FDA

USA – The Anti-Abortion Movement’s Biggest Fear

BY DAHLIA LITHWICK
MARCH 25, 2024

On Tuesday, the Supreme Court is scheduled to hear oral arguments in FDA v. Alliance for Hippocratic Medicine, a case that could determine national access to mifepristone, one of two pills used as part of medication abortion. In this week’s episode of Amicus, Dahlia Lithwick spoke with Carrie N. Baker, whose book, History and Politics of Abortion Pills in the United States, is being published by Amherst College Press this year.

Lithwick and Baker discussed the anti-abortion movement’s decadeslong efforts to target the abortion pill, how those efforts hampered FDA approval of the medication in the first place, and how having easier access to reproductive care through a pill that can be sent in the mail and taken at home fundamentally threatens the strategy of those seeking to dismantle abortion rights in this country. The following transcript has been edited for length and clarity.

Continued: https://slate.com/news-and-politics/2024/03/abortion-pill-supreme-court-preview-mifepristone-history.html

25.03.2024
Interviews/Podcasts
abortion pills by mail
anti-choice cruelty
anti-choice harassment
anti-choice misogyny
anti-choice terrorism
anti-choice threats
anti-choice violence
Carrie N. Baker
crisis pregnancy center
Dahlia Lithwick
Danco Laboratories
FACE Act
FDA
Food and Drug Administration
Guttmacher Institute
history of anti-choice activism
Marjorie Taylor Greene
Matthew Kacsmaryk
mifepristone
Population Council
Roussel-Uclaf
telemedicine abortion
U.S. Supreme Court
United States
Anti-choice
Human Rights
Law

Abortion pill maker sues FDA to preserve access

The lawsuit from GenBioPro, which makes the generic version of the drug, comes as SCOTUS action looms.

By ALICE MIRANDA OLLSTEIN
04/19/2023

The company that makes the generic version of a common abortion pill sued the FDA on Wednesday, hoping to bar the agency from rolling back access to the drug if the Supreme Court allows sweeping restrictions to take effect this week.

The challenge filed in federal court in Maryland, where the agency is headquartered, argues that if the FDA implements a court order suspending approval of the drug, mifepristone, it would be “depriving GenBioPro of its constitutional and statutory rights to market mifepristone without affording GenBioPro due process of law.”

Continued: https://www.politico.com/news/2023/04/19/abortion-pill-maker-sues-fda-to-preserve-access-00092810

19.04.2023
News
abortion pills
Alliance for Hippocratic Medicine
FDA
Food and Drug Administration
GenBioPro
mifepristone
United States
Human Rights
Law

Democratic Lawmakers Blast Abortion Pill Ruling In Scathing Letter

Nearly 600 legislators from 49 states signed the letter attacking the "dangerous" ruling by a Trump-appointed judge to revoke FDA approval of mifepristone.

By Kevin Robillard
Apr 14, 2023

Nearly 600 Democratic state legislators have signed on to a letter protesting a federal judge’s ruling revoking FDA approval of mifepristone, saying the “health and wellbeing of our constituents that we were put into office to protect is at grave risk.”

The 588 legislators [now 621] who signed come from every state except North Dakota, a sign of how the party views promoting access to mifepristone, one of the two drugs involved in medication abortion, and defending the Food and Drug Administration from political interference as a winning issue even in conservative areas.

Continued: https://www.huffpost.com/entry/democratic-lawmakers-abortion-pill-ruling-letter_n_64393cb0e4b0ac40918ac299

14.04.2023
News
FDA
Food and Drug Administration
Gretchen Whitmer
Jennifer Driver
Julie von Haefen
State Innovation Exchange
United States
Human Rights
Law
Politics

Texas abortion pill ruling could undermine U.S. FDA, experts say

By Ahmed Aboulenein, Reuters
Posted April 10, 2023

A federal judge’s decision last week to suspend the U.S. Food and Drug Administration’s (FDA) approval of abortion pill mifepristone could severely weaken the agency if allowed to stand, health policy and legal experts said.

U.S. District Judge Matthew Kacsmaryk’s ruling on Friday, which followed a March 15 hearing, was a preliminary injunction that would essentially ban sales of mifepristone while the case by anti-abortion groups before him continues in the Northern District of Texas.

Continued: https://globalnews.ca/news/9612569/texas-abortion-pill-us-fda/

10.04.2023
News
Alliance for Hippocratic Medicine
FDA
Food and Drug Administration
Kaiser Family Foundation
Laurie Sobel
Matthew Kacsmaryk
mifepristone
Scott Lassman
Xavier Becerra
United States
Health
Law

The Latest Attack on the Abortion Pill Is Forty Years in the Making

If a Texas lawsuit prevails, mifepristone will no longer be available anywhere in the nation, even in states where abortion is legal.

By Sue Halpern, The New Yorker
March 9, 2023

In 1987, Ms. magazine asked me to write about RU-486, a new medication that caused the uterus to expel a fertilized egg before it could gestate. It wasn’t a contraceptive, but it wasn’t what most people considered an abortion, either. At the time, anti-abortion campaigners were brandishing ultrasound images that purported to show fetuses crying out in pain as they were being surgically removed. RU-486, which was developed in France but not yet available in the United States, threatened to stymie this tactic: there would be no fetal development to flaunt. Even the president of the National Right to Life Committee acknowledged that there was little P.R. value in images of what appeared to be menstruating women. This disarming of the pro-life movement, and the drug’s seemingly benign effect, I wrote, “may serve to decimate the ranks of abortion foes.” Étienne-Émile Baulieu, the primary developer of RU-486, which is better known as mifepristone, was even more hopeful. With this drug, he declared, abortion “should more or less disappear as a concept, as a fact, as a word in the future.”

