Some Democrats are pushing for the FDA to ignore a court ruling suspending the agency’s approval of mifepristone.
Democrats are gearing up for a fight over the right to access abortion pills. Over half of US abortions are performed using medication, and abortion access, already restricted in the wake of Roe v. Wade being overturned, is now again at risk.
Two federal courts have now issued conflicting rulings on the Food and Drug Administration’s 2000 decision to approve the abortion drug mifepristone. Texas Judge Matthew Kacsmaryk, who has been outspoken about his anti-abortion views, suspended the FDA’s approval of the drug on Friday but there are seven days to allow for an appeal. That same day, a Washington judge barred the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available” in 17 states and Washington, DC.
For now, mifepristone is still available. But the conflicting rulings last week have made a US Supreme Court showdown on the issue much more likely — triggering a five-alarm fire for Democrats, who have proposed bills to protect access to mifepristone and are weighing other options to save medication abortion.
There’s a limit to what congressional Democrats can do to protect access given that they don’t control the US House and don’t have a filibuster-proof majority in the Senate. That leaves most of Democrats’ potential solutions in the executive branch’s hands. The government has already appealed the Kacsmaryk ruling, and Health and Human Services Secretary Xavier Becerra told CNN on Sunday that “everything is on the table.”
That includes directing the FDA to ignore any court decision, an idea that would raise numerous legal questions and could set an unpredictable precedent. Still, some legal experts argue the executive branch does have the power to order the FDA to do so.
But at the very least, the issue presents a pro-abortion-access messaging opportunity similar to the one that arose in the wake of the Supreme Court’s decision to overturn Roe v. Wade last year. That’s especially true given that the midterms proved abortion rights were a motivating issue for voters, and that they appear to remain so in light of the results of the recent Wisconsin Supreme Court election, where the candidate who espoused her pro-abortion rights position won in a blowout.
“Members of Congress and state legislators must continue to sound the alarm and educate the public about this ruling, which aims to ban mifepristone even in states where abortion is protected,” said Ryan Stitzlein, senior national political director for NARAL Pro-Choice America. “State executives and attorneys general must continue to pursue every legal path to keep mifepristone available in their states.”
What Democrats in Congress are doing to protect abortion pills
In the wake of last week’s rulings, Democratic Reps. Pat Ryan of New York and Lizzie Fletcher of Texas are introducing on Monday the Protecting Reproductive Freedom Act. The bill would not only affirm the FDA’s decision more than 20 years ago to approve mifepristone but also providers’ ability to prescribe the medication via telehealth. That’s especially critical for patients who live in red states that have issued abortion bans and who rely on telehealth for access to abortion, as well as rural Americans who live far away from abortion providers.
“We will fight this ruling in the courts, and we must fight this assault on the health and freedom of American women in all the ways we can,” Fletcher said in a statement.
The bill is not likely to pass the GOP-controlled House. But abortion advocates argued lawmakers in the Senate do have the power to do something: They want to see the Democratic senators respond to Kacsmaryk, a former activist for the Christian right appointed to the bench by former President Donald Trump, by appointing new judges. Senate Democrats have already appointed 119 federal judges during Biden’s presidency, but 74 openings remain.
“It has never been more urgent for the Senate to move ahead to fill every federal judicial vacancy with President Biden’s fair-minded, highly qualified nominees,” People For the American Way President Svante Myrick said in a statement.
To the extent that Democrats can proactively protect mifepristone right now, though, it would have to be through executive action.
What the Biden administration can do
The Biden administration rushed to appeal the Texas ruling, which President Joe Biden characterized in a series of tweets Friday as “the next step toward an abortion ban that Republican elected officials vowed to make law” and an attack on the FDA’s expert authority to approve drugs. He added that he and Vice President Kamala Harris are “committed to protecting a woman’s right to an abortion. Period.”
In the past, Biden has not capitalized on abortion politics as a messaging opportunity. It’s long seemed to be a subject that Biden, a practicing Catholic, has been uncomfortable talking about. He gave only cursory mentions to the subject in his State of the Union address earlier this year — a puzzling choice given that Democrats owed their midterm performance, including historic wins at the state level in places like Michigan and Kansas, in no small part to voters who came out in support of abortion access. He was previously criticized for never saying the word “abortion” and for not pushing Congress to abolish the filibuster in order to codify Roe.
His party has long been pushing him to go further in protecting abortion rights — and the case over access to mifepristone is no exception. Sen. Ron Wyden (D-OR) and Rep. Alexandria Ocasio-Cortez (D-NY) have called for the FDA to ignore the Texas ruling and keep the drug on the market anyway. Ocasio-Cortez told CNN that she did not “believe that the courts have the authority over the FDA that they just asserted.”
Some law professors have supported that argument, saying that the FDA has enforcement discretion under longstanding precedents in administrative law. Under that discretion, the FDA can choose whether to carry out an enforcement action for the distribution of unapproved drugs based on demonstrated safety concerns — and mifepristone has been heavily studied and found to be very safe, even more so than penicillin. So the idea is the FDA could issue guidance saying that it won’t be taking enforcement actions against mifepristone manufacturers that continue to sell the drug. Doing so might invite court challenges, but the agency’s discretion is well-established in the law.
Health and Human Services Secretary Xavier Becerra has not ruled out directing the FDA to ignore the courts, but his agency has warned that it’s not a costless measure. A future administration could use any precedent set by the Biden administration to restrict access to mifepristone or some other drug.
“People are rightly frustrated about this decision — but as dangerous a precedent it sets for a court to disregard FDA’s expert judgment regarding a drug’s safety and efficacy, it would also set a dangerous precedent for the Administration to disregard a binding decision,” HHS spokesperson Kamara Jones tweeted.
