Skip to content
Center for Reproductive Rights
Center for Reproductive Rights

Primary Menu

  • About
    • Overview
    • The Center’s Impact
    • Center Leadership & Staff
    • Annual Reports
    • Corporate Engagement
    • Diversity, Equity and Inclusion
    • Careers
    • Contact Us
  • Work
    • Overview
    • Litigation
    • Legal Policy and Advocacy
    • Resources & Research
    • Recent Case Highlights
    • Landmark Cases
    • Cases Archive
    • World’s Abortion Laws Map
    • After Roe Fell: Abortion Laws by State
  • Issues
    • Overview
    • Abortion
    • Adolescent Sexual and Reproductive Health and Rights
    • Assisted Reproduction
    • Contraception
    • Humanitarian Settings
    • Maternal Health
    • COVID-19
  • Regions
    • Overview
    • Global Advocacy
    • Africa
    • Asia
    • Europe
    • Latin America and the Caribbean
    • United States
  • News
    • Latest News
    • Stories
    • Events
    • Center in the Spotlight
    • Press Releases
    • Statements
    • Press Room
    • Newsletters
  • Resources
    • Resources & Research
    • U.S. Abortion Rights: Resources
    • Maps
    • World Abortion Laws Map
    • After Roe Fell: Abortion Laws by State
    • Repro Red Flags: Agency Watch
  • Act
    • Overview
    • Give
    • Act
    • Learn
  • Donate
    • Become a Monthly Donor
    • Make a Donor Advised Fund Gift
    • Leave a Legacy Gift
    • Donate Gifts of Stock
    • Give a Gift in Honor
    • Attend an Event
    • Employee Matching Gifts
    • Mail a Check
  • Twitter
  • Facebook
  • Instagram
  • YouTube
  • LinkedIn
Donate
icon-hamburger icon-magnifying-glass Donate
icon-magnifying-glass-teal

Texas Court’s Radical Decision Attempts to Block FDA Approval of a Medication Abortion Drug Used for More Than 20 Years

Center for Reproductive Rights - Center for Reproductive Rights - search logo
search Close Close icon
Center for Reproductive Rights -
Menu Close Menu Close icon
Donate

Primary Menu

  • About
    • Overview
    • The Center’s Impact
    • Center Leadership & Staff
    • Annual Reports
    • Corporate Engagement
    • Diversity, Equity and Inclusion
    • Careers
    • Contact Us
  • Work
    • Overview
    • Litigation
    • Legal Policy and Advocacy
    • Resources & Research
    • Recent Case Highlights
    • Landmark Cases
    • Cases Archive
    • World’s Abortion Laws Map
    • After Roe Fell: Abortion Laws by State
  • Issues
    • Overview
    • Abortion
    • Adolescent Sexual and Reproductive Health and Rights
    • Assisted Reproduction
    • Contraception
    • Humanitarian Settings
    • Maternal Health
    • COVID-19
  • Regions
    • Overview
    • Global Advocacy
    • Africa
    • Asia
    • Europe
    • Latin America and the Caribbean
    • United States
  • News
    • Latest News
    • Stories
    • Events
    • Center in the Spotlight
    • Press Releases
    • Statements
    • Press Room
    • Newsletters
  • Resources
    • Resources & Research
    • U.S. Abortion Rights: Resources
    • Maps
    • World Abortion Laws Map
    • After Roe Fell: Abortion Laws by State
    • Repro Red Flags: Agency Watch
  • Act
    • Overview
    • Give
    • Act
    • Learn
  • Donate
    • Become a Monthly Donor
    • Make a Donor Advised Fund Gift
    • Leave a Legacy Gift
    • Donate Gifts of Stock
    • Give a Gift in Honor
    • Attend an Event
    • Employee Matching Gifts
    • Mail a Check
  • Twitter
  • Facebook
  • Instagram
  • YouTube
  • LinkedIn

Related Content

Issues:

Abortion, Legal Restrictions

Regions:

United States

Work:

Reporting on Rights

Type:

News, Story

Follow the Center

Donate Now

Join Now

04.07.2023

Reporting on Rights Abortion United States News

Texas Court’s Radical Decision Attempts to Block FDA Approval of a Medication Abortion Drug Used for More Than 20 Years

Virginia Sobol
Ruling is a devastating blow to abortion access across the U.S.

Share

  • facebook
  • Twitter
  • linkedin
  • Email id
©Olga Yastremska / Alamy Stock Photo

In a devastating blow to abortion access across the United States, on April 7 a federal court attempted to block the long-standing FDA approval of mifepristone, a drug used in medication abortion.  

