- The common abortion pill mifepristone is currently at the center of a legal argument.
- The DOJ is asking the Supreme Court to weigh in after an appeals court ruled mifepristone can stay on the market with new restrictions.
- The appeals court decision comes days 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.
A federal appeals court ruled that one of the medications used to end early pregnancies, mifepristone, can stay on the market with new restrictions.
The decision is a response to the Department of Justice (DOJ) request for the appeals court to block a ruling issued by Texas-based Judge Matthew Kacsmaryk on Friday that ordered the Food and Drug Administration (FDA) to suspend its approval of the drug. Per the 42-page ruling from the 5th Circuit Court of Appeals, mifepristone can only be taken within seven months of pregnancy and it can not be delivered by mail.
Previously, mifepristone could be taken up through 10 weeks of pregnancy and it was commonly obtained via mail-order and telehealth services.
Mifepristone access likely to end up as U.S. Supreme Court case
Though the new restrictions will tighten access to the drug, thereby making abortion care even harder to come by for millions of Americans, the drug will continue to be available as the case, Alliance for Hippocratic Medicine v. FDA, is expected to head to the Supreme Court next.
Danco Laboratories LLC, the drug manufacturer of mifepristone, had similarly asked the appeals court to freeze Judge Kacsmaryk’s order.
The drug is also used to manage miscarriages. One in four pregnancies ends in miscarriage.
In addition, 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.
The 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 that results in serious complications like bleeding in about 20% of patients.
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 recent data from the FDA showing that, since the drug’s approval in 2000, approximately 5.6 million people have taken the medication and in over 23 years only 28, or 0.0005% died — potentially from other causes.
Comparatively, acetaminophen which is commonly sold as Tylenol generally is linked to 500 deaths every year in the U.S.
“There is no merit whatsoever to these arguments. The safety claim has been refuted by decades of peer-reviewed clinical studies,” says Jessie Hill, JD, a constitutional law professor at Case Western Reserve University specializing in reproductive health rights.
Conflicting orders complicate healthcare
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.
Because the Texas judge ordered the suspension of mifepristone without any needed action from the FDA, many states are at risk of losing access to the most common pill used for abortion across the country.
No court has ever overturned a long-standing FDA drug approval.
But if mifepristone is taken off the market, the second drug in the abortion medication combination — misoprostol — can be taken on its own to induce an abortion.
“I expect that in most places, providers will continue to offer this option, which is also safe and effective (although less effective than mifepristone),” Hill said.
Hill believes the two rulings don’t technically conflict.
“For this reason, the FDA’s most likely response, if both orders stand, would simply be to do nothing and to allow the approval to be revoked,” Hill said.
That said, there are serious legal issues with the lawsuit and Hill does not suspect the ruling to stick around for long.
Reproductive health organizations react to the ruling
In the wake of Judge Kacsmaryk’s ruling, reproductive health organizations have released statements criticizing the ruling.
Kelly Blanchard, the president of Ibis Reproductive Health, says the ruling ignores decades of clinical evidence demonstrating that mifepristone is a safe and effective medication.
“The FDA reviewed extensive safety and effectiveness data and the process for its approval was sound; millions of people have used mifepristone medication abortion safely. This unprecedented move defies the FDA’s authority and rigorous scientific process to ensure people’s access to safe, effective medications,” Blanchard said in a statement.
The American College of Obstetricians and Gynecologists (ACOG) released a statement sharing similar sentiments.
“Mifepristone has been used safely and effectively for medication abortion for more than two decades. That safety and efficacy is backed up by robust, evidence-based, clinical data and its observed use by millions of people with support from clinicians, including obstetrician–gynecologists. Regardless of the opinion of one judge on this matter, mifepristone is a safe, effective part of comprehensive health care,” the ACOG’s president, Iffath Abbasi Hoskins, MD, FACOG, wrote.
Pharma leaders condemn Texas decision
Over 400 executives and leaders at pharmaceutical companies 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.
Medication abortion accounts for over half of all abortions in the U.S.
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.
The FDA approved mifepristone in 2000 and research has consistently shown it’s a safe, effective way to end early pregnancy.
“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 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.
The restrictions will have the greatest impact on people who already face barriers to care, including Black people, Indigenous people, people of color, LGBTQ+ people, people who are immigrants, have low incomes and people in geographically-isolated areas, Basu Serna added.
“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 bottom line:
Access to mifepristone, the widely-used medication for abortion, is hanging in legal limbo.
The Department of Justice asked the Supreme Court to review court decisions on the common abortion pill mifepristone.
An appeals court partially blocked the ruling issued by Texas-based Judge Matthew Kacsmaryk that demanded the Food and Drug Administration freeze its approval of the drug.
Leave A Comment