FDA Should Lift Abortion Pill Restrictions, Says Former Agency Head

For two decades, the Food and Drug Administration has maintained restrictions on the abortion drug mifepristone that require patients to receive it from a licensed provider at a hospital or clinic, despite overwhelming evidence that shows the drug is safe and effective to take outside of immediate medical supervision. For patients, that has meant that instead of filling a prescription at the pharmacy—as we do with countless other medications—they must face all the obstacles to accessing abortion clinics, which dwindle in number every year, just to be handed a pill.

Even under ordinary circumstances, these regulations make it harder to access vital early abortion care, according to advocates. But Jane Henney, a former FDA commissioner and physician said that during a pandemic, the restrictions create unnecessary risks for those seeking abortion care, forcing patients to travel long distances to clinics and come into contact with clinic staff at a time when social distancing is necessary to contain the spread of coronavirus. (The FDA did not return VICE’s requests for comment about whether the agency has any plans to reevaluate the regulations by the time of publication.)

Henney served as the head of the FDA when mifepristone was approved in 2000 and the restrictions were put in place. But for several months now, she has been speaking out against the FDA’s overregulation of mifepristone, and urging the agency to revisit the restrictions on the drug to reflect its robust safety profile. In light of the coronavirus pandemic, 21 state attorneys general and three United States senators, have joined her call. VICE spoke to Henney about how the pandemic has strengthened her arguments.

This conversation has been edited for length and clarity.

Last we spoke, you had recently published a piece in the New England Journal of Medicine about revisiting the restrictions on mifepristone. With social distancing measures and strain on clinics, many people have revived arguments to lift the restrictions as soon as possible. Is this feasible?
We’re clearly in a situation in this country unlike any other. I think the imperatives we were trying to raise in our paper last summer about how what we know about the safety of the product doesn’t align with the REMS [Risk Evaluation and Mitigation Strategy] restrictions—I think that’s still the situation, and it’s been made more stark by this current circumstance. Unless they have such an extensive file of concerns about this product, they should be reviewing it to see if there’s a way to make the access issue easier.

The U.K. has eased its restrictions on mifepristone on a temporary basis. Is that something the FDA could do?
I would like to think you could temporarily ease restrictions, but I’m not sure what avenues the FDA would have to do what the UK has done. The FDA has responded in an urgent fashion to other [public health] issues [during the pandemic] and have looked into accommodations to address them, and women’s health certainly warrants that same kind of attention.

What might abortion access look like right now, during the pandemic, if the FDA reevaluated these regulations?
It’s hard to know exactly. Looking at some of the telemedicine studies you can imagine that if some of the requirements were lifted you would be able to get a prescription [for mifepristone] and be able to go out and get it at a local drugstore. It would mean you could honor the stay-at-home recommendations which excludes essential places like grocery stores and pharmacies. You might just have a phone conversation with a physician and then you would have that line of contact in the rare event that a complication arises.

Could the REMS be putting people at greater risk of exposure to coronavirus?
This is anecdotal, but I’ve been reading news stories about people driving very long distances to get abortion services during the pandemic. You have to think that that involves stopping along the way, getting gas, and getting something to eat before finally getting to the clinic. That’s a lot of contact and a lot of time out of the house, even if you are practicing some social distancing. They’re putting themselves and others at risk by being out and about. And this isn’t like an elective procedure, where you have the ability to wait and have it at any time—there’s a real time-sensitive element to it. Being able to go to your drugstore or have something delivered to your home in this kind of environment is a much better approach.

Do you think the extreme nature of the pandemic and the limitations it’s placing on people’s access to abortion care will put pressure on the FDA to act?
We have safety data from millions of women in the U.S. from the last 20 years, as well as all of the data from other countries that show using this product is safe—using it at home seems not to increase your risks [of complications] at all. I think because of the pandemic it’s more imperative to look at it because of the access issues, and because it’s an essential medicine for women’s health. I think the agency can look at [this situation] in a clear-eyed way and come to a reasonable conclusion based on the information that they have from a variety of sources. But what I don’t know is if anyone is asking them to do that review: The FDA can modify REMS directives, but what usually triggers their action is a request to do so. And those requests come from the drug companies.

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