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

Originally published in Vox on April 8, 2023.

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.


The sole US supplier of a major abortion pill said it would not distribute the drug in 31 states

Originally published in Vox.com on March 17, 2023.

Earlier this month, Politico broke news that Walgreens, the nation’s second-largest pharmacy chain, assured 21 Republican attorneys general that it would not dispense abortion pills in their states should the company be approved to dispense them. The decision was met with sharp protest by Walgreens customers, abortion rights activists, and Democrats, who accused the pharmacy of caving needlessly to pressure.

But fear of state prosecution is not the only factor shaping Walgreens’ decision-making. Another previously unreported constraint on the company is that its sole supplier of Mifeprex — the brand-name drug for the abortion pill mifepristone first approved by the Food and Drug Administration in 2000 — circulated a list to its corporate clients in January naming 31 states that it would not supply the abortion medication to. Vox spoke with two sources who had reviewed that list recently.

The sole US distributor for Mifeprex is AmerisourceBergen, one of the largest pharmaceutical distribution companies in the world. (The federal government is currently suing AmerisourceBergen for allegedly distributing opioids while knowing they would later end up on the illegal market. The Pennsylvania-based company has denied this.) Back in January, AmerisourceBergen created its list of 31 states using as a source the website of the Guttmacher Institute, a reproductive research organization that tracks state abortion restrictions, according to sources with knowledge of the list’s origin.

The list’s existence underscores the precarious state of abortion rights in the US in the wake of Dobbs v. Jackson — the 2022 Supreme Court ruling that struck down Roe v. Wade, effectively leaving abortion rights to each state. Walgreens drew condemnation for saying it would not dispense abortion pills, even in states where it’s currently legal to do so. AmerisourceBergen’s list indicates another reason influencing Walgreens’ stance: a distributor — it’s the only one for this drug — had signaled that it would not supply pharmacies with abortion pills.

Walgreens and Danco Laboratories, the manufacturer of Mifeprex, declined to comment. A source with knowledge of the contractual agreement between Walgreens and AmerisourceBergen told Vox that the parties are legally barred from talking publicly about the supplier, but that advocates have been trying to persuade AmerisourceBergen to adopt a less risk-averse stance on abortion-pill distribution.

Lauren Esposito, a spokesperson for AmerisourceBergen, told Vox over email that the situation “is dynamic and ever evolving. Any information that you’re referring to from January is certainly out of date by now. Additionally, as I’m sure you can appreciate, for contractual purposes we are not able to discuss specific products.” The company later released an additional statement, emphasizing that AmerisourceBergen does not “independently decide what medications should be available to health care professionals as part of their treatment plans” and does “not make clinical decisions or values-based judgements on which FDA approved products it distributes.”

Vox asked Guttmacher about the supplier’s list and its reported use of the institute’s site as a guide for compiling the list. “We would like to understand what data AmerisourceBergen is basing these claims on, as we are not aware of any policies that would prevent the shipping of mifepristone to such a large number of states,” said Elizabeth Nash, a Guttmacher policy analyst. “Private companies should be extremely careful not to limit access to mifepristone in response to threats from anti-abortion groups or politicians.”

Abortion rights advocates and consumers responded with outrage to the Politico report, calling for a boycott of Walgreens until it reverses its stance. At particular issue is the fact that four states on Walgreens’ list — Montana, Kansas, Iowa, and Alaska — have restrictions on pharmacists that are blocked in court. California Democratic Gov. Gavin Newsom announced he would not renew a multimillion-dollar contract with the pharmacy chain to signal his disapproval.

Walgreens spokesperson Fraser Engerman maintained the company’s position hasn’t changed, and that they still intend to dispense mifepristone “in any jurisdiction where it is legally permissible to do so.”

In January, the Food and Drug Administration announced that brick-and-mortar pharmacies could apply for certification to sell abortion medication at their stores, a move hailed as an important step toward expanding access to the safe and effective drug that has become the most common method for ending pregnancies in the United States.

