Top related persons:
Top related locs:
Top related orgs:

Search resuls for: "GenBioPro"


25 mentions found


If the Supreme Court agrees with the appeals court, the approval of mifepristone could be reset to where it stood before 2016, limiting telehealth access to medication abortion and reimplementing other restrictions. “Nevertheless, drug developers invest in new medicines because, if their investments succeed, FDA’s rigorous drug approvals and subsequent regulatory actions are sturdy enough to facilitate reliable returns. “And without necessary investment, drug development would freeze, stifling innovation and limiting treatment options for patients.”Of course, if the Supreme Court upholds the appeals court decision, the most immediate impact would be to mifepristone itself. “It is both my hope and my ‘bet’ that the court doesn’t uphold the 5th Circuit on the standing argument,” Cohen wrote. “But I have learned the Supreme Court is hard to predict much of the time.”
Persons: thalidomide, mifepristone that’s, , Daniel Grossman, ” Grossman, ” PhRMA, Glenn Cohen, Dr, Sanjay Gupta, Cohen, ” Cohen Organizations: CNN, Food and Drug, Federal Food, FDA, US, University of California San, Reproductive, Guttmacher Institute, Circuit, Appeals, Pharmaceutical Research, Manufacturers of America, Harvard Law School, CNN Health Locations: Massengill, University of California San Francisco, Texas
Boxes of Mifepristone, the first pill in a medical abortion, are seen at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. Circuit Court of Appeals means for doctors and patients:CAN PATIENTS STILL GET THE ABORTION PILL? WHAT IS MEDICATION ABORTION? Medication abortion is a two-drug regimen consisting of mifepristone followed by misoprostol used to terminate a pregnancy within the first 10 weeks. If the ruling is upheld, doctors could still prescribe the abortion pill, but with restrictions.
Persons: Evelyn Hockstein, mifepristone, misoprostol, Wade, Matthew Kacsmaryk, Danco, GenBioPro, Brendan Pierson, Noeleen Walder, Lisa Shumaker Organizations: Alamo Women's, REUTERS, New, Circuit, U.S, Supreme, Danco Laboratories, FDA, Hippocratic Medicine, U.S . Food, Drug Administration, District, Thomson Locations: Carbondale , Illinois, U.S, New Orleans, United States, Texas, Amarillo , Texas
Circuit Court of Appeals stopped short of ruling that the drug must be pulled off the market altogether, as a lower court had done. A spokesperson for the U.S. Department of Justice said that the Biden administration will appeal the ruling to the U.S. Supreme Court. President Joe Biden, a Democrat, supports abortion rights and last year ordered the federal health agency to expand access to mifepristone. [1/2]Used boxes of Mifepristone, the first pill in a medical abortion, line a trash can at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. The U.S. Supreme Court last year overturned its landmark Roe v. Wade ruling that had legalized abortion nationwide.
Persons: Biden, Joe Biden, Matthew Kacsmaryk, Kacsmaryk, Erin Hawley, Susan B, Anthony Pro, Alexis McGill Johnson, Evan Masingill, Evelyn Hockstein, James Ho, mifepristone, telemedicine, Jennifer Walker Elrod, Wade, Brendan Pierson, Patrick Wingrove, Nate Raymond, Sharon Bernstein, Trevor Hunnicutt, Cynthia Osterman Organizations: Circuit, U.S . Department of Justice, U.S, Supreme, Alliance, Hippocratic Medicine, FDA, Alliance Defending, Planned Parenthood Federation of America, U.S . Food, Alamo Women's, REUTERS, Guttmacher Institute, American College of Obstetricians, American Medical Association, Reuters, Thomson Locations: U.S, New Orleans, Amarillo , Texas, Alamo, Carbondale , Illinois, New York, Boston, Sacramento , California, Washington
May 8 (Reuters) - A group of abortion providers on Monday filed a lawsuit aiming to preserve access to the abortion pill mifepristone as anti-abortion opponents aim to ban it in a separate case. The lawsuit, filed in federal court in Charlottesville, Virginia, is similar to one filed in Spokane, Washington by the Democratic attorneys general of 17 states and the District of Columbia in February. GenBioPro Inc, which sells a generic version of mifepristone, is also suing to block the FDA from restricting the drug. All three lawsuits come in response to a lawsuit last year by anti-abortion groups in Amarillo, Texas federal court challenging the FDA's approval of the drug in 2000. They said the dueling district court orders had created "day-to-day, week-to-week uncertainty" about using the drug.
