In Washington, FDA lawsuit is part of larger strategy to preserve abortion access

Court ruling preserves status quo in several states as fight continues elsewhere over abortion pill

BY: KELCIE MOSELEY-MORRIS
APRIL 19, 2023

As the nation grapples with continuing changes in court rulings affecting the U.S. Food and Drug Administration’s approval of a drug used in abortion care, Washington state’s competing lawsuit and other offensive and defensive moves related to abortion are working exactly as officials and advocates say they intended.

Washington Attorney General Bob Ferguson’s office filed a lawsuit against the FDA in late February, about a month after the federal agency announced it would keep mifepristone, a drug used in tandem with another to end a pregnancy of up to 10 weeks’ gestation, under restrictions associated with its Risk Evaluation and Mitigation Strategies program — also known as REMS.

Continued: https://oregoncapitalchronicle.com/2023/04/19/in-washington-fda-lawsuit-is-part-of-larger-strategy-to-preserve-abortion-access/

USA – The sole US supplier of a major abortion pill said it would not distribute the drug in 31 states

A list circulated in January by the distributor to Walgreens and CVS underscores the uncertainty surrounding abortion pills in the post-Roe era.

By Rachel M. Cohen
Updated Mar 17, 2023

Earlier this month, Politico broke news that Walgreens, the nation’s second-largest pharmacy chain, assured 21 Republican attorneys general that it would not dispense abortion pills in their states should the company be approved to dispense them. The decision was met with sharp protest by Walgreens customers, abortion rights activists, and Democrats, who accused the pharmacy of caving needlessly to pressure.

But fear of state prosecution is not the only factor shaping Walgreens’ decision-making. Another previously unreported constraint on the company is that its sole supplier of Mifeprex — the brand-name drug for the abortion pill mifepristone first approved by the Food and Drug Administration in 2000 — circulated a list to its corporate clients in January naming 31 states that it would not supply the abortion medication to. Vox spoke with two sources who had reviewed that list recently.

Continued: https://www.vox.com/policy/2023/3/15/23639267/walgreens-abortion-pill-mifepristone-mifeprex-misoprostol

USA – The new front in the right’s war on abortion

Abortion pills are at the heart of the fight over abortion access in a post-Roe world.

By Rachel M. Cohen
Jan 9, 2023

The Biden administration helped expand access to medication abortion last week, with the US Food and Drug Administration finalizing a rule to make the pills more readily available in pharmacies. But this effort to help patients get pills to end a pregnancy could be dwarfed by a major push to restrict access to the medication from anti-abortion leaders and their Republican allies.

As lawmakers head back to state legislatures this month, many for the first time since Roe v. Wade was overturned in June, Republicans face new pressure to restrict access to the combination of abortion-inducing drugs, mifepristone and misoprostol, used typically within the first 10 to 12 weeks of a pregnancy. Medication abortion has become the most common method for ending pregnancies in the United States, partly due to its safety record, its lower cost, diminished access to in-person care, and greater opportunities for privacy.

Continued: https://www.vox.com/policy-and-politics/2023/1/9/23540562/abortion-pills-medication-dobbs-roe-mifepristone

USA – Label change for mifepristone could reduce barriers to care for miscarriages, advocates say in petition to FDA

Regulations around mifepristone, a common drug used for medication abortion, make it difficult for miscarrying patients to access it. A new petition to the FDA asks for a label change to make it easier to obtain.

Jennifer Gerson
October 4, 2022

Over 40 medical and advocacy groups submitted a petition to the Food and Drug
Administration (FDA) asking for miscarriage management to be added as a use
case for mifepristone, a drug commonly used in medical abortions, and ease the
restrictions around who can prescribe it.

Groups including the American College of Obstetricians and Gynecologists
(ACOG), SisterReach, Physicians for Reproductive Health and the Expanding
Medication Abortion Access (EMAA) Project were behind the petition. The changes
they asked for Tuesday would make the drug easier to access for people
experiencing miscarriages as some doctors and pharmacies have become more
reluctant to distribute it after the end of Roe v. Wade.

Continued: https://19thnews.org/2022/10/mifepristone-miscarriage-label-change-fda-petition/

Medication Abortion Now Accounts for More Than Half of All US Abortions

Rachel K. Jones, Elizabeth Nash, Lauren Cross, Jesse Philbin, Marielle Kirstein
Guttmacher Institute
First published online: February 24, 2022

In 2000, the US Food and Drug Administration (FDA) approved mifepristone as a method of abortion. Taken along with misoprostol, the two-drug combination is known as medication abortion or the “abortion pill.” New research from the Guttmacher Institute shows that 20 years after its introduction, medication abortion accounted for more than half of all abortions in the United States.

Specifically, preliminary data from the Guttmacher Institute’s periodic census of all known abortion providers show that in 2020, medication abortion accounted for 54% of US abortions. That year is the first time medication abortion crossed the threshold to become the majority of all abortions and it is a significant jump from 39% in 2017, when Guttmacher last reported these data. This 54% estimate is based on preliminary findings from ongoing data collection; final estimates will be released in late 2022 and the proportion for medication abortion use is not expected to fall below 50%.

