The Biden administration, seeking to reassure abortion rights activists without provoking the courts, is privately promising an array of liberal groups that it will wage a fierce legal battle to preserve access to abortion medication, while also developing contingency plans in case those efforts fall short.
Since a Texas judge ruled on Friday to suspend approval of mifepristone, a pill that can help end a pregnancy, Biden officials have held numerous calls with abortion rights groups, according to three people familiar with the calls, who spoke on the condition of anonymity to describe private discussions. That effort to reassure activists comes as some liberal lawmakers are urging the administration to effectively ignore U.S. District Judge Matthew J. Kacsmaryk’s ruling, which the White House says it will not do.
At the same time, federal health officials, long worried about the potential for such a ruling from Kacsmaryk, have been developing contingency plans for months, according to a former Food and Drug Administration employee who was in touch with agency officials.
“It’s a shock when you see [the ruling], but they knew this might happen,” said the former staffer, who spoke on the condition of anonymity to describe internal agency discussions. The staffer added that while the agency’s plans are not clear, the FDA has several options it can consider to try to make mifepristone accessible even if court decisions go against the government.
One possibility is that Danco Laboratories, the manufacturer of Mifeprex, the brand-name version of mifepristone, could file a new application to have the drug approved under the standard process, the ex-staffer said. That would be time-consuming, however, and Jessica Ellsworth, counsel for Danco Laboratories, told reporters the company will seek guidance from the FDA if Kacsmaryk’s injunction stands.
“If the drug approval is withdrawn, we will work expeditiously with FDA to reinstate the label as soon as the conditions allow us to do so,” the company said in a statement late Tuesday. “We’ve been providing Mifeprex to people in the United States for over 20 years and are committed to ensuring it is a legally available option.”
The drug’s suspension will take effect by Saturday if it is not paused by a higher court, potentially confronting the White House with a mushrooming legal and political crisis within days. A judge in Washington state, meanwhile, has ordered the FDA to leave the current mifepristone regime in place for 17 states and D.C. that brought a case separate from the one that Kacsmaryk heard.
Advocates say the Supreme Court is ultimately likely to weigh in, given the various complications, but how and when is difficult to predict.
The fast-paced maneuvering highlights the potential tensions between President Biden’s impassioned pledges to protect abortion rights and his equally forceful promises to respect the country’s institutions and legal system.
Asked Tuesday for his thoughts on Kacsmaryk’s ruling, the president said, “My thoughts are, it’s completely out-of-bounds what the judge did.”
Yet the White House is rejecting calls by some more liberal Democrats for the FDA to declare that despite the judge’s ruling, it will simply decline to pursue violations against drugmakers and distributors who provide mifepristone. That, Biden officials argue, would pave the way for administrations of both parties to disregard any judicial opinion they dislike.
“We stand by FDA’s approval of mifepristone, and we are prepared to have a long legal fight here,” White House press secretary Karine Jean-Pierre said Monday. But she added that while Kacsmaryk has set a dangerous precedent by second-guessing the FDA’s expert judgment, “it would also set a dangerous precedent for this administration to disregard a binding decision.”
Not all legal experts agree, with some contending the FDA has broad discretion over its enforcement policies
‘The FDA has a lot more flexibility than people appreciate,” said Nathan Cortez, a law professor at Southern Methodist University. Cortez, who signed an amicus brief supporting the agency’s position that the pill was properly approved in 2000, pointed to the authority the agency exerted during the coronavirus pandemic to quickly make vaccines available to the public.
The FDA declined to comment.
The Biden administration has found itself walking a difficult path since the Supreme Court issued its Dobbs decision that removed the constitutional right to abortion in June. A series of courts and state legislatures have sought to rein in abortion rights, prompting liberal activists to demand forceful action by the administration, from opening clinics on federal lands to declaring a reproductive health emergency.
Biden has rejected such ideas as impractical or inappropriate. Instead, the president has urged voters to elect more Democrats who will enact abortion rights protections.
