On March 1, the New York Times reported that over the following few weeks, some retail pharmacies owned by Walgreens and CVS will begin dispensing mifepristone, a key drug used in medication abortions.

It’s a big change: Before the pandemic, people could only obtain the drug in-person at the office or clinic of the health care provider who prescribed it. But in 2021, the Food and Drug Administration (FDA) removed that in-person dispensing requirement, opening the door to getting abortion medications through the mail — an important second option for people seeking an abortion. At the same time, the agency said it would create a pathway for retail pharmacies to get certified to dispense mifepristone, giving Americans a third way to access the drug.

In early 2023, less than a year after the US Supreme Court overturned the constitutional right to abortion, the FDA finalized changes to its rules that newly allowed brick-and-mortar pharmacies to dispense the drug. (Although the FDA can’t decide in which states abortion is legal or whether there’s a national right to abortion, it can and often does modify its rules that determine who can prescribe drugs used in having an abortion; who can dispense them; and what hoops prescribers, patients, and pharmacies have to jump through when they’re used.) Late last year, independent pharmacies began dispensing the drug, and last week’s news indicates national pharmacy chains are also getting on board.

This moment might feel like the culmination of something, but it’s really just the start, says Kirsten Moore, who directs the Expanding Medication Abortion Access Project. “We have finally reached the end of the beginning phase of expanding access,” she says.

In the short term, the move gives Americans another avenue for accessing a critical medication. But it will likely have even more important effects on improving abortion access in the long term, says Julia Kaye, an attorney with the American Civil Liberties Union who led the litigation culminating in the FDA’s 2021 loosening of mifepristone restrictions.

Before these changes were set into motion, health care workers had to “effectively act as both the prescriber and the pharmacist,” Kaye says. Now, however, prescribers will be able to either use a mail order pharmacy, or send a prescription to a local pharmacy for the patient to pick up — just as they would any other equally safe drug.

Anti-abortion activists have throttled mifepristone access from the start by burying it under piles of arbitrary restrictions

Mifepristone works by blocking the progesterone hormone. During pregnancy, progesterone helps keep the lining of the uterus intact; without it, a pregnancy cannot go on. In the context of an abortion, mifepristone is usually used in conjunction with misoprostol, a drug that relaxes the opening to the uterus and helps the uterus contract and empty itself. (Misoprostol can already be legally dispensed in drugstores.)

The FDA’s official labeling for mifepristone indicates it’s approved for inducing abortions and, in a different formulation, treating a hormonal condition called Cushing’s syndrome. But like many other drugs, mifepristone also has “off-label” uses. An important one: It can speed up miscarriages once they’ve already begun, which helps reduce the need for surgery in these cases.

When mifepristone was first FDA-approved for abortions in 2000, it had already been in use in France since 1988. (Notably, France enshrined abortion rights in its constitution this week.) Back then, there was already a fair amount of data suggesting the drug, in combination with a medication like misoprostol, effectively ended pregnancies in 95 percent of the people who took it for that purpose. Additionally, its side effects were mild, including nausea and vomiting, dizziness, weakness, abdominal pain, and headache.

Moore participated in the initial effort to get mifepristone FDA-approved for use in the US. “My boss at the time was like, ‘This is it — we finally turned the corner,’” she said. She thought the availability of medication abortion would mean people who wanted to end a pregnancy would be able to get a prescription from their primary care doctor or OB-GYN, pick up the medication from a pharmacy like any other medication, and take it in the comfort and safety of their own home. That meant more than just convenience — it meant people no longer had to subject themselves to the harassment and violence that has long plagued people working and seeking care at abortion clinics and that has worsened in the wake of the Supreme Court’s decision to overturn Roe v. Wade.

But because mifepristone made abortion simpler — and increased privacy and safety for people seeking one — anti-abortion activists saw mifepristone as a huge threat. Over the decades since the drug was approved, these activists, and the legislators and justices they lobby and fund, have responded by pushing for a web of regulation aimed at reducing mifepristone access in numerous ways. (In some cases, these restrictions were justified with ham-fisted research conducted by anti-abortion researchers who did not always disclose their conflicts of interest; some of this research is now being retracted by the journals that initially published it.)

Reams of data, however, have emerged proving mifepristone’s safety. In 2016, the FDA began loosening some of its restrictions on the drug, raising the gestational age at which it could be used for an abortion from seven to 10 weeks and allowing it to be prescribed by a broader range of health care providers. The changes that allow the drugs to be mailed and now dispensed by retail pharmacies followed in 2021 and 2023.

Anti-abortion activists have continued to push back: After the 2023 FDA rule change, 20 attorneys general from red states wrote a letter to CVS and Walgreens threatening legal action if the chains sold mifepristone by mail, and a Texas judge suspended the FDA’s approval of the drug. That latter decision has been appealed, and the US Supreme Court is expected to hear the case on March 26.

“They’re trying to put the genie back in the bottle and they know they can’t,” says Moore.

The biggest impact of this change may be to increase the number of mifepristone prescribers

The short-term impact of this change will be limited to a few states. Initially, Walgreens will make it available only at a few of its pharmacies in a handful of states where abortion is still legal — New York, Pennsylvania, Massachusetts, California, and Illinois — and CVS will dispense the drug only at its pharmacies in Massachusetts and Rhode Island.

In states where abortion is illegal, retail pharmacies will still be unable to dispense mifepristone to patients if it’s prescribed to induce an abortion. However, they have been and will continue to be able to dispense the drug for other, off-label uses: Most importantly, patients in these states who are prescribed mifepristone to prevent complications of a miscarriage should still be able to get the drug in retail pharmacies. GenBioPro, the company that produces a generic version of mifepristone, maintains a list of independent pharmacies that stock the drug.

It’s not yet clear how much demand there will be for the drug at retail pharmacies, nor how patients can identify which Walgreens outlets can dispense it for use in an abortion. For now, Moore recommends that people considering an abortion visit I Need an A or Abortion Finder to identify prescribers.

People who favor online ordering might not immediately grasp why a retail pharmacy pick-up may be more convenient than receiving the drug in your mailbox. “Obtaining mifepristone by mail is not a realistic option for some patients,” said Kaye, including unhoused or unstably housed people without permanent mailing addresses, or people who aren’t able to confidentially receive mail at home because they live with a controlling or abusive partner (or just have a nosy family). A pharmacy pickup also makes it possible to take the drug the same day it’s prescribed, rather than wait a few days for it to show up in the mail.

The bigger impact of this change will likely be to increase the number of mifepristone prescribers. Under the old rule, the health care provider “had to be both doctor and pharmacist — meaning they had to pre-purchase the medication and stock it in their clinic in order to hand it over to a patient,” says Moore. Now, although prescribers will still have to get certified to prescribe mifepristone, they won’t also have to deal with everything that dispensing it entails.

That would open the door to many more health care providers — including OB-GYNs and, in many states, primary care providers and other generalists who comfortably prescribe other reproductive health medications like birth control — to provide a fuller spectrum of women’s health care.

Kaye says it’s important for people who favor increased abortion access to give positive feedback to the pharmacies that are helping to do that. “Folks who are opposed to abortion do not stay quiet about their feelings on increased access, and so those of us who believe that patients should have access to all critical medications they need for reproductive health care should make our voices heard,” she says.

Moore also suggests that people who favor increasing abortion access ask their own health care providers to become certified mifepristone prescribers — and, in turn, to ask the pharmacies where they send prescriptions to dispense mifepristone.

Although barriers to mifepristone access remain in many settings, these chains’ decision to expand mifepristone dispensing is “still a really BFD” — a big fucking deal — says Moore. Whatever the caveats, she says, it means major industry players “are saying, ‘We do in fact, think this drug should be treated like other FDA-approved medications. And we’re ready to do that.’”

QOSHE - Abortion meds can now be sold in drugstores. Here’s why that’s so important. - Keren Landman, Md
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Abortion meds can now be sold in drugstores. Here’s why that’s so important.

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05.03.2024

On March 1, the New York Times reported that over the following few weeks, some retail pharmacies owned by Walgreens and CVS will begin dispensing mifepristone, a key drug used in medication abortions.

It’s a big change: Before the pandemic, people could only obtain the drug in-person at the office or clinic of the health care provider who prescribed it. But in 2021, the Food and Drug Administration (FDA) removed that in-person dispensing requirement, opening the door to getting abortion medications through the mail — an important second option for people seeking an abortion. At the same time, the agency said it would create a pathway for retail pharmacies to get certified to dispense mifepristone, giving Americans a third way to access the drug.

In early 2023, less than a year after the US Supreme Court overturned the constitutional right to abortion, the FDA finalized changes to its rules that newly allowed brick-and-mortar pharmacies to dispense the drug. (Although the FDA can’t decide in which states abortion is legal or whether there’s a national right to abortion, it can and often does modify its rules that determine who can prescribe drugs used in having an abortion; who can dispense them; and what hoops prescribers, patients, and pharmacies have to jump through when they’re used.) Late last year, independent pharmacies began dispensing the drug, and last week’s news indicates national pharmacy chains are also getting on board.

This moment might feel like the culmination of something, but it’s really just the start, says Kirsten Moore, who directs the Expanding Medication Abortion Access Project. “We have finally reached the end of the beginning phase of expanding access,” she says.

In the short term, the move gives Americans another avenue for accessing a critical medication. But it will likely have even more important effects on improving abortion access in the long term, says Julia Kaye, an attorney with the American Civil Liberties Union who led the litigation culminating in the FDA’s 2021 loosening of mifepristone restrictions.

Before these changes were set into motion, health care workers had to “effectively act as both the prescriber and the pharmacist,” Kaye says. Now, however, prescribers will be able to either use a mail order pharmacy, or send a prescription to a local pharmacy for the patient to pick up — just as they would any other equally safe drug.

Anti-abortion activists have throttled mifepristone........

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