Tag Archives: abortion medication

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.”

A Texas judge just issued a national ruling against medication abortion. What now?

Originally published in Vox on April 8, 2023.
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A decision in a highly anticipated federal court case was issued Friday night: A district judge in Texas, with longstanding and outspoken anti-abortion views, suspended the US Food and Drug Administration’s approval of mifepristone, a widely used drug to end pregnancies.

But the judge, Matthew Kacsmaryk of the Northern District of Texas, ordered that his decision would not take effect for seven days to allow the federal government time to appeal his decision. Within hours, both the US Justice Department and Danco Laboratories, a manufacturer of mifepristone, announced their plans to challenge the ruling.

For now, access to the drug remains unchanged.

Adding to the chaos and uncertainty, a second and competing federal court decision regarding mifepristone was released Friday in Washington state, in a case led by 17 Democratic attorneys general who argued the FDA had actually been too restrictive when it approved mifepristone.

The federal judge in that case, Thomas Rice, issued a preliminary injunction blocking the FDA from taking “any action to remove mifepristone from the market or otherwise cause the drug to become less available.”

While Rice’s decision applies only to the 17 states involved in the lawsuit, his order would conflict with the nationwide injunction Kacsmaryk just issued, which could set up an accelerated path for the US Supreme Court to take up the issue. The Biden administration said it is still reviewing the Washington state decision.

Kacsmaryk’s decision was riddled with false statements about medication abortion and the risks of mifepristone, which has been used by millions of women since it was first approved by the FDA 23 years ago. It’s unprecedented for a district judge to reverse the FDA’s approval of a drug, and some reproductive rights groups warn this could set the stage for similar challenges to other drugs anti-abortion groups oppose, like birth control and emergency contraception.

On Friday night, President Biden vowed to fight the Texas decision, emphasizing that if it were to stand, “there would be virtually no prescription approved by the FDA safe from this kind of attack.”

Sen. Ron Wyden (D-OR), who chairs the Senate Finance Committee that oversees the FDA, said in a statement that he believes the FDA has the authority to ignore Kacsmaryk’s ruling. “The FDA, doctors, and pharmacies can and must go about their jobs like nothing has changed and keep mifepristone accessible to women across America,” he said.

The availability of the drug will ultimately be decided by higher courts. But if mifepristone were to be pulled off the market, the consequences for access to abortion would be severe. Medication abortion — referring to the combination of mifepristone and misoprostol — accounts for more than half of all abortions in the US, and is used typically within the first 10 to 12 weeks of a pregnancy. It’s become the most common method for ending pregnancies in the United States, partly due to its safety record, its lower cost, diminished access to in-person care, and greater opportunities for privacy.

The anti-abortion movement has been trying to restrict access to medication abortion since before the overturn of Roe, but past attempts to challenge the FDA’s approval process were all summarily rejected. The Texas lawsuit and the plaintiffs’ demand for a nationwide injunction represent the increasing aggressiveness of the anti-abortion movement to take aim at abortion access not only in conservative states controlled by Republicans, but also in deep blue states run by Democrats.

What is mifepristone?

Mifepristone is a prescription drug that works by blocking the hormone progesterone, which maintains the interior of the uterus. If progesterone is blocked, the uterus can’t support a pregnancy and the embryo is detached.

For medication abortions, a second drug — misoprostol — is then used. Misoprostol has been around since the 1970s and was first developed to treat stomach ulcers. An individual seeking to end a pregnancy would take misoprostol 24 to 48 hours after mifepristone, causing their cervix to soften and their uterus to contract and expel the embryo.

Mifepristone is also used for other situations like miscarriage management, and helping patients with Cushing’s syndrome who also have Type 2 diabetes. Lawyers for the plaintiffs insist restricting mifepristone for abortion won’t impact patients who use the drug for other reasons, but already some pharmacists and doctors have resisted prescribing misoprostol to patients, wary of breaking new laws or suspicious patients will use the drugs covertly for an abortion.

The drug was authorized by the FDA in 2000 and is approved for ending a pregnancy in the US up to 10 weeks’ gestation, though the World Health Organization recommends mifepristone up to 12 weeks.

Between 2000 and 2018, 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 that 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 a generic version, GenBioPro.

Why is there a lawsuit attacking mifepristone?

Back in November, a lawsuit challenging the legality of mifepristone was filed on behalf of a coalition of anti-abortion groups and doctors known as the Alliance for Hippocratic Medicine. Led by the conservative legal advocacy group Alliance Defending Freedom, the lawsuit claims the FDA caved to political pressure under Bill Clinton when it approved mifepristone more than 22 years ago, and it should thus be pulled from the market.

The lawsuit claims the FDA didn’t properly assess mifepristone’s safety, and that the federal government has put people at risk more recently by making the medication easier to obtain. Examples it cites include the FDA extending in 2016 the recommended window of time to take mifepristone from seven weeks of a pregnancy up to 10, and removing a requirement in 2021 that women must pick up mifepristone in person, thereby making telehealth and mail orders more accessible.

The National Academies of Sciences, Engineering, and Medicine has affirmed medication abortion as a safe method to terminate pregnancy, and concluded that there is no medical need for the drugs to be administered in the physical presence of a health care provider. The FDA has also repeatedly rejected the evidence the plaintiffs claim shows medication abortion is unsafe.

