ReportWire

Tag: WOMHEA

  • U.S. FDA allows abortion pills to be sold at retail pharmacies

    U.S. FDA allows abortion pills to be sold at retail pharmacies

    [ad_1]

    WASHINGTON, Jan 3 (Reuters) – The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban medication abortion.

    The regulatory change will potentially expand abortion access as President Joe Biden’s administration wrestles with how best to protect abortion rights after they were sharply curtailed by the Supreme Court’s decision to overturn the landmark Roe v Wade ruling and the state bans that followed.

    Pharmacies can start applying for certification to distribute abortion pill mifepristone with one of the two companies that make it, and if successful they will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber.

    The FDA had first said it would be making those changes in December 2021 when it announced it would relax some risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily in 2021 due to the COVID-19 pandemic.

    The changes included permanently removing restrictions on mail order shipping of the pills and their prescription through telehealth.

    The agency finalized the changes on Tuesday after reviewing supplemental applications from Danco Laboratories and GenBioPro, the two companies that make the drug in the United States.

    “Under the Mifepristone REMS Program, as modified, Mifeprex and its approved generic can be dispensed by certified pharmacies or by or under the supervision of a certified prescriber,” the agency said on its website on Tuesday.

    Mifeprex is the brand name version of mifepristone which, in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy in a process known as medication abortion.

    Abortion rights activists say the pill has a long track record of being safe and effective, with no risk of overdose or addiction. In several countries, including India and Mexico, women can buy them without a prescription to induce abortion.

    “Today’s news is a step in the right direction for health equity,” Planned Parenthood President Alexis McGill Johnson said in a statement.

    “Being able to access your prescribed medication abortion through the mail or to pick it up in person from a pharmacy like any other prescription is a game changer for people trying to access basic health care,” Johnson added.

    NO EQUAL ACCESS

    The regulatory change will, however, not provide equal access to all people, GenBioPro, which makes the generic version of mifepristone, said in a statement.

    Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped the 1973 Roe v. Wade ruling last year.

    Women in those states could potentially travel to other states to obtain medication abortion.

    The president of anti-abortion group SBA Pro-Life America, Marjorie Dannenfelser, said the latest FDA move endangers women’s safety and the lives of unborn children.

    “State lawmakers and Congress must stand as a bulwark against the Biden administration’s pro-abortion extremism,” she said in a statement.

    FDA records show a small mortality case number associated with mifepristone. As of June 2021, there were reports of 26 deaths linked with the pill out of 4.9 million people estimated to have taken it since it was approved in September 2000.

    Retail pharmacies will have to weigh whether or not to offer the pill given the political controversy surrounding abortion, and determine where they can do so.

    A spokesperson for CVS Health (CVS.N) said the drugstore chain owner was reviewing the updated REMS “drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy.”

    A spokesperson for Walgreens (WBA.O), one of the largest U.S. pharmacies, said the company was also reviewing the FDA’s regulatory change. “We will continue to enable our pharmacists to dispense medications consistent with federal and state law.”

    Reporting by Ahmed Aboulenein; Additional reporting by Eric Beech in Washington, Shivani Tanna, Rahat Sandhu, and Kanjyik Ghosh in Bengaluru; Editing by Himani Sarkar

    Our Standards: The Thomson Reuters Trust Principles.

    Ahmed Aboulenein

    Thomson Reuters

    Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.

    [ad_2]

    Source link

  • U.S. Supreme Court takes up Texas abortion case, lets ban remain

    U.S. Supreme Court takes up Texas abortion case, lets ban remain

    [ad_1]

    Oct 22 (Reuters) – The U.S. Supreme Court on Friday agreed to hear on Nov. 1 a challenge to a Texas law that imposes a near-total ban on the procedure and lets private citizens enforce it – a case that could dramatically curtail abortion access in the United States if the justices endorse the measure’s unique design.

    The justices took up requests by President Joe Biden’s administration and abortion providers to immediately review their challenges to the law. The court, which on Sept. 1 allowed the law to go into effect, declined to act on the Justice Department’s request to immediately block enforcement of the measure.

    The court will consider whether the law’s unusual private-enforcement structure prevents federal courts from intervening to strike it down and whether the federal government is even allowed to sue the state to try to block it.

    Register now for FREE unlimited access to Reuters.com

    The measure bans abortion after about six weeks of pregnancy, a point when many women do not yet realize they are pregnant. It makes an exception for a documented medical emergency but not for cases of rape or incest.

    Liberal Justice Sotomayor dissented from the court’s deferral of a decision on whether to block enforcement of the law while the litigation continues. Sotomayor said the law’s novel design has suspended nearly all abortions in Texas, the second most populous U.S. state, with about 29 million people.

    “The state’s gambit has worked. The impact is catastrophic,” Sotomayor wrote.

    The Texas dispute is the second major abortion case that the court, which has a 6-3 conservative majority, has scheduled for the coming months, with arguments set for Dec. 1 over the legality of a restrictive Mississippi abortion law.

    The Texas and Mississippi measures are among a series of Republican-backed laws passed at the state level limiting abortion rights – coming at a time when abortion opponents are hoping that the Supreme Court will overturn the landmark 1973 Roe v. Wade that legalized the procedure nationwide.

    Mississippi has asked the justices to overturn Roe v. Wade, and the Texas attorney general on Thursday signaled that he also would like to see that ruling fall.

    A supporter of reproductive rights holds a sign outside the Texas State Capitol building during the nationwide Women’s March, held after Texas rolled out a near-total ban on abortion procedures and access to abortion-inducing medications, in Austin, Texas, U.S. October 2, 2021. REUTERS/Evelyn Hockstein

    Lower courts already have blocked Mississippi’s law banning abortions starting at 15 weeks of pregnancy.

    The Texas measure takes enforcement out of the hands of state officials, instead enabling private citizens to sue anyone who performs or assists a woman in getting an abortion after cardiac activity is detected in the embryo. That feature has helped shield the law from being immediately blocked as it made it more difficult to directly sue the state.

    Individual citizens can be awarded a minimum of $10,000 for bringing successful lawsuits under the law. Critics have said this provision lets people act as anti-abortion bounty hunters, a characterization its proponents reject.

    Nancy Northup, president of the Center for Reproductive Rights, which is representing the abortion providers, said Friday’s decision to hear their case “brings us one step closer to the restoration of Texans’ constitutional rights and an end to the havoc and heartache of this ban.”

    Alexis McGill Johnson, president of healthcare and abortion provider Planned Parenthood, said it is “devastating” that the justices did not immediately block a law that already has had a “catastrophic impact” after being in effect nearly two months.

    “Patients who have the means have fled the state, traveling hundreds of miles to access basic care, and those without means have been forced to carry pregnancies against their will,” she added.

    Kimberlyn Schwartz, a spokesperson for the Texas Right to Life anti-abortion group, praised the court’s action, saying it “will continue to save an estimated 100 babies per day, and because the justices will actually discuss whether these lawsuits are valid in the first place.”

    The Supreme Court only rarely decides to hear cases before lower courts have ruled, indicating that the justices have deemed the Texas matter of high public importance and requiring immediate review.

    The Justice Department filed its lawsuit in September challenging the Texas law, arguing that it is unconstitutional and explicitly designed to evade judicial review.

    Rulings in Texas and Mississippi cases are due by the end of next June, but could come sooner.

    Register now for FREE unlimited access to Reuters.com

    Reporting by Andrew Chung in New York; Editing by Will Dunham

    Our Standards: The Thomson Reuters Trust Principles.

    [ad_2]

    Source link