After hearing oral arguments last week, the Supreme Court appeared dubious of the plaintiff's legal challenge to the abortion pill in Food and Drug Administration (FDA) v. Hippocratic Alliance of Medicine, the latest major abortion case since Dobbs v. Jackson overturned the constitutional guarantee to an abortion. Even though this outlook could lead pro-choice activists to breathe a minor sigh of relief and temporarily quell Big Pharma's fear over other challenges to FDA approvals, one indirect consequence regardless of the case outcome is the growing American reliance on imported abortion pills from overseas.
This manner of accessing abortion has been increasing in popularity since Dobbs, and safeguarding the provision of these pills from unapproved foreign distributors could soon become a flashpoint in the American battle over reproductive care, given that these imports are illegal because they operate outside the formal U.S. health-care system and beyond FDA oversight.
The Abortion Access at Stake
At stake in FDA v. Hippocratic Alliance of Medicine is access to mifepristone, which is used alongside the drug misoprostol to conduct medication abortion, a procedure currently accounting for more than 60% of annual abortions in the United States. Set to issue a ruling this summer, the Supreme Court will determine whether to uphold the Fifth Circuit Court of Appeals' decision to override FDA authority and reimpose pre-2016 restrictions on mifepristone.
Among these constraints is the requirement that mifepristone be dispensed in person by a licensed physician and a mandate of multiple in-person visits to receive the drug. Both restrictions would quash the pill's availability via telehealth and delivery by mail.
Medication Abortion on the Rise
In 2023, medication abortion accounted for more than one-half of abortions in the United States
This reversion would have an outsized impact on reproductive care and abortion access. Although medication abortion is possible using misoprostol alone, doing so is "both less comfortable and somewhat less safe because it can lead to more bleeding," says Professor Mary Ziegler, a reproductive rights expert and legal historian at University of California, Davis School of Law. The two-drug regimen is the standard process approved by the FDA and endorsed by the World Health Organization's model list of essential medicines.
The prescription of medication abortion via telemedicine and distribution by mail has also become integral to ensuring access across the country since Dobbs—namely, for patients in remote areas far from providers or those unable to visit clinics in person. According to the Guttmacher Institute, the fraction of abortion providers offering a telemedicine consultation "by video, phone call, text or online platform" and the delivery of abortion pills by mail increased from 7% to 31% between 2021 and 2022. In addition, online-only abortion clinics, first introduced in 2021, were found to account for 8% of abortions in the first half of 2023.
In a country already facing uneven abortion access, Professor Ziegler explains that returning to the pre-2016 rules "would have the biggest impacts on access to abortion where abortion is currently unrestricted. But it would also have downstream effects on states where abortion is already illegal because they are operating under shield laws that are still mailing to those states. It would change legal uncertainty about these laws to legal certainty."
Shield Laws Under Threat
Of the 24 states allowing telehealth for medication abortion, only six have shield laws that protect providers who prescribe the pills to people living in anti-abortion states
For women in the 26 states with total abortion bans or restrictions on telehealth medication abortion, access to the procedure has been partially maintained via telehealth providers in states where the practice is legal. New "shield laws" passed in six Democratic states have empowered telehealth abortion providers to prescribe and mail abortion pills to patients in states with abortion restrictions. These laws aim to block officials from cooperating with other states' criminal investigations into potential providers and prevent prosecutorial reprisals such as interstate extradition. If the Supreme Court were to reimpose restrictions on telehealth medication abortion nationally, shield laws and this pipeline of abortion access could be upended.
Import Demand for Abortion Pills
History shows that when access to legal abortion is limited women will find alternative solutions. Since Dobbs, in addition to seeking medication abortion by mail from providers in states without restrictions, American women in restricted states in need have increasingly headed online to buy abortion pills from overseas suppliers. Effectively immune to enforcement measures, such suppliers have stepped in to meet American abortion demand. A New York Times investigation from last spring estimated that as many as 100,000 people, or 10% of yearly U.S. abortions, were on course to be supplied by foreign providers of medication abortion in 2023.
The landscape of these foreign suppliers includes a variety of providers, including both advocacy groups offering pills at little or no cost as well as for-profit sellers that promise a faster delivery. Aid Access, founded by Dutch physician Rebecca Gomperts, has become the most established advocacy group in this arena and has been prescribing abortion pills since 2018. The largest of these foreign suppliers to the United States, the group offers abortion pills in two to three weeks for less than $105. Aid Access first connects women through an online consultation to providers in Europe, and now those in states with shield laws. If a woman is eligible for medication abortion, the organization then prescribes the pills for delivery via a trusted pharmaceutical partner in India. Another activist group, Mexican-based Las Libres, functions similarly by delivering pills from manufacturers based in India and Mexico to the United States.
History shows that when access to legal abortion is limited women will find alternative solutions
A slew of smaller, for-profit suppliers, made popular by the online repository Plan C, source abortion pills from India, Vietnam, and other countries and then work with domestic distributors to provide the medicine to the United States in as little as three days. The downside to these sellers is their products often come at a higher cost, which can approach nearly $500.