Continued: https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions

Abortion pills by mail are safe. The FDA finally acknowledged it.

But it left other unnecessary restrictions in place, reminding us that abortion care is treated differently.

By Daniel Grossman
Dec 20, 2021

It took a pandemic, a lawsuit and an eight-month review of the evidence, but the Food and Drug Administration has finally loosened some of the restrictions it imposed 21 years ago on mifepristone, which is used together with a second medication, misoprostol, for medication abortion. While the FDA could have gone further, this move is based on solid scientific evidence and will improve access to abortion care for at least some people.

At issue was the FDA’s risk evaluation and mitigation strategy, or REMS, an extra layer of regulatory scrutiny that the agency applies to a small number of drugs that have safety concerns. Given decades-long experience with mifepristone and documenting the safety of the medication, physicians and researchers have been urging the FDA for years to remove mifepristone’s REMS. Not only was there no clear rationale about how the restrictions on mifepristone improved the drug’s safety, but there are many medications, including Viagra, with more significant risks without a REMS.

Continued: ttps://www.washingtonpost.com/outlook/2021/12/20/telemedicine-abortion-fda-safe/

What Does an At-Home Abortion Look Like in 2021?

The practice is often assumed to be dangerous, but Abigail Aiken’s data suggest that ordering abortion pills online, and inducing a miscarriage at home, is as safe as going to a clinic.

By Lizzie Widdicombe
November 11, 2021

It was the year 2000 in Derry, the second-largest city in Northern Ireland. The Good Friday Agreement had gone into effect two years earlier, bringing the Troubles to an end. The city seemed to be full of hope. But Abigail Aiken was full of dread. An academic star, she should have been focussed on the G.C.S.E.s, a set of exams that determine whether a sixteen-year-old in the U.K. will advance on a university track or end her education in high school. But as the exam date approached, Aiken’s mind kept wandering to something else: her period, which was more than a week late. Recently, her long-distance boyfriend had come to town for a weeklong visit, which had resulted in an unplanned romantic incident. Could she have gotten pregnant after her first time? That would be just her luck. She wanted to know, one way or the other, but this was Derry, a place where everyone knew everyone else’s business. What was she supposed to do, walk into the pharmacy and ask for a pregnancy test?

Continued: https://www.newyorker.com/news/news-desk/what-does-an-at-home-abortion-look-like-in-2021

USA – What if You Had Abortion Pills in Your Medicine Cabinet?

Oct. 13, 2021
By Patrick Adams

In 2018, the Austria-based nonprofit Aid Access began offering Americans a new service: For the first time, pregnant people could obtain abortion pills by mail, with a prescription from a licensed physician, without ever visiting a clinic. For years, the group’s founder, Dr. Rebecca Gomperts, had been doing similar work overseas. But as abortion rights were steadily eroded by Republican-controlled legislatures, Dr. Gomperts found herself inundated with requests from the United States and decided to act.

Three years later, American abortion rights are more threatened than ever, with the fate of Roe v. Wade resting on several Supreme Court justices appointed by Donald Trump. In response, Aid Access has introduced a service that offers a possible path forward for doctors adapting to the changing abortion landscape and reckoning with their role in gate-keeping a politically fraught drug: prescribing abortion pills in advance, to be kept on hand in the event of a future unwanted pregnancy.

Continued: https://www.nytimes.com/2021/10/13/opinion/abortion-pills-texas-prescription-doctors.html

The FDA Should Remove Its Restrictions on the ‘Abortion Pill’ Mifepristone

The science is clear: abortion by medication is safe and effective

By Kelly Cleland
on August 21, 2021

The pandemic has shown us that it’s time to change the way we get health care and that essential health care, including abortion, has always been out of reach for far too many. As we look ahead to the future of care, the science is clear: medication abortion care is safe and effective, and it’s past time to remove the restrictions on it. Now, actions from the FDA and new research show us that removing the restrictions on medication abortion care has the potential to expand access for many people who need care. The July 2021 special issue of the journal Contraception focuses on the restrictions on medication abortion, mifepristone, including its impacts on safety and efficacy, access to abortion, and burdens on patients and providers.

Continued: https://www.scientificamerican.com/article/the-fda-should-remove-its-restrictions-on-the-abortion-pill-mifepristone/

Exclusive: First Large-Scale Telemedicine Abortion Service Launches in U.S.

On the heels of a Biden administration announcement that temporarily allows telehealth abortion, a new, first-of-its-kind telehealth service, Abortion on Demand, opens to help women get care.

By Susan Rinkunas
Apr 13, 2021

A new telemedicine site is changing the future of abortion access, hopefully, permanently: Launching today, Abortion on Demand (AOD), the first large-scale telehealth abortion (a.k.a. teleabortion) service run by a U.S.-based provider, will help people who want to end their pregnancies with pills. The launch comes immediately after the Biden administration announced it would temporarily allow telemedicine abortions during the pandemic; it's a change long-awaited by reproductive rights advocates and AOD's founder, Dr. Jamie Phifer, who has been building the service for the last year and a half—keeping it under wraps until such a policy change enabled her to legally get it off the ground.

Continued: https://www.marieclaire.com/health-fitness/a36028641/abortion-on-demand-telemedicine-service-launch/