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Access to abortion pills has grown since Dobbs

Originally published in Vox on December 27, 2023.
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Eighteen months after the Dobbs v. Jackson decision that overturned the constitutional right to abortion, and with a new Supreme Court challenge pending against the abortion medication mifepristone, confusion abounds about access to reproductive health care in America.

Since the June 2022 decision, abortion rates in states with restrictions have plummeted, and researchers estimated last month that the Dobbs decision led to “approximately 32,000 additional annual births resulting from bans.” Journalists profiled women who carried to term since Dobbs because they couldn’t afford to travel out of their restrictive state.

The total number of abortions in the US, however, has increased since the overturn of Roe v. Wade, driven by more people ending pregnancies in states that have laws friendly to abortion care. And often lost in this conversation is the fact that access to medication abortion has actually expanded in significant ways since the overturn of Roe v. Wade, both in terms of lower costs and avenues to obtain the pills quickly. The problem is many people who would be able to take advantage don’t know about it.

Taking a combination of mifepristone and misoprostol within the first 12 weeks of a pregnancy was already the most common method for abortion in the United States before the Dobbs decision, partly due to its safety record, its lower cost, diminished access to in-person care, and greater opportunities for privacy. The popularity of medication abortion has only grown since then: A poll released in March found majorities of Americans support keeping medication abortion legal and allowing women to use it at home to end an early-stage pregnancy. Another survey found 59 percent of voters disapprove of overturning the FDA’s approval of abortion medication, including 72 percent of Democrats, 65 percent of independents, and 40 percent of Republicans.

A June report from the Society of Family Planning found abortion via telemedicine “increased by 85 percent compared to the pre-Dobbs period, going from comprising 5 percent of all abortions to 9 percent.” And this is likely an understatement, Dana Northcraft, the founding director of Reproductive Health Initiative for Telehealth Equity and Solutions, told Vox. “That number does not include telehealth visits by providers who also do brick-and-mortar visits, [and] it does not include self-managed abortions outside of the formal medical system,” she said.

Getting the word out about medication abortion has been difficult for activists, especially with headline-grabbing news stories about new efforts to restrict the pills and punish those seeking to bypass state bans. In the early months following the Dobbs decision, if you lived in a state that banned abortion, your best bet was probably ordering pills from overseas, via the reproductive health care nonprofit Aid Access, even though their shipments could take two to three weeks.

Today, though, providers and new organizations ship pills directly from the US to pregnant people living in more restrictive states, dramatically reducing the amount of time it takes to send the medication through the mail. International volunteer networks have also expanded to help women end their pregnancies, and campaigns to destigmatize misoprostol-only abortions, a common method used around the world, have accelerated.

“We’re trying to shout this all from the rooftop,” Elisa Wells, the cofounder of Plan C, told Vox. “People are worried and there’s a lot of questions out there — is this all legit? Are the pills actually going to arrive? And we’re trying to say yes, these really are real routes of access.”

How “shield laws” have transformed the distribution of abortion pills

One of the biggest expansions to access since Dobbs is via broader access to telehealth abortion care in the US, even for those living in states with bans. Telehealth abortion care means a patient can consult virtually with a provider, either on an app or in a phone call or videoconference. Following that consultation, the provider would fill a prescription for the medication, and it would be delivered via mail.

Efforts to expand telehealth abortion care existed prior to the overturn of Roe v. Wade. Over the objections of groups like the ACLU and the American Congress of Obstetricians and Gynecologists, the Food and Drug Administration had long barred doctors from prescribing mifepristone without an in-person health care visit first. The Biden administration eased up on this rule during the pandemic, and in December 2021 the FDA permanently lifted its restriction on telemedicine for mifepristone. (State-level restrictions on abortion telemedicine still exist.)

“I think Dobbs just lit a fire under the innovations that were already underway,” Kirsten Moore, the director of the Expanding Medication Abortion Access project, told Vox. “[Telemedicine] was already happening during the pandemic and then in the post-Dobbs world everyone started thinking, ‘Oh wait, this is what we’ve got to do.’”

