Abortion pills in pharmacies could face legal quagmire

WASHINGTON — A green light from federal regulators for pharmacists to dispense abortion pills is colliding with legal issues and simmering court battles.

The Food and Drug Administration (FDA) earlier this month removed a long-standing restriction that only doctors could dispense mifepristone, which is approved for abortions up to 10 weeks. The move opens the door for pharmacists to dispense the drugs and strengthens protections for mail-order orders, which have become an important channel for abortion access after Roe’s overturn last summer.

But it also puts abortion pills in a legal gray area in 12 of the country’s most restrictive states, where the procedure is prohibited from conception to six weeks. In two other states, Montana and Wisconsin, there are currently no clinics offering abortion services, according to abortion rights group the Guttmacher Institute. Eighteen states require a doctor to be present when someone takes the pill, effectively banning mifepristone from mail-order sales, though the Biden administration exceeded those limits with a recent Justice Department opinion.

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In those particularly restrictive states, it’s not entirely clear whether state laws can effectively prevent people from accessing an FDA-approved drug. State governments have sometimes added additional warning labels to drugs or limited dosage amounts, primarily for pain relievers like opioids, but limiting access entirely is unprecedented territory.

While the FDA’s authority is generally assumed to win, as it did in a 2014 district court case over Massachusetts’ attempt to ban an opioid, it will take a lawsuit to test the mifepristone argument. .

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“Right now, states are assuming they have the power to do whatever they want about abortion,” said Greer Donley, a bioethicist at the University of Pittsburgh who studies abortion law. “It’s not really going to make any difference to how states act unless a court makes a ruling.”

Pharmacists and doctors, who operate under state licenses, are unlikely to take such a step, say abortion advocates. That leaves reproductive rights groups, the makers of mifepristone (one of which, GenBioPro, has previously sued), and possibly the federal government.

When asked about the possibility of a lawsuit, White House spokesman Kevin Munoz said that litigation decisions are made by the Department of Justice, “however, generally speaking, mifepristone is a drug that has been approved and used safely and effectively for two decades in the US, and is used in more than 60 countries.”

In the meantime, “it’s going to be a disaster,” Kirsten Moore, director of the pro-abortion advocacy group Expanding Medication Abortion Access, told STAT. “We are going to have to fight very hard to preserve [the] FDA and its authority to approve drugs and ensure that people have access to FDA-approved drugs.”

Moore joined Biden’s health secretary, Xavier Becerra, at a briefing Wednesday on access to abortion drugs more broadly that addressed legal issues surrounding the new decision on the availability of mifepristone in pharmacies. .

“Our mothers and grandmothers fight once again to roll that rock of equality up the hill, and now it’s up to our daughters to help roll that rock with them. The good news is that they are not alone,” said the secretary. “The President and Vice President have taken a hands-on approach to protect and expand access to reproductive care, including abortion care, for all.”

Becerra left the call before reporters could ask questions. The FDA did not respond to questions about legal jurisdiction prior to the publication of this article.

Major drugstore chains, including Walgreens and CVS, have indicated they plan to register pharmacies to dispense the drug, but have not provided details on how they will navigate the conflict between federal policy and state law.

Walgreens is evaluating which pharmacies to register “and will waive [mifepristone] in accordance with federal and state laws,” a spokesperson said in an email.

Similarly, a CVS spokesperson said the chain plans to register pharmacists “where legally permitted.”

With confusion over whether states can restrict access to a federally approved drug, some doctors and reproductive rights groups argue that the FDA’s update isn’t enough to ensure care for millions of people living in states. who have instituted sweeping abortion bans.

“While it is amazing that this has happened through the FDA, the reality remains that in many parts of the country, state laws [are] it will continue to be a direct barrier to patients accessing safe and affordable abortion care,” said Smita Carroll, an OB/GYN in New Mexico and a member of Physicians for Reproductive Health. “It’s a big step, but it’s not enough.”

President Biden and top health officials pledged in the wake of Roe’s overturn to bolster access to mifepristone, which the FDA approved in 2000 for discontinuation up to seven weeks of pregnancy and was extended to 10 weeks in 2016. . More than half of abortions in the US are performed with mifepristone, and the vast majority of abortions occur before 13 weeks of pregnancy, according to federal data.