The ruling came in Alliance for Hippocratic Medicine v. FDA, a lawsuit filed by anti-abortion advocates against the FDA and the U.S. Health and Human Services (HHS) challenging the FDA’s initial approval of the drug. The court’s decision will take effect in seven days, giving the FDA time to appeal the ruling before it takes effect.  

In the U.S., medication abortion is the most commonly used method of abortion, accounting for more than half of all abortions. Mifepristone is part of a two-drug regimen. 

If allowed to take effect, the ruling could gravely limit access to abortion care across the country, including in states where abortion is protected, and disproportionately impact people living in rural areas or parts of the country where the nearest clinic is hundreds of miles away. In addition, it threatens to exacerbate the continuing public health crisis resulting from the overturning of Roe v. Wade, which cleared the way for states to ban and severely restrict abortion.  

Read more.

Case Background: Alliance for Hippocratic Medicine v. FDA

Anti-abortion groups sued the FDA over its initial approval of mifepristone, one of the drugs used in medication abortion.

“The goal of the anti-abortion movement has always been to ban abortion nationwide—overturning Roe was never going to be enough,” said Jenny Ma, senior counsel at the Center for Reproductive Rights. “Anti-abortion advocates are chipping away at every form of abortion care, in every state.” 

Ruling Has “No Basis in Law or Fact” 

Despite mifepristone being used safely in the U.S. and around the world for decades, Judge Matthew Kacsmaryk sided with plaintiffs who falsely claim that the FDA did not sufficiently study the safety and efficacy of the drug or use the proper process to approve it over 20 years ago.  

“Today’s decision has no basis in law or fact. This lawsuit was manufactured as part of an orchestrated campaign to deny all women in the U.S. access to abortion, even those living in states with strong abortion rights protections,” said Nancy Northup, president and CEO at the Center for Reproductive Rights. “While the decision is without merit, its impact will be devastating, threatening access to a safe and effective medicine used by over five million patients in the past two decades. The ruling should be swiftly reversed on appeal. It’s abundantly clear that those who rely on a fact-based, scientific FDA drug approval process, including major pharmaceutical companies, need to speak out about the travesty of this case.” 

FDA Action to Expand Access to Medication Abortion

In January, the FDA permanently removed the in-person dispensing requirement for mifepristone and allowed retail and online pharmacies to directly provide the medication to patients.

Immediately after the ruling, a federal court in Washington issued a conflicting decision, ordering the FDA to keep mifepristone available under the current regulations in some states. The interaction of the conflicting orders by the two federal courts is unclear at this time.

Leading Medical Organizations Support Medication Abortion  

Leading medical organizations—including the American Medical Association (AMA) and the American College of Obstetricians and Gynecologists (ACOG)—have repeatedly expressed concern over the lack of access to abortion and its impact on patients’ health. 

ACOG and the AMA predict that that the country’s maternal mortality crisis will worsen without access to abortion care, including medication abortion. In a statement, pharmacist organizations raised concerns about the risks to patients’ health without access to mifepristone, which is also used to treat ectopic pregnancies, miscarriages, and other medical conditions.   

“Are Abortion Pills Safe? Here’s the Evidence,” The New York Times, 04.01.23

An amicus brief submitted by ACOG and other medical groups for this case stated, “Medication abortion’s relative availability makes it more accessible to patients who otherwise face challenges to access medical care, including low-income patients and patients of color –the very people who are most likely to experience severe maternal morbidity and more likely to die from pregnancy-related complications.” 

In addition to endangering access to medication abortion, the ruling also threatens the FDA’s authority over the drug approval process, which could severely limit the development of new drugs overall and have far-reaching repercussions on patients’ access to FDA-approved medications. 

Medication Abortion in Global Context: Frequently Asked Questions

The Facts: Medication Abortion is Safe and Effective

Medication abortion was approved by the FDA in 2000 and has since been used by more than 4 million women in the U.S. It has a well-documented safety record, demonstrated in real-world use and in more than 100 research publications in peer-reviewed journals.   

  • The FDA has conducted in-depth analyses on mifepristone over the years which repeatedly demonstrate the drug’s safety and efficacy, including during initial approval in 2000, follow-up review in 2016, and as recently as this year.  
  • The FDA’s decision to allow patients to obtain medication abortion via mail was made after a comprehensive review in line with evidence.   
  • Medication abortion accounts for more than half (54%) of all abortions in the U.S and is the preferred method for many patients.    
  • Leading medical and scientific organizations, including the American Medical Association (AMA), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Family Physicians (AAFP), recognize medication abortion care as safe and effective.  
  • A robust audit by the Government Accountability Office in 2008 found that the FDA’s approval of mifepristone was consistent with the approval of other drugs.    

See “The Safety of Medication Abortion Care,” published by the Expanding Medication Abortion Access (EMAA) Project, for more information. 

