A common medication used to end pregnancy is now in question after a federal judge in Texas struck down its legality.
However, another federal judge in Washington simultaneously ruled that U.S. authorities not make any changes to access of the abortion drug, mifepristone, putting the conflicting rulings at odds.
The Texas judge, U.S. District Judge Mattew J. Kacsmaryk, who was appointed by former President Donald Trump, ruled April 7 that mifepristone ordered a stay on the drug to the Food and Drug Administration (FDA) while a lawsuit over the safety of the drug continues. Mifepristone was originally approved by the FDA in 2000 and has been the most common method of safe abortion in the United States for more than two decades.
The ruling has big implications for drug policy in the country if it is not overturned, and also calls into question the ability of the FDA to make decisions.
“The Court in this case has substituted its judgment for FDA, the expert agency that approves drugs,” the White House said April 7. “If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.”
With such a long history of safe use, Kacsmaryk’s ruling to side with the conservative group Alliance Defending Freedom, which brought about the lawsuit to outlaw mifepristone, is a major turn of events in the ongoing battle to end abortion access in the United States from radical ideological groups and certain lawmakers.
The courts have played a major role in this battle as of late. Though abortion access was a guaranteed, Constitutionally-protected right in the United States since the 1973 case Roe v. Wade, the conservative-leaning Supreme Court ended that 50-year precedence in June 2022 when it overturned the case. Since then, several states immediately moved to ban abortions at various stages, and conservative groups have taken aim at national bans by targeting medication abortion and other access points.
The latest decision by Kacsmaryk was met with disapproval by medical groups.
“Today’s decision by a sole federal district judge in Texas to overturn FDA approval of mifepristone is a grievous legal overstep into America’s well-established regulatory system,” Iffath Abbasi Hoskins, MD, FACOG, president of the American College of Obstetricians and Gynecologists (ACOG), and Maureen G. Phipps, MD, MPH, FACOG, CEO of ACOG,” said in a statement April 7. “The decision itself betrays the bias and prejudice that informed its rhetoric, which deliberately ignores decades of evidence-based scientific data and eschews clinically appropriate language about mifepristone, a critical medication used for both abortion and miscarriage management.”
The FDA also appealed the decision.
FDA approved Mifeprex more than 20 years ago based on a comprehensive review of the scientific evidence available and determined that it was safe and effective for its indicated use – medical termination of early pregnancy," the agency said in a statement following the decision. "The approval was based on the best available science and done in accordance with the laws that govern our work. FDA stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to FDA-approved medications that FDA has determined to be safe and effective for their intended uses.”
While the ruling was shocking enough, Spokane, Washington-based Judge Thomas O. Rice has blocked the FDA from making changes to access to mifepristone. Specifically, the ruling impacts the 17 states that sued over the issue to keep mifepristone access legal. These Democrat-led states were granted their request to ensure the abortion drug will remain accessible and legal for now, but the two conflicting decisions ensure the judicial impact is far from over on the issue.
The Department of Justice has filed an appeal over the Texas ruling and is seeking an immediate stay of the decision.
“The lawsuit, and this ruling, is another unprecedented step in taking away basic freedoms from women and putting their health at risk,” the White House said. “This does not just affect women in Texas – if it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state. It is the next big step toward the national ban on abortion that Republican elected officials have vowed to make law in America.”
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."