Representatives from CVS and Rite Aid, which like Walgreens said they would seek certification, have remained conspicuously quiet on the issue for the last two weeks, and did not return requests for comment. (No drugstore has yet been certified, and it is not clear how long the process will take.)

The ongoing debate over what pharmacies like Walgreens can and should do when it comes to dispensing mifepristone reflects the political challenge of navigating the patchwork of conflicting state abortion restrictions in the post-Roe era. With a bevy of new laws and litigation, individuals, abortion providers, and companies are left to make consequential decisions in a highly fraught and confusing legal environment — which, in the case of Walgreens and AmerisourceBergen, means inaction in the face of uncertainty.

Pharmacists are caught in the middle

Caught in the middle of this legal and political tug-of-war are abortion providers. While it’s easy for Democratic governors in states like Illinois and California to tell companies they should dispense medication abortion, it’s harder to insist that they should put their pharmacists at risk.

“Violating the has-to-be-done-by-a-physician requirements in some of these states is punishable by jail,” a Walgreens spokesperson told the New York Times. “In other states, it’s punishable by a civil fine, and in a number of them it’s punishable by licensing sanctions. And so these are restrictions that present real risks to pharmacists.”

The 21 states where Walgreens has said it will not dispense mifepristone fall into a few different categories, explained Nash of Guttmacher. Some have banned abortion entirely, while others have laws requiring physicians to dispense drugs in-person, or require in-person counseling and ultrasounds, making the prospect of dispensing mifepristone through a pharmacy impractical. And still others, like Alaska, should feasibly be able to dispense through a pharmacy, Nash said.

“Overall there’s a lot of confusion in the marketplace as pharmacies and pharmacists try and follow all the laws and regulation and litigation,” said Ilisa Bernstein, the interim CEO of the American Pharmacists Association. “It’s unsettled right now.”

Bernstein told Vox that beyond legal risks, members are grappling with new safety issues: “Pharmacy team staff safety is a concern, whether it’s getting into the pharmacy and going through people who may be demonstrating and picketing outside or in the pharmacy, where team members want to be sure they’re in a safe space when they’re working,” she said. Recently anti-abortion activists protested Walgreens’ annual shareholder meeting, casting drugstores as the new abortion clinic.

Next week the American Pharmacists Association is holding its annual meeting where hundreds of delegates from across the country plan to revisit the group’s policies on mifepristone and reproductive health care.

Regardless of what pharmacists want their group’s policies to be, they will remain bounded by the FDA’s Risk Evaluation and Mitigation Strategies (REMS) list, a restrictive designation the federal government places on mifepristone over the objections of groups like the American Congress of Obstetricians and Gynecologists. Pharmacists will also be circumscribed by the lawyers of their companies, and other actors involved in the medication abortion supply chain, like drug distributors and lawmakers.

Esposito, the spokesperson for AmerisourceBergen, told Vox, “We continue to make FDA-approved medications, including reproductive health medications, available to health care facilities and providers in all 50 states and territories that meet local, state, and federal requirements to distribute and dispense.”

But whether AmerisourceBergen will let Walgreens and other drugstores sell Mifeprex in all the locations pharmacies would be willing to dispense them from is another question.

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

Originally published in Vox on June 29, 2022.

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.


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.”

Should you keep abortion pills at home, just in case?

Originally published in Vox on June 22, 2022

Medication abortion, or taking a combination of the drugs mifepristone and misoprostol, is an increasingly common method for ending pregnancies in the United States. Reasons vary and overlap: Some women lack access to in-person abortion clinics; others prefer to end pregnancies in the comfort of their own home. Others seek out the pills because they cost far less than surgical abortion.

With more in-person clinics shuttering and a Supreme Court that’s threatening to overturn Roe v. Wade, a small but growing number of reproductive experts have been encouraging discussion of an idea called “advance provision” — or, more colloquially, stocking up on abortion pills in case one needs them later.

