the FDA.

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.

Here is a snapshot of pending and passed legislation seeking to restrict or protect access in 2023. KANSAS: Although Kansans voted in favor of state abortion rights on a ballot measure last year, the Republican-led state Senate has passed a prohibition on prescribing abortion pills via telemedicine. The Republican-led state is currently enforcing a total abortion ban, with exceptions for rape, incest or the life of the mother. MONTANA: The Republican-led state Senate has passed a bill seeking to overturn a 1999 state Supreme Court ruling that found that the state constitution protected a right to abortion. SOUTH CAROLINA: Despite the fact that the state Supreme Court recently struck down a six-week abortion ban in a 3-2 vote, Republicans have introduced a near-total abortion ban and a six-week ban this year.

☆ Washington state purchases three-year supply of abortion pill
▼ + stars: | 2023-04-05 | by ( ) www.reuters.com time to read: +1 min

April 4 (Reuters) - Washington state's government said on Tuesday it had purchased a three-year supply of abortion pill mifepristone as a Texas judge mulls a nationwide ban on the medication's sale. The state's Democratic governor directed its Department of Corrections, which has a pharmacy license, to purchase the medication last month, a government statement said. "Health care should be decided by a patient and their doctor, not a judge in Texas," Washington Governor Jay Inslee said in a tweet, adding that the purchase ensured "continued access" for all patients in his state. loadingLegal fights over abortion rights have ramped up in the United States after a Supreme Court ruling last year that overturned the landmark 1973 Roe v. Wade decision legalizing the procedure. Reporting by Kanjyik Ghosh in Bengaluru; Editing by Jamie FreedOur Standards: The Thomson Reuters Trust Principles.

March 28 (Reuters) - A federal judge in Texas on Tuesday refused to transfer to another court a lawsuit by Republican states challenging a Biden administration rule allowing socially conscious investing by retirement plans, rejecting claims of "judge shopping." U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, said the Biden administration had provided no evidence that the litigation did not belong in his court or that plaintiffs were attempting to manipulate the process. His courthouse has become a favored destination for Republicans seeking to challenge aspects of Democratic President Joe Biden's agenda. The Labor Department argues the rule is valid because it still requires retirement plans to consider traditional financial factors when choosing investments. Congress in early March voted to repeal the ESG rule, but Biden vetoed that bill.

☆ Dueling court cases in Washington state and Texas could determine legality of abortion pill
▼ + stars: | 2023-03-29 | by ( Spencer Kimball | ) www.cnbc.com time to read: +5 min

Two federal judges are poised to issue rulings soon in dueling cases that could dramatically impact access to the abortion pill mifepristone. In Washington state, U.S. Judge Thomas Rice is weighing whether to scrap federal regulations on mifepristone that complicate access even where abortion is legal. In the case of Texas, medical associations that oppose abortion are asking the judge to pull the abortion pill from the U.S. market nationwide. Ferguson and the 17 other attorneys general are asking the judge in Washington state to drop these restrictions. The states include Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania and Washington State.

Of the various potential rulings possible in the case involving the abortion pill mifepristone, either of those outcomes would be unprecedented judicial intervention in the agency's regulatory process. Some of the FDA's options could be politically and legally risky both for the agency and mifepristone suppliers, they said. The FDA said the pill was deemed safe after extensive studies and use, and that the challenge comes much too late. Under FDA statutes and regulations, drug approval withdrawal generally begins with an informal hearing, which can entail extensive document preparation and the convening of an advisory committee. Overseas provider Aid Access, an Austria-based service that ships abortion medication to U.S. patients, said it would continue providing the pill no matter how the FDA responds.

☆ 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.

☆ 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.

☆ 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.

March 15 (Reuters) - A U.S. judge in Texas is set to hear arguments on Wednesday in a bid by anti-abortion groups to ban sales of the abortion pill mifepristone across the country, even in states where abortion is legal, as they challenge regulatory approval granted more than two decades ago. Twelve of the 50 states now ban abortion outright while some others prohibit it after a certain length of pregnancy, according to the Guttmacher Institute, a research organization that supports abortion rights. The judge cited death threats and harassment directed at the court during the case and a wish to avoid disruption. After appealing to the 5th Circuit, the losing side could seek to take the matter to the U.S. Supreme Court. Reporting by Brendan Pierson in New York; Editing by Will Dunham and Alexia GaramfalviOur Standards: The Thomson Reuters Trust Principles.

