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.

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


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/


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


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


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/


USA – Abortion Pill Effective for Treating Fibroids, But Anti-Abortion Politics Stymie Access

7/26/2021
by CARRIE N. BAKER, Ms. Magazine

In 2000, the U.S. Federal Drug Administration (FDA) approved mifepristone for abortion during the first seven weeks of pregnancy, later extending allowable use to ten weeks in 2016. While widely known as an abortion pill, mifepristone is very effective for treating fibroids and may also be effective for treating endometriosis and depression.

Yet the drug is not available to use for these serious conditions because the FDA tightly restricts the medication due to intense anti-abortion pressure. The politicization around mifepristone has made research on its usefulness in treating these conditions difficult to conduct, preventing its development for treatments that could significantly enhance women’s health.

Continued: https://msmagazine.com/2021/07/26/mifepristone-abortion-pill-fibroids-endometriosis-depression-fda-rems-biden/


USA – Telemedicine options for abortion are here to stay

Through pandemic necessity, an ad-hoc, telehealth model for reproductive healthcare is sticking around.

By KYLIE CHEUNG
PUBLISHED JUNE 20, 2021

As much of the country prepares to return to some form of post-pandemic normalcy, reproductive health care providers and advocates hope we continue one vital pandemic tradition: telemedicine options for receiving and providing reproductive care from home.

Some researchers and providers have found offering medication abortion care via telehealth is crucial to bridging gaps in abortion access. Abortion medication care is safe and effective up to 10 weeks into one's pregnancy, and providers say that having a telehealth component to abortion care may even help establish greater medical trust and comfort for patients from marginalized communities seeking care.

Continued: https://www.salon.com/2021/06/20/telehealth-abortion-access-pandemic/