Last year, the FDA made the companies’ plans possible when the agency permitted doctors to prescribe mifepristone — the first of two pills patients take in the medication abortion regimen — via telemedicine and to ship it in the mail. But the FDA could reverse course if an anti-abortion president were to win election.
“Post-Roe America demands that we reimagine where and how abortion care is delivered,” said Carolyn Witte, the co-founder and CEO of Tia, which provides telehealth appointments and abortion pills in California and New York. “We must shift from a siloed approach where abortion is treated as a separate issue to a whole women’s health care model.”
Though primary care doctors could provide medication abortion, many are reluctant to do so. That’s because of the FDA’s certification rules for mifepristone distributors, the need to store the pills, the controversy surrounding abortion, and the possibility of being targeted by anti-abortion activists.
Most U.S. abortions are induced with drugs, and the online firms offer advantages for patients as well as doctors: There is no location to picket and companies can obscure which physicians are prescribing to protect them from anti-abortion activists.
Already, several online abortion clinics — including Choix, Hey Jane, and Aid Access — have physicians on staff certified to prescribe mifepristone. They rely on mail-order pharmacies like Honeybee Health to ship the pills.
The FDA last year said it would use its enforcement discretion to permit online pharmacies to send mifepristone through the mail so long as they worked with doctors certified to dispense the drug.
Now primary care organizations as well as maternity care companies like Millie Clinic in California and Viva Eve in New York, both of which offer in-person and virtual appointments, are providing medication abortion to patients.
Telehealth company Wisp offers medication abortion to patients in California, New York, Illinois, Colorado, Maryland, Maine and Washington. Carbon Health, which provides primary care in person in 17 states and telehealth in 23 states, is now providing medication abortion throughout California and plans to expand to every state where abortion is legal.
Roadblocks for doctors
Three percent of recently graduated family doctors provide some form of abortion care, per a 2018 study. And the vast majority of obstetricians, who specialize in reproductive health care, don’t provide abortions.
FDA restrictions on the distribution of mifepristone, which are designed to alleviate safety concerns, are an impediment, doctors say. Distributors must be certified by the manufacturers of the drug, a process overseen by the FDA.
Doctors who want to distribute the pills must demonstrate they understand mifepristone is used to induce abortions, that it does so by blocking hormones necessary to maintain a fetus in the uterus and that they understand how to counsel patients on its use. They also must have patients sign a disclosure form acknowledging they know they are taking mifepristone to end a pregnancy.
In addition to FDA regulations, some states require abortion patients to have ultrasounds, make multiple trips to a clinic before undergoing the procedure or ban abortion via telemedicine altogether.
The Hyde Amendment prevents “federally qualified health centers” — community clinics that receive federal funding and serve 30 million Americans — from using federal dollars for abortion. Doctors who want to provide medication abortion put themselves and their clinics at risk of harassment and more expensive liabilty insurance. (New York state recently passed a law to stop malpractice insurers from charging higher rates to abortion providers.)
In a small survey of 48 physicians on hurdles to prescribing medication abortion, published this year by the Journal of the American Board of Family Medicine, one doctor said, “I would be doing it in a heartbeat if I could prescribe mifepristone, and my patient could pick it up at a commercial pharmacy, but she cannot because of the way it is regulated by the FDA.”
Pills by mail
For years, certified physicians were only able to give patients mifepristone in person. That changed during the pandemic when a Maryland federal district court judge, Theodore Chuang, approved an injunction sought by physician groups allowing abortion medication to be prescribed via telehealth and shipped through the mail for the duration of the federal public health emergency.
The Supreme Court reinstated the in-person prescribing requirement in January 2021 at the request of the FDA while Donald Trump was still president. However, after Joe Biden was elected, the agency reversed course and permitted prescriptions by telemedicine, allowing the pills to be sent through the mail or dispensed from local pharmacies. A new president could reverse that again.
And the FDA is reviewing applications from mifepristone’s manufacturers to determine how corner pharmacists can dispense it safely at their brick-and-mortar stores. GenBioPro and Danco Laboratories submitted proposals in June. The FDA has six months to take action on the submission.
For abortion-rights advocates, the new interest from primary care organizations in prescribing medication abortion is one bright spot to emerge following the Supreme Court’s decision.
“The more we can normalize abortion care and spread it across more providers, we are spreading the risk around and normalizing this health service,” said Upadhyay.
Online access to pills isn’t a panacea for abortion patients in states where the procedure is banned. They must travel to states where it’s legal to meet with a doctor, whether in-person or online. And they may not be able to receive pills at their home address.
Upadhyay said she’s eager for the FDA to update its certification rules so pharmacies can apply to distribute mifepristone. The University of California has expressed its interest in dispensing medication abortion at its campus pharmacies.
Of course, health care providers that prescribe medication abortion — online or off— still face risks. Alpha Medical, an online primary care provider, plans to provide medication abortion later this year, but is still working through the legalities. Alpha Medical Chief Medical Officer Mary Jacobson said she is concerned that if she prescribes medication abortion in states where it’s legal, she might have her medical license revoked in states where it is banned.
She said Alpha Medical faces similar legal risks when it connects patients to abortion resources: “If someone from Texas contacts us for navigation, are we considered aiding and abetting if we give advice?”