In the mifepristone case, a re-approval of the drug would seek to defang Kacsmaryk’s claim that it was wrongly cleared because the FDA used a regulatory provision called Subpart H, which allows for expedited approval for drugs for serious illnesses. The government has asserted that mifepristone did not receive accelerated treatment — it took four years to approve the drug — but that using Subpart H allowed the agency to impose certain safety restrictions.
The medication was approved as safe and effective by the FDA in 2000 and has since been used by millions of women and has a strong safety record, experts say.
But some experts cautioned that a re-approval would not resolve all the issues raised by Kacsmaryk. If upheld, “other parts of the judge’s opinion — the Comstock Act, for example — are independent obstacles,” said I. Glenn Cohen, a former Justice Department attorney who is a health law expert and professor at Harvard Law School.
In his ruling, Kacsmaryk repeatedly invoked the Comstock Act, a 150-year-old law that has not been applied for decades and that prohibits mailing any drug used “for producing abortion.” Arguments that the Comstock Act no longer applies are “unpersuasive,” Kacsmaryk wrote, adding that federal criminal law declares abortion pills “nonmailable.”
Meanwhile, Democratic governors are assessing what they can do amid the dueling rulings. The Reproductive Freedom Alliance, composed of governors who support abortion rights, held emergency staff-level meetings after the rulings came out, according to Brandon Richards, a spokesman for California Gov. Gavin Newsom (D).
Governors say they are acutely aware of the legal uncertainty, and that is prompting some to take protective measures. “We will keep fighting until we win,” New Mexico Gov. Michelle Lujan Grisham (D) said in an interview. “What does that actually look like as it gets navigated? I think it’s hard for me to tell you what my legal crystal ball looks like.”
In the interim, some have decided to buy large batches of abortion pills. On Monday, Newsom announced that he had secured an emergency stockpile of up to 2 million doses of misoprostol, which is used alongside mifepristone in a two-step protocol for medication abortions. The drug is also used widely around the world to end a pregnancy on its own, although that method is considered slightly less effective and can cause more cramping and bleeding.
New York Gov. Kathy Hochul (D) announced that her state would soon buy roughly 150,000 doses of misoprostol, which amounts to a five-year supply of the drug. Meanwhile, the Democratic governors in Massachusetts and Washington have instead decided to purchase large quantities of mifepristone.
Kacsmaryk’s decision, if it is upheld, would put at least a temporary dent in abortion protections because mifepristone is used in more than half of U.S. abortions, but many providers say they would switch to a misoprostol-only regimen. Some clinics are promising to continue prescribing mifepristone even if Kacsmaryk’s ruling remains in place unless the FDA directs them not to, while others may instead focus on surgical abortions.
The number of abortions taking place across the country dramatically dropped in the six months after the Supreme Court overturned Roe v. Wade, according to data published Tuesday by the Society of Family Planning. Meanwhile, telehealth appointments, where providers consult patients on medication options, increased from 4 percent of all abortions in April 2022 to 11 percent in December.
Democratic leaders have recognized the potency of abortion rights for the party, especially after the recent victory of Janet Protasiewicz, an outspoken supporter of abortion rights, in Wisconsin’s consequential state Supreme Court race. Meanwhile, few Republicans have publicly applauded Kacsmaryk’s ruling, suggesting the strain the party is under to appeal to its conservative base while not alienating much of the public.
Partisan divisions on abortion have deepened over the years, but polling shows a clear majority of Americans support legal abortion. By more than 2 to 1, Americans say medication abortion should be legal in their state, according to a Pew Research Center poll published Tuesday.
Support outpaced opposition among all age, racial and ethnic groups and nearly all religious groups, while Republicans and those who lean Republican were split — with 35 percent saying abortion should be legal and 36 percent saying it should not — and Democrats and Democratic-leaning voters overwhelmingly thought it should be legal, 73 percent to 8 percent.