It’s an idea that has merit: Mifepristone has a shelf life of about five years, misoprostol about two, and both drugs work better the earlier in a pregnancy you take them. In states that are ramping up abortion restrictions, there’s often a race against the clock to access care. In Texas, for example, if you don’t realize until eight weeks in that you’re pregnant — which could be only a couple of weeks after a missed period — you would have already passed the state’s new legal deadline for obtaining abortion pills. But if you had already stored them in your home, or your friend or neighbor had, then you’d be able to take them.

In a 2018 nationally representative survey of women ages 18 to 49, 44 percent expressed support for advance provision, and 22 percent said they were personally interested in it. Those who had previously had a medication abortion and those who reported facing greater barriers to reproductive health care were more likely to support the idea.

Data on these kinds of abortions — often called “self-managed” or “self-administered” — are harder to track. Research published in 2020 estimated that 7 percent of women will self-manage an abortion in their lifetime, though this was calculated with the assumption that Roe was still in place. New Guttmacher data published last week on US abortion incidence found there were 8 percent more abortions in 2020 than in 2017, but self-managed abortions are excluded from this count.

“We know there are thousands of self-managed abortions that we aren’t capturing,” Rachel Jones, a Guttmacher research scientist, told Vox. “If the Supreme Court overturns Roe, and abortion becomes illegal in 26 states and people can’t travel to another state, then self-managed is going to be the only other option they have for an abortion.”

Talking more frankly about self-managed abortion goes against longstanding American cultural norms. For years US reproductive rights groups stressed that the decision to end a pregnancy “was made between a woman and her doctor.” Internationally, where abortion has been more heavily criminalized, there is less pressure to involve medical professionals. It was in the legally restrictive context of Brazil in the late 1980s that women first pioneered the use of misoprostol to self-manage their abortions.

Rebecca Gomperts, the Dutch physician who in 2018 founded Aid Access to deliver abortion pills to US patients, has been one of the most vocal advocates for advance provision, and began offering it as an option to people in all 50 states last fall. Costs for the pills range from $110 to $150, with a sliding scale for those who lack funds. Recently, in Politico, Gomperts encouraged doctors to begin prescribing mifepristone and misoprostol to those who are not pregnant, so they have the medication available if they need it later.

“Abortion pills are something that, actually, you cannot die from,” she said. “There’s no way that you can overdose on it. And what we know from research is that you don’t need to do an ultrasound for a medical abortion.”

The idea of getting medication in advance of need is nothing new. Doctors also used to commonly prescribe emergency contraception to women before it became available over the counter.

Right now large mainstream abortion rights groups are mostly staying quiet on advance provision, leaving lesser-known organizations like Aid Access and Plan C to try to get out the word. (NARAL and Guttmacher declined to comment, and Planned Parenthood did not return requests for comment.)

Aid Access and Forward Midwifery are among the few groups currently offering US patients the option to order pills in advance, though Elisa Wells, co-director of Plan C, said she knows others are considering it. “I was just having a conversation with a provider in Montana,” she told me. “We believe it will become more common. Sometimes we call it the ‘just in case’ plan, because unplanned pregnancy is so common.”

It’s a safe option for most patients

When it comes to safely ending pregnancies, medication abortion is over 95 percent successful, according to Guttmacher. Less than 0.4 percent of patients require hospitalization. The National Academies of Sciences, Engineering, and Medicine has also affirmed medication abortion as a safe method to terminate pregnancy, one with very low risk of complications.

Research published earlier this year in the medical journal Lancet found self-managed abortions specifically to be very effective, and with high rates of patient satisfaction.

Gomperts also urges more attention on misoprostol-only abortions, which are common internationally. The drug can be easier for women to access since misoprostol is less tightly regulated; it’s used for other ailments including stomach ulcers and managing miscarriages, and is sold over the counter in many countries.

