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The Supreme Court, which has a 6-3 conservative majority, is expected to act before the deadline to either grant or reject the requests or further pause the litigation. The Food and Drug Administration (FDA), the U.S. agency that signs off on the safety of food products, drugs and medical devices, approved mifepristone in 2000. Circuit Court of Appeals on April 12 declined to block the curbs ordered by Kacsmaryk. Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November. The plaintiffs contend that the agency used an unlawful process to approve the drug, which they consider to be dangerous.
CompaniesCompanies Law Firms Grail Inc FollowIllumina Inc Follow(Reuters) - A U.S. appeals court on Tuesday said it will accelerate reviewing Illumina Inc's challenge to a federal agency order requiring the biotechnology company to divest cancer diagnostic test maker Grail LLC. The agency said Illumina had not shown why the appeals court needed to speed up its consideration of the antitrust dispute. San Diego-based Illumina, which specializes in gene sequencing, is appealing an April 3 FTC order that said the company's $7.1 billion acquisition of Grail will curb competition in the cancer-testing market. The FTC in 2021 sued Illumina over its bid for Grail, a former subsidiary of the company. The case is Illumina Inc and Grail Inc v. Federal Trade Commission, 5th U.S.
HOW DID IT REACH THE SUPREME COURT? Whether or not the Supreme Court decides to stay Kacsmaryk's order, it will not decide the merits of the case. The Biden administration said in its petition to the Supreme Court that the FDA cannot comply with both orders. WHAT HAPPENS AFTER THE SUPREME COURT RULES? Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
WASHINGTON, April 19 (Reuters) - The U.S. Supreme Court on Wednesday faces a self-imposed deadline to act before significant limits on access to the abortion pill mifepristone take effect in a challenge by anti-abortion groups to the drug's federal regulatory approval. The Supreme Court, which has a 6-3 conservative majority, is expected to act before the deadline to either grant or reject the requests or further pause the litigation. In a case that could undercut federal regulatory authority over drug safety, the New Orleans-based 5th U.S. The 5th Circuit did halt a part of Kacsmaryk's order that would have suspended the U.S. Food and Drug Administration (FDA) approval of the drug in 2000 and effectively pull it off the market. Some 56% of respondents said they have an unfavorable view of the Supreme Court.
The Supreme Court gave itself more time to consider whether to allow restrictions on abortion pill mifepristone to take effect. Legal challenges to mifepristone's FDA approval continue. The justices had given themselves a deadline on Wednesday in a fast-moving case from Texas in which abortion opponents are seeking to roll back FDA approval mifepristone. Even as the abortion landscape changed dramatically in several states, abortion opponents set their sights on medication abortions, which make up more than half of all abortions in the United States. Mifepristone has been available for use in medication abortions in the United States since the FDA granted approval in 2000.
WASHINGTON, April 19 (Reuters) - The U.S. Supreme Court on Wednesday gave a boost to Texas death row inmate Rodney Reed's bid for DNA testing of crime-scene evidence that he argues will help exonerate him in the 1996 abduction, rape and murder of a 19-year-old woman. A Texas trial court in 2014 denied Reed's bid for DNA testing. The Texas Court of Criminal Appeals also rejected it in 2017 based on the procedures it determined were required under the state law that gives prisoners a chance to seek post-conviction DNA testing. That court denied a request for rehearing six months later. Circuit Court of Appeals in 2021 decided that Reed should have filed suit within two years of the initial 2014 trial court decision.
WASHINGTON, April 18 (Reuters) - The U.S. Supreme Court should restrict the availability of the abortion pill mifepristone, anti-abortion groups challenging the medication's federal regulatory approval told the justices in a filing on Tuesday, urging them to implement curbs ordered by a conservative federal judge in Texas. Mifepristone is taken with another drug called misoprostol to perform medication abortion, which now accounts for more than half of all U.S. abortions. The Supreme Court has a 6-3 conservative majority. Anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors sued the FDA in November seeking to reverse approval of mifepristone. Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy.
[1/2] The U.S. Supreme Court building is seen in Washington, U.S., April 6, 2023. Two laws, the Federal Trade Commission Act and the Securities Exchange Act, funnel judicial review of adverse agency orders to federal appeals courts only after those orders become final. The Supreme Court's conservative justices have signaled wariness toward expansive federal regulatory power and the previously recognized duty of judges, under Supreme Court precedent, to give deference to that authority. Federal agencies have had their powers curtailed in recent Supreme Court rulings. Axon sued the FTC in 2020 in federal court in Arizona following an investigation by the agency into its 2018 acquisition of Vievu, a rival body-camera provider.
