Last year, the FDA made the companies’ plans possible when the agency allowed doctors to prescribe mifepristone – the first of two pills that patients take as part of the medical abortion regimen – via telemedicine and to send it by post. But the FDA could change course if an anti-abortion president wins the election.
“Post-Roe America demands that we reimagine where and how abortion care is delivered,” said Carolyn Witte, co-founder and CEO of Tia, which offers telehealth appointments and abortion pills in California and around the world. New York. “We need to move from a siled approach where abortion is treated as a separate issue to a holistic model of health care for women.”
Although primary care physicians can offer medical abortion, many are reluctant to do so. This is due to FDA certification rules for mifepristone dispensers, the need to stock the pills, the controversy surrounding abortion, and the possibility of being targeted by anti-abortion activists.
Most abortions in the United States are drug-induced, and online companies offer advantages to patients as well as doctors: there is no place to picket and companies can hide which doctors prescribe to protect them from anti-abortion activists.
Already, several online abortion clinics — including Choice, Hey Jane and Aid Access — have doctors on staff certified to prescribe mifepristone. They rely on mail-order pharmacies like Honeybee Health to ship the pills.
Last year, the FDA said it would use its discretion to allow online pharmacies to mail mifepristone as long as they work with certified physicians 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, which both offer in-person and virtual appointments, are offering medical abortions to patients.
Telehealth company Wisp offers medical abortions to patients in California, New York, Illinois, Colorado, Maryland, Maine and Washington. Carbon Health, which provides in-person primary care in 17 states and telehealth in 23 states, now offers medical abortions throughout California and plans to expand to all states where abortion is legal.
Roadblocks for doctors
According to a 2018 study, 3% of recently graduated family physicians provide some form of abortion care. And the vast majority of obstetricians, who specialize in reproductive health care, do not perform abortions.
FDA restrictions on the distribution of mifepristone, which are designed to mitigate safety concerns, are a hurdle, doctors say. Distributors must be certified by the drug manufacturers, a process overseen by the FDA.
Physicians wishing to dispense the pills must demonstrate that they understand that mifepristone is used to induce abortions, that it does so by blocking the hormones necessary to maintain a fetus in the womb, and that they know how to advise patients about its use. They must also have patients sign a disclosure form acknowledging that 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 telemedicine abortion altogether.
The Hyde Amendment prevents “federally licensed health centers” — community clinics that receive federal funding and serve 30 million Americans — from using federal dollars for abortions. Physicians who wish to perform medical abortion expose themselves and their clinics to harassment and more expensive liability insurance. (New York State recently passed a law to prevent malpractice insurers from charging higher rates to abortion providers.)
In a small survey of 48 physicians about barriers to prescribing medical abortion, published this year by the Journal of the American Board of Family Medicine, one physician said, “I would do it in a pinch if I could prescribe mifepristone, and my patient could pick it up at a commercial pharmacy, but she can’t because of how it’s regulated by the FDA.
Pills by mail
For years, certified physicians could only administer mifepristone in person. That changed during the pandemic when Maryland Federal District Court Judge Theodore Chuang approved an injunction sought by groups of physicians allowing abortion drugs to be prescribed via telehealth and mailed to them for the duration of the pandemic. federal public health emergency.
The Supreme Court reinstated the in-person prescription 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 allowed telemedicine prescriptions, allowing pills to be mailed or dispensed from local pharmacies. A new president could reverse that again.
And the FDA is reviewing applications from manufacturers of mifepristone to determine how local pharmacists can safely distribute it in their physical stores. GenBioPro and Danco Laboratories submitted proposals in June. The FDA has six months to respond to the submission.
For abortion rights advocates, the new interest of primary care organizations in prescribing medical abortions is a bright spot emerging in the wake of the Supreme Court ruling.
“The more we can standardize abortion care and spread it among more providers, the more we spread the risk and normalize this health service,” Upadhyay said.
Online access to pills is not a panacea for abortion patients in states where the procedure is banned. They must travel to states where it is legal to meet with a doctor, either in person or online. And they may not be able to receive pills at home.
Upadhyay said she wants the FDA to update its certification rules so pharmacies can apply to dispense mifepristone. The University of California has expressed interest in dispensing medical abortions at its campus pharmacies.
Of course, health care providers who prescribe medical abortion – online or offline – still face risks. Alpha Medical, an online primary care provider, plans to offer medical abortion later this year, but is still working on the legalities. Alpha Medical’s chief medical officer, Mary Jacobson, said she was concerned that if she ordered medical abortion in states where it is legal, her medical license could be revoked in states where it is prohibited.
She said Alpha Medical faces similar legal risks when connecting patients to abortion resources: “If someone from Texas contacts us for navigation, are we considered helping and encouraging if we give advices ?”