Despite importing from providers outside the U.S. health-care system and FDA oversight, both Aid Access and Plan C insist that the pills they provide are both safe and legitimate. Aid Access participated in a 2022 study published by The Lancet that examined the outcomes of more than 4,000 recipients of mailed pills. The study found that 96.4% reported successfully ending their pregnancy and only 1% needed treatment for "any serious adverse event."
Plan C has also conducted quality assessments, which it uses to verify pills from the 25 sellers currently listed on its site. In 2017, the group contracted an independent laboratory to examine medication from these companies—kits containing mifepristone and misoprostol—and published the results in the journal Contraception. The mifepristone pills were found to contain amounts within 8% of what was labeled on the bottle but the misoprostol pills had wider variability.
Elisa Wells, Plan C's cofounder, told CNBC "there is never a guarantee, but based on our test purchases and initial laboratory testing, the sites we list on our website appear to provide real pills of adequate quality." It is unclear when and how often these pills have since been tested.
Potential Obstacles to Overseas Suppliers
Potential obstacles could stymie the use of international suppliers by American women if demand continues to rise due to restricted legal access. The trade-off between the cost and the speed of delivery could prevent receipt of these overseas drugs and their safe consumption, with women either unable to pay for faster access or at risk of getting the medication too late.
Mifepristone and misoprostol are authorized for use up to 12 weeks of pregnancy, but insurance companies are unlikely to reimburse women operating outside the health-care system and the law to obtain international deliveries.
Similarly, as order volumes increase, quality control may become a public health priority and subject to greater regulatory scrutiny. The lead author of The Lancet study, Abigail Aiken, professor of reproductive health at the University of Texas at Austin, told CNBC that the authenticity of pills from online websites like those on Plan C need to be routinely vetted; others have raised concerns over pill packages being properly sealed from potential damage by moisture and heat.
Enforcement could also become a concern. According to the New York Times, only rarely has an Aid Access package been seized by customs. The Joe Biden administration has additionally chosen to use its discretion to not go after these suppliers and their domestic distributors. As the federal government controls the postal service and customs enforcement, "rooting out individual shipments of illicit abortion pills among the millions of packages a day processed at the country's international mail facilities" has not been a priority over the past few years.
But if the White House changes parties in the upcoming election, the legal landscape and enforcement of importation of these pills could shift. In 2019, the FDA ordered Aid Access in a letter to "immediately cease causing the introduction of these violative drugs into U.S. Commerce." Although mechanisms for legal retribution against foreign providers are unclear, Ziegler says that prosecutors could ramp up enforcement against domestic distributors for foreign sellers.
Another possibility is the emergence of stricter rules on online content coming from foreign abortion pill sellers. Texas legislators considered a bill last spring that would require internet service providers to block websites with information on abortion access and how to order abortion pills, calling out Aid Access and Plan C. Although such a measure could face court challenges, some lawyers worry that the threat of expensive legal battles could pressure internet search providers such as Google and Microsoft to censor search results.
Moving to Safeguard Supply from Sellers Abroad
If the Supreme Court rules against the FDA and reinstates pre-2016 restrictions, the curbed national access to medication abortion could push women toward online providers. But mifepristone imports could still increase even if the FDA wins the case.
Another recent study from Aiken published early this year in JAMA analyzed thousands of pill requests to Aid Access and found that during periods of legal uncertainty over access to abortion, such as after the leak of the Dobbs decision and the Fifth Circuit's ruling on mifepristone last spring, demand surged as Americans stockpiled pills in a practice known as "advance provision."
Such uncertainty is bound to continue with more legal challenges to abortion expected. In April, the Supreme Court will hear a challenge to the Emergency Medical Treatment and Labor Act that requires a doctor to provide an abortion in emergencies when it would stabilize a patient. As other cases move through the courts, Ziegler warns that the success of the legal argument employed by the Alliance for Hippocratic Medicine in earlier versions of the case, which draws on the 1873 Comstock Act, has established a new strategy of attacks beyond mifepristone to "ban abortion in effect full stop."
Shield laws, too, remain untested. Prosecutors in states with abortion bans could question these laws in federal court if they try to extradite abortion providers from shield law states. Until then, their impact is uncertain. According to Ziegler, how well shield laws work "will depend really on the details of the shield law, and determining when and how well they would apply is not a simple thing."
Regardless of how the Supreme Court rules, the FDA v. Hippocratic Alliance of Medicine illustrates how uncertainty over access and building legal threats to abortion could push more Americans into ordering abortion pills online from foreign providers. As this extralegal abortion route embeds itself within the reproductive care landscape, pro-choice advocates will likely continue to monitor the potential barriers to this pathway, such as increased enforcement under a new administration, the trade-off between cost and speed of delivery, and restricted information access.
Along with long-term strategies to restore legal protections to abortion across the country, ensuring continued abortion access could require further maintaining safe extralegal access. FDA v. Hippocratic Alliance of Medicine sheds light on this reality, one that will continue beyond its ruling this summer.
