Abortion medications set to become the next legal battleground | Analysis
State abortion bans clash with FDA approval of the pills
By Christine Vestal
In the nearly three weeks since the U.S. Supreme Court overturned Roe v. Wade, abortion has become illegal in at least 10 states, with more states to follow in the weeks ahead.
That means doctors and other health care providers in those states can no longer perform the clinical procedure or prescribe the medications used to end an early pregnancy.
But abortion rights advocates and the Biden administration want people living in the 26 states with current or impending abortion bans to have another option: receiving abortion medications through the mail after consulting with a physician in another state or overseas via phone or online.
The U.S. Food and Drug Administration approved the abortion medication mifepristone in 2000, deeming it safe and effective for aborting a pregnancy. In 2016, the FDA approved the drug for use in combination with another widely used drug, misoprostol. By 2018, more than 3.7 million patients in the United States had used the medications to end an early pregnancy with minimal complications.
When the Supreme Court overturned the nearly 50-year-old federal right to abortion June 24, Attorney General Merrick Garland issued a statement saying, “States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
But it will be difficult to prove in state and federal courts that the FDA approval mandates access to the medications and preempts state abortion bans, legal experts on both side of the issue said in interviews and emails with Stateline.
It’s a gray area of the law that may take years of complex legal battles to resolve, said Greer Donley, an associate professor at the University of Pittsburgh School of Law. The arguments will vary depending on the state law at issue, she said.
Arguments that some state restrictions on medication abortion are excessive, such as requiring in-person doctor visits when the FDA requires only a telehealth consultation, may be straightforward, Donley said. “But it’s much more attenuated and difficult to argue that broad abortion bans conflict with FDA policy, since the bans are regulating morality, and the FDA is regulating safety and efficacy.”
The fact that women in states with abortion bans are seeking pills from out of state and overseas raises another legal dilemma: enforcement.
If federal courts allow state bans on mail-order abortion medications to take effect, legal experts predict the laws will be difficult to enforce without punishing the patient, which abortion opponents assiduously have avoided for decades.
When South Dakota Republican Gov. Kristi Noem announced in June, for example, that she would work with lawmakers to ban mail-order abortion pills, she insisted the patient should never be punished for seeking the pills. Instead, the doctor who knowingly breaks the law should be prosecuted, she said in an interview on CBS News “Face the Nation.”
Some officials likely would want to prosecute women, said David Cohen, law professor at Drexel University in Philadelphia. “It’s hard to say that publicly. Their position is already unpopular, but to say they want to prosecute women is even more unpopular.”
It’s not clear how states with abortion bans plan to enforce prohibitions on mail-order abortion medications, particularly when the only doctor involved is overseas. Donley and other experts suggest one possibility is Texas’ citizen enforcement provision that allows anyone to sue a person who aids someone in obtaining an abortion.
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“There’s been a clear line that abortion restrictions shouldn’t punish women themselves but only providers and those aiding or abetting an abortion,” said Lawrence Gostin, a professor at Georgetown Law School who specializes in health law. But when it comes to medication abortion, he said, “that line may well be crossed in the post-Roe abortion culture wars.”
Last week, President Joe Biden issued an executive order calling on the Department of Health and Human Services to ensure access to the pills nationwide, though no concrete details have been made available.
Crossing State Lines
Ever since Roe v. Wade was overturned, people have been crossing state lines in droves to visit doctors willing to provide a clinical abortion or a packet of five pills to take at home to end a pregnancy. But few providers are willing to mail pills.
“It would be an understatement to say that doctors in states where abortion is still legal would be on risky legal ground if they mailed the pills to patients in states that ban abortion,” Donley said.
As a result, most patients are receiving abortion medications through an international organization called Aid Access, headed by Dutch physician Rebecca Gomperts. She and a small staff of medical professionals consult online with American patients and ship the pills from a pharmacist in India.
Abortion opponents want to put an end to that and other online sources of abortion medications, calling them loopholes in state abortion bans.
“The FDA’s authority is limited to safety and efficacy,” said Clarke Forsythe, senior counsel at Americans United for Life, which opposes abortion. “The FDA does not establish a national judgment or a federal judgment that chemical abortion is good public policy that overrides state law to the contrary.”
To stop the flow of abortion medications through the mail, abortion opponents say they intend to criminalize possession and use of the pills in states that ban abortion, setting up what legal experts predict will be a complex series of court battles pitting the federal government against conservative states intent on abolishing abortion by any means.
Forsythe suggested that when states defend medication abortion bans in court, “they likely will lead with the argument that they’re prohibiting the sale of the drug based on the need to save the life of the fetus,” not necessarily because they disagree with the FDA’s ruling that the drug is safe and effective.
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He also argued that a recent Supreme Court ruling in West Virginia v. Environmental Protection Agency will have a bearing on future lawsuits over state bans on the use of abortion medications. The June 30 decision specifically limited the EPA’s ability to regulate greenhouse gas emissions from power plants. But the ruling also might affect the FDA’s authority on abortion medication because the court asserted that the EPA’s powers as a federal agency are limited to those specifically assigned to it by Congress.
In addition to federal-state battles over abortion pills, skirmishes between states that protect abortion rights and those that ban it also are likely to occur in the months and years ahead, legal experts say.
A handful of states where abortion will remain legal, including California, Connecticut, Delaware, New Jersey, New York and Washington, have laws that shield abortion providers from out-of-state investigations and lawsuits. But, according to Donley, none of them specifically protects physicians who choose to ship abortion medication to out-of-state residents.
As of 2020, medication abortions accounted for 54% of all abortions in the United States, according to the Guttmacher Institute, which supports abortion access.
No federal law definitively establishes that FDA rulings on the safety and efficacy of medications preempt state law. A federal law establishes FDA supremacy over states when it comes to medical devices, but it does not mention medications. The preemption is implied, Donley argues.
In 2014, a federal court found that Massachusetts did not have the authority to ban the sale of an opioid painkiller that the state argued was a hazard to public health. A U.S. District Court said that by imposing its own conclusion about the safety and efficacy of the drug, Zohydro, the state was obstructing the FDA’s constitutionally mandated charge.
The first case likely to shed light on the legal question of whether states can restrict or ban the FDA-approved medication is being heard in Mississippi. GenBioPro, which makes a generic version of the drug mifepristone, filed new arguments July 1 in a case started in 2020.
The Las Vegas-based company originally argued that Mississippi’s law banning FDA-approved telehealth visits to get a prescription for mifepristone violated federal policy.
In its new brief, the company argued that the state’s trigger law criminalizing all abortions will create a “that-much more direct and glaring conflict” with the federal agency. Donley said the judge in the Mississippi case might declare the case moot since states are now allowed to ban abortions altogether.
But an attorney for GenBioPro told Politico that the company plans to file lawsuits against restrictions and bans on the medication in other states.
Christine Vestal is a reporter for Stateline, an initiative of the Pew Charitable Trusts, where this story first appeared.
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