The novel coronavirus outbreak, which began in November 2019, has now expanded to touch nearly every nation, with serious public health consequences in the United States. As countries and states have locked down and enforced social distancing, millions of people have been ordered to stay at home for all but essential activities.
It is no secret that hundreds of thousands of pregnant people will need an abortion during this crisis. For many of these people, access to safe and effective medication abortion could be a lifeline, ensuring they receive prompt abortion care up to 10 weeks from the first day of their last period without having to visit a clinic, or even leave their homes. But without immediate federal and state action, many pregnant people in self-isolation and those with health conditions who experience an unwanted pregnancy will be forced to make completely unnecessary trips to access early abortion care, or worse. Now more than ever, it is critical to lift unnecessary restrictions on abortion pills.
The United Kingdom has already taken necessary measures to ensure the safety of pregnant people during the global crisis. On March 30, 2020, the United Kingdom government announced that it was updating its guidance to help women who need an abortion but cannot access a clinic because of measures put in place to stem the spread of coronavirus. According to the guidance, the move will be made on a temporary basis, limited for two years or until the coronavirus crisis is over. The measures allow women to be mailed mifepristone and misoprostol following a telephone or video consultation with a doctor.
But here in the U.S., restrictions imposed by the FDA prevent most pregnant people from being able to access abortion pills through the mail or at their neighborhood pharmacy. That’s because the FDA mandates that mifepristone may only be dispensed in a clinic, medical office, or hospital by or under the supervision of a certified provider — even though the FDA permits patients to wait until they get home to actually swallow the pill.
These restrictions are part of a broader risk evaluation and mitigation strategy (REMS) that the FDA claims make medication abortions safer but are really designed to make abortion pills harder to access. When the full scope of the mifepristone REMS are reviewed comprehensively — as we do here — their absurdity is clear: The FDA permits patients to meet with their doctors by phone or video call, take the pills at home, have their abortions at home, and follow up with their doctors by phone or video call after their abortion is over. But first, the FDA insists that patients must travel just to pick up their pills in person. The FDA doesn’t impose these restrictions on any other medication that is administered at home.
It is Past Time to Lift Medically Unnecessary Restrictions on Medication Abortion
Even before the pandemic, telehealth was becoming more and more common, often serving as the only means for providers to connect with rural patients or others who live far away from health services. Now, during the global pandemic, it is urgent that the FDA eliminate the requirement for in-person pick-up of abortion pills to ensure that the entire process can be completed without forcing pregnant people to travel or even leave their homes.
With the global pandemic at hand, these restrictions will burden pregnant people in hazardous ways. Telemedicine abortion specifically enables providers to prescribe abortion pills from a distance. Requiring in-person pickup negates some of these benefits, unreasonably burdening patients and further straining the health system.
Under the REMS imposed by the FDA on mifepristone, both patients and clinic staff are forced to travel during a pandemic, don protective gear, and increase their exposure to potentially sick individuals, with no corresponding health benefit to justify these serious risks. Organizations, such as the American College of Gynecologists and Obstetricians, support the elimination of REMS regulations, which they maintain are medically unnecessary and impede access to medical abortion.
Requiring pregnant people to travel to providers for services that could be performed remotely through telehealth consultations in order to receive FDA-approved medication that could be available at retail pharmacies through pickup or delivery, threatens both patient and provider.
The FDA is aware of these dangers — at least when it comes to other medications. In guidance issued in March, the FDA noted its “critical role in protecting the United States from threats including emerging infectious diseases” and its commitment “to providing timely guidance to support response efforts to this pandemic.”
The guidance states:
FDA recognizes that during the COVID-19 PHE [public health emergency], completion of REMS-required laboratory testing or imaging studies may be difficult because patients may need to avoid public places and patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine. Under these circumstances, undergoing laboratory testing or imaging studies in order to obtain a drug subject to a REMS can put patients and others at risk for transmission of the coronavirus.
In light of the FDA’s March guidance and explicit recognition of the dire risks, the FDA must lift the REMS restrictions on mifepristone to ensure that pregnant people have access to this safe and effective drug even during this national public health crisis. If everyone who needs a medication abortion can safely access mifepristone through telehealth appointments and have it shipped to them, then that action alone would alleviate strain on the health system while protecting patients.
In the absence of this action, the FDA will force pregnant people to pursue alternatives. Some will turn to overseas pharmacies. While we believe that this can be a safe method for procuring medication abortion, the FDA has argued that doing so “poses an inherent risk to consumers who purchase those products.” Some pregnant people will use alternative, non-medical methods of self-managed abortion — as long practiced by pregnant people — that can be safe and effective. But many others will turn to dangerous or unproven methods. Some people who travel (often over long distances) to pick up mifepristone in a clinic will be exposed to COVID-19. And, of course, many people will be forced to carry an unwanted pregnancy to term during a pandemic, with unknown but likely significant risks. In making a risk-benefit analysis around the REMS for mifepristone, the FDA must weigh all of these real-world considerations.
Given these dangerous risks during these very difficult and uncertain times, the FDA should lift the REMS.
As we (the NWHN) highlighted in our letter to the FDA, signed by over eighty organizations, the FDA is putting the lives of pregnant people at risk. The FDA needs to take steps now to ensure that mifepristone remains a safe and effective form of abortion care during the crisis. States and the federal government must lift the restrictions on medication abortion as COVID-19 spreads across the U.S. The restrictions on medication abortion will not make the procedure safer, and certainly not to make it more effective. Rather, they are an attack on abortion itself and must be lifted during this global pandemic.
Beyond the FDA, State Restrictions Put Patients and Others at Risk for COVID-19 Transmission or Worse
By lifting the REMS on mifepristone, the FDA would immediately enable more than half the country to receive abortion care without ever leaving their homes. But for pregnant people locked in states with restrictive rules for medication abortion, FDA action is only the first step. Those states must take action by putting the health of pregnant people first, deeming abortion procedures as essential, and removing state-based restrictions that require in-person visits.
Attempting to prohibit clinic-based abortion services altogether, some states have falsely declared that abortions are “nonessential” procedures and can be delayed during the outbreak. The constitutionality of these efforts is likely to end up before a U.S. Supreme Court that is deeply hostile to abortion rights, raising serious questions about clinic access in conservative states.
Furthermore, while the FDA permits the use of telehealth appointments for medication abortion and permits patients to take the pills home with them, individual states have imposed their own restrictions. When all of these provisions are enforced by an individual state, pregnant people have to make several trips to a health care provider and are required to initiate every step of the process under the direct supervision of a clinician, rather than in the privacy of their homes. Even in the most restrictive states, the actual medication-induced abortion takes place outside of a clinic over the course of several hours or days. This is unreasonably dangerous for pregnant people in the best of times, and even more so now.
In many states, physicians are the only health professionals permitted to provide medication abortion. In these states, a pregnant person seeking a medication abortion may have to wait a long time for an appointment and travel long distances to visit a clinic attended by a physician. The situation is even more burdensome by the provision that requires that the physician be physically present. Twenty-one states have enacted laws that require the clinician providing a medication abortion to be physically present during consultations and when the patient takes the medication, effectively prohibiting the use of telemedicine to prescribe medication for abortion remotely. In these states, additional changes would be required before abortion pills could be picked up at a pharmacy or sent in the mail, even after the FDA acts.
The NWHN is calling on the FDA to lift politically motivated, medically unnecessary restrictions on the abortion pill right now and let pregnant people receive the abortion pill through the mail so that they can get the pill where they take the pill, at home. You can also join the fight by contacting your state officials and signing our petition to urge the FDA to lift unnecessary restrictions on medication abortion.