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May 17 (Reuters) - Federal appeals court judges appeared to express support on Wednesday for opponents of the abortion pill mifepristone to pursue their challenge to its U.S. approval, which has potentially far-reaching consequences for abortion access across the country. Circuit Court of Appeals in New Orleans to overturn last month's unprecedented ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas suspending mifepristone's approval. [1/2] A patient prepares to take Mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. Circuit Judges James Ho and Wilson were appointed by Donald Trump. SAFE AND EFFECTIVEMifepristone remains available for now, following an emergency order from the U.S. Supreme Court putting Kacsmaryk's order on hold during the appeal.

[1/2] A patient prepares to take Mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. REUTERS/Evelyn Hockstein/File PhotoMay 17 (Reuters) - U.S. appeals court judges began hearing arguments on Wednesday in a legal battle over the availability of the abortion pill mifepristone, with potentially far-reaching consequences for abortion access across the United States. Circuit Court of Appeals in New Orleans to overturn last month's unprecedented ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas suspending mifepristone's approval. Danco Laboratories, which sells the drug under the brand name Mifeprex, is also expected to argue before the court. The emergency room doctors said they were being forced to complete surgical abortions, which was against their conscience, for women who took the pill and failed to complete a medical abortion.

[1/2] A patient prepares to take Mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois, U.S., April 20, 2023. REUTERS/Evelyn Hockstein/File PhotoMay 17 (Reuters) - A federal appeals court in New Orleans will hear arguments on Wednesday in a closely watched case brought by anti-abortion activists seeking to ban the abortion pill mifepristone, with potentially far-reaching impact on abortion access across the United States. Circuit Court of Appeals to overturn last month's unprecedented ruling by U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas suspending mifepristone's FDA approval. Mifepristone remains available for now, following an emergency order from the U.S. Supreme Court putting Kacsmaryk's order on hold during the appeal. Whichever way the 5th Circuit panel rules, the decision is sure to be appealed, first to the full court and then to the U.S. Supreme Court.

☆ A Birth Control Pill May Soon Be Available Over the Counter. Here’s What to Know.
▼ + stars: | 2023-05-10 | by ( Alisha Haridasani Gupta | ) www.nytimes.com time to read: +1 min

Food and Drug Administration advisers concluded that the benefits outweighed the risks of making a hormonal contraceptive pill — sold under the brand name Opill and produced by the French company HRA Pharma — available without a prescription. follows the nonbinding recommendation of its advisers — and there is a chance the agency might not — Opill would become the first and only birth control pill to be available over the counter since oral contraceptives were introduced in the U.S. in 1960. A 2022 survey found that 77 percent of more than 5,000 female participants favored the idea of getting the birth control pill over the counter, with many saying it would be more convenient and efficient to get it without a prescription. Progestin-only pills have been widely used in the United States since the first one was approved in 1973. Like other oral contraceptives, they require a prescription from a health care provider or, in some states, a pharmacist.

☆ FDA advisors recommend sale of birth control pill without a prescription
▼ + stars: | 2023-05-10 | by ( Spencer Kimball | ) www.cnbc.com time to read: +3 min

A panel of experts who advise the Food and Drug Administration unanimously recommended Wednesday that the agency for the first time allow women to obtain a birth control pill without a prescription. The panel had been asked whether the benefits of selling HRA Pharma's birth control pill Opill outweighed the risks of consumers improperly using the medication resulting in unintended pregnancy. Medical associations such as the American College of Obstetricians and Gynecologists for years have urged over-the-counter sales of birth control pills be allowedMore than 50 members of Congress in March 2022 called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system." Shrinking access to abortion across the U.S. in turn sparked renewed calls for expanded access to birth control to prevent unwanted pregnancies.

☆ FDA may allow birth control pill without prescription this summer as experts weigh data
▼ + stars: | 2023-05-09 | by ( Spencer Kimball | ) www.cnbc.com time to read: +2 min

The Food and Drug Administration could approve the sale of birth control medication without a prescription for the first time by this summer. The FDA approved prescription sales of HRA Pharma's birth control pill in 1973. Medical associations such as the American College of Obstetricians and Gynecologists for years have supported over-the-counter access to birth control without age restrictions. In March 2022, more than 50 members of Congress urged FDA Commissioner Dr. Robert Califf to review applications for over-the-counter sales of birth control without delay. "Despite decades of proven safety and effectiveness, people still face immense barriers to getting birth control due to systemic inequities in our healthcare system."

