- The common abortion pill mifepristone is currently at the center of a legal argument.
- The U.S. Supreme Court ruled today that the medication will remain fully legal as appeals work their way through the lower court system.
- The court comes after a Texas judge ordered the FDA to suspend its approval of the drug.
- Over 400 drug company executives and leaders have also issued a statement decrying that Texas decision.
The U.S. Supreme Court has ruled that a commonly prescribed abortion medication will remain available.
The decision is a response to the Department of Justice (DOJ) request for the court to block a ruling issued by Texas-based Judge Matthew Kacsmaryk that ordered the Food and Drug Administration (FDA) to suspend its approval of the drug.
Previously, a lower court ruled that mifepristone could remain available as the case plays out, however, it would only be accessible under new restrictions.
For example, the drug could only be taken through seven weeks of pregnancy, rather than the FDA-approved 10 weeks and it could no longer be distributed by mail order services, the lower court had ruled.
The Supreme Court’s ruling will block these restrictions and preserve access to the drug, likely for months, as lower courts tackle appeals aimed at removing the FDA’s authorization of mifepristone.
The case now heads to the New Orleans-based U.S. Court of Appeals for the 5th Circuit, which will hear arguments in the case on May 17.
The Supreme Court decision will ensure that the medication remains widely available. But appeals to the case will be heard in the 5th Circuit Court of Appeals and the case could potentially return to the Supreme Court in the coming months.
The decision provides some clarity after dueling court decisions left access to the commonly used medication in limbo.
In addition to the Texas decision, a federal judge in the Eastern District of Washington, Judge Thomas Rice, ordered the FDA to keep the drug available in 17 states and the District of Columbia this month.
The previous rulings were made in response to a lawsuit filed against the FDA by anti-abortion groups claiming that medication abortion is a high-risk procedure despite it’s widespread use for decades.
The drug is also used to manage miscarriages. One in four pregnancies ends in miscarriage.
The plaintiffs say the FDA accelerated the drug’s approval without thoroughly evaluating the safety of the medication, however, numerous studies have found the drug to be safe and effective, including
Comparatively, acetaminophen which is commonly sold as Tylenol generally is linked to
“There is no merit whatsoever to these arguments. The safety claim has been refuted by decades of peer-reviewed clinical studies,” Jessie Hill, JD, a constitutional law professor at Case Western Reserve University specializing in reproductive health rights said in an earlier interview.
Because the Texas judge ordered the suspension of mifepristone without any needed action from the FDA, many states were at risk of losing access to the most common pill used for abortion across the country.
The ruling from Judge Rice in Washington, which said the FDA cannot take any action to reduce the availability of mifepristone, only applies to 17 states plus Washington D.C., most of which are blue states.
Planned Parenthood said on Friday that the decision was good news but criticized the earlier judgments that led to the Supreme Court intervention.
The American College of Obstetricians and Gynecologists (ACOG) released a statement sharing similar sentiments.
“ACOG is grateful that the Supreme Court listened to the medical experts and has maintained access to safe, effective mifepristone. Even though mifepristone has remained available over the past several weeks, the ongoing judicial attacks have led to widespread chaos and confusion, with clinicians uncertain as to whether and where they could prescribe the medication for abortion and miscarriage management. Moreover, the inflammatory, biased language that pervaded the lower court decision instilled fear and falsehoods about medication abortion, the impact on patients, and the clinicians who provide compassionate abortion care.
Over 400 executives and leaders at pharmaceutical companies also issued a statement condemning the Texas ruling.
“The decision ignores decades of scientific evidence and legal precedent,” they wrote. “Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry.”
The drug company leaders also stated their concerns that the decision could undermine regulation around drugs and potentially lead to other medications being pulled from the market for political reasons.
“If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone,” they wrote.
Dr. Tania Basu Serna, a board-certified OB/GYN and complex family planning specialist in San Francisco, CA, says it’s devastating to see abortion care options continually being chipped away at by politics.
“There is an overwhelming body of scientific and medical evidence that shows that mifepristone when used in combination with misoprostol is safe and over 95% effective for medication abortion and management of early pregnancy loss,” Basu Serna said.
Delays and disruptions in abortion care contribute to poorer maternal health and infant outcomes.
The previous ruling from Judge Kacsmaryk will create more fear and uncertainty for people who need abortions along with healthcare workers who provide them, says Basu Serna.
“Health care providers — the medical experts — should be the decision makers around what care is offered. People who have abortions, patients that I see in my office, should be the ultimate deciders in the care and support they need,” Basu Serna said.
The U.S. Supreme Court has ruled that a commonly used medication used for abortion and miscarriage will remain legal. However, this does not guarantee the medication will remain legal. An appeal to this case will currently be heard in lower courts and the case could ultimately end up in the Supreme Court again.