One major facilitator of expanded telemedicine is the profusion of new so-called “shield laws” that would protect blue-state abortion providers who send pills to people living in states where abortion is illegal. Today, six states — New York, Massachusetts, Vermont, Washington, Colorado, and California — have such telemedicine abortion shield laws, though not all have taken effect (California’s won’t until January 1). Julie Kay, the co-founder of the Abortion Coalition for Telemedicine, told Vox these laws are already facilitating the distribution of pills to 6,000 patients per month in states with bans. One major advantage is that shipping pills from a US state with a shield law is much faster than shipping pills from overseas. The medication can arrive in days, rather than weeks.

Kay said the effort to pass shield laws was led by the medical community, not traditional pro-choice advocacy groups. “Our focus has really been on serving marginalized communities in red states that have been denied abortion, West Virginia all the way through Texas,” she said. “A lot of people living there are not able to travel but do not know they have another option.”

While these laws have yet to be tested in court, providers expect legal challenges eventually and have been taking steps to protect themselves, like avoiding travel to states with abortion bans in case a prosecutor tries to arrest them for violating their criminal statute.

Some providers living in states with shield laws are interested in stocking and shipping the medication themselves. Others say they’d be interested if they could send prescriptions to a pharmacy that would handle the mailing for them. Starting in the new year, one online pharmacy based in California, Honeybee Health, aims to help abortion providers living in states like New York and Massachusetts serve more patients nationally.

“We think people, including the media, are less familiar with the idea that you can have an abortion by mail and that the service of telehealth abortion is available in every single state — even those with bans,” said Wells, of Plan C. “That didn’t exist before Dobbs. That is the big change that’s happened. People find it unbelievable, but it’s also fantastic.”

Wells says the big shift really happened in June 2023, when Aid Access became the first organization to start leveraging the new shield laws in the US. No longer would a pregnant person in Texas or Oklahoma searching for Aid Access online be routed to an abortion provider in Europe or need to wait for a pharmacist in India to mail them medication. Shortly thereafter, a new US organization, Abuzz, launched to provide telemedicine abortion to 30 states, followed in September by the Massachusetts Medication Abortion Access Project, which also utilizes shield laws for telemedicine care.

The e-commerce marketplace for abortion medication has expanded, and the cost for pills has fallen dramatically

Outside of telemedicine options, there are over two dozen e-commerce websites that sell and ship medication abortion to the US. This international supply chain has grown significantly since Dobbs and most of these sites do not require prescriptions and do not require people to upload their IDs or have medical consultations. Plan C has vetted 26 of these sites, including testing their pills to ensure they’re “real products of acceptable quality.”

Seven of the sites Plan C has vetted offer pills for prices ranging from $42 to $47, with delivery times between two and nine days. The sites are typically selling generic medications originating from India, with the help of US-based shippers.

One unexpected development this year was that many of these e-commerce websites ultimately dropped their prices by hundreds of dollars, in an effort to get higher placement on Plan C’s website.

Another pharmaceutical provider — ProgressiveRx — provides a prescription, pills, and a telehealth consultation all for $25, though its shipments from India typically take three to four weeks to arrive. Wells says ProgressiveRx is a great option for women living in restrictive states to stock up on pills in advance. (Mifepristone has a shelf life of about five years, and misoprostol about two years.)

The New York Times estimated in April that international suppliers were likely to provide abortion pills to about 100,000 Americans in the year after Dobbs was decided, or “enough pills to cover about 10 percent of the country’s annual abortions.” Anti-abortion groups have acknowledged the difficulty in stopping the flow of abortion drugs into the US.

Volunteer distribution networks have expanded

Community support groups, also known as “companion networks,” have grown since the overturn of Roe v. Wade and now actively provide free abortion pills to people living in states with bans on reproductive health care. These groups, some of which can be found on sites like Plan C and Red State Access, mail medication abortion and offer doula support.

“You communicate with these groups via [encrypted messaging apps like] Signal, and you don’t need a credit card or a bank account, which can be especially important for young people who might not have those resources,” Wells said. “We know the volunteer networks well and we have no hesitation in recommending them.”

