Looming court rulings to decide future of abortion pills

This story was originally published by Stateline, an initiative of The Pew Charitable Trusts. Story by Christine Vestal.

Medication abortion, which accounts for more than half of all abortions in the United States, has become more common since the Supreme Court overturned the federal right to abortion this summer.

But in federal courts and state legislatures, abortion opponents are trying to limit the use of abortion-inducing pills. Meanwhile, abortion rights supporters have filed lawsuits arguing the opposite — that federal approval of the drugs should prevail over state restrictions.

Earlier this month, the U.S. Food and Drug Administration made permanent its 2021 ruling that abortion medications mifepristone and misoprostol are safe enough to be administered through a telemedicine consultation, rather than an in-person visit, with pills delivered by mail.

And the Biden administration last week called on the Justice, Health and Human Services and Homeland Security departments to “support patients, providers, and pharmacies who wish to legally access, prescribe, or provide mifepristone — no matter where they live.”

Meanwhile, two lawsuits filed by abortion rights advocates last week claim that federal law overrules state laws that restrict the use of abortion medications.

But a ruling in a Texas court case brought in November by anti-abortion advocates could take the medications off the shelves as soon as next month. And a deluge of new state laws limiting the use of abortion pills is expected in this first full legislative session since Roe v. Wade was overturned.  

“Medication abortion is going to be a hot issue in state legislatures this year,” said Elizabeth Nash, principal policy associate at the Guttmacher Institute, which supports abortion rights. 

“We expect abortion opponents in conservative states to try to limit access by banning the mailing of pills, regulating manufacturers and pharmacies and expanding laws that allow health care providers to refuse to prescribe or dispense the medication,” she said.

“What we’ve been seeing in many states is abortion opponents talking about how medication abortion is dangerous, when we know it’s not,” Nash said.

Limiting Access

Inflamed by the FDA’s decision to loosen regulation of abortion medications, Alabama Attorney General Steve Marshall, a Republican, led GOP attorneys general from 22 other states in a letter this month to FDA Commissioner Robert Califf, calling the decision “both illegal and dangerous.”

In 2018, the FDA reported that 24 women had died out of more than 3.7 million U.S. patients who had used the medications to end an early pregnancy, with minimal complications. The agency said it was unclear whether any of the 24 deaths were directly related to use of the drug.

Steven Aden, general counsel at Americans United for Life, which opposes abortion, predicted that a flurry of new legislation aiming to restrict medication abortion can be expected this year. Most bills, he said, are likely to be modeled after a draft law developed by his organization and other anti-abortion groups.  

The model law would ban the mailing of abortion pills, require in-person exams to obtain pills and track medical complications that may occur. Its goal, Aden said, is to protect women from lax medical protocols that could endanger their health and life. Similar versions were enacted in Kentucky, Louisiana, South Dakota and Tennessee last year.

“FDA guidance is just that,” Aden said. “The FDA determines that a drug is safe and effective under certain conditions, but it doesn’t occupy the whole field of public health. The federal government has an ancillary authority in approving certain drugs, but that doesn’t stop states from adding additional limits.” 

In 2000, the FDA approved the drug mifepristone for terminating a pregnancy of up to seven weeks. In 2016, the federal agency extended the gestation period to 10 weeks. The World Health Organization has approved its use through 12 weeks of pregnancy.

Even before Roe v. Wade was overturned in June, abortion pills accounted for more than half of all abortions — 53 percent in 2020, according to the Guttmacher Institute. Now, with most abortions outlawed in 15 states and clinics vanishing in other states where bans are imminent, medication abortion is becoming an even more common method.

Three Court Cases

A Texas case filed by abortion opponents claiming that the FDA erred in approving abortion medications more than two decades ago could be decided as early as mid-February.

Two other cases aiming to protect abortion rights, filed last week in West Virginia and North Carolina, challenge the constitutionality of state laws that restrict the use of abortion medications, arguing that federal rules prevail when it comes to setting standards for drugs.

If the North Carolina and West Virginia lawsuits are successful, it would represent an exception to the states’ newfound ability to completely ban abortion under this summer’s Supreme Court decision, said Greer Donley, a professor who specializes in abortion law at the University of Pittsburgh School of Law. 

The case in West Virginia, filed by pharmaceutical company GenBioPro, a maker of generic mifepristone, claims that the state’s total ban on all forms of abortions “conflicts with the strong national interest in ensuring access to a federally approved medication to end a pregnancy.”

The North Carolina case, filed by Dr. Amy Bryant, OB-GYN, argues that the state’s restrictions on the use of medication abortion conflict with federal regulations.  

The Texas case, filed in November, could have an immediate sweeping effect nationwide. Its plaintiffs argue that the FDA ignored serious medical concerns and agency procedures when it originally approved the use of mifepristone and misoprostol in 2000. The case also claims that federal law prohibits the mailing of any abortion medications.

Under review by a conservative justice appointed by former President Donald Trump, the case could result in an injunction requiring the federal government to pull the drugs from the market immediately, legal experts say. 

The Texas case presents a “high potential for a ruling that could be disastrous” for abortion rights, at least in the short-term, Donley said.

And the prospects for a reversal of such a decision by the conservative 5^th U.S. Circuit Court of Appeals and ultimately a conservative U.S. Supreme Court, she noted, are not great.  

If the judge in the Texas case rules that mifepristone must be removed from the market nationwide, the cases in North Carolina and West Virginia claiming the state overregulates the drug could be put on hold pending a final appeal of the Texas case.

State Laws

The use of medication to end a pregnancy is prohibited in the 12 states with near-total bans on abortions: Alabama, Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, South Dakota, Tennessee, Texas and West Virginia.

But lawmakers in some of those states are proposing additional legislation to stamp out the use of abortion pills.

In Missouri, for example, a bill proposed this month would outlaw “trafficking” of “abortion-inducing drugs” and levy penalties against pharmacies that dispense them.

A bill in Texas would allow pharmacists to refuse to fill prescriptions for abortion medications, and a bill in West Virginia would require doctors and patients to be in the same location when a prescription is written.

Providing pills for medication abortion already is outlawed under existing bans in Missouri, Texas and West Virginia. But lawmakers in those states appear to want to tighten medication abortion restrictions to make clear that the pills are included in the bans and that both doctors and pharmacists are subject to penalties for providing them — including to people from other states, according to Guttmacher’s Nash.  

In Kansas, where abortion is legal, a bill introduced this month would ban medication abortions via telehealth and prohibit the mailing of pills.

Even before the federal right to abortion was overturned last summer, 19 states had banned the use of telehealth visits for prescribing abortion pills, and some states had required in-person follow-up visits and waiting periods.

In 2020, GenBioPro challenged Mississippi’s medication abortion restrictions on the basis of the supremacy clause in the U.S. Constitution, which establishes that federal law takes precedence over state laws.

But the company withdrew its case after the Supreme Court decision eliminated the federal right to abortion. Last week’s cases also cite the supremacy clause in arguing that tighter state restrictions on abortion pills conflict with FDA rulings.

Donley predicted that depending on the outcome of the cases filed in West Virginia and North Carolina, more lawsuits may be filed against individual state laws arguing that federal law preempts state laws.