☆ Health Plan Coverage of Abortion and Related Services
▼ + stars: | 2023-05-01 | by ( Practical Law Employee Benefits | Executive Compensation | ) www.reuters.com time to read: +36 min

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.)

April 28 (Reuters) - A federal judge in Denver on Friday rejected a Catholic medical center's bid to block Colorado from banning an unproven treatment meant to reverse the effects of a medication abortion drug. Medication abortion begins with the drug mifepristone, which blocks action of the hormone progesterone, crucial for sustaining pregnancy, and is completed with a second drug, misoprostol. Proponents of medication abortion reversal say that if a woman changes her mind after taking mifepristone but before taking misoprostol, the pregnancy can be continued by administering a high dose of progesterone. Mifepristone is the subject of a heated legal battle as anti-abortion groups seek to pull it from the market. Republican state legislatures have also taken steps to restrict access to the drug, while Democratic legislatures have sought to protect it.

☆ Lindsey Graham repeats false claim that Democrats support 'abortion at the moment of birth' on CNN
▼ + stars: | 2023-04-23 | by ( Katie Balevic | ) www.businessinsider.com time to read: +4 min

Graham falsely claimed that Democrats support abortion up until the "moment of birth." Democrats in fact support legislation allowing abortion after viability only when the mother's life and health are at risk. The senator repeated claims that Democrats support elective abortion at birth – a claim that medical experts say is false. Abortion up to the moment of birth, taxpayer-funded," Graham, a Republican, told CNN's Dana Bash on "State of the Union." They introduced legislation that allowed abortion demand with taxpayer-funded – you paying for it, the taxpayer – up to the moment of birth," Graham responded.

☆ Live updates: Supreme Court protects access to abortion pill
▼ + stars: | 2023-04-21 | by ( Elise Hammond | Matt Meyer | ) edition.cnn.com time to read: +3 min

A patient prepares to take Mifepristone, the first medication in a medical abortion, at Alamo Women's Clinic in Carbondale, Illinois. Along with misoprostol, mifepristone is one of the drugs used for an abortion via medication, as opposed to surgery. Someone having a medication abortion takes mifepristone and then, after 24 to 48 hours, takes misoprostol. Side effects of mifepristone: Mifepristone usually doesn’t have many side effects, doctors say, but as with any drug, there can be short-lived ones. Preliminary data published February 2022 from the Guttmacher Institute, a research and policy organization focused on sexual and reproductive health that supports abortion rights, showed that medication abortion accounted for 53% of all abortions in the US.

WASHINGTON, April 20 (Reuters) - Use of the drug misoprostol on its own to terminate pregnancies is on the rise in the United States as providers seek a preemptive alternative while a ban on abortion pill mifepristone is being considered in court. Misoprostol is already part of the only medication abortion protocol approved by the U.S. Food and Drug Administration, but only when taken in combination with mifepristone. The drug, which the FDA first approved in 1988 for gastric ulcers, is often prescribed off-label to treat miscarriages or induce abortions. "If providers are forced to stop providing mifepristone, misoprostol alone is also safe and effective," said Dr. Ushma Upadhyay, a public health professor at the University of California, San Francisco. Because misoprostol is approved for medication abortion in the United States as part of the two-drug combination, prescribing it alone to terminate pregnancies would also be considered off-label.

☆ A federal appeals court co-opted anti-abortion terms in its ruling on mifepristone, calling a fetus an 'unborn child'
▼ + stars: | 2023-04-13 | by ( Grace Eliza Goodwin | ) www.businessinsider.com time to read: +2 min

A federal appeals court used anti-abortion terminology in decision on abortion pill mifepristone. The decision calls a fetus an "unborn child" and refers to the pill as "chemical abortion." In the court filing, the decision referred to a fetus as an "unborn child" — phrasing often used by anti-abortion groups. The American College of Obstetricians and Gynecologists says on its website that using a phrase like "unborn child" centers the language on "the future state of a pregnancy," which it calls "medically inaccurate." The Fifth US Circuit Court of Appeals' decision came after the Justice Department filed an emergency motion asking for time for the Biden administration to appeal the ban on mifepristone sales.

