SEATTLE — A federal judge in Eastern Washington on Friday prohibited the U.S. Food and Drug Administration from pulling a commonly used abortion pill off the market, raising immediate questions about the implications of a contradictory same-day decision in a Texas case.
Nationwide access to and approval of mifepristone has drawn intense scrutiny since the U.S. Supreme Court overturned Roe v. Wade in June, most notably in a Texas lawsuit filed against the FDA last year. The lawsuit argued mifepristone was improperly approved in 2000, despite its high efficacy and low mortality rates.
The country has anxiously awaited a decision in the Texas case for weeks, and on Friday U.S. District Judge Matthew J. Kacsmaryk in Amarillo ordered a hold on U.S. approval of the drug, a direct contradiction to the decision of U.S. District Judge Thomas O. Rice in Spokane. The stay will apply while a lawsuit challenging the safety and approval of the drug continues, Kacsmaryk decided.
The Texas order does not go into effect for seven days, while Rice’s preliminary injunction takes effect immediately, according to a statement from Washington state Attorney General Bob Ferguson’s office. In other words, Washingtonians will continue to get mifepristone for now.
“Today’s ruling will preserve vital access to mifepristone while our case continues,” Ferguson said in the statement. “Mifepristone is scientifically proven to be safe and effective after more than 20 years of use in the United States. Attacks on reproductive freedom will continue, but we will continue to fight for the right to access mifepristone in Washington.”
Friday’s preliminary injunction was filed in a multistate lawsuit against the FDA led by Ferguson. The lawsuit argues that the FDA was actually too restrictive when it approved mifepristone, because it attached limitations such as requiring drugstores and doctors be specially certified to distribute or prescribe the drug.
Sixteen other states, and Washington, D.C., joined the lawsuit. Mifepristone will remain accessible for the time being in each of those states, and Washington, D.C., too.
Despite assurances from Ferguson’s office, specifics about how these two decisions will play out are unclear and could depend on how appeals courts in the 5th and 9th circuits rule on each case. The conflicting decisions may not be resolved until reaching the U.S. Supreme Court.
Federal lawyers representing the FDA are expected to swiftly appeal Kacsmaryk’s decision, according to The Associated Press.
On Friday, U.S. Sen. Patty Murray, D-Wash., called the Texas ruling “outrageous” and one that “can’t stand.”
“It would effectively create a nationwide ban on the most common way people get an abortion,” she tweeted. “The science has long been settled — medication abortion is safe & effective — but GOP extremists will stop at nothing to force women to stay pregnant.”
Gov. Jay Inslee noted on Twitter that mifepristone will also remain available in the state in part because his office recently ordered thousands of doses of the pill for Washingtonians. The Department of Corrections, which has a pharmacy license, bought 30,000 doses, while UW Medicine purchased 10,000 more.
Between the two, the state has about a four-year supply, Inslee said.
“Bottom line: mifepristone remains available to WA women because of our acquisition of this medication last week,” Inslee tweeted. “This court ruling by a Trump-appointed judge in Texas will not affect access to this medication which has been used safely for two decades.”
Mifepristone is one of two common abortion pills in the U.S. usually taken to end pregnancies in their early stages in what’s known as a medication abortion. This type makes up nearly 60% of abortions in Washington. Mifepristone first blocks the hormone progesterone, causing the lining of the uterus to break down and end a pregnancy. Misoprostol, the second pill, causes the uterus to empty.
The FDA approved the two-pill plan, shown to be effective at least 95% of the time, in 2000, after it had been widely used in Europe for years.
If mifepristone is pulled from the market, clinics and doctors have said they would switch to using only misoprostol, according to the AP. The state Department of Health has said the single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but the AP reported it’s widely used in countries where mifepristone is illegal or unavailable.
Without mifepristone, more misoprostol would have to be given, which would prolong side effects such as chills, nausea and bleeding, Dr. Deborah Nucatola, chief medical officer of the Seattle-based Planned Parenthood affiliate that stretches across most of the Northwest to Hawaii, Indiana and Kentucky, told The Seattle Times before the judges’ rulings.
The potential nationwide ban on mifepristone also creates “unnecessary risk” for medical providers and patients who travel to the state for abortion care, particularly as some states shore up restrictions on abortions, Ferguson’s office said. This week, Idaho became the first state to restrict interstate travel for abortions, prohibiting minors from traveling for an abortion without parental consent.
The Texas judge, Kacsmaryk, wrote in his decision that “”The Court does not second-guess FDA’s decision-making lightly.”
“But here, FDA acquiesced on its legitimate safety concerns — in violation of its statutory duty — based on plainly unsound reasoning and studies that did not support its conclusions,” he wrote.
However, millions of women have used mifepristone. The AP reported that medical groups note complications from the drug occur at a lower rate than that seen with wisdom teeth removal, colonoscopies and other routine medical procedures.
Elsewhere, Kacsmaryk sided with the plaintiffs in stating that the FDA overstepped its authority in approving mifepristone, in part, by using a specialized review process reserved for drugs to treat “serious or life-threatening illnesses,” according to the AP. The judge brushed aside FDA arguments that its own regulations make clear that pregnancy is a medical condition that can sometimes be serious and life-threatening, instead calling it a “natural process essential to perpetuating human life.”
Meanwhile, the Washington judge, Rice, found that plaintiffs demonstrated that “irreparable injury” to patients is likely without a preliminary injunction. For example, they could miss the window for medication abortion and have to opt for a “procedural abortion” or carry their pregnancy to term.