Continued: https://www.newyorker.com/news/daily-comment/the-latest-attack-on-the-abortion-pill-is-forty-years-in-the-making

09.03.2023
Commentary
Alliance for Hippocratic Medicine
American College of Obstetricians and Gynecologists
American Medical Association
David S. Cohen
Étienne-Émile Baulieu
FDA
Food and Drug Administration
Guttmacher Institute
I. Glenn Cohen
Jacqueline Darroch Forrest
Matthew Kacsmaryk
mifepristone
misoprostol
National Right to Life Committee
RU-486
Samuel Alito
Sue Halpern
Walgreen's refusal
United States
Anti-choice
Health
Human Rights

Judge extends deadline in lawsuit seeking to pull abortion pill mifepristone from U.S. until Feb. 24

FRI, FEB 10 2023
Spencer Kimball

A federal judge in Texas has extended until Feb. 24 the deadline in a lawsuit seeking to overturn the Food and Drug Administration’s approval of the abortion pill.

Judge Matthew Kacsmaryk on Thursday ordered one of the companies that makes the pill, Danco Laboratories, to lay out its opposition to the attempt to pull the medication from the U.S. market. The anti-abortion physicians who originally filed the lawsuit then have until Feb. 24 to reply.

Continued: https://www.cnbc.com/2023/02/10/abortion-pill-judge-extends-deadline-in-lawsuit-seeking-to-pull-medication-from-us.html

10.02.2023
News
abortion pills
Alliance for Hippocratic Medicine
Danco Laboratories
FDA
Food and Drug Administration
GenBioPro
Matthew Kacsmaryk
mifepristone
Naral Pro-Choice America
United States
Human Rights
Law

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/

04.10.2022
Featured
News
American College of Obstetricians and Gynecologists
Dr. Maureen G. Phipps
Expanding Medication Abortion Access Project
FDA
FDA restrictions on mifepristone
Food and Drug Administration
in-person requirement
Kirsten Moore
mifepristone
misoprostol
Physicians for Reproductive Health
Risk Evaluation and Mitigation Strategies
SisterReach
United States
Health
Human Rights

Galvanized by Dobbs, more doctors are distributing abortion pills by mail

A new president could reverse an FDA rule change that made it possible.

By RUTH READER
09/21/2022

Doctors at online and brick and mortar primary care companies are slowly starting to prescribe medication abortion pills via telemedicine in states where it’s still legal following the Supreme Court’s Dobbs decision ending the constitutional right to the procedure.

The FDA has yet to update its rules to make way for large retail pharmacies to dispense medication abortion, limiting how patients can get pills. In the meantime, these companies are leaning on two mail-order pharmacies to fill their prescriptions.

Continued: https://www.politico.com/news/2022/09/21/dobbs-abortion-pills-roe-00057877

21.09.2022
Featured
News
abortion pills at home
Aid Access
Alpha Medical
Carolyn Witte
Choix
FDA
Food and Drug Administration
Hey Jane
Honeybee Health
Hyde Amendment
mail order abortion
online pharmacies for abortion
telemedicine abortion
Tia
Ushma Upadhyay
United States
Clinical
Health
Human Rights

19 States Ignore Global Evidence and Move to Block Access to Abortion Pills

Despite a wealth of research that shows medical abortion at home is effective, safe, acceptable and improves access to care, 19 U.S. states are introducing laws to block access to the medication.

2/10/2022
by SARAH SHAW, Ms. Magazine

At the end of 2021, the U.S. Federal Drug Administration (FDA) announced it would permanently ease federal restrictions on abortion pills. They’re allowing these drugs to be sent by mail, after a medical consultation by phone rather than requiring an in-person visit. The change has been welcomed by healthcare providers who point to the importance of providing women with safe methods in the fight to eliminate unsafe abortion and related deaths and injury.

Along with the need to overcome obstacles created by COVID-19, so that women can safely exercise their right to choose even during the pandemic, supporters also point to the sharp increase in gender-based violence during the pandemic—with many women unable to leave their homes—as another reason why medical abortion at home is so important.

Continued: https://msmagazine.com/2022/02/10/medication-abortion-pills-usa-states-reproductive-health/

10.02.2022
Commentary
Featured
abortion pills
abortion pills by mail
anti-choice misogyny
anti-choice restrictions
at-home abortion
Covid-19 and abortion
FDA
Food and Drug Administration
gender-based violence
MSI Nepal
MSI Reproductive Choices
self-managed abortion
state restrictions
telemedicine abortion
Africa
Asia
Ghana
Nepal
South Africa
United States
Anti-choice
Health
Human Rights
Politics

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/

20.12.2021
Featured
Opinion
Daniel Grossman
FDA
Food and Drug Administration
in-person requirement
medication abortion
mifepristone
misoprostol
Risk Evaluation and Mitigation Strategies
telemedicine abortion
North America
United States
Health
Human Rights