Mail-order access to a drug used in the most common form of abortion in the U.S. would end under a federal appeals court ruling issued Wednesday that cannot take effect until the Supreme Court weighs in.
The decision by three judges on the 5th U.S. Circuit Court of Appeals in New Orleans overturned part of a lower court ruling that would have revoked the Food and Drug Administration’s 23-year-old approval of mifepristone. But it left intact part of the ruling that would end the availability of the drug by mail, allow it to be used through only the seventh week of pregnancy rather than the 10th, and require that it be administered in the presence of a physician.
Those restrictions won’t take effect right away because the Supreme Court previously intervened to keep the drug available during the legal fight.
The panel’s ruling would reverse changes the FDA made in 2016 and 2021 that eased some conditions for administering the drug.
“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 for the panel. She was joined by Judge Cory Wilson. Judge James Ho dissented, arguing to fully uphold a Texas-based federal judge’s April ruling that would revoke the drug’s approval, which the FDA granted in 2000.
President Joe Biden's administration said it would appeal, with Vice President Kamala Harris decrying the potential effect on abortion rights, as well as on the availability of other medications.
“It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA,” Harris' statement said.
Abortion rights advocates said the ruling poses a major threat to abortion availability following last year's Supreme Court ruling that overturned Roe v. Wade and the nationwide right to abortion.
"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 during an online news conference. “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.”
Abortion opponents hailed the ruling, although they, too, might appeal to seek full revocation of the FDA's approval of the drug.
“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 the anti-abortion 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. The conservative Christian legal group was also involved in the Mississippi case that led to the June 2002 Supreme Court ruling that has allowed states to ban abortion.
An attorney for drugmaker Danco Laboratories, which argued in favor of upholding the FDA approval and revisions, did not respond to an email from The Associated Press seeking comment. Drugmaker GenBioPro, which was not part of the lawsuit, noted that the ruling would keep its generic mifepristone available, subject to the restrictions.
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.
However, during a May 17 hearing, the 5th Circuit panel pushed back frequently against assertions that U.S. District Judge Matthew Kacsmaryk’s April 7 ruling was unprecedented and unwarranted.
Kacsmaryk, Ho and Wilson are all appointees of former President Donald Trump. Elrod was appointed to the 5th Circuit by former President George W. Bush. All of the judges have a history of supporting abortion restrictions.
Elrod’s opinion said the full revocation of FDA’s approval of the drug was likely barred by legal time limits. Ho argued that the approval violated the 19th century 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.
Mifepristone is one of two pills used in medication abortions. The other drug, misoprostol, is also used to treat other medical conditions. Health care providers have said they could switch to misoprostol if mifepristone is no longer available or is too hard to obtain. Misoprostol is somewhat less effective in ending pregnancies.
