Federal Appeals Court Strikes Down FDA's Decision to Allow Abortion Drug by Mail
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A federal appeals court has ruled that safeguards should be in place when it comes to a powerful drug that causes abortions.
Safety Measures Restored
The Fifth Circuit Court of Appeals ruled that the Food and Drug Administration (FDA) was wrong to remove safety measures for mifepristone. Most recently, the FDA had allowed mail-order access to the drug, but the court struck down that move.
"In loosening mifepristone's safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it," Judge Jennifer Walker Elrod wrote. She was joined by Judge Cory Wilson.
The court also restored other safety measures to protect women, saying mifepristone should only be allowed through the seventh week of pregnancy rather than the 10th, and it must be administered in the presence of a physician.
Did the FDA Violate a Safety Law When It First Approved Mifepristone?
The complicated ruling also considered another major matter – whether the FDA should have ever approved mifepristone in the first place back in 2000.
Elrod's opinion said a lower court was wrong to have revoked the FDA's approval of the drug, saying it was likely barred by legal time limits.
Another judge on the panel, Judge James Ho, dissented, arguing that the FDA's initial approval violated the Comstock Act. He also said the FDA gave the green light to mifepristone under a law that allows approval for drugs that treat serious or life-threatening illness. "Pregnancy is not an illness," Ho wrote.
What Comes Next?
The safety restrictions won't go into effect immediately as the case makes its way through the judicial process.
The Biden administration said it would appeal the ruling and it's ultimately expected to land at the U.S. Supreme Court.
Abortion advocates denounced the Fifth Circuit's decision, saying the ruling poses a major threat to abortion availability.
"If the Supreme Court affirms this decision, it will prevent patients from receiving their medication in the mail in all 50 states in the nation," Jennifer Dalven of the American Civil Liberties Union said. "That means that patients will have to travel often hundreds of miles, especially if they're coming from a state that has banned abortion, for the sole purpose of picking up a pill."
Chemical abortions currently account for more than half of all abortions in the U.S., according to the Guttmacher Institute.
Liberty Counsel Founder and Chairman Mat Staver called the Fifth Circuit's decision "great" when it comes to abolishing mail-in abortions.
"Abortion is never safe for the child or the woman," Staver said in a press release.
Mifepristone, part of a two-drug protocol taken with misoprostol, slowly starves a baby to death in the womb over one to two days, and then misoprostol induces labor and causes severe cramping, contractions, and bleeding to expel the baby's body from the womb, according to the Liberty Counsel which had filed an amicus brief with the Fifth Circuit on behalf of the Frederick Douglass Foundation and the National Hispanic Christian Leadership Conference.
Jor-El Godsey, president of Heartbeat International, also welcomed the Fifth Circuit's ruling.
"The FDA should pursue the best interest of the people and not the politics of Big Pharma and the ideology of Big Abortion. Women deserve better than abortion," Godsey said in a statement.
"Restoring protections for women should be followed by real research into the full impact chemical abortions have. More should be done at the federal and state level to help women have true choice and not be forced into an abortion decision they don't really want," he added.
"Chemical Abortion Pills take one life almost every time, an innocent child, and exposes women to all kinds of known problems," said a statement from Students for Life of America.
Erin Hawley, an attorney for the Alliance Defending Freedom, which filed the Texas lawsuit, said her organization had not yet decided whether to appeal to the Supreme Court to try to get mifepristone's approval fully revoked.
There is virtually no precedent for a U.S. court overturning the approval of a drug that the FDA has deemed safe and effective. While new drug safety issues often emerge after FDA approval, the agency is required to monitor medicines on the market, evaluate emerging issues and take action to protect U.S. patients. Congress delegated that responsibility to the FDA — not the courts— more than a century ago.
But the concern, in this case, is that the FDA quickly approved the drug to satisfy a political agenda rather than following the science regarding women's safety.
During a May 17 hearing, the 5th Circuit panel pushed back frequently against assertions that U.S. District Judge Matthew Kacsmaryk's April 7 decision to strike down mifepristone was unprecedented and unwarranted.
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