While medication abortion is a safe option for almost everyone with an early pregnancy, the pills are not recommended for people who take blood thinners, who have bleeding disorders, or who are at high risk of ectopic pregnancies. (Ultrasounds are recommended for those in this latter category.)

Still, one upside of advance provision — and medication abortion generally — is the greater number of people who could potentially provide the pills, including primary care doctors. Another upside is that it could be easier to share pills with those who need the medication quickly but lack access to it. Research suggests the drugs are best taken within the first 10 to 12 weeks of a pregnancy.

Paying attention to legal risks and criminalization

Outside of groups that exploit international law like Aid Access, advance provision is unlikely to be a legal option in every state. Some states, for example, require patients to get ultrasounds before a provider can give them abortion pills. Other states are cracking down on abortion pills themselves.

While few states currently ban self-managed abortion outright, many have existing laws that overzealous prosecutors could use to go after women, like fetal homicide statutes. “I am concerned that if people stockpile, without knowing the legal risks or how to cover their digital footprints, they could be subject to criminalization,” said Renee Bracey Sherman, founder of the abortion storytelling group We Testify.

The National Right to Life Foundation also released model legislation in mid-June that encourages states to criminalize those who “aid or abet” illegal abortions, including those who provide instructions over the phone or internet about self-managed methods.

Even in states with fewer legal concerns, advance provision won’t be the right option for everyone. “It’s a potentially high cost for a patient that is unlikely to be covered by insurance,” said Daniel Grossman, a physician and a professor of obstetrics and gynecology at the University of California San Francisco. Not everyone can afford to spend $150 to have a backup method available, and some people will still need or prefer in-person clinic care.

It hasn’t gone mainstream, yet

In the days following the leaked draft of the Supreme Court’s decision to overturn Roe v. Wade, telehealth abortion providers reported spikes in internet searches and pill orders. Still, most Americans lack familiarity with not only abortion medication but also the few groups that currently provide the pills in advance. Some activists say leaders and more well-resourced organizations should do more to promote self-managed abortion as an option.

In December 2021, three UCSF reproductive health researchers, including Grossman, published an article calling advance provision “an unexplored care model that we believe holds promise and merits further study.”

Grossman told Vox that he believes more people should ask their primary care and reproductive health providers if they’d be open to prescribing or giving them abortion pills to store for later use. “Even if the doctor doesn’t want to, I think it’s worth just sparking a conversation with them and get their provider thinking,” he said. Grossman previously told Jezebel he’s found it challenging to get other researchers and health care providers to give advance provision the attention it deserves.

“We have ibuprofen in case of a headache, cough syrup in case of a cold, and Plan B in case of a broken condom,” said Bracey Sherman of We Testify. “It’s already normal for other health care and we should normalize it for abortion.”

Wells, from Plan C, said the historical restrictions placed on abortion have likely made some groups and individuals more reticent to talk about advance provision. “I think there’s probably a lot of fear about not wanting to break any rules,” she said.

Another factor limiting discussion, Wells suggested, is the way abortion has been heavily medicalized in the US, to the point where people believe the drugs have to be or are best administered by a medical professional. Attitudes are different internationally, she said.

“We have become so invested in saying that we need to have safe abortions and that doctors and clinicians and the clinics can provide that,” Wells said. “Clinicians have done a wonderful job, and we have to have all these different types of care options available, but [self-managed abortions] can be a bit of a threatening message to that whole system.”

In The Fight for Reproductive Rights, Don’t Forget the Medicaid Gap

Originally published in The Intercept on October 1, 2021.

IN ONE OF the grimmest periods ever for reproductive rights, advocates are scrambling to react to a spate of new restrictions on abortion. The Biden Justice Department filed a lawsuit against Texas in the wake of S.B. 8, the state’s new law that invites private citizens to enforce abortion bans through civil litigation. House Democrats passed the Women’s Health Protection Act, a bill that would protect abortion providers and remove barriers for patients. And some advocates see hope in medication abortion, a combination of two drugs — mifepristone and misoprostol — which people can take to safely end pregnancies.