[1/2] The sun sets on the U.S. Supreme Court building after a stormy day in Washington, U.S., November 11, 2022. REUTERS/Leah MillisApril 14 (Reuters) - New court-imposed restrictions on the abortion pill mifepristone could cut off access to the drug entirely for months, the Biden administration and the drug's distributor, Danco Laboratories, said in petitions asking the U.S. Supreme Court to lift the curbs. Circuit Court of Appeals on Wednesday will require a new approval from the U.S. Food and Drug Administration and new labeling, they said. Danco, whose sole product is the abortion pill, said that if the Supreme Court does not act, it may have to halt its operations. Some Democratic-led states have said that they have taken steps to stockpile mifepristone in case it becomes unavailable.
HOW DID IT REACH THE SUPREME COURT? Circuit Court of Appeals for an emergency stay putting his injunction on hold. Whether or not the Supreme Court decides to stay Kacsmaryk's order, it will not decide the merits of the case. WHAT HAPPENS AFTER THE SUPREME COURT RULES? Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
Some in-person clinics in New York, California and Kansas will offer mifepristone for now, but are preparing to provide an alternative abortion pill if a subsequent decision essentially bans the drug. U.S. abortion pill providers are scrambling to make backup plans as the Supreme Court decides whether to keep restrictions on the key drug mifepristone. Those restrictions will limit access to mifepristone even in states where abortion is legal. Some in-person abortion clinics in states where the procedure is legal told CNBC that operations will remain largely the same. Other clinics in states where abortion is legal can prescribe mifepristone off-label beyond the first seven weeks of pregnancy, according to Hill.
Danco Laboratories, the manufacturer of mifepristone, also asked the U.S. Supreme Court for similar relief on Friday. The Supreme Court has a 6-3 conservative majority. The administration said the lower court orders would have "sweeping consequences" for women who need access to mifepristone and the FDA's scientific judgment authority over drug safety. "The resulting disruption would deny women lawful access to a drug FDA deemed a safe and effective alternative to invasive surgical abortion," the Justice Department told the justices. Since last year's Supreme Court decision, 12 U.S. states have put in place outright bans while many others prohibit abortion after a certain length of pregnancy.
A messy legal fight over the Food and Drug Administration's approval of the abortion pill mifepristone poses risks to the biopharma industry that go beyond the single drug. If a subsequent decision tosses out the pill's approval, it could potentially stifle innovation in the sector and deter investments in the development of life-changing drugs, biopharma companies and experts in law and economics say. More than 200 biopharma companies made a similar claim Monday in an open letter calling for the reversal of Kacsmaryk's decision. But Hastings said biopharma companies still respect the FDA when the agency turns down their drugs. Suliman offered a more hopeful take on how the legal fight could affect biopharma innovation.
A federal appeals court late on Wednesday blocked part of a ruling issued last week by a Trump-appointed judge that endangers access to the abortion pill mifepristone. The Justice Department can still ask the Supreme Court to intervene in an attempt to completely block Kacsmaryk's ruling. The Justice Department has filed a motion in the federal district court in Washington state, asking for clarification on Friday's ruling. Kacsmaryk's ruling, if allowed to stand, would not mean that access to mifepristone would immediately be cut off nationwide. The agency has broad power to do so, with the Supreme Court in a 1985 ruling saying that such decisions generally cannot be challenged in court.
April 13 (Reuters) - U.S. telehealth abortion providers scrambled on Thursday to keep their services available after a federal appeals court ruled that the abortion pill mifepristone could be distributed amid ongoing litigation but with significant restrictions. Mifepristone is used with another drug called misoprostol to perform medication abortion, which accounts for more than half of U.S. abortions. Jayaram Brindala, founder of Abortion Telemedicine, said the provider would "no longer be able to send the mifepristone medication by mail anywhere." Brindala added the company would still send the misoprostol-only regimen to states that allow it. Other telehealth practices that provide abortion medication said they were waiting to see what happens next in court before announcing any changes in policy.
