The FDA Just Lifted A Major Restriction On Abortion Pills. Here’s What You Need To Know
The FDA has permanently lifted a restriction on the mailing of abortion pills. Here’s what that means for the changing rules on abortion access.
It’s been nearly 50 years since the Supreme Court’s Roe v. Wade decision confirmed that people who are pregnant have a constitutional right to choose abortion — and for just as many years, opponents have been trying to chip away at that right with legal challenges and restrictions.
Those legal challenges and restrictions are throwing more intense scrutiny on mifepristone and misoprostol, the two-drug combination that can be used for a medical abortion.
“Abortion pills,” which can be prescribed in a telehealth visit and sent via mail under certain circumstances, are an important alternative to a surgical abortion, particularly for people in states without abortion clinic access.
This Thursday, the FDA permanently relaxed a restriction on mailing abortion pills to patients. This news comes as anti-abortion groups are mounting several legal challenges to how people access these drugs,
About 1 in 4 women have an abortion by age 45, according to the American College of Obstetricians and Gynecologists (ACOG). About 40% do so with medications rather than surgery in a clinic, as do 60% who have an abortion before 10 weeks gestation. The medications are a safe and effective way to get an abortion.
Note that we didn’t say easy — the rules about medication abortions have been strict since mifepristone was first approved more than 20 years ago. They are governed by something called REMS, which stands for risk evaluation and mitigation strategy. That's a safety plan put in place by the FDA that traditionally meant that only certain providers, usually at abortion clinics or hospitals, could give the medication, and then only in person.
In 2020, due to the pandemic and a lawsuit filed by medical groups including ACOG, the government relaxed the REMS restrictions so people could get abortion medication via mail after a telemedicine appointment with a certified provider. Now, the FDA has relaxed that restriction permanently, which means abortion medication can be mailed to patients in states that allow it.
More than 60 drugs have REMS, but experts say that mifepristone is on the list for largely political reasons, not medical ones.
“We have decades of evidence supporting that mifepristone is safe and that these additional restrictions are not necessary and are not based in science,” said Nisha Verma, the Darney-Landy Fellow with ACOG.
“ACOG very strongly supports permanently lifting these regulations completely,” said Verma, and the group has submitted letters to the FDA with data and evidence to support that.
Now that medication abortions will be permanently available via mail and telemedicine in most states, here’s what you need to know about them, and how access may be changing.
What exactly is a medication abortion?
A medication abortion is a combination of mifepristone and misoprostol. Mifepristone (the brand name is Mifeprex) blocks the hormone progesterone, which a pregnancy needs to continue. Misoprostol then causes the uterus to contract and expel the pregnancy.
Mifepristone was approved by the FDA in 2000, after years of intense debate and controversy about the drug, which used to be called RU-486. Mifepristone is sometimes used off-label (or not for an FDA-approved use) to treat fibroids, endometriosis, brain tumors, and other types of cancer.
First approved in 1988, misoprostol is also used to treat miscarriages and stomach ulcers, as well as sometimes used to induce labor and reduce bleeding after childbirth.
How do you take abortion pills?
Basically you take one pill of mifepristone, followed by misoprostol 24 to 48 hours later.
Healthcare providers may also prescribe antibiotics and anti-nausea medication at the same time to deal with any side effects.
The FDA has approved mifepristone and misoprostol to induce an abortion if used within the first 70 days since the first day of your last period, or within the first 10 weeks of pregnancy.
Verma said they are sometimes used up to 11 weeks by providers because research suggests it's still safe and effective.
The REMS restrictions on medical abortions made it more difficult for people to meet that window of efficacy, she said. In Georgia, half of all women live in one of the 96% of counties that don’t have an abortion clinic or provider who can dispense the pills, Verma said.
That means that before the pandemic, many people had to travel a long distance, find transportation and childcare, and take time off from work to access the pills, even though “we know we could just as easily and safely and effectively mail it to them,” she said.
Lifting the restrictions made it easier to see patients by telehealth and mail the medications.
Are abortion medications available in every state?
No. Verma noted that even with the FDA relaxing its restriction, not all states will allow the medication to be mailed.
States can pass state laws that still restrict the use of mifepristone, which would supersede the FDA lifting the restriction on mailing the medication. “That definitely is a concern,” she said. “Some states already have laws on the books that prevent mailing out mifepristone or prevent telehealth for an abortion.”
Already, 19 states require people to be physically present to get a medication abortion, which effectively bans the acquisition of the medication via telemedicine and mail.
Who shouldn’t have a medication abortion?
If you have an IUD, it must be removed before taking mifepristone. There are some people who shouldn't take the medication, which includes those with an ectopic pregnancy, bleeding problems, who are taking blood-thinners, or who have an allergy to the drugs.
The drug is also not recommended if you are currently on long-term corticosteroids, which are anti-inflammatories; have problems with your adrenal glands; or have inherited porphyria, a group of conditions that lead to a buildup of chemicals in the body related to red blood cell proteins.
What are the side effects?
The side effects of the procedure include cramping and bleeding, much like a miscarriage.
The bleeding may be heavier than a period and you can pass large blood clots; you can also have nausea, diarrhea, and fever or chills.
Is a medication abortion safe?
Yes. Medical abortions are “very, very safe,” said Verma. “Part of what’s so frustrating about these additional regulations on mifepristone is that they feel very much based in politics and not on the science and evidence.”
There are other medications with similar safety profiles that aren’t regulated in this way, she said. A study published in December in the New England Journal of Medicine appears to underscore the drugs’ safety.
Laura Schummers, a postdoctoral fellow in the family practice department at the University of British Columbia in Vancouver, and colleagues looked at abortions in Canada before mifepristone was available and after similar mifepristone restrictions were lifted in November 2017.
Canada was the first to remove restrictions and treat the drug like any other medication. That means any doctor or nurse practitioner can prescribe it, and it can be dispensed by any pharmacy and taken at home, Schummers said.
In the United States, there still are additional restrictions that have not been lifted — for example, the medications cannot be prescribed by just any doctor — only people who have special certification can provide it. You still can’t fill a prescription for the medication at all retail pharmacies (ones that dispense the drug need to be certified), and additional consent forms may be required of both providers and patients.
In Canada, the researchers found that abortion safety did not change after all the restrictions were lifted, according to the study.
“So that means that abortion was safe to begin with, with really infrequent adverse events or complications, and remains safe after this big regulatory shift,” said Schummers.
How can you access these medications?
To find out more details, Planned Parenthood offers information on where you can get abortion pills.