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

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.  

“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.” 

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.   

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 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.