The FDA’s Abortion Announcement Is Not What You Think

The FDA just reinforced “abortion exceptionalism” in health care and added paternalistic busywork for pharmacists dispensing medication abortion.

By Renee Bracey Sherman, Dr. Daniel Grossman and Tracy Weitz
JANUARY 6, 2023

This week, the Food and Drug Administration announced that it would allow mifepristone, the first pill taken in the two-drug medication abortion regimen, to be dispensed at retail pharmacies. The FDA’s decision is a welcome move that has garnered headlines, but the fine print contains significant red tape that will continue to serve as a barrier for people already struggling to access medical care.

Because of “abortion exceptionalism” allowing abortion care (and miscarriage management) to be treated differently from other health care, medication abortion has always been more regulated than it should be. When the FDA approved the drug in 2000, it did so under a little-known bureaucratic system known as the Risk Evaluation Mitigation Strategy (REMS). Drugs under REMS usually carry significant side effects or are highly addictive, neither of which is true for mifepristone. Under these restrictions, clinicians who provide medication abortion must register with the FDA and then dispense mifepristone directly to the patient. As Renee and Dr. Grossman wrote last year, this requirement has made it impossible for mifepristone to be available over the counter, or at the very least to be dispensed without unnecessary certifications, despite the fact that it’s safer than Tylenol.

Continued: https://www.thenation.com/article/society/fda-medication-abortion-pharmacies/

06.01.2023

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Featured

abortion exceptionalism

Daniel Grossman

Food and Drug Administration

pharmacy abortion pills

REMS

Renee Bracey Sherman

Risk Evaluation Mitigation Strategy

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

FDA relaxes controversial restrictions on access to abortion pill by mail

Updated December 16, 2021
Sarah McCammon, Jonathan Franklin – NPR

The Food and Drug Administration has announced it will relax controversial restrictions on a heavily regulated medication used to induce abortions — easing access to the drug at a time when abortion rights are being increasingly restricted nationwide.

The drug, mifepristone, is approved for use in combination with another medication, misoprostol, to terminate pregnancies up to 10 weeks and is sometimes used to treat women experiencing miscarriages.

Continued: https://www.npr.org/2021/12/15/1064598531/the-fda-could-permanently-lift-some-restrictions-on-abortion-pills

The FDA may be about to make the abortion pill more accessible

BY USHMA UPADHYAY
DEC. 10, 2021

In the course of just a few weeks, the U.S. Supreme Court heard two cases on abortion access. The first, SB 8, is a Texas law banning abortion as early as six weeks into pregnancy. The second, Dobbs vs. Jackson Women’s Health Organization, is a Mississippi law banning abortion after the 15th week of pregnancy. Both cases could bring an end to the ability to access abortion as a federal right.

While the constitutional fight continues in court, there is another opportunity in the coming days for the federal government to help maintain abortion access: by allowing people to get abortion pills as soon as they need them.

Continued: https://www.latimes.com/opinion/story/2021-12-10/fda-abortion-pill-accessible

21 Years After FDA Approval, Abortion Pill Is More Critical Than Ever

With the Supreme Court poised to overturn Roe v. Wade, the fight for access to the abortion pill has become a matter of life and death.

9/27/2021
by CARRIE N. BAKER

Twenty-one years ago, the U.S. Food and Drug Administration (FDA) approved the abortion pill mifepristone for distribution in the United States. As states are now passing laws to ban abortion and the U.S. Supreme Court is poised to overturn Roe v. Wade, the abortion pill is what will make a post-Roe world very different from the pre-Roe world, when thousands of women died each year from illegal abortions, and many more were left permanently harmed by unsafe and illegal abortions.

Abortion pills are safe and effective, widely accessible online and easy to use. A grassroots movement led by the organization Plan C is now working to ensure that women across the country know how to get abortion pills and how to use them.

Continued: https://msmagazine.com/2021/09/27/fda-approval-abortion-pill-anniversary-medication-abortion-biden-texas-ban/

USA – These Start-Ups Could Make Abortion One Click Away

During the pandemic, women have been able to get abortion pills to take at home through an email or phone call. Will it stay that way?

Emily Shugerman, Gender Reporter
Updated May. 16, 2021

In California right now, you can get an abortion without speaking to a single other human being. You log onto a website—mychoix.co—put in your health information, answer some questions, and wait for an email from a clinician letting you know if you’ve been approved. If you are, an online pharmacy will ship you a package of mifepristone and misoprostol—a two-pill regime that is safer than many prescription drugs and 98 percent effective at terminating early-stage pregnancies. You will take it, you will bleed, your pregnancy will—in all likelihood—end.

This particular configuration is available in only one state, for a limited time, due to an emergency declaration issued by the Food and Drug Administration during the pandemic. But make no mistake: This is the future abortion advocates want.

