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.


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

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

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/

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

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

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/

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

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


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

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.

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/

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/

FDA says abortion pills can be sent by mail

By Tierney Sneed, CNN
Thu December 16, 2021

(CNN)The US Food and Drug Administration announced Thursday that it is lifting a requirement that patients seeking medication abortion had to pick up the medication in-person, instead allowing pills to be sent by mail. The move comes as the Supreme Court is poised to undo its abortion rights precedent.

Relaxing the federal restrictions on medication abortion is one thing that the Biden administration could do mitigate the fallout from a Roe v. Wade reversal, but red states are already on the march to counteract what the federal government has opted to do.

Continued: https://www.cnn.com/2021/12/16/politics/medication-abortion-fda-supreme-court/index.html