☆ Texas abortion pill case: Lawyers requesting mifepristone’s removal from market concede there’s no precedent
▼ + stars: | 2023-03-15 | by ( Michelle Mark | ) www.businessinsider.com time to read: +3 min

A Texas lawsuit has demanded that the judge revoke the FDA approval of the abortion pill mifepristone. The group alleged in their lawsuit that the FDA approved an "unsafe" drug back in 2000. During Wednesday's hearing, The Washington Post and Associated Press reported that all parties acknowledged the unprecedented nature of the Alliance Defending Freedom's demand. The attorney representing the Alliance Defending Freedom, Erik Baptist, responded, "No, I can't." Drugs like mifepristone and misoprostol have been thrown into the spotlight ever since the Supreme Court overturned Roe v. Wade last June.

☆ 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.

☆ An anti-abortion judge overseeing a Texas lawsuit that could ban an abortion pill wanted to delay announcing the hearing date, The Washington Post reported
▼ + stars: | 2023-03-12 | by ( Lloyd Lee | ) www.businessinsider.com time to read: +6 min

Judge Matthew Kacsmaryk is overseeing a lawsuit that challenges the FDA approval of mifepristone. A hearing was scheduled for Wednesday, but the judge hoped to delay publicizing the date, per WaPo. But the Texas judge overseeing the case — who is known for his conservative politics and anti-abortion stance — hoped to hide the date of the hearing until right before the scheduled date, The Washington Post reported. In addition, he told attorneys on the call that members of the courthouse have received threats due to the lawsuit, the Post reported. According to the report, the Post had attempted to seek information about the date of the hearing before the Friday call but received no response.

The U.S. Department of Labor rule, which took effect Jan. 30, lifts barriers to ESG investing imposed by the Trump administration. The new rule sets guidelines for ESG investing, including requiring that socially conscious investments are still financially sound. They claim that allowing ESG investing will jeopardize the retirement savings of millions of people and lower state tax revenue. The Biden administration rule has divided the business community. The U.S. Securities and Exchange Commission (SEC) has proposed various rules aimed at increasing transparency related to ESG investing.

☆ 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.

Companies Liberty Energy Inc FollowFeb 22 (Reuters) - A coalition of Republican-led states has asked a federal judge to block a Biden administration rule allowing retirement plans to consider environmental, social and corporate governance (ESG) factors in selecting investments pending the outcome of their legal challenge. The 25 states in a motion filed in Amarillo, Texas federal court on Tuesday said the rule, which took effect Jan. 30, could lead to millions of Americans losing retirement investments and harm states' finances. The Biden administration has moved to transfer the lawsuit to a different court, accusing the states of engaging in judge shopping. An appointee of Republican former President Donald Trump, Kacsmaryk has previously struck down Biden administration rules on immigration and healthcare protections for LGBTQ people. The ESG rule makes it easier for retirement plans to invest in socially-responsible funds and companies, though it also requires traditional financial considerations.

Feb 21 (Reuters) - A Texas federal judge on Tuesday refused to set an accelerated trial schedule for a lawsuit by anti-abortion groups seeking to end U.S. sales of the abortion pill mifepristone, in a case that could severely disrupt access to medication abortion nationwide. Mifepristone is approved for medication abortion in the first 10 weeks of pregnancy in combination with another drug, misoprostol. Medication abortion accounts for more than half of U.S. abortions. Medication abortion has drawn increasing attention since the U.S. Supreme Court last year reversed its landmark 1973 Roe v. Wade ruling, which had guaranteed abortion rights nationwide. President Joe Biden, a Democrat, directed federal agencies to expand access to medication abortion in response to the decision, which has allowed more than a dozen Republican-led states to adopt new abortion bans.

☆ 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.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last year reversed its landmark 1973 Roe v. Wade ruling, which had guaranteed abortion rights nationwide. President Joe Biden, a Democrat, directed federal agencies to expand access to medication abortion in response to the decision. Mifepristone is used in combination with another drug, misoprostol, for medication abortion, which accounts for more than half of U.S. abortions. They said ending access to the drug would force patients to have unnecessary surgical abortions or prevent them from accessing abortion altogether. The Texas lawsuit could move quickly, as the plaintiffs in a filing on Friday asked Kacsmaryk to skip a hearing on a preliminary order and instead go straight to trial.

☆ 22 attorneys general say pulling abortion pill from U.S. would have 'devastating consequences'
▼ + stars: | 2023-02-10 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

The attorneys general from 21 states and Washington, D.C., on Friday argued that the attempt to pull the abortion pill from the U.S. market would have "devastating consequences" for women. "This would have devastating consequences," the attorneys general told Judge Matthew Kacsmaryk, who is presiding over the case in the U.S. District Court in Northern Texas. He ordered one of the abortion pill makers, Danco Laboratories, to lay out its opposition to the lawsuit. New York led the coalition of state attorneys general and Washington, D.C., in arguing to keep mifepristone on the market. GenBioPro, the other abortion pill manufacturer, is suing to overturn West Virginia's ban.

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