Continued: https://www.thedailybeast.com/these-start-ups-could-make-abortion-one-click-away

16.05.2021

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Abortion Care Network

abortion on demand

abortion pills

abortion pills at home

abortion pills by mail

abortion reversal

ACLU

American College of Obstetricians and Gynecologists

American Public Health Association

Covid-19 and abortion

Dr. Colleen McNicholas

Dr. Jamie Phifer

Erin Grant

Expanding Medication Abortion Access Project

Food and Drug Administration

in-person requirement

Judge Theodore Chuang

Maine Family Planning

merican Medical Association

Planned Parenthood of the St. Louis Region

REMS

telemedicine abortion

USA – Covid Put Remote Abortion to the Test. Supporters Say It Passed.

Medication abortion was briefly available online in some states, but a court ruling blocked it. Advocates want it back.

BY REBECCA GRANT
04.05.2021

LAST SUMMER, Cindy Adam and Lauren Dubey received the news they had hoped for, but hadn’t expected to get so soon. Their new telemedicine clinic would be able to offer remote medication abortion services, at least for the time being.

Medication abortion — which most commonly involves taking two medications, 24 to 48 hours apart, during the first 10 weeks of pregnancy — has been available in the U.S. since 2000. But, despite a growing chorus of advocates and experts who say remote access is just as safe as in-clinic care, the Food and Drug Administration requires providers to dispense mifepristone, the first of the two medications, inside the walls of a clinic, hospital, or medical office, citing the risk of complications. Most abortion providers interpreted this language to mean they could not mail mifepristone to patients’ homes, rendering fully remote abortion care impossible.

Continued: https://undark.org/2021/04/05/digital-abortion-access/

05.04.2021

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Featured

abortion access during pandemic

abortion pills by mail

ACLU

Advancing New Standards in Reproductive Health

Aid Access

American Association of Pro-Life Obstetricians and Gynecologists

American Civil Liberties Union

ANSIRH

Bill and Melinda Gates Foundation

Charlotte Lozier Institute

Choix

Covid-19 and abortion

Daniel Grossman

Elisa Wells

Elizabeth Raymond

Food and Drug Administration

Graham Chelius

Gynuity Health Projects

Hey Jane

Ibis Reproductive Health

in-person requirement

Reproductive Freedom Project

Risk Evaluation and Mitigation Strategies

Sonia Sotomayor

TelAbortion Study

telehealth

telemedicine abortion

traveling for abortion

The Future of the Abortion Pill

FDA’s regulation of medication abortion must be guided by science, not politics.

Jan 26, 2021
Jasmine Wang

Erectile dysfunction drugs have a mortality rate nearly four times greater than Mifeprex, otherwise known as the abortion pill. But despite being less safe, erectile dysfunction drugs are available over the counter at pharmacies. Mifeprex, by contrast, remains one of the U.S. Food and Drug Administration’s (FDA) most heavily regulated drugs—and is even more restricted than fentanyl, an opioid.

This divergence in the regulation of Mifeprex compared to other drugs stems from highly politicized debates over abortion and reproductive rights. FDA’s regulation of Mifeprex, however, should be informed by science, not politics. Despite a demonstrated safety record, Mifeprex remains subject to restrictions that significantly limit its availability to consumers—restrictions that should be reserved for the most dangerous of drugs.

Continued: https://www.theregreview.org/2021/01/26/wang-future-abortion-pill/

USA – Telemedicine abortion is here to stay

By Carrie N. Baker

Published: 12/23/2020

The COVID-19 pandemic is transforming many aspects of our lives, and
abortion is no exception. Telemedicine is expanding access to abortion health
care in ways that are likely to persist long after the pandemic is over.

Telemedicine abortion combines medication abortion — which uses pills to end a
pregnancy — and telemedicine — which allows health providers to supervise the
use of abortion pills via videoconferencing or telephone consultations.

Continued: https://www.gazettenet.com/Baker-column-37937013

Biden Could Expand Abortion Access, Even Without the Senate

The path lies not in legislation but through the deregulation of mifepristone—the only drug the FDA has approved to safely and effectively terminate an early pregnancy.

Nov 28, 2020
Greer Donley

Joe Biden is now poised to become the next president of the United States. His victory, however, is bittersweet for many Democrats, especially those for whom abortion rights are a top issue. Democrats lost seats in the House of Representatives, and their odds for a Senate majority seem to be dwindling. Just eight days before the election, Justice Amy Coney Barrett was confirmed to the Supreme Court. Without a Senate majority and with a hostile Supreme Court, some may wonder whether any progress on abortion rights can be made in the next four years.

Abortion-rights advocates need not accept that all is lost. They simply need to look outside legislation and the courts for their answer.

Continued: https://www.theatlantic.com/ideas/archive/2020/11/biden-abortion-access/616913/