NEWS: FDA to allow pharmacies to dispense abortion pills

Repro Health Watch

January 5, 2023 | Health Care, Abortion, Reproductive Rights

 

FDA to Allow Pharmacies to Dispense Abortion Pills to Patients

CNN, January 3, 2023

The US Food and Drug Administration is allowing certified pharmacies to dispense the abortion medication mifepristone to people who have a prescription. Mifepristone can be used along with another medication, misoprostol, to end a pregnancy. Previously, these pills could be ordered, prescribed and dispensed only by a certified health-care provider. During the Covid-19 pandemic, the FDA allowed the pills to be sent through the mail and said it would no longer enforce a rule requiring people to get the first of the two drugs in person at a clinic or hospital. As of Tuesday, the in-person requirement has been permanently removed, according to Danco Laboratories, which markets the drugs under the brand name Mifeprex. Pharmacies that become certified to do so can dispense the drugs directly to someone who has a prescription from a certified prescriber. The updated information was posted Tuesday on the FDA’s website. “A time when people across the country are struggling to obtain abortion care services, this modification is critically important to expanding access to medication abortion services and will provide healthcare providers with an additional method for providing their patients with a safe and effective option for ending early pregnancy,” Danco said in a statement. Laws vary by state, but the medications can be taken up to 11 weeks after the first day of the last menstrual period. Telehealth prescriptions are an option in some states, or a person could travel to a state where abortion is legal to get the pills. Medication abortion is used in more than half of abortions in the US, outpacing surgical procedures for the first time in 2020, according to the Guttmacher Institute, a research group that supports abortion rights. Pharmacy chain CVS said in a statement Tuesday that it is reviewing the updated requirements. “We’re reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (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.” Walgreens also said it is reviewing the changes. The FDA’s move comes days after a new Justice Department legal opinion declared that federal law allows the US Postal Service to deliver the abortion drugs – a move the Biden Administration believes could help protect access to abortion in states that have enacted bans following the Supreme Court decision to overturn Roe v. Wade.

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Postal Service Is Clear to Deliver Abortion Drugs, DOJ Says

The Hill, January 4, 2023

The U.S. Postal Service is legally allowed to deliver prescription abortion drugs even in states that have curtailed access to abortion, the Justice Department said. A legal opinion from the agency’s Office of Legal Counsel (OLC) found that mailing mifepristone or misoprostol does not violate the Comstock Act, a nearly 150-year-old law originally written to stop anything that could “corrupt” morals from being sent in the mail, if the sender does not know if the drugs will be used illegally. The Justice Department’s opinion was requested by the Postal Service in the wake of the Supreme Court’s June decision overturning Roe v. Wade, a ruling that ended nearly 50 years of guaranteed federal abortion protections. Republican-led states have been moving to limit or even completely ban access to the drugs, and advocates have been concerned the Supreme Court’s decision will embolden even more states to crack down. There has been a growing effort to circumvent the laws by mailing the drugs, often from overseas, directly to people seeking them. Mifepristone is a prescription drug approved by the Food and Drug Administration (FDA) to induce an abortion up to 10 weeks into a pregnancy. It must be followed by a second drug, misoprostol. Federal law does not prohibit the use of mifepristone and misoprostol, and the FDA has found them to be safe and effective for terminating early pregnancy. “There are manifold ways in which recipients in every state may use these drugs, including to produce an abortion, without violating state law,” OLC chief Christopher Schroeder wrote in the opinion. “Therefore, the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully.” The opinion also applies to other carriers that could be used to send abortion drugs, like UPS or FedEx. In the opinion, the OLC wrote that even in a jurisdiction with restrictive abortion laws, women can still lawfully use mifepristone and misoprostol because there are no prohibitions on abortions necessary to preserve the life of the woman. Some state abortion restrictions also include exceptions for cases of rape or incest, to protect the health of the pregnant person or where there are severe fetal anomalies.

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FDA Changes Plan B Label to Say It Does Not Cause Abortion

Reuters, December 23, 2022

The U.S. Food and Drug Administration on Friday changed the label for the emergency contraception known as Plan B One-Step to make clear that the pill does not alter the course of an existing pregnancy. The consumer information distributed with the morning after pill known as Plan B One-Step, which has been available over the counter for everyone since 2013, now makes clear its mechanism of action does not alter the implantation of an egg. It explains that Plan B One-Step works before the release of an egg from the ovary and as a result, usually stops or delays the release of an egg. Contraception has come under renewed pressure in the United States after the Supreme Court in June overturned the landmark 1973 Roe v. Wade ruling that recognized the constitutional right to an abortion and legalized it nationwide. The FDA also issued an updated question-and-answer section on its website, where the question "Is Plan B One-Step an abortifacient (causing abortion)" is answered with "No." The FDA said that current science suggests Plan B One-Step works by inhibiting or delaying ovulation and midcycle hormonal changes. It said evidence supports the conclusion that the pill has no direct effect on fertilization or implantation. Foundation Consumer Healthcare, which owns the Plan B brand, had requested approval to modify some of the mechanism of action information on the label, the U.S. Food and Drug Administration (FDA) said. Generic versions of the morning-after pill will also need to change their label, it said.

