- The medication mifepristone has been approved by the FDA for over 20 years for ending early pregnancies.
- On Friday two different decisions by federal judges has essentially left the FDA with competing directives.
- In Texas a federal judge ordered the FDA overturn their approval of the drug, but in Washington a judge ordered that the FDA not restrict the medication.
- The Justice Department has now appealed a decision in one ruling that would restrict the medication.
A common pill used for abortion that has been approved for 20 years by the Food and Drug Administration (FDA,) could soon be pulled from the market due to a court case.
The medication, called mifepristone, has been approved by the FDA for ending early pregnancies for over 20 years.
On Friday in Texas a federal judge ordered the FDA overturn their approval of the drug, but on the same day a judge in Washington ordered that the FDA not restrict the medication.
The FDA is now currently under two competing court orders regarding the medication.
The Justice Department announced today they have filed an appeal in Texas case. In the Texas decision the judge had delayed the decision from going into effect to give the Justice Department time to file an appeal.
Major health groups have come out against the Texas court decision.
Leaders at the American College of Gynecologists and Obstetrics released a statement Friday the Texas decision.
“This decision decidedly misrepresents medication abortion care. It is inflammatory, brazenly substitutes the court’s judgment for that of trained professionals, and distorts the reality of the ACOG members who compassionately provide abortion care, of the millions of patients whose health and lives have been impacted by medication abortion, and of the decades of decisive scientific data that prove its safety and efficacy.
“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.
On Monday over 400 executives and leaders at pharmaceutical companies issued a statement condemning the Texas ruling calling it “judicial activism.”
“The decision ignores decades of scientific evidence and legal precedent. 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 officials also reiterated that they “unequivocally support” the FDA to continue regulating medications.
“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. While the drug development, approval and monitoring process is not perfect, the Agency’s framework has resulted in decades of unsurpassed medical innovation and in statutory mechanisms to remove drugs from the market if, among other reasons, they fail to maintain the anticipated safety and efficacy profile.”
The judge who is overseeing the case — Judge Matthew J. Kacsmaryk — ordered a hold on federal approval of the drug, essentially overturning the FDA approval.
The FDA asked the judge to deny the motion, claiming that removing access to mifepristone would cause worse health outcomes and irreversible harm for many patients looking to terminate their pregnancies.
Research has consistently shown that the abortion medications — which account for over half of all abortions in the United States — are safe and effective.
If mediation abortions were to be banned, millions of Americans — particularly those in marginalized populations — would lose access to safe abortions and the number of counties with an abortion care provider would plummet.
“I believe if access to safe methods for pregnancy termination are banned there will be more botched abortions, septic abortions, hysterectomies, hemorrhages, and maternal deaths,” Dr. Kecia Gaither, a double board-certified OB/GYN and maternal-fetal medicine specialist, told Healthline.
In an earlier interview, Jessie Hill, JD, a constitutional law professor at Case Western Reserve University specializing in reproductive health rights, says the lawsuit is frivolous.
The FDA has a process for withdrawing drugs that have a safety problem from the market.
“It requires that the drug manufacturer be given notice and an opportunity to respond to the evidence,” Hill said.
But there are no safety concerns for mifepristone and there also isn’t a precedent that’s forced the FDA to withdraw a drug from the market.
Nicholas Creel, JD, PhD, an assistant professor of business law at Georgia College & State University who specializes in constitutional law, says a nationwide abortion ban is not out of the question.
Judge Kacsmaryk has a history of backing anti-abortion policies, says Creel.
“This is the ideal judge you’d want if you were hunting for a radical ruling that upends existing precedent when it comes to reproductive choice,” Creel said.
Even though the case is being appealed, there’s no guarantee the 5th Circuit Court of Appeals — and even the Supreme Court — will take action to stop Judge Kacsmaryk’s rulings, given their track record with S.B. 8, a law that banned early pregnancies in Texas by penalizing anyone who helps a pregnant person get an abortion. That law allows private citizens to sue any individual who performs an abortion or helps a pregnant person get an abortion after 6 weeks of pregnancy for a minimum of $10,000.
“We can expect to see them again sit idly by as precedent is thrown to the wind and the rights of tens of millions of women are curtailed,” Creel said.
Medication abortion is the most common type of abortion in the U.S.
If the drugs were banned, over 64 million women of reproductive age would immediately lose access to medication abortions.
Millions more — including people who identify as non-binary or are or have transitioned — would lose access.
Reproductive health advocate also suspect that the removal of medication abortions would further reduce availability at in-person clinics.
People could expect longer wait times, unnecessary delays for booking appointments, and higher costs for care.
Research consistently shows that the abortion medications are a safe, effective option for ending early pregnancies.
Less than 0.4% of patients who take the medications require hospitalization.
Mifepristone impacts hormone function, which causes the uterine lining to degrade and the embryo to detach from the uterine walls, explains Gaither.
Misoprostol binds to uterine cells and cause contractions that lead to expulsion of tissue.
“Used correctly, Mifepristone/Misoprostol have been noted to be safe and effective through 63 days estimated gestational age for medical pregnancy termination,” Gaither said.
On Friday in Texas a federal judge ordered the FDA overturn their approval of a drug used to end pregnancies, but on the same day a judge in Washington ordered that the FDA not restrict the medication.