A federal judge in Texas soon could make one of the two pills used in medication abortions harder to come by, even in blue states that support abortion rights.
Officials and advocates in those states aren’t waiting for the judge to rule. They’re trying to ensure continued access to the drugs that a growing number of Americans are using to end their pregnancies at home.
Last week, California Democratic Gov. Gavin Newsom declared that his state’s government would stop doing business with Walgreens because the pharmacy chain decided earlier this month that it won’t sell mifepristone in states where Republicans have threatened legal action, even in those states where abortion remains legal.
And in February, Washington state Attorney General Bob Ferguson and Oregon Attorney General Ellen Rosenblum, both Democrats, filed a complaint in a U.S. district court against the U.S. Food and Drug Administration for what they argue is its excessive regulation of mifepristone. The case was joined by attorneys general in 10 other abortion rights states — Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island and Vermont.
Abortion rights advocates also are trying to inform the public that the Texas judge’s ruling will not make using the pills illegal.
Even if U.S. District Court Judge Matthew Kacsmaryk, who was appointed by former President Donald Trump and is known for his conservative views, orders the FDA to revoke its approval of mifepristone, legal experts say the abortion medication will not disappear from pharmacy shelves overnight, and possession and use of the pills will remain legal.
“The judge wasn’t asked to ban mifepristone, and he wasn’t asked to take it off the market,” said David Cohen, professor of law at Drexel University in Philadelphia and co-author of a legal analysis that outlines the limits of the Texas judge’s authority.
The lawsuit seeks a preliminary injunction compelling the FDA to withdraw or suspend its 2000 approval of the drug, as well as its 2016 ruling extending the gestation period in which the drug can safely be used from seven to 10 weeks, and its 2021 ruling allowing the medication to be prescribed without an in-person doctor’s visit.
The FDA has discretion granted by Congress to undertake a public process for suspending or withdrawing approval of a drug. That could take months or years, Cohen said. In the meantime, the Biden administration likely would appeal any decision against the FDA.
And even if the FDA were eventually to remove its 2000 approval of mifepristone, it could use its enforcement discretion to allow manufacturers to keep producing the in-demand drug, as it did last year with infant formula, Cohen pointed out.
In addition, the FDA and Danco Laboratories, one of two makers of mifepristone, are the only parties named in the case, which means the Texas judge’s decision will not affect health care providers, patients or the generic maker of mifepristone, Cohen explained.
Still, abortion providers are preparing for a worst-case scenario, developing new protocols for ending an early pregnancy using only the second drug, misoprostol, which is safe and widely used throughout the world to end pregnancies but can involve more side effects.
The publicity surrounding the impending Texas court ruling has sowed fear and confusion among abortion patients, and some providers worry that people who use the medications won’t seek the follow-up care they may need because of legal concerns.
“No matter what happens in the Texas case, it’s likely to make it more difficult for people to access abortion with pills as providers, state officials and law enforcement try to process the legal issues surrounding abortion pills,” said Farah Diaz-Tello, senior counsel and legal director for If/When/How, which provides legal advice and support for people seeking abortions.
“We’re worried that people will come away with a message that abortion pills are illegal to use, which is not what a ruling in any direction would mean,” she said.
Even so, police and local prosecutors may still investigate and arrest people who self-manage their abortions, as they have in the past, despite the fact that the pills remain legal to use, Diaz-Tello said.
A question of safety
The Texas case was filed in November by anti-abortion groups that argued that mifepristone, which ends a pregnancy by blocking the hormone progesterone, is a dangerous drug, and that the FDA failed to adequately research its risks when it approved the medication in 2000.
According to their complaint, “the FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”
In December 2021, the FDA made permanent a COVID-era ruling that mifepristone and misoprostol could safely be administered using telemedicine with pills delivered by mail, rather than requiring an in-person doctor’s visit.
Out of more than 3.7 million U.S. patients who used mifepristone and misoprostol to end an early pregnancy, 26 people have died, and the agency said it was unclear whether any of those deaths were directly related to use of the drug.
Clarke Forsythe, senior counsel at Americans United for Life, which filed a brief in the Texas case on behalf of members of Congress who oppose abortion, said state and federal public health agencies have failed to capture adequate data on the health risks of abortion pills.
“The bleeding, hemorrhaging, infection and toxic shock cases are showing up in the ER, but they’re being miscoded,” Forsythe said. “Instead of being attributed to mifepristone, they’re being attributed to miscarriage or heavy period or something else. The negative repercussions of chemical abortion are basically being filtered out of public health data collection.”
Elizabeth Nash, principal policy associate at the Guttmacher Institute, a nonprofit research organization that supports abortion rights, disagrees.
“The science on the safety of medication abortion is clear,” she said. “The fact that this case wasn’t laughed out of court is incredibly disturbing. Should mifepristone become unavailable because of alleged health risks, it will further stigmatize abortion pills and limit access to abortion unnecessarily, particularly for Black and brown people and low-income individuals.”
Amy Merrill, digital director and co-founder of Plan C, an organization that helps people get access to abortion pills from domestic and foreign sources, said, “We absolutely know that mifepristone does not cause harm, and that any harm that may occur is being caused by the courts and politicians who are enacting these bans to access.”
The Washington state complaint filed by 12 Democratic state attorneys general argues the FDA applied excessive restrictions to mifepristone that typically are reserved for high-risk medications such as opioid pain relievers and psychiatric drugs. The attorneys general asked the court to order the FDA to remove all remaining restrictions, including a requirement that patients sign for the pills and attest that they plan to use them to end a pregnancy.
Of the more than 20,000 drugs approved by the FDA, only 60, including mifepristone, fall under a set of regulations known as Risk Evaluation and Mitigation Strategy.
Increasing use
In 2020, medication abortion accounted for more than half of all reported abortions, and the number has been increasing ever since the Supreme Court overturned the federal right to abortion this past summer.
“Medication abortions are vastly undercounted since self-managed abortions are not necessarily reported to the CDC,” Merrill said, referring to the Centers for Disease Control and Prevention. Her organization estimates that at least 30,000 people self-managed abortions using mifepristone and misoprostol, or misoprostol alone, within the first six months after last summer’s decision.
This year, the use of abortion pills is expected to far outpace clinical abortions, spurring continued legal and political battles over their use.
In addition to the Texas and Washington state cases, two other lawsuits filed in January by a drug maker in West Virginia and a physician in North Carolina challenge the constitutionality of state laws restricting abortion medications under the legal premise that federal FDA rules preempt state laws.
In 2021, the FDA eased rules requiring an in-person doctor’s visit to get a prescription for abortion pills. But some states still have laws on the books that require it. This year, a handful of lawmakers in states that already ban most abortions doubled down and proposed new restrictions on medication abortion.
In Missouri, a bill would outlaw “trafficking” of “abortion-inducing drugs” and levy penalties against pharmacies that dispense them. In Texas, a bill would allow pharmacists to refuse to fill prescriptions for mifepristone and misoprostol. And in West Virginia, a bill would require doctors and patients to be physically present in the same location for abortion pills to be prescribed.
Drexel’s Cohen speculated the bills were proposed to make medication abortions more difficult to access, as a hedge against the chance the states’ abortion bans would be blocked by state courts.
Cohen and other legal experts predict a flurry of additional legal actions on medication abortions this year. But for now, advocates on both sides of the debate are waiting for Kacsmaryk to rule.
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