Some of the volunteer companion networks are aided by activists in Mexico. The most prominent Mexican activist group is Las Libres, which was founded in 2000 to serve Mexican women. Abortion access in Mexico has improved, though, and in 2021 Las Libres pivoted to helping Texas women who were newly subject to the state’s six-week ban. The group’s US focus expanded further after Dobbs, and after Mexico’s Supreme Court decriminalized abortion nationwide in September 2023. In 2022 alone, Las Libres helped terminate roughly 20,000 pregnancies in the United States.

How medication abortion access could change in 2024

Earlier this month, the US Supreme Court announced it would hear a challenge to mifepristone, the abortion medication that anti-abortion groups claim was unlawfully approved back in 2000.

While abortion advocates doubt the justices will go so far as to pull mifepristone off the market, as a federal judge in Texas attempted to do earlier in 2023, they are bracing for the possibility that the court might reimpose medically unnecessary restrictions on access, like bans on prescribing mifepristone via telemedicine.

Even if that happens, though, most of the aforementioned options for accessing medication abortion would remain intact. It’s not clear if the FDA would even abide by such a Supreme Court ruling, but if it did, providers using shield laws could still legally ship misoprostol to patients in banned states.

“A Supreme Court ruling wouldn’t affect the community-based networks, ProgressiveRx, or the e-commerce websites that sell pills at all, and so there would still be ways of getting mifepristone and misoprostol in the mail,” Wells said. “The Supreme Court could affect services like Aid Access and Abuzz, but they could also switch to misoprostol-only abortions and that’s what they’re planning to do.”

While not FDA-approved, misoprostol-only abortion is a method backed by the World Health Organization, and a common way of ending pregnancies around the world. The National Abortion Federation, in its clinical guidelines, says that “where mifepristone is either not legally available or inaccessible, misoprostol-alone regimens may be offered.”

Kay, of the Abortion Coalition for Telemedicine, told Vox that some abortion providers will probably continue to ship mifepristone even if the Supreme Court reinstates the ban on mailing the pills, given that the combination of mifepristone and misoprostol is slightly more effective than misoprostol-only abortions. (Both options are considered safe for patients, but studies show using just misoprostol is effective at ending pregnancy about 88 to 93 percent of the time, versus 95 to nearly 100 percent for the two-drug regimen.)

A bigger threat to medication abortion access than the Supreme Court may be the election of a Republican to the White House next November, who would control appointments to key federal enforcement agencies like the Justice Department, the Department of Health and Human Services, the US Postal Service, and the FDA.

Anti-abortion groups have already declared medication abortion their top priority if Donald Trump or another Republican is reelected. While GOP lawmakers in Congress might not have enough votes for a federal abortion ban, activists see new executive orders as an alternative way to restrict pill distribution. Anti-abortion activists say they intend to track the views of potential GOP appointees, rather than press Republican presidential candidates on their specific regulatory plans.

Moore, of Expanding Medication Abortion Access, said one risk is that the government will raise the threats of criminal or financial penalties against providers, dissuading more clinicians from offering care.

How abortion rights activists are working to further improve access to pills

Though the cost of medication abortion has dropped substantially since Dobbs, the price is still out of reach for some who need it, and activists are working to help more pregnant people cover the cost of their care.

Kay told Vox the Abortion Coalition for Telemedicine is working on a project dedicated to funding abortion pills for those who can’t afford to pay, something the organization hopes to launch in early 2024.

Moore said leaders need to do more to support women in the two or three days after they take the abortion drugs. “Medication abortion can be an ongoing process for 24 to 48 hours, and we can get people their pills really quickly but helping them manage the process does require more time and investment,” she said. “To be honest, I think we’re still building out the infrastructure for that part of the care.”

Even as activists work to expand access, anti-abortion lawmakers plan to continue their efforts to restrict access to medication abortion, including by exploring new strategies banning website visits to Aid Access and Plan C and making health care providers newly liable for disposing of aborted fetal tissue. Some lawmakers want to test the limits of their extraterritorial powers, and are exploring how they might retaliate against providers in other states, even those operating under shield laws.

Despite these threats, the odds of shutting down all these avenues for abortion medication is low, and the bigger challenge is really helping more people learn about their evolving options. Sometimes that means activists battling big tech platforms over what abortion-related content they’re censoring, and sometimes it means media outlets doing a better job of conveying new information to the public.

Northcraft, of Reproductive Health Initiative for Telehealth Equity and Solutions, added that while telehealth can alleviate many of the expenses associated with getting an abortion — such as travel costs, taking time off work, and lining up child care — there is still more work needed to ensure equity, like ensuring that platforms and providers communicate in multiple languages.

“At the end of the day medication abortion is safe, effective, and what people want,” Kay said. “And it’s going to be available by licensed medical professionals, by people who are mission-driven but not medically certified, or through a for-profit thing on the world wide web. We know it’s not going away.”

What a lawsuit in Mississippi tells us about the future of abortion pills

Originally published in Vox on June 29, 2022.
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As some states have moved to fully ban abortion in the wake of Dobbs v. Jackson Women’s Health, new questions emerged about abortion pills: Do states have the legal authority to outright ban drugs that have been approved by the U.S. Food and Drug Administration?

An ongoing federal lawsuit in Mississippi could provide a glimpse at the answer. GenBioPro, the manufacturer of generic abortion pills, is fighting to overturn state restrictions that impede access to the abortion pill mifepristone. Their lawsuit, filed in 2020, hinges on an argument that many legal experts expect other states and advocates to make in the coming months: that Mississippi’s restrictions on medication abortion are unduly excessive, illegally pre-empting the FDA’s authority on drug safety.

The FDA approved mifepristone for use in 2000. Over the next 18 years, more than 3.7 million women in the United States used the medication — sold under the brand Mifeprex — to end an early pregnancy. In 2016 the FDA reported mifepristone’s “efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.” Three years later the agency approved GenBioPro’s generic version.

Today medication abortion — a combination of both mifepristone and misoprostol — account for more than half of all abortions in the US, and fights over accessing the pills are expected to be among the most fiercely contested in the post-Roe era.

Just hours after the US Supreme Court overturned Roe, President Joe Biden gave a speech promising to protect a woman’s access to drugs approved by the FDA, including mifepristone. Biden announced he was directing the federal Department of Health and Human Services “to ensure that these critical medications are available to the fullest extent possible” and Attorney General Merrick Garland pledged to use the powers of the Justice Department to crack down on states trying to ban medication abortion.

But the Biden administration has stayed quiet on the Mississippi lawsuit. The White House declined to comment on the case, as did the FDA and DOJ. HHS did not return requests for comment.

Mississippi has urged for a dismissal of the case. Judge Henry Wingate, a Reagan appointee on the United States District Court for the Southern District of Mississippi, requested that both parties provide written submission on the impact, if any, of the Dobbs decision on the lawsuit, and on Mississippi’s “trigger law” banning abortions, which is set to take effect next week. Submissions are due on Thursday.

A ruling in favor of Mississippi could have implications for other jurisdictions seeking to ban abortion pills in a post-Roe landscape.

If upheld, it “would also open the floodgates for states to substitute their judgment for FDA’s in other controversial areas of medicine — some of which we may be aware of — some of which we may not be,” said Delia Deschaine, a DC-based attorney who specializes in FDA regulation. “For example, if there were a group of individuals opposed to palliative care, a state could conceivably limit access to medications that are approved for use in that context. This then becomes a situation where the practice of medicine using pharmaceuticals unpredictably varies between states — which creates its own host of public health issues.”

What it means to “pre-empt” the FDA

Through the passage of the Federal Food, Drug, and Cosmetic Act in 1938, Congress empowered the FDA as the sole agency to approve drugs in the US. It’s responsible for reviewing a drug’s safety, weighing its risks and benefits, and regulating appropriate conditions for safe and effective use.

Even though many reproductive health experts — including the American College of Obstetricians and Gynecologists — actually say the FDA has too many restrictions on mifepristone (for example, only certified pharmacies or providers can dispense the drug) everyone must abide by the agency’s determinations.

But many red states, including Mississippi, have passed laws that go even further than FDA’s rules around mifepristone. For example, Mississippi requires a doctor to physically examine a patient prior to offering the drug, and for patients to ingest the medication “in the same room and in the physical presence of” the physician who gave it to them, rather than taking the medication at home.

Experts say there is a “strong, though legally uncertain” argument that the Supremacy Clause of the US Constitution gives the federal government authority over these conflicting state rules. Indeed, GenBioPro has argued Mississippi’s law is “an impermissible effort by Mississippi to establish its own drug approval policy and directly regulate the availability of drugs within the state.”

This idea — that federal regulation of drugs would take precedence, and a state cannot ban a drug that has been given federal approval — is known as the preemption argument.

For now, legal scholars say it’s unclear how preemption arguments will play out in court. Courts often grant deference to the FDA, though there are relatively few examples involving drugs. The main precedent is a 2014 case where a federal judge struck down a Massachusetts effort to restrict the opioid Zohydro, since the FDA had approved the painkiller.

“The fact that this case relates to a medication that is used in abortion is one reason we might see the district court take a different stance than other courts on this issue,” said Deschaine.

Anti-abortion advocates maintain that states have the authority to restrict or ban mifepristone, because states can regulate medical practice, and the FDA lacks the authority to regulate abortion. Legal scholars also note that Congress has never explicitly said that FDA drug approval supersedes state law, though it has expressed that for medical devices.

While the DOJ declined to comment on the GenBioPro case, Attorney General Garland’s recent public statements suggest the agency is thinking about the preemption argument. “The FDA has approved the use of the medication Mifepristone,” Garland said Friday, adding that, “states may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

What’s next for the GenBioPro lawsuit

Gwyn Williams, an attorney representing GenBioPro, told Vox that in response to the judge’s request, their team submitted a statement reiterating their previous position that the legal issues decided by the US Supreme Court in Dobbs “do not affect GenBioPro’s claims, which are based on federal preemption and not on constitutional rights to privacy or abortion.” Williams says they expect the judge to issue his decision on dismissing the case soon.

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Paul Barnes, a Mississippi Assistant Attorney General representing the state, declined to comment.

Greer Donley, a University of Pittsburgh law professor who specializes in reproductive law, told Vox that one reason why the court has been “pretty delayed” in issuing any rulings could be because the judge “might be trying to look for an opportunity to kick the case.”

If Mississippi fully bans abortion statewide — which it’s set to do next week, though that trigger law is now being challenged in court — then the state’s mifepristone restrictions might become moot. “If there’s a statewide ban, then I can imagine the defendant saying the lawsuit is moot now because all these laws that regulate abortion providers are subsumed by the bigger abortion ban generally,” said Donley.

But Donley says the preemption argument would still have broad merit, since the FDA still acts as a gatekeeper.

“To earn the right to sell a drug product, manufacturers must produce years, if not decades, of expensive, high-quality research proving that the drug is safe and effective,” she wrote, along with law professors David Cohen and Rachel Rebouché in a legal article cited in the Dobbs dissent. “If they are successful, they can sell their product in every state; if unsuccessful, they cannot sell their product anywhere. If a state were to ban abortion, it would in effect ban the sale of an FDA-approved drug.”

In other words, if it is impossible to comply with both state and federal law at the same time, there remains a plausible preemption argument.

Deschaine, the attorney who specializes in FDA regulation, thinks upholding state restrictions on abortion pills could certainly affect whether other drug companies seek to go through the FDA approval process in the future.

“The incentives for developing FDA-approved drug products are strong, but those start to erode the more fractured the regulatory scheme for these products becomes,” she said. “If a company does not believe that it will be able to market its product in all US states/jurisdictions, then it may not be willing to assume the risk of pursuing the drug approval pathway. Indeed, even absent those restrictions, that pathway is very costly and uncertain.”