The FDA Didn’t Liberate Abortion—but We Still Can

The FDA Didn’t Liberate Abortion—but We Still Can

The FDA Didn’t Liberate Abortion—but We Still Can

The Food and Drug Administration’s decision to lift restrictions on mifepristone is good news for people in states that allow telemedicine abortion, but means nothing for everyone else. 

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The abortion liberation movement received some much needed good news Thursday: The Food and Drug Administration announced that it would modify its outdated and medically unnecessary restrictions on mifepristone, the first of two pills used in a medication abortion, lifting the requirement to obtain the drug in person. (Under previous guidelines, providers had to distribute the medication in person, while the second medication, misoprostol, is taken up to two days later outside of the clinic setting.) Getting rid of in-person dispensing is good because it allows for the expansion of telehealth medication abortion, and it expands the pool of clinicians who want to provide medication abortion. And in this moment, the lifting of any barrier to abortion care is a welcome reprieve from the current crisis. However, the truth is that the people who need access to abortions the most may never reap the benefits of this decision.

For over 20 years, the FDA has placed a Risk Evaluation and Mitigation Strategy, or REMS, restriction on mifepristone, blocking it from being dispensed in a pharmacy or mailed to one’s home, meaning that patients had to physically go to a clinic to receive the medication from a provider. REMS are placed on medications that the FDA believes could be dangerous if not regulated in some way. One example is clozapine, an antipsychotic medication that has a REMS requiring prescribers and pharmacists to check patients to make sure their white blood cell count is normal, since the drug can cause a dangerous reduction in these cells.

In mifepristone’s case, it has a stellar safety record; it’s safer than Tylenol or Viagra, yet neither has a similar restriction. As a result of the REMS, clinicians must stock the medication in their offices and dispense it directly to patients. A recent survey of practicing ob-gyns found that this is a significant barrier to providing medication abortion.

This in-person requirement became especially untenable as clinics were shuttered during the pandemic and stay-at-home orders limited access to in-person visits. But even before the pandemic, the requirement has been logistically impossible in some places: One doctor in Hawai’i sued in 2017 because his patients would have to travel to a different island just to receive the pills.

When the FDA announced in May that it would review the mifepristone REMS, we were hopeful the agency would follow the science, which clearly shows that medication abortion with pills dispensed by pharmacists and by mail is safe and effective. The FDA started down this path with a temporary suspension in April, allowing the mailing of medication abortion pills from a clinic or using a mail-order pharmacy. But the suspension was available only in states that allowed telehealth for abortion care. Brick-and-mortar pharmacies were excluded from the FDA’s temporary suspension of the REMS, even though local pharmacies may be the most timely way to get abortion pills to patients, who are quite literally racing the clock, particularly in states with extreme abortion bans.

But the FDA did not fully repeal the REMS with its decision on Thursday. Instead, it left in place several meaningless certification components for providers and pharmacies, and maintained duplicative patient agreements that the FDA division staff previously recommended removing—all of which serves no purpose other than to appease legislators who are unwilling to do all that it takes to liberate abortion as reproductive freedom is under direct attack at the Supreme Court.

While the removal of the in-person requirement is critical for many in states that are not regulating medication abortion out of existence, it’s just another bittersweet moment for those in conservative gerrymandered states with politicians hell-bent on banning abortion as soon as the Supreme Court gives them the go-ahead. The FDA’s decision, for example, is rather meaningless in Texas, which banned medication abortion after seven weeks’ gestation earlier this month, on top of the currently in-effect SB8, which allows the nosy person behind you in the pharmacy line to sue your friend or the pharmacist if they suspect you’re terminating a pregnancy after six weeks.

In 19 states—including Alabama, Mississippi, and South Dakota—legislators have banned telemedicine specifically for abortion care. Research clearly demonstrates that nurse practitioners and midwives can provide medication abortion, yet 32 states restrict their practice. Given the abysmal state of abortion access in this country, it’s even more difficult to watch medical technology and innovation revolutionize the way patients—particularly in rural areas—receive care, while abortion is purposely excluded.

People seeking abortions are already turning to medication abortion as a method to self-manage their care. In a recent nationally representative survey of US women of reproductive age, about half supported being able to get the abortion pill through alternative means, such as online, over the counter, or from a clinician in advance of need. Unfortunately, thanks to overzealous prosecutors, a racist and classist criminal justice system, and outdated laws, a handful of women have been arrested for self-managing their abortions. These changes don’t mean much for those Black and brown people who are already overpoliced and criminalized simply because of the outcomes of their pregnancies. They deserve full, uninhibited access to health care, including medication abortion care, as a basic human right.

There was never a reason to hold abortion pills hostage at a doctor’s office, since the data are now clear that in-person dispensing does not improve the safety or effectiveness of the regimen.

The FDA should have completely eliminated the mifepristone REMS and clearly stated that in the eyes of the federal government, there was no need for additional restrictions on this life-saving pill. If that had happened, advocates and health care providers in the United States could be thinking creatively about what might come next, including providing abortion pills even before you’re pregnant to have on hand if needed—or eventually over-the-counter access. We won’t get to that vision of liberated abortion care simply by putting all our trust in the FDA—and certainly not in the courts.

We’re standing on the cliff of a crisis and, until abortion restrictions are abolished, we’ll always have patchwork access, particularly for Black and brown communities. To achieve abortion access at any time, for any reason, anywhere, we have to start by following the science.

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