“There is no medical justification for the FDA’s restrictions."
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If you want to get Viagra in the United States, the process is pretty straightforward. You go to your regular doctor, she calls in a prescription to your local pharmacy, and you pick it up when it's ready. With a few exceptions, this is how it works for most prescription medications.
But if you want the abortion pill, it's a completely different story. For starters, you can't get it at any pharmacy. Your regular doctor might be able to prescribe and dispense it to you, but you probably won't be that lucky. You might be so unlucky that the nearest doctor who can actually prescribe you the medication is 150 miles away, which means you'll spend hours on the road and possibly stay overnight. And if you're really unlucky you might live in Hawaii, where those 150 miles include an ocean.
This last scenario is all too familiar for Graham Chelius, a family medicine doctor in Kauai, Hawaii. Kauai has no abortion clinics, and Chelius says he wants to be able to prescribe medication abortion so his patients don't have to waste precious time and money booking a flight to the next island with a clinic.
But his hands are tied due to restrictions the Food and Drug Administration has placed on mifepristone, also known as RU-486, a drug that induces miscarriage in pregnancies up to 10 weeks along when taken with the drug misoprostol. Patients can't get the medication from a retail pharmacy; they can only get it from a clinic, medical office, or hospital. Not only that, but the medical facility dispensing mifepristone has to register with the drug manufacturer in advance, and agree to order and stock the medication on-site.
These are major administrative burdens that many medical facilities just don't want to bother with—and being added to a list of abortion providers can cause political headaches and fears of anti-abortion harassment. In Chelius's case, he is unable to stock the medication because of his colleagues's opposition to abortion.
So Chelius is suing the FDA, with the help of the American Civil Liberties Union, to try to force the agency to lift the restrictions and allow mifepristone to be distributed at pharmacies. If the lawsuit succeeds, it could dramatically transform early abortion access in the United States.
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"The FDA restrictions defy common sense," says Julia Kaye, a staff attorney at the ACLU's Reproductive Freedom Project. "There is simply no safety benefit to a pill handed out at a clinic rather than handed out at a pharmacy."
The FDA placed an unusually strict set of regulations, known as a Risk Evaluation and Mitigation Strategy (REMS), on mifepristone when the agency first approved the drug for sale in the US in 2000. But since then, medication abortion has come to make up about a third of all abortions in the US. The FDA itself said in 2016 that "serious complications have proven to be extremely rare" for patients using mifepristone. Yet the FDA hasn't loosened the REMS restrictions at all, even though REMS is only supposed to be used for drugs with especially risky side effects.
"Medication abortion is extremely safe and there is no medical justification for the FDA's restrictions on where this medication can be administered," Hal Lawrence, CEO of the American Congress of Obstetricians and Gynecologists, said in an emailed statement supporting the lawsuit.
Some REMS restrictions make sense, says Daniel Grossman, director of Advancing New Standards in Reproductive Health (ANSIRH) and professor of obstetrics, gynecology, and reproductive sciences at University of California San Francisco. For instance, the schizophrenia drug clozapine tends to lower a patient's white blood cell count, so pharmacists have to check to make sure the patient has had a recent blood count before dispensing the medication. But the risks and side effects of medication abortion aren't even close to that severe, Grossman says—and clozapine is still available in pharmacies, while mifepristone isn't.
Mifepristone is also much safer than many common, widely available drugs that have no REMS restrictions at all, per a February paper in the New England Journal of Medicine. The risk of death is four times higher for Viagra than for mifepristone, and common anticoagulant drugs carry a much higher risk of serious bleeding. Medication abortion doesn't carry any more risks of serious complications than surgical abortion does, and both options are 14 times less lethal than childbirth, the authors conclude.
"You might be able to argue this extra layer of regulatory scrutiny made sense back in 2000 when the drug was first approved, but it certainly doesn't now, after 17 years of experience with the medication showing how safe it is," says Grossman, a co-author of the NEJM paper. "It seems very clear that this drug is being singled out in some way that doesn't make sense."
The one way it does make sense is in the context of how women's health is stigmatized and restricted in America. Even during the Obama administration, women's health advocates had to fight the FDA to make emergency contraception like Plan B (which doesn't cause abortion) available over the counter. And when anti-abortion Republicans swept state legislatures in 2010, they started passing an avalanche of abortion restrictions that forced many abortion clinics to close, often citing the erroneous idea that abortion is generally dangerous. (Whether or not lawmakers believed this to be true, it turned out to be a very efficient strategy for closing abortion clinics for no good medical reason.)
Many states now have their own restrictions on medication abortion. Thirty-four states make it harder for women to get a prescription by requiring them to get it from a doctor rather than a nurse practitioner, certified nurse midwife, or physician's assistant. The World Health Organization says this makes no difference in patient outcomes—but it does limit a woman's options, and strains the schedules of those few doctors who are willing and able to provide medication abortion.
There's also no difference in outcomes between patients who are prescribed abortion pills in person and those who talk to a doctor via video conference, aka telemedicine—an important option for women living in rural or medically underserved areas. Yet 19 states ban prescribing abortion pills, but not other medications, using telemedicine.
Access to medication abortion is so severely limited in some areas that some women turn to ordering the pills online without a prescription. Luckily, a new study found that pills ordered from 20 sites would still be effective—but none of them came with instructions. If the FDA wants women following best medical practice in taking abortion medication, restricting its distribution so harshly that women turn to unofficial channels isn't the best strategy.
When a landmark Supreme Court ruling struck down two major anti-abortion laws in Texas last year, it declared that lawmakers can't burden a woman's access to abortion with "health" regulations that don't actually improve women's health. It's a powerful precedent that will likely bolster the ACLU's case, and those of other women's health advocates who are taking proactive steps to knock down abortion restrictions.
But these fights will take time. Meanwhile, America still has an abortion access crisis, where regulations mean more women face longer wait times, greater expense and hassle, later and riskier procedures, and sometimes not being able to get an abortion at all.
This crisis has inspired some bold experimentation, like a limited trial of mail-order abortion pills in Hawaii. And some states will still be able to tightly restrict the abortion pill no matter what the FDA does. But few things would open up access to medication abortion more effectively than repealing the FDA's restrictions on mifepristone and allowing women to get it from a pharmacy.
Correction 10/13/17: This post has been updated to reflect that Chelius is unable to stock mifepristone at his office because some of his colleagues are opposed to abortion and stocking and dispensing the medication would create internal conflict, not because his colleagues didn't want their facility added to a list of abortion providers, as originally stated.
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