PHILADELPHIA (KYW Newsradio, AP) —Opposing rulings on the legality of an FDA-approved pill commonly used for abortion and miscarriage could mean that a final decision on access to the drug could be made by a higher court.
In the wake of two separate rulings, issued in quick succession by federal judges in Texas and Washington, the abortion medication mifepristone appeared to remain available — at least for now.
U.S. District Judge Matthew Kacsmaryk, a Trump appointee, ordered a hold on federal approval of mifepristone, while a lawsuit challenging the safety and approval of the drug continues. The decision overruled decades of scientific approval. Kacsmaryk’s 67-page order gave the government seven days to appeal.
But that decision came at nearly the same time that U.S. District Judge Thomas O. Rice, an Obama appointee, essentially ordered the opposite and directed U.S. authorities not to make any changes that would restrict access to the drug in at least 17 states, including Pennsylvania, where Democrats sued in an effort to protect availability.
“It essentially orders the FDA to keep the status quo, to keep mifepristone on the market,” said Temple Law School Dean Rachel Rebouche. “And the reason for the differing decisions are completely different takes on the safety of the drug.”
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Rebouche described the opposing opinions.
“The Washington court relies on the same evidence that the FDA relied on over the last couple of decades: that mifepristone is very safe, there are very few adverse effects that happen, and it's very effective,” she said.
“The Texas court expresses a different view: that mifepristone is dangerous, that abortion is a public health problem, that mifepristone is risky. So you really have night and day takes on what's been pretty settled evidence for the last couple of decades.”
The abortion drug has been widely used in the U.S. since securing FDA approval in 2000, and Rebouche says it's practically unheard of that a federal district court in Amarillo could undo 23 years of decision making by a federal agency tasked with making sure that drugs are safe and effective.
The lawsuit in the Texas case was filed by the Alliance Defending Freedom, which was also involved in the Mississippi case that led to Roe v. Wade being overturned. At the core of the lawsuit is the allegation that the FDA's initial approval of mifepristone was flawed because it did not adequately review its safety risks.
“At the heart of these cases is the question of FDA authority and the extent of that authority to approve drugs and that has implications for the authority and power of federal agencies across the board," Rebouche said.
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Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency's authority faces new challenges in a post-Roe legal environment in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.
Mifepristone is one of two drugs used for medication abortion in the United States, along with misoprostol, which is also used to treat other medical conditions.
Mifepristone has been used by millions of women over the past 23 years, and complications from mifepristone occur at a lower rate than that seen with wisdom teeth removal, colonoscopies and other routine medical procedures, medical groups have recently noted.
Clinics and doctors that prescribe the two-drug combination have said that if mifepristone were pulled from the market, they would switch to using only the second drug, misoprostol. That single-drug approach has a slightly lower rate of effectiveness in ending pregnancies, but it is widely used in countries where mifepristone is illegal or unavailable.
The FDA now has seven days to appeal the Texas ruling, but Rebouche says the federal agency also has the jurisdiction to keep the status quo based on the Washington ruling. She says the issue is complicated because of the ease with which this pill can be mailed from overseas or across state lines.
“I think it's part and parcel of the fight that we're going to see in the coming years over medication abortion specifically,” Rebouche said.
The whiplash of the conflicting decisions is likely to put the issue on an accelerated path to the Supreme Court. Rebouche expects there to be significant developments in this case over the coming weeks.
“The fact that the judge in Amarillo stayed his order for seven days suggests that this litigation is going to move quickly.”