A federal judge in Texas heard arguments Wednesday in a closely watched dispute that could halt distribution of a key drug used for medication abortion and disrupt access nationwide, even in states where reproductive rights are protected.
The case before U.S. District Judge Matthew Kacsmaryk was brought in November by a conservative legal organization on behalf of anti-abortion rights medical associations and targets the Food and Drug Administration’s decades-old approval of the drug mifepristone, one of two medications used to terminate an early pregnancy.
The associations requested Kacsmaryk order the FDA to withdraw its 2000 approval of mifepristone, arguing the agency erred when it gave the green-light to the drug under a regulation that allows accelerated approval of medications for “serious or life-threatening illnesses.”
“The contrast between these illnesses and the FDA jamming pregnancy into … the FDA regulations could not be more stark,” Erik Baptist, a lawyer with the Alliance Defending Freedom who argued on behalf of the physicians and medical groups, told Kacsmaryk, according to The Associated Press.
The Biden administration has warned that removing mifepristone from the market would harm patients who rely on abortion pills and further strain state health care systems, particularly in places with clinics already grappling with overcrowding as a result of abortion restrictions in neighboring states.
The hearing before Kacsmaryk, appointed by former President Donald Trump, lasted just over four hours, and the judge said he would issue a decision “as soon as possible.” If Kacsmaryk sides with the associations and orders the FDA to undo its approval of mifepristone, the Justice Department requested he put the decision on hold to give the government time to appeal to the U.S. Court of Appeals for the 5th Circuit.
While questioning Baptist, Kacsmaryk asked for an example of a court intervening — as he is being asked to do — so long after the FDA has approved a drug, according to the AP.
Baptist said he could not recall past instances, though he accused the FDA of “stonewalling” challenges to its mifepristone approval filed through citizen petitions in 2002 and 2019.
Biden administration lawyers have also said in court papers they have been unable to find any case where a court has “second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market — much less an example that includes a two-decade delay.”
A decision halting access to mifepristone would “upend the status quo by banning a drug that has been used safely for 22 years,” Julie Straus Harris, an attorney at the Justice Department, told the court.
She said the medical associates are “trying to dictate national policy by withdrawing a safe drug.”
The challenge to the FDA’s 22-year-old approval of mifepristone has attracted immense interest, particularly as it comes amid a legal landscape upended by the Supreme Court’s June decision overturning Roe v. Wade.
After the high court ended the constitutional right to an abortion, more than a dozen states imposed near-total bans on abortion, and 14 have limits on medication abortion in place. But the lawsuit challenging mifepristone’s approval is the latest effort to further restrict abortion access.
In papers filed with the court, the anti-abortion rights groups claimed the FDA exceeded its regulatory authority to approve mifepristone and has over the years removed safeguards by changing the dosage and route of administration in 2016, and lifting an in-person dispensing requirement to allow the pills to be mailed in 2021.
“The FDA took these actions by running roughshod over the laws and regulations that govern the agency and, more importantly, protect the public from harmful drugs,” they argued.
Erin Hawley, a lawyer representing the medical associations, argued the abortion pill is not 100% effective and in some instances, pregnant women need medical treatment to complete the abortion after taking the two-drug protocol, which requires the participation of doctors who oppose abortion.
The Biden administration countered that the challengers’ request for the court to withdraw approval of mifepristone is “extraordinary and unprecedented.” The regimen of mifepristone and the second drug, misoprostol, is 98% effective at ending a pregnancy up to 10 weeks gestation.
Taking aim at the associations’ claim that the FDA improperly accelerated approval of mifepristone without substantial evidence of its safety, Justice Department lawyers noted that the 2000 approval of the drug came more than four years after manufacturer Danco Laboratories submitted its application.
The drug maker, too, told the court in a filing that forcing the FDA to withdraw its long standing approval of mifepristone would not only “seismically disrupt the agency’s governing authority as to whether drugs are safe and effective,” but also put Danco out of business.
“The public has no interest in a hastily cobbled together, and overtly political, attempt by private parties to wrest control of the drug approval process from the United States agency responsible for it — an agency that has acted deliberately, thoughtfully, and consistent with its authorizing statute and implementing regulations,” the company said.
The Biden administration argued that serious adverse events associated with mifepristone are rare and said the claims raised by the medical associations are speculative. Patients, they said, would be harmed by a court order rescinding mifepristone’s approval.
“Removing access to mifepristone would cause worse health outcomes for patients who rely on the availability of mifepristone to safely and effectively terminate their pregnancies,” they wrote, noting that patients will still seek legal access to abortion regardless of what the court does.
An injunction, however, would force women who want to terminate a pregnancy “to do so through an invasive medical procedure that increases health risks for some patients and that may be otherwise inaccessible to others.”
The Justice Department further warned that halting access to mifepristone would threaten the capacity of state healthcare systems, as it would lead more patients to seek surgical abortions at clinics already under stress from patients traveling from states with restrictive abortion laws to seek care.
“This would lead to delays for an array of healthcare services as providers and resources are unnecessarily diverted to surgical abortions,” they said.
The battle lines drawn in the dispute over the abortion pill mirror those in other court fights involving abortion.
A coalition of 22 red states that have tightened abortion restrictions after the Supreme Court reversed Roe are siding with the anti-abortion rights associations and accused the FDA of contravening federal law.
The agency relied on a regulation that permits it to approve new drugs that treat “serious or life-threatening illness,” but early-stage pregnancy is neither an “illness” nor a condition that is “serious or life-threatening,” attorneys general for the Republican-led states argued.
“The FDA and the Administration as a whole have no intention to respect the Constitution, the Supreme Court, or the democratic process when it comes to abortion,” they claimed in a friend-of-the-court brief.
Backing the FDA and Biden administration are 21 blue states and the District of Columbia. Officials from those jurisdictions argued the continued availability of mifepristone is critical for protecting the health, safety and rights of their residents.
“The consequences of annulling the FDA’s approval of medication abortion — currently the most common method of obtaining early abortion — would be nothing short of catastrophic, causing shock waves nationwide,” they wrote to the court.
The Democratic-led states said that without the option of medication abortion, patients will turn to other methods or be forced to delay care.
“The more access to abortions is denied, the more such needless and heartbreaking outcomes can be expected to increase, with the brunt of the harms falling on communities of color,” the Democratic attorneys general said.
Medication abortions accounted for more than half of all abortions in the U.S. in 2020, according to the Centers for Disease Control and Prevention.
Under the regimen, a patient will first take mifepristone, which blocks progesterone, the hormone necessary for a pregnancy to develop. It is followed by a dose of misoprostol, which is approved to treat gastric ulcers and brings on contractions.
In anticipation of an order from Kacsmaryk blocking access to mifepristone, abortion providers are preparing to offer misoprostol-only abortions.