CNN —Dueling decisions in two federal district courts last week are likely to set up a showdown at the Supreme Court over the fate of the abortion pill mifepristone. When the Supreme Court upheld the federal Partial-Birth Abortion Ban Act in 2007, dubious scientific arguments became even more central to anti-abortion advocacy. In Gonzales v. Carhart, the court held that in circumstances of scientific uncertainty, legislators would have more latitude to regulate abortion. Implausible scientific claims are now visible on social media, in lawsuits and in congressional hearings. (By taking this position, abortion opponents can still defend bans with no or few exceptions by claiming that abortion is never necessary.)

☆ Abortion pill alternative: The drug that could be used if Texas ban on mifepristone upheld
▼ + stars: | 2023-04-11 | by ( Annika Kim Constantino | ) www.cnbc.com time to read: +3 min

A federal judge's ruling could take the abortion pill mifepristone off the market — but there is another medication that could provide an alternative for people seeking to terminate their pregnancies. Two states in reaction to that ruling already are stockpiling supplies of misoprostol, the drug that doctors typically prescribe with mifepristone to induce an abortion. That leaves misoprostol available as a safe and effective treatment for women who want to end their pregnancies. Some U.S. abortion providers are prepared to offer misoprostol as a stand-alone treatment, according to Jenny Ma, senior staff attorney at the Center for Reproductive Rights, a legal advocacy group that represents abortion providers worldwide. A study released in February by abortion researchers at the University of Texas in Austin found that misoprostol was 88% effective at causing an abortion.

☆ Texas GOP Rep. Tony Gonzales dodges questions on mifepristone ruling: 'Women have a whole lot of other issues than just abortion'
▼ + stars: | 2023-04-09 | by ( Katie Balevic | ) www.businessinsider.com time to read: +3 min

Tony Gonzales said women face "other issues" than abortion when asked about the fate of mifepristone. Gonzales argued that the Biden administration was stepping on states' rights by appealing the mifepristone ruling. A federal judge in Texas ordered a hold on the drug's decades-old federal approval on Friday. Gonzales replied that the "states started this" with the Texas ruling, but "now the federal government is coming in and dictating theirs." "No, I think it's important that we take care of women," Gonzales said.

[1/2] A sign urging voters to reject a state constitutional amendment declaring there is no right to abortion is seen during the primary election and abortion referendum at a Wyandotte County polling station in Kansas City, Kansas, U.S. August 2, 2022. Opponents say the bill undermines the will of Kansas voters who in an August statewide referendum rejected by nearly 60% a state constitutional amendment that would have declared there was no right to abortion. A similar bill failed in Kansas in 2019 after its Republican supporters narrowly failed to get the two-thirds majority needed to overcome Kelly's veto in the state House. The Kansas legislature earlier this week approved a bill creating new punishments for doctors accused of not providing sufficient care to infants that are delivered alive during an abortion. The bill has veto-proof majorities in both houses, but it could still be challenged and overturned in court.

☆ 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.

☆ 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.

WASHINGTON, Feb 24 (Reuters) - Vice President Kamala Harris is expected to offer a defense of the abortion drug mifepristone in a meeting on Friday, according to a White House official, as some activist groups work to end U.S. sales of the pill. 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. 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.

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.

☆ 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.

Medication abortion has drawn increasing attention since the U.S. Supreme Court last June overturned its landmark 1973 Roe v. Wade decision that had legalized abortion nationwide. Nearly all abortions, including medication abortions, are now banned in 12 states, and 16 states that permit some abortions also had laws restricting medication abortion as of November, according to the Guttmacher Institute, a research group that supports abortion rights. "The FDA, by approving chemical abortion drugs for home use, puts a woman or girl's life at risk." In its court filing, the FDA said there was no basis for second-guessing the FDA's judgment. The FDA said that pulling the drug would force patients seeking abortions in many cases to undergo unnecessary and more invasive surgical abortion.

Walgreens and CVS will sell the prescription abortion pill mifepristone after the Food and Drug Administration this week dropped a long-standing rule that prevented drug stores from doing so. The decision by the two largest drug store chains in the U.S. will significantly expand access to mifepristone in states where abortion is legal. The FDA on Tuesday changed its regulations to allow retail drug stores to dispense mifepristone so long as they complete a certification process. The agency dropped a long-standing rule that required patients to obtain the abortion pill in-person at clinics, hospitals and other certified health-care providers. CVS also plans to get certified in states where it is legal to do so, spokesperson Amy Thibault said.

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