The UK allows home use of the abortion pill — the US should do the same
In late March, the United Kingdom issued new guidance authorizing physicians to provide medication abortion pills to those wishing to end their pregnancies during the COVID-19 pandemic. The change was immediately embraced by the public and by British abortion providers who know home use is a safe and effective way to experience an early abortion.
British patients who need an early abortion now consult with a provider by telephone or video link and the medication abortion pills are then delivered to the patient’s home. This is a safe, sensible way to protect pregnant women and their doctors during an epidemic. British leaders and medical experts are to be commended for recognizing that abortion is an essential health care service that can be provided safely within the constraints of physical distancing and stay-at-home orders.
In contrast, the United States Food and Drug Administration has been notably silent, despite calls for action from dozens of reproductive health, women’s and medical organizations; thousands of consumers; and 21 attorneys general. Every day the FDA does not act, people who need abortions and the clinicians who care for them are needlessly risking their health and lives by increasing the risk of exposure to COVID-19.
This is not insignificant. Hundreds of thousands of women will need an abortion over the next several months. That need doesn’t disappear during an epidemic. As the American College of Obstetricians and Gynecologists and other leading medical societies recently stated, “abortion is an essential component of comprehensive health care.”
Access to abortion underpins the ability of women to manage their lives, and in many cases to care for the children they already have. Abortion is also a time-sensitive procedure. Unlike screening mammograms and Pap smears, women cannot wait until the epidemic is over to get the abortion care they need.
How did we get into this situation, where prescription medications must be picked up in a clinic or doctor’s office before being taken at home? The FDA established Risk Evaluation and Mitigating Strategy (REMS) restrictions on medication abortion that forbid retail pharmacies from stocking mifepristone — one of two FDA-approved medications used in tandem to end a pregnancy — and require that it be dispensed only by certified practitioners in “clinics, medical offices and hospitals.”
These restrictions are unnecessary and delay timely access to medication abortion in the best of times. Now, when some governors are trying to use the epidemic as an excuse to ban abortion by ruling it “non-essential,” women in those states may have to travel hundreds of miles during a pandemic to be seen in-person at a clinic, even though they are allowed to swallow the pills at home. We believe the FDA should allow pregnant people to get the pill where they take the pill – at home, and not require them to make an unnecessary and risky visit to a clinic.
The FDA has a clear legal authority to end these restrictions on medication abortion. In fact, the FDA has already relaxed REMS restrictions on other, more dangerous, drugs such as Turalio and clozapine. The FDA took that step on March 22. And yet, the FDA has let over four weeks go by without taking any action on medication abortion.
Why is the FDA not doing what needs to be done and instead of leaving restrictions on medication abortion in place? As long-time advocates for women’s health who have personal experience with the FDA’s handling of reproductive health technologies, we suspect that it is a combination of self-censorship and outside political pressure. One of us (SW) was Assistant Commissioner for Women’s Health at the FDA when the Bush administration ignored the recommendations of scientists and stopped the agency from approving emergency contraception pills (Plan B) for over-the-counter use in 2005. One of us (CP) observed first-hand the impact the FDA’s fear of the anti-abortion movement had on its decision-making process for the initial approval of medication abortion drugs.
It took a lawsuit and ten years of work for FDA to do the right thing and simply approve emergency contraception pills for over the counter use with no age restrictions. But we don’t have time for lawsuits and long advocacy campaigns during an epidemic.
The physicians and scientists at FDA know what they should do, and FDA leadership must step up in the face of COVID-19. FDA protected the health of other types of patients by allowing telemedicine and relaxing REMS restrictions over a month ago. The U.K. protected the health of patients using early medication abortion weeks ago. The FDA must lift its restrictions and protect medication abortion patients in the United States now. Every day makes a difference.
Susan F. Wood is a former FDA assistant commissioner for Women’s Health and a professor of health policy and management at George Washington University; she currently teaches online from the UK. Cynthia A. Pearson is the executive director of the National Women’s Health Network.