But many states still restrict where providers can mail drugs, and most groups still only service states with relatively friendly abortion laws. Last week, a Republican state representative in Florida introduced a bill that mirrors S.B. 8, and lawmakers in other GOP-controlled states have signaled interest in following suit. The U.S. Supreme Court has refused thus far to block Texas’s notorious statute, and the Women’s Health Protection Act stands little chance of passage in the Senate.

As long as the Senate filibuster remains in place, and the U.S. Supreme Court maintains its anti-abortion majority, advocates in the South say there’s little that Washington can really do to aid their plight. There is one crucial method, though, which often falls off the radar: Medicaid expansion.

“What people have forgotten is [in] this entire swath of the southeast, from Texas and Georgia and Florida, we never got Medicaid expansion, so there’s a lot of people, especially people capable of becoming pregnant, unable to access any sort of insurance,” said Robin Marty, a journalist, activist, and head of operations for West Alabama Women’s Center, an independent abortion clinic in Tuscaloosa. “We need national organizations to remember that we’re still five steps behind. While they’re trying to get new medication abortion programs standing, we’d like to even use the [Affordable Care Act] birth control mandate.”

As Congress considers proposals to include in the upcoming reconciliation bill — a $3.5 trillion social spending package that Sens. Kyrsten Sinema, D-Ariz., and Joe Manchin, D-W.Va., are threatening to derail — Democrats are weighing at least two measures that would expand Medicaid access in the 12 states that have refused. One pathway, led by Democratic Sens. Raphael Warnock and Jon Ossoff of Georgia and Tammy Baldwin of Wisconsin, would create a program that’s like Medicaid but administered by the federal government rather than by individual states. Their proposal would require the Centers for Medicare and Medicaid Services to offer coverage to those eligible in the 12 holdout states. Texas Democratic Rep. Lloyd Doggett also has a bill that would allow cities and counties to expand Medicaid in states that have refused. And some powerful lawmakers, including House Majority Whip Jim Clyburn, D-S.C., have cited Medicaid expansion as a top priority for inclusion.

Sen. Jon Ossoff, D-Ga., speaks on Medicaid expansion and the reconciliation package during a press conference with fellow lawmakers at the Capitol in Washington, D.C., on Sept. 23, 2021.

The cost for expansion so far is estimated at potentially $250 to $300 billion, but the price could shrink if legislators put an expiration date on their plans. Clyburn suggested last week that he would back a few years of Medicaid expansion, which he said could be harder to strip away once it’s in place.

Lawmakers are under pressure to reduce the cost of the reconciliation package — despite the fact that the $3.5 trillion price tag would be spread over 10 years and partially covered by raising taxes on the wealthy — and several health care priorities are competing for space. These include expanding Medicare, bolstering Obamacare subsidies, and ensuring access to in-home care for the elderly. A Washington Post report on Thursday made the chances for a permanent Medicaid expansion look less likely: Some advocates and Democratic senators expressed concern that it might reward recalcitrant GOP lawmakers, or even incentivize states that have expanded Medicaid to reverse course, potentially forcing the federal government to pick up the tab for states that had previously expanded Medicaid.

THERE ARE MORE than 2 million poor, uninsured adults in the so-called Medicaid gap. Of those, roughly 800,000 are women of reproductive age. Most people who fall into the gap are unlikely to afford insurance on the individual marketplace because they’re ineligible for premium subsidies, which help offset high monthly costs. And while the Affordable Care Act applies to most private insurance plans, according to the Guttmacher Institute, 13 percent of workers in 2019 were enrolled in “grandfathered” plans exempt from the ACA’s protections — including the mandate for contraception coverage.

