What if You Had Abortion Pills in Your Medicine Cabinet?

New York Times - Wed Oct 13 23:48

Guest Essay

Credit...Marta Monteiro

Patrick Adams

Mr. Adams is a freelance journalist who covers public health.

In 2018, the Austria-based nonprofit Aid Access began offering Americans a new service: For the first time, pregnant people could obtain abortion pills by mail, with a prescription from a licensed physician, without ever visiting a clinic. For years, the group’s founder, Dr. Rebecca Gomperts, had been doing similar work overseas. But as abortion rights were steadily eroded by Republican-controlled legislatures, Dr. Gomperts found herself inundated with requests from the United States and decided to act.

Three years later, American abortion rights are more threatened than ever, with the fate of Roe v. Wade resting on several Supreme Court justices appointed by Donald Trump. In response, Aid Access has introduced a service that offers a possible path forward for doctors adapting to the changing abortion landscape and reckoning with their role in gate-keeping a politically fraught drug: prescribing abortion pills in advance, to be kept on hand in the event of a future unwanted pregnancy.

First approved by the Food and Drug Administration in 2000, medication abortion — a two-drug regimen consisting of mifepristone and misoprostol — has increasingly become the preferred method of ending an early pregnancy, accounting for more than half of all such abortions in the United States in 2017.

That, in turn, has made it possible for patients to get abortions via telemedicine, whereby a health care provider supervises the use of abortion pills via videoconferencing or a secure messaging platform. The demand for telemedicine abortion has grown over the past decade, and significantly so during the coronavirus pandemic. But with that growing popularity has come a backlash. A number of states have effectively outlawed telemedicine abortions and are otherwise restricting access to medication abortion.

One of the latest to do so is Texas, where Senate Bill 8, which makes nearly all abortions in the state illegal, took effect on Sept. 1. That law is facing several legal challenges, including from the Biden administration. But even if S.B. 8 is ultimately struck down, Texas will still ban medication abortions after seven weeks of pregnancy because of another anti-abortion law that the state passed last month — this one receiving far less attention — and that is set to go into effect on Dec. 2.

It was in the days after S.B. 8 went into effect, as Texans poured across state borders to get abortions after the six-week limit imposed by the law, that Aid Access began advance prescribing abortion pills, first to people in Texas and now in all states.

Advance provision of prescription medications is not a new idea. Doctors have long prescribed medicines before they’re needed, mostly as a way of preparing for a possible emergency. Children with severe allergies are advance-prescribed EpiPens, antibiotics are routinely prescribed in advance for self-treatment of travelers’ diarrhea, and all Americans are encouraged to carry and learn to administer the drug naloxone, which can temporarily reverse the effects of an opioid overdose.

There’s a reproductive health precedent for advance prescription as well: emergency contraception, also known as the morning-after pill or Plan B. In 2001, several years before the F.D.A. approved the over-the-counter sale of Plan B, the American College of Obstetricians and Gynecologists tried to bypass political opposition to the move, urging its 40,000 members to offer their patients advance prescriptions during routine gynecologic visits.

“If most women had emergency contraception in their medicine cabinet, or a prescription for it, we could help cut the U.S. rate of unintended pregnancy in half,” Dr. Thomas F. Purdon, then the president of A.C.O.G., said ​​during the group’s annual clinical meeting in Chicago. “Ob-gyns — indeed, all primary care physicians — can help make that happen.” And indeed, advance provision of emergency contraception soon became common practice.

Access to mifepristone, one of the drugs taken for a medication abortion, has been politically fraught since the drug was approved more than 20 years ago. Mifepristone is regulated under what’s called a risk evaluation and mitigation strategy, or REMS — a designation generally reserved for drugs that carry a high risk to patient safety. As such, it can be dispensed only in clinics, medical offices and hospitals; only by, or under the supervision of, a specially certified doctor or other medical provider; and only to patients who have signed an F.D.A.-approved patient agreement.

For years, reproductive health experts have urged that the access requirements for mifepristone be permanently lifted, arguing that there are no significant safety reasons for a patient to get the pills in person from a doctor’s office when she is likely to take them, and experience the abortion, after she gets home. The rule places an especially great burden on low-income women, who may struggle to get to an abortion clinic, and those in areas with limited access to abortion providers.

In April, the F.D.A. said that for the duration of the pandemic, it would stop enforcing the requirement that mifepristone be dispