Abortion pills in pharmacies may encounter legal quagmires

wASHINGTON – Federal regulators’ green light for pharmacists to distribute abortion pills is hitting legal issues and igniting court battles.

Food and Drug Administration earlier this month Remove a long entry That only doctors can prescribe mifepristone, which is approved for abortions up to 10 weeks. The move opens the door for pharmacists to supply medication and protection support for mail orders, which have become an important channel for abortion access in the wake of Rowe’s coup last summer.

But it also puts the abortion pill in a legal gray area in 12 of the most restrictive states in the country, where the procedure is prohibited from pregnancy up to six weeks. In two other states, Montana and Wisconsin, there are no clinics that currently offer abortion, according to the abortion rights group. Guttmacher Institute. Eighteen states require a doctor to be present when someone takes a pill, effectively banning mail-order mifepristone, though the Biden administration has pushed against those limits by The latest opinion of the Ministry of Justice.

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In those particularly restrictive cases, it’s not entirely clear whether state laws can effectively prevent people from accessing an FDA-approved drug. State governments have sometimes added extra warning labels to medications or limited dose amounts — mainly for pain medications like opioids — but putting a complete end to access is unprecedented territory.

While it is generally assumed that FDA authority wins out – as it did in a 2014 District Court Case On Massachusetts’ attempt to ban an opioid – it will take a lawsuit to put the mifepristone argument to the test.

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“Right now, states assume they have the power to do whatever they want about abortion,” said Greer Donnelly, a University of Pittsburgh bioethicist who studies abortion law. “It will make absolutely no difference to how states act unless the court actually issues a ruling.”

Abortion advocates say pharmacists and doctors, who operate under state licenses, are unlikely to take this step. That leaves reproductive rights groups, and the makers of mifepristone (one of them, GenBioPro, have filed a lawsuit before) – and possibly the federal government.

In response to a question about the possibility of filing a lawsuit, White House spokesman Kevin Munoz said that litigation decisions are made by the Department of Justice, “But in general, Mifepristone is a drug that has been approved and used safely and effectively for two decades in the United States, and it is used in more than 60 countries.

Meanwhile, Kristen Moore, director of the pro-abortion advocacy group Expanding Medication Abortion Access, told STAT, “In the meantime, it’s going to be a huge mess.” “We have to fight hard to keep it [the] The Food and Drug Administration and its authority to approve drugs and make sure people get FDA-approved drugs.”

Moore joined Biden’s health secretary Xavier Becerra in a briefing Wednesday on wider access to abortion drugs that touched on legal issues related to the new order to make mifepristone available in pharmacies.

“Our mothers and grandmothers are fighting again to roll the 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 they are not alone,” the minister said. “The President and Vice President have taken a comprehensive, pragmatic approach to protecting and expanding access to care. reproductive health that includes abortion care for all.

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

Major pharmacy chains including Walgreens and CVS have indicated that they plan to register pharmacies to dispense the drug but have not provided details on how to navigate federal policy and state laws.

Walgreens is evaluating which pharmacies to register” and will make the distribution [mifepristone] in compliance with federal and state laws,” a company spokesperson said in an email.

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

Because of haze over whether states can restrict access to a federally approved drug, some doctors and reproductive rights groups argue that updating the FDA isn’t enough to secure care for the millions of people living in states that have blanket abortion bans.

“While it’s surprising that these things are happening through the FDA, the reality remains that in many parts of the country, state laws [are] “It still stands in the way of patients’ access to safe, accessible abortion care,” said Smita Carroll, MD, a New Mexico-based ob-gyn and fellow at Physicians for Reproductive Health. “It’s a great step, but it’s not enough.”

President Biden and top health officials vowed in the wake of Roe’s coup to boost access to mifepristone, which was approved by the Food and Drug Administration in 2000 for termination of pregnancy up to seven weeks gestation and in 2016 extended to 10 weeks of gestation. More than half of all abortions in the United States are performed with mifepristone and the vast majority of abortions occur before 13 weeks of gestation, according to the Federal data.

Many of the administration’s actions to protect reproductive rights came from the Food and Drug Administration, which in 2021 removed a requirement that patients go to their doctors’ offices to get their mifepristone prescription. The agency also in late December Label changed on emergency contraception known as Plan B, to make it clear that it is not an abortion medication amid calls by some anti-abortion advocates to limit access to the over-the-counter pill.

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

said Rona Hauser, senior vice president of policy and pharmacology.

While no lawsuit has yet been filed over the FDA’s update, 20 Republican attorneys general criticized the decision in court. message to the agency last week.

Led by Alabama Attorney General Steve Marshall, they wrote: “The FDA’s decision to abandon common-sense restrictions on the remote prescribing and administration of abortion-inducing drugs is illegal and dangerous.”

The broader question of state versus FDA authority is likely to go to the US Supreme Court, said Mark Shinson, a partner at law firm Alston & Beard and a former FDA commissioner. “Traditionally, FDA approval preempts state hurdles,” he said, noting that while legal battles can help clarify the problem, federal authority must stand up. “The only way to challenge this would not be on the basis of the agency’s jurisdiction but on the basis of whether the agency was arbitrary and capricious.”

Basically: Discuss that the Food and Drug Administration has ignored or didn’t have enough data about potential risks.

An anti-abortion coalition called the Freedom Defense Alliance has already made the case in a lawsuit filed last November that says the pill should be taken off the market entirely. The case is before Texas Conservative Judge Matthew J.

“States are entitled to restrict chemical abortion drugs in a more protective manner than the FDA-approved regime, especially given the country’s strong interest in protecting its citizens from the harmful effects of dangerous drugs,” said coalition spokesperson Hayden Sledge, who was asked about the subject. The latest update of the Food and Drug Administration.

In nearly two decades, 20 people have died after using mifepristone, many from sepsis — in the extremely rare cases when a pregnancy is not completely removed from the uterus after taking the drug — and others from unrelated homicide and drug overdose, according to analysis From the FDA negative reporting data. There have been more than 2,000 reports of serious side effects, many of them related to ectopic pregnancies that required surgery. The report’s authors, including Kathy Aultmann of the Lozier Anti-Abortion Institute, recommended that an ultrasound be performed to rule out ectopic pregnancies before dispensing the drug. The rates of serious side effects or death with mifepristone are relatively lower than with other FDA-approved medications. For example, the agency received 522 deaths associated with Viagra at 13 months after approval.

Faced with some legal challenges, the White House is relying on mail-order protection to keep channels of mifepristone open. On the same day that the FDA announced the pharmacy update, the Department of Justice issued an opinion stating that Mifepristone has been removed of a 19th-century law restricting mail-order abortion services, arguing that it was federally approved for medical purposes.

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

Even in states where pharmacists are willing to supply pills, doing so can run risks that many are unwilling to take. Doctors and clinics that perform abortions regularly deal with protesters who may similarly threaten pharmacies stocking mifepristone or customers filling prescriptions. Mail-order pharmacies have safeguards in place to keep patient information confidential, but traditional stores do Including major chains like Walgreens You may need to put similar safeguards in place.

For people from abortion-restricting states who travel to other states to see doctors and get prescriptions and care, the insurance company may also deny out-of-state coverage, said Jessica Lee, MD, an OB-GYN and professor at the University of Maryland. their medical school.

“These are tough decisions for them, one has to make, but then they have to travel and spend hundreds [or] thousands [of] said Lee, who, like Carroll in New Mexico, has seen a surge in patients from states that limit abortion since last summer. “I worry almost more about who I don’t see because by and large, all of these patients who come to us from out of state are wealthy and not people of color.”

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