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More Bans and Creative Clinics: The Future of Abortion Access in a Post-Roe U.S.

The Guardian, December 27, 2022

It was a landmark year for abortion rights, for all the wrong reasons. In the summer, the US supreme court, with its new hard-right supermajority, dismantled the constitutional right to abortion secured almost 50 years ago through Roe v. Wade. After that came a slew of laws passed in state legislatures, court battles and – indeed – some surprise victories for abortion rights advocates. All this has changed the way Americans can access pregnancy care and the way they think about women’s rights. Here are the key points from 2022. New bans abound: For some it may have felt like abortion rights changed in the US overnight on 24 June 2022. But even before Roe fell, 22 states already had laws on the books that would make abortion bans likely if not inevitable once the supreme court ruled, after years of anti-abortion activism. After Roe was overturned, things became complicated. Many bans written before the June decision bounced right into effect; others were held up in court – and continue to be – and in some places, such as Michigan, local activists and politicians found ways around them. But the reality cannot be overstated: by October, 66 clinics across 15 US states were known to have closed, more than 80% of the total of 79 clinics open in June in those states. As of last summer, about 33 million women of child-bearing age lived in states that had or were poised to ban abortion, according to Bloomberg. Some states now ban all abortion without exception, while others allow abortion up to a certain time limit or in extreme exceptions, such as rape or incest, or to protect the life of the pregnant person. And an onslaught of new restrictions looms. Legal crackdowns loom: In April 2022, 26-year-old Texan Lizelle Herrera was arrested on murder charges for allegedly self-inducing an abortion. The case was without legal basis, and was quickly dismissed, but it was a harbinger for more extreme measures since Roe was overturned. Louisiana tried (and failed) to bring murder charges against people who obtained abortions. Missouri sought to ban out-of-state travel for abortions. South Carolina attempted to limit even basic information sharing about how to access abortions online. None of these laws passed, but they highlight the measures that anti-abortion activists are willing to use. Medication abortion proliferates: In 2021, the US Food and Drug Administration made abortion medication accessible by mail.

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South Carolina Abortion Ban Violates State's Constitution, State Supreme Court Rules

CBS News, January 5, 2023

The South Carolina Supreme Court struck down Thursday a ban on abortion after cardiac activity is detected – typically around six weeks – ruling the restriction violates the state constitution's right to privacy. The decision comes nearly two years after Republican Gov. Henry McMaster signed the measure into law. The ban, which included exceptions for pregnancies caused by rape or incest or pregnancies that endangered the patient's life, drew lawsuits almost immediately. Since then, legal challenges have made their way through both state and federal courts. "The State unquestionably has the authority to limit the right of privacy that protects women from state interference with her decision, but any such limitation must be reasonable and it must be meaningful in that the time frames imposed must afford a woman sufficient time to determine she is pregnant and to take reasonable steps to terminate that pregnancy. Six weeks is, quite simply, not a reasonable period of time for these two things to occur, and therefore the Act violates our state Constitution's prohibition against unreasonable invasions of privacy," Justice Kaye Hearn wrote in the majority opinion. Currently, South Carolina bars most abortions at 20 weeks. Varying orders have given the law's supporters and opponents both cause for celebration and dismay. Those seeking abortions in the state have seen the legal window expand to the previous limit of 20 weeks before returning to latest restrictions and back again. Federal courts had previously suspended the law. But the U.S. Supreme Court's overturning of Roe v. Wade allowed the restrictions to take place – for just a brief period. The state Supreme Court temporarily blocked it this past August as the justices considered a new challenge. The high court's momentous decision in Dobbs v. Jackson Women's Health Organization set off a flurry of activity at the state level. Republican-dominated states moved forward with new restrictions while abortion rights' advocates sought additional safeguards. With federal abortion protections gone, Planned Parenthood South Atlantic sued in July under the South Carolina constitution's right to privacy. Meanwhile, other states have seen challenges to restrictions as a matter of religious freedom. "We are encouraged by South Carolina's Supreme Court ruling today on the state's extreme and dangerous abortion ban," tweeted White House press secretary Karine Jean-Pierre. "Women should be able to make their own decisions about their bodies."

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