The Dobbs ruling, which returned the regulation of abortion to the individual states, has led to legislation that restricts abortion, including medication abortion, in many states. In response to the rapidly changing post-Dobbs legal landscape, this article addresses health plan coverage of abortion, medication abortion coverage and litigation, abortion-related travel benefits, and related Practical Law resources concerning these topics. The insurer in a fully insured health plan, health maintenance organization (HMO), or similar arrangement:Assumes the risk of providing health coverage for insured events by paying medical costs for eligible claims incurred under the plan. Self-Funded Health PlansBy contrast, employers with self-funded arrangements may have more discretion in providing coverage for abortion and related services. Changes to plan coverage of medication abortion will likely require plan administrators to:(For more on coverage of medication abortion, see Newly Launched, ReproductiveRights.gov Website Addresses Access to Medication Abortion (Mifepristone) Using Telehealth on Practical Law.)
HOW DID THE CASE GET TO THE SUPREME COURT? The Biden administration and Danco immediately asked the Supreme Court to overrule the 5th Circuit and impose an emergency stay. WHAT DID THE SUPREME COURT DO? The injunction was not at issue before the Supreme Court, and remains in effect. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
However the 5th Circuit rules, the case will likely continue for months or years. HOW DID THE CASE GET TO THE 5TH CIRCUIT? WHAT COULD THE 5TH CIRCUIT DO? No matter what the court does, the losing party will have a chance to appeal to the full 5th Circuit and then to the U.S. Supreme Court. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.
Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023. The Supreme Court on Friday ordered the abortion pill mifepristone to remain broadly available as litigation plays out in a lower court. The appeals court has scheduled oral arguments for Wednesday, May 17 at 1 pm CT. Mifepristone has become the central flashpoint in the legal battle over abortion since the Supreme Court last summer overturned Roe v. Wade, the landmark 1973 decision that guaranteed abortion as a constitutional right nationwide. The appeals court judges also suspended the 2019 approval of the generic version of mifepristone.
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.
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.
GenBioPro asked the U.S. District Court for Maryland to preemptively block the FDA from pulling the company's 2019 approval to distribute the company's version of mifepristone. GenBioPro has said in court filings that it supplies two-thirds of the mifepristone used in the U.S. for abortions. "GenBioPro will use all regulatory and legal tools to protect access to mifepristone for patients and providers." The Supreme Court last week temporarily put the appeal's court rulings on hold. But the Supreme Court as early as Wednesday could move to lift that ban or leave it in place pending further legal challenges to the rulings
[1/2] A box containing a Mifepristone tablet is seen at Blue Mountain Clinic in Missoula, Montana, U.S. February 28, 2023. REUTERS/Callaghan O'Hare/File PhotoCompanies Genbiopro Inc FollowWASHINGTON, April 19 (Reuters) - GenBioPro Inc, maker of the only U.S. generic version of the abortion pill mifepristone, on Wednesday filed a lawsuit seeking to ensure that it can continue selling its pill amid ongoing legal challenges. The lawsuit, filed in federal court in Baltimore, comes as the U.S. Supreme Court is poised to decide by midnight whether to block a lower court order that would undo the U.S. Food and Drug Administration's approval of GenBioPro's generic pill. GenBioPro in its lawsuit named the FDA as a defendant so that it can ask the court to order the agency to keep the drug on the market. The privately held, Nevada-based company currently supplies a majority of the mifepristone used for medication abortion in the United States.
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.
Demonstrators rally in support of abortion rights at the US Supreme Court in Washington, DC, April 15, 2023. Supreme Court Justice Samuel Alito on Wednesday issued an order allowing the abortion pill mifepristone to remain available by mail delivery and without tighter restrictions on how it is used until at least late Friday night. Although that ruling keeps mifepristone on the market, the restrictions are so sweeping that many women would not have access to the medication even in some states where abortion is legal. The appeals court restrictions included blocking mail delivery of the medication, re-imposing doctor visits as a requirement to obtain the drug, and shortening the length of time women can use the pill to the seventh week of pregnancy. The court also blocked the generic version of mifepristone made by a second company, GenBioPro, which supplies about two-thirds of the medication for the U.S. market.
The Justice Department and the abortion pill distributor Danco Laboratories on Friday asked the Supreme Court to block an order that threatens access to mifepristone, an escalation of a legal fight that could make it harder to undergo the procedure nationwide. But the appeals court voted 2-1 to temporarily reimpose restrictions on mifepristone, which will significantly limit access to the drug even in states where abortion is legal. Mifepristone, used in combination with another drug called misoprostol, is the most common method to terminate a pregnancy in the U.S., accounting for about half of all abortions. Misoprostol, which is used a standalone abortion drug in other parts of the world, is not impacted by the lower court rulings. Prelogar said the lower court rulings would immediately make all doses of mifepristone misbranded because their labelling would not be consistent with the FDA's original approval.