In Washington, D.C., and 38 states that have expanded Medicaid since 2014, public health researchers found an immediate and large increase in insurance coverage for low-income women of reproductive age. Health and economics researchers also found that low-income women in expansion states were more likely to use effective birth control methods during their postpartum period than their counterparts in holdout states, and were more likely to use long-acting reversible contraception, considered among the best methods for preventing unwanted pregnancies. The proposed Medicaid expansion plans would increase access to birth control and reproductive services in the remaining 12 states.

On Tuesday, Planned Parenthood Federation of America issued new fact sheets detailing what Medicaid expansion would mean for each state that has until now resisted broadening coverage. In Alabama, for example, Planned Parenthood says 51,000 women of reproductive age would gain access to affordable health insurance, including more than 20,000 Black women. In Texas, more than 324,000 women of reproductive age would gain affordable health insurance and access to services, including 48,000 Black women and 1930,000 Latina women.

“I can’t tell you how many people I’ve seen who wanted birth control and were not able to get it,” said Marty. “The county health departments are booked two to three months in advance, so by the time they get there it’s too late; and then we have patients who do have private doctors, but the doctors are denying them the coverage.”

Jamila Taylor, the director of health care reform and a senior fellow at the Century Foundation, said expanding Medicaid could definitely help support women who fall into the coverage gap, who lack insurance or access to comprehensive maternal services. “We know this affects people not ready to be parents, and those who are ready to have children,” she said.

So if either the Ossoff-Warnock-Baldwin plan or the Doggett proposal passes, the changes could expand access to contraception for thousands of currently uninsured people. But would they allow Medicaid to cover solutions like medication abortion? Thanks to the Hyde Amendment — a prohibition on using federal funds to cover abortions outside of the exceptions of rape, incest, and endangerment to a woman’s life, which Congress has reauthorized every year since 1976 — the answer is still no.

There is legislation pending in the House and Senate, called the Equal Access to Abortion Coverage in Health Insurance Act of 2021, or EACH Act, that would overturn the Hyde Amendment — but like the Women’s Health Protection Act, it stands little chance of passage with the filibuster in place. On Wednesday, Manchin told the conservative National Review that he was open to considering Medicaid expansion as part of reconciliation — but only if the package includes the Hyde Amendment. States can, however, still opt to use their own Medicaid funding to cover abortions, and 16 primarily blue states already do.

As long as the Hyde Amendment remains in place, those living in regions at odds with reproductive health access will have to rely on more difficult and sometimes risky measures to terminate their pregnancies. If the amendment were repealed, Medicaid funds could potentially be used to prescribe medication abortion, offering an alternative in places where clinics are closed. But many hostile states have broadened their anti-abortion measures to cover mifepristone and misoprostol. Since April, lawmakers in Republican-led states, working closely with anti-abortion groups like the Susan B. Anthony List, have moved to pass even more restrictions on medication abortion.

Marty, who authored “Handbook for a Post-Roe America” in 2019, said for now people should consider obtaining medication abortion pills before they are pregnant, a process known as advanced provision. Some are are already doing this in Texas through Aid Access, an organization based in Europe that a Dutch doctor started in April 2018.

“At this point [activists] do not believe that someone who takes this step is under threat of a lawsuit because pregnant people are explicitly excluded from [SB8], but it could be a potential lawsuit if that person who ordered it gave it to someone else,” said Marty.

But shipping pills from Europe can result in delays. “Hypothetically, there might be people who try get ahold of medication abortion from one of these online retailers despite living in a different city,” said Marty, referring to U.S.-based telehealth organizations like Abortion on Demand. In those cases, which could also present legal risk, women might ask contacts they know living in more abortion-friendly states to obtain the medication and then quietly mail them the pills.

“As an author and activist, I firmly believe that all people need to be [ready] for when abortion is completely illegal and inaccessible,” said Marty. “It’s become clear to me that abortion will mostly disappear in red states.”