Many of the administration’s actions to protect reproductive rights stem from the FDA, which in 2021 removed the requirement for patients to go to their doctors’ offices to fill their mifepristone prescription. The agency also changed the label of emergency contraception known as Plan B in late December, clarifying that it is not an abortion medication amid calls from some anti-abortion advocates to limit access to over-the-counter pills.

But doctors who perform abortions or prescribe mifepristone worry that the mosaic of national access will only persist. Pharmacist groups like the National Association of Community Pharmacists have advised their members to follow state law.

“It’s really going to be a state-by-state issue that our members need to be aware of, like in the licensing rules for the state they’re in,” said Ronna Hauser, senior vice president of pharmacy policy and affairs.

While no litigation has yet been filed over the FDA update, 20 Republican attorneys general criticized the decision in a letter to the agency last week.

“The Food and Drug Administration’s decision to abandon common-sense restrictions on the prescription and remote administration of abortion-inducing medications is illegal and dangerous,” they wrote, led by Alabama Attorney General Steve Marshall.

The broader question of status versus FDA authority would likely go to the US Supreme Court, said Marc Scheineson, a partner at the Alston & Bird law firm and a former FDA deputy commissioner. “Traditionally, FDA approval would bypass state hurdles,” he said, noting that while legal battles could help clear up the issue, federal authority should remain. “The only way to challenge this would not be based on the jurisdiction of the agency, but on whether the agency is being arbitrary and capricious.”

Essentially: arguing that the FDA ignored or did not have enough data on the potential risks.

An anti-abortion coalition called the Alliance for Defending Freedom is already making that case in a lawsuit filed last November that argues the pills should be taken off the market altogether. The case is before conservative Texas Judge Matthew J. Kacsmaryk, who could rule in favor of ADF, effectively removing mifepristone from the market pending appeal.

“States have the right to restrict chemical abortion drugs in a way that is more protective than the FDA-approved regimen, especially given the state’s strong interest in protecting its citizens from the harmful effects of dangerous drugs,” Hayden said. Sledge, a spokesman for the Alliance, asked about the recent FDA update.

Based on an analysis of FDA Adverse Reporting Data. There were more than 2,000 reports of serious side effects, many of them related to ectopic pregnancies requiring surgery. The report’s authors, who include Kathi Aultman of the Lozier Anti-Abortion Institute, recommended an ultrasound to rule out ectopic pregnancies before dispensing the drug. The rates of serious side effects or death with mifepristone are comparatively much lower than with other FDA-approved drugs. For example, the agency received 522 reports of Viagra-related deaths in the 13 months after its approval.

Faced with certain legal challenges, the White House is relying on mail-order protections to keep mifepristone channels open. The same day the FDA announced the pharmacy update, the Justice Department issued an opinion that removed mifepristone from a 19th-century law restricting abortion-by-mail services, arguing that it is approved by the federal government for medical purposes. .

“There are legal uses for mifepristone in literally all 50 states,” Jen Klein, director of the White House Council on Gender Policy, told STAT at the time. “If you live in a state that even has a six-week ban, using mifepristone at five weeks, five days is legal use.”

Even in states where pharmacists are licensed to dispense the pills, doing so could create risks that many are unwilling to take. Doctors and abortion clinics regularly grapple with protesters who could similarly threaten pharmacies that stock mifepristone or customers filling prescriptions. Mail-order pharmacies have protections to keep patient information confidential, but brick-and-mortar stores, including major chains like Walgreens, may need to put in place similar protections.

For people from abortion-restricting states who travel to other states to see doctors, get prescriptions and care, their insurer may also deny out-of-state coverage, said Jessica Lee, an obstetrician-gynecologist at the University of Maryland and a professor at her School of Medicine.

“These are tough decisions for them, one, they have to make, but then they have to travel and spend hundreds [or] Thousands [of] dollars of their money to try to figure it out,” said Lee, who, like Carroll in New Mexico, has seen a surge in patients from abortion-limiting states since last summer. “It almost worries me more who I’m not seeing because, overwhelmingly, all of these patients that come to us from out of state are wealthy and not people of color.”