Tags: medication abortion, american college of obstetricians and gynecologists, AMA, american medical association, mifepristone access, medication abortion access, Alliance for Hippocratic Medicine v. FDA, u.s. food and drug administration, FDA, Nationwide abortion ban, Texas, mifepristone, ACOG

Related Posts

While Anti-Abortion Lawmakers Rush to Enforce State Bans, U.S. Senator Proposes Nationwide Abortion Ban

The ban “exposes the pretext that reversing Roe v. Wade was about letting each state decide its own laws.” --Nancy...

Abortion, Legal Restrictions,United States,Engaging Policymakers, In Washington D.C., U.S. Congressional Advocacy, Reporting on Rights
While Anti-Abortion Lawmakers Rush to Enforce State Bans, U.S. Senator Proposes Nationwide Abortion Ban

Nationwide Threat to Medication Abortion

Anti-abortion advocates sue the FDA attempting to remove an abortion medication in all 50 states.

Abortion, Legal Restrictions,United States,Reporting on Rights
Nationwide Threat to Medication Abortion

New Report Shows More Evidence of Harm Caused by Abortion Bans

Report by ANSIRH details poor-quality care post-Roe and its harm to patients and providers.

Abortion, Legal Restrictions, Maternal Health, Access to Quality Care, SRHR General,United States,Reporting on Rights
New Report Shows More Evidence of Harm Caused by Abortion Bans

Sign up for email updates.

The most up-to-date news on reproductive rights, delivered straight to you.

Footer Menu

  • Careers
  • Privacy Policy
  • Gift Acceptance Policy
  • Contact Us

Center for Reproductive Rights
© (1992-2024)

Use of this site signifies agreement with our disclaimer and privacy policy.

Better Business Bureau Charity Watch Top Rated Center for Reproductive Rights
This site uses necessary, analytics and social media cookies to improve your experience and deliver targeted advertising. Click "Options" or click here to learn more and customize your cookie settings, otherwise please click "Accept" to proceed.
OPTIONSACCEPT
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThis cookie is installed by Google Analytics. The cookie is used to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. The cookies store information anonymously and assign a randomly generated number to identify unique visitors.
_gat_UA-6619340-11 minuteNo description
_gid1 dayThis cookie is installed by Google Analytics. The cookie is used to store information of how visitors use a website and helps in creating an analytics report of how the wbsite is doing. The data collected including the number visitors, the source where they have come from, and the pages viisted in an anonymous form.
_parsely_session30 minutesThis cookie is used to track the behavior of a user within the current session.
HotJar: _hjAbsoluteSessionInProgress30 minutesNo description
HotJar: _hjFirstSeen30 minutesNo description
HotJar: _hjid1 yearThis cookie is set by Hotjar. This cookie is set when the customer first lands on a page with the Hotjar script. It is used to persist the random user ID, unique to that site on the browser. This ensures that behavior in subsequent visits to the same site will be attributed to the same user ID.
HotJar: _hjIncludedInPageviewSample2 minutesNo description
HotJar: _hjIncludedInSessionSample2 minutesNo description
HotJar: _hjTLDTestsessionNo description
SSCVER1 year 24 daysThe domain of this cookie is owned by Nielsen. The cookie is used for online advertising by creating user profile based on their preferences.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
CookieDurationDescription
_fbp3 monthsThis cookie is set by Facebook to deliver advertisement when they are on Facebook or a digital platform powered by Facebook advertising after visiting this website.
fr3 monthsThe cookie is set by Facebook to show relevant advertisments to the users and measure and improve the advertisements. The cookie also tracks the behavior of the user across the web on sites that have Facebook pixel or Facebook social plugin.
IDE1 year 24 daysUsed by Google DoubleClick and stores information about how the user uses the website and any other advertisement before visiting the website. This is used to present users with ads that are relevant to them according to the user profile.
IMRID1 year 24 daysThe domain of this cookie is owned by Nielsen. The cookie is used for storing the start and end of the user session for nielsen statistics. It helps in consumer profiling for online advertising.
personalization_id2 yearsThis cookie is set by twitter.com. It is used integrate the sharing features of this social media. It also stores information about how the user uses the website for tracking and targeting.
TDID1 yearThe cookie is set by CloudFare service to store a unique ID to identify a returning users device which then is used for targeted advertising.
test_cookie15 minutesThis cookie is set by doubleclick.net. The purpose of the cookie is to determine if the user's browser supports cookies.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
CookieDurationDescription
adEdition1 dayNo description
akaas_MSNBC10 daysNo description
cookielawinfo-checkbox-functional1 yearThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-others1 yearNo description
geoEdition1 dayNo description
next-i18next1 yearNo description
SAVE & ACCEPT
Powered by CookieYes Logo
Scroll Up