An appeals court put part of that decision on hold late Wednesday, preserving access to the pill for now, with significant restrictions the Justice Department will ask the Supreme Court to lift. Neither Kacsmaryk's order, known as a preliminary injunction, nor the 5th Circuit's emergency stay is a final ruling on the merits of the case. REUTERS/Evelyn HocksteinThe Biden administration said on Thursday it will appeal to the Supreme Court for an emergency stay of Kacsmaryk's order in full. If the FDA wins a stay from the Supreme Court blocking the injunction, mifepristone will remain available with no new restrictions. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
[1/2] Boxes of mifepristone, the first pill given in a medical abortion, are prepared for patients at Women's Reproductive Clinic of New Mexico in Santa Teresa, U.S., January 13, 2023. However, the appeals court declined to block portions of Kacsmaryk's order, effectively reinstating restrictions on the pill's distribution that had been lifted since 2016. The FDA and lawyers for the groups suing to block the drug could not immediately be reached for comment. The lawsuit before Kacsmaryk was filed against the FDA in November by four anti-abortion groups led by the recently formed Alliance for Hippocratic Medicine and four anti-abortion doctors. Reporting By Brendan Pierson in New York, Editing by Alexia Garamfalvi, Bill Berkrot and William MallardOur Standards: The Thomson Reuters Trust Principles.
April 12 (Reuters) - Abortion opponents on Tuesday urged a U.S. appeals court to allow the suspension of Food and Drug Administration's approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the government regulates medicine. The abortion opponents' requests came one day after the U.S. Department of Justice urged the appeals court to put U.S. District Judge Matthew Kacsmaryk's April 7 order voiding the FDA's approval on hold through the appeals process. It is not clear when the 5th Circuit will rule on extending the stay. Twelve of the 16 5th Circuit judges who hear cases are Republican appointees. Circuit Court of Appeals, No.
Kacsmaryk, an appointee of Republican former President Donald Trump, stayed his ruling for seven days to allow the Biden administration time to appeal. The Justice Department asked that a stay be entered by April 13, and that it remain in place until all appeals, including if necessary to the Supreme Court, are resolved. Lawyers for the anti-abortion groups that challenged the FDA's approval of mifepristone did not immediately respond to requests for comment. The conflicting rulings could foreshadow a resolution by the Supreme Court, which last June overturned the 1973 Roe v. Wade decision that eliminated a constitutional right to abortion. The Supreme Court has a 6-3 conservative majority.
"We are discussing ways to offer them legal support," one of the sources said of manufacturers and retail pharmacies. Major U.S. manufacturers of abortion pills include GenBioPro Inc and Danco Laboratories. Walgreens said in March it would not dispense abortion pills in the 20 states where it risked breaking the law. Discussions between the Biden administration and pill manufacturers and pharmacies over the issue have been ongoing for months, sources said, but Friday's decision brings fresh urgency. It is unclear whether the administration is considering following in California Governor Gavin Newsom's footsteps by withholding federal contracts from chains that suspend abortion pill sales.
The Biden administration is seeking an emergency stay of Kacsmaryk's order from the New Orleans-based 5th U.S. The 5th Circuit has a conservative reputation, with 12 of its 16 active judges appointed by Republican presidents. The FDA could then petition the U.S. Supreme Court for an emergency stay. Regardless of whether it wins an emergency stay of the injunction, the FDA will continue its appeal of Kacsmaryk's preliminary injunction. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
"Bump stocks allow a shooter to fire hundreds of bullets a minute by a single pull of the trigger. Like other machine guns, rifles modified with bump stocks are exceedingly dangerous." Bump stocks use a semiautomatic's recoil to allow it to slide back and forth while "bumping" the shooter's trigger finger, resulting in rapid fire. Cargill sued, challenging the ATF's rule in 2019, which required him to surrender his two bump stocks. Two days after that ruling, Biden signed into law the first major federal gun reform in three decades.
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.
Adding to the volatile legal landscape around abortion, a federal judge in Washington state on Friday issued a seemingly conflicting injunction that prevented federal regulators from altering access to the same abortion drug. Kacsmaryk's ruling is a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues. By choosing to sue in Amarillo, the plaintiffs ensured that the case would go before Kacsmaryk, a conservative former Christian activist. Circuit Court of Appeals, which has a conservative reputation, with more than two-thirds of its judges appointed by Republican presidents. The FDA in January said that the government for the first time will allow mifepristone to be dispensed at retail pharmacies.
Companies Tesla Inc FollowMarch 31 (Reuters) - A U.S. appeals court on Friday said Tesla Inc (TSLA.O) CEO Elon Musk violated federal labor law by tweeting that employees of the electric vehicle maker would lose stock options if they joined a union. Amid an organizing campaign at Tesla's Fremont, California, plant by the United Auto Workers union, Musk tweeted: "Nothing stopping Tesla team at our car plant from voting union ... But why pay union dues & give up stock options for nothing?" In Friday's case, Tesla had argued that the tweet about unionizing was not a threat and merely reflected the fact that union workers at other auto companies did not receive stock options. The labor board in a separate case last year said Tesla violated labor law by prohibiting workers at the Fremont plant from wearing shirts supporting the union campaign.
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