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.”

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

Originally published in Vox on June 22, 2022
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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.
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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.”