[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.
"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.
North Carolina has divided government. Stein told North Carolina lawmakers the FDA determined that restrictions like those in North Carolina unduly burden patients' access to a safe and effective drug. A federal judge on Friday allowed North Carolina lawmakers to defend restrictions on the abortion pill mifepristone, after the state attorney general declined to do so. The abortion pill has become the central flashpoint in the battle over abortion access since the Supreme Court overturned Roe. Democratic attorneys general have asked a federal judge in Washington state to declare the remaining FDA restrictions on mifepristone unconstitutional.
Boxes of the medication Mifepristone used to induce a medical abortion are prepared for patients at Planned Parenthood health center in Birmingham, Alabama, March 14, 2022. The Food and Drug Administration's power to approve drugs does not override state bans on the abortion pill, a coalition of Republican attorneys general told a federal judge this week. The company has asked the court to overturn West Virginia's abortion ban, arguing that it conflicts with how the FDA regulates mifepristone under federal law. The GOP attorneys general said West Virginia's law does not completely ban the abortion pill. "A State's police power does not extend to functionally banning an article of interstate commerce — the Constitution leaves that to Congress," the company's lawyers wrote.
West Virginia's attorney general is urging a judge to dismiss a lawsuit seeking to overturn the state's restrictions on the abortion pill. GenBioPro sued West Virginia in January, arguing that the Food and Drug Administration's powers to approve and regulate medications pre-empt the state's restrictions on the abortion pill. GenBioPro has asked the court to declare unconstitutional West Virginia's law that bans abortion with a few exceptions. West Virginia does not allow patients to obtain a prescription for mifepristone through telemedicine appointments. "West Virginia retains the police power to regulate how drugs may be prescribed and dispensed by medical professionals," Morrisey argued.
A federal judge in Texas has extended until Feb. 24 the deadline in a lawsuit seeking to overturn the Food and Drug Administration's approval of the abortion pill. The abortion rights group NARAL Pro-Choice America, in an analysis published Friday, said 40 million women would lose access to the abortion pill if the Alliance for Hippocratic Medicine succeeds and mifepristone is effectively banned. It would also weaken the FDA's drug approval powers and hinder drug development by creating regulatory uncertainty in the marketplace. Two separate lawsuits are also seeking to overturn state restrictions on mifepristone, arguing that they conflict with FDA regulations. Republican attorneys general in 20 states also recently warned CVS and Walgreens against mailing the abortion pill in their states, indicating that they would take legal action.
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.
In one, generic mifepristone maker GenBioPro is asking a federal judge to block West Virginia, which has a near-total abortion ban, from prohibiting sales of the pills. The state is one of 16 that allow abortion under some circumstances, but impose additional restrictions on mifepristone that make it harder to access. WHAT WOULD HAPPEN IF THE TEXAS PLAINTIFFS WIN? IS A WIN BY TEXAS PLAINTIFFS LIKELY? The West Virginia lawsuit makes a more novel legal argument, since West Virginia's abortion ban applies to all abortions and does not specifically regulate mifepristone.
Feb 1 (Reuters) - A group of 20 Republican state attorneys general on Wednesday told Walgreens Boots Alliance Inc (WBA.O) and CVS Health Corp (CVS.N) that they risk running afoul of federal and state law if they dispense the abortion drug mifepristone by mail. Walgreens and CVS have said they intend to become certified and dispense the drug in states where abortion is legal, though neither has yet done so. Mifepristone, used in combination with another drug, misoprostol, is approved for abortion within the first 10 weeks of pregnancy. The attorneys general called this interpretation "bizarre" and warned that mailing the drug could violate some states' laws. Meanwhile, generic mifepristone manufacturer GenBioPro and a doctor have challenged restrictions on the drug in West Virginia and North Carolina, respectively.
Abortion pill manufacturer GenBioPro filed a lawsuit Wednesday arguing that West Virginia's sweeping ban on the procedure is unconstitutional — one of a spate of suits testing the legality of medication abortion in the post-Roe legal landscape. GenBioPro manufactures mifepristone, the first pill in a two-drug regimen used to carry out medication abortion. Medication abortion has become a hot-button issue since the Supreme Court’s June decision to overturn Roe v. Wade, which guaranteed a constitutional right to abortion. The drugmaker, which filed its case in West Virginia federal court, argues that the Food and Drug Administration's regulations on abortion medication override state law. “Abortion law and the status of the legality of abortion flickers on and off,” Rebouché said.
Total: 25