The case has virtually no scientific merit, and challenging the use of a drug that has been studied and safely used for over two decades is highly unusual. Jack Resneck Jr., the president of the American Medical Association, said in a statement Friday night that Kacsmaryk’s “disregard for well-established scientific facts in favor of speculative allegations and ideological assertions will cause harm to our patients and undermines the health of the nation.”

Most Americans also believe medication abortion should be accessible. A poll released in early 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 recent 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.

But legal experts concede these are legally unpredictable times given the politicization of the courts. The federal lawsuit was intentionally filed in Amarillo, Texas, so that Kacsmaryk, a conservative judge, would hear the case. Kacsmaryk was appointed by Donald Trump and is a former Christian activist who has openly opposed abortion for decades.

Last year, he ruled that federal law prohibiting certain forms of discrimination by health providers does not protect against anti-LGBTQ discrimination, and in a separate case, he concluded that teenagers can’t access birth control without their parents’ permission under Title X, a federal program that provides family planning and preventative health services.

What are the implications of the decisions?

Both decisions in Texas and Washington state were issued by lower courts, so these legal battles are not over. The federal government has already said it will appeal the Texas decision, but it’s unclear if the Biden administration will appeal to the Fifth Circuit, or go directly to the US Supreme Court.

Will mifepristone remain available? One possibility is that the Fifth Circuit or the Supreme Court issues a “stay” as the case continues to be litigated, meaning the drug could continue to be prescribed, while the lawsuit stretches on. When Roe was on the books, there were lots of court-ordered abortion bans upheld in district courts like Kacsmaryk’s, but then never enforced because lawyers would successfully win “stays” as they proceeded to challenge the bans in higher-level courts. Whether appellate courts in the post-Roe era would be as willing to block a lower judge’s order while the case continues is an open question.

David Cohen, a law professor at Drexel University who specializes in reproductive rights law, said before Kacsmaryk issued his order that typically an appellate court would consider whether a district court order would be so disruptive to the status quo that it needs to be halted while they consider the case. In normal times, abruptly taking off the market an FDA-approved drug that has been safely used by millions of women for over 20 years would certainly meet the threshold of “very disruptive” to the status quo.

“But I think we are in a world where the conservative Fifth Circuit feels very emboldened, so we can’t count on” a stay, Cohen told Vox. It’s possible, especially given the Washington state decision, that the Biden administration skips the Fifth Circuit and appeals directly to the Supreme Court. “We’ve seen more litigants doing that in recent years, though usually it’s been conservative litigants,” Cohen explained. “I don’t know if the FDA would want to do that, but it’s possible they think they’d get a fairer shake at the Supreme Court.”

What options for abortion are still available right now?

For at least the next week, nothing will change,

If mifepristone is ultimately pulled from the market, people seeking abortions could still access care at in-person clinics for surgical abortions. But those procedures typically cost more money, and require more time and resources from already-strapped abortion clinics. In its legal filing opposing the Texas case, the Justice Department warned that taking mifepristone off the market would lead to delays and overcrowding at these clinics, which were already managing an influx of out-of-state patients since Roe’s overturn.

Another option that would remain even if the order takes effect is ordering pills either from the European-based nonprofit Aid Access, which bypasses US restrictions by prescribing the drugs to patients from overseas, or through alternative methods vetted by the reproductive justice group Plan C such as mail forwarding. “We will not let this unjust ruling stop people from accessing abortion pills, which are readily available through alternate supply routes in the US,” Plan C co-director Elisa Wells said Friday night.

Another option would be pursuing medication abortion using only misoprostol. While not FDA-approved, this method is backed by the World Health Organization, and a common way of ending pregnancies around the world. In February, researchers found misoprostol-only abortions in the US to be 88 percent effective, with few incidents of serious adverse events or signs of a potential abortion complication. In comparison, research in the US on using mifepristone and misoprostol together has shown success rates of 95 percent. But research on misoprostol-only abortions in other countries has also shown similar efficacious results, ranging between 95 and 99 percent.

Abortion providers, though they expressed adamant opposition to the Texas lawsuit, have been preparing to offer misoprostol-only abortions if mifepristone is taken off market. 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.” Because misoprostol has been FDA-approved to treat stomach ulcers and can be prescribed off-label for solo use, there is less concern that access to that drug will disappear.

There are also pending federal lawsuits to expand access to medication abortion

In addition to battling this lawsuit from anti-abortion groups, reproductive health organizations have been planning their own legal strategies to expand access to abortion pills. In January, two such lawsuits were filed, claiming two states’ restrictions on mifepristone illegally preempt 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.

With this in mind, GenBioPro, the generic manufacturer of mifepristone, argued in a lawsuit that West Virginia’s state abortion ban is unconstitutional because it violates the supremacy and commerce clauses of the US Constitution, which empowers the FDA as the sole regulator of drugs across the country.

In response to Kacsmaryk’s ruling, GenBioPro issued a statement affirming that as it reviews the Texas decision, it will continue to make its product available. “The bottom line is, we are confident in the legality of mifepristone’s approval,” CEO Evan Masingill said.

A similar case, filed in January by an OB-GYN in North Carolina, challenged state officials for imposing restrictions on mifepristone that go beyond what the FDA requires. North Carolina requires doctors to provide mifepristone in person at a particular type of facility after a 72-hour waiting period and, in some cases, an ultrasound.

Experts say there is a “strong, though legally uncertain” argument that the supremacy clause of the Constitution gives the federal government authority over these conflicting state rules. 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. If the plaintiffs win their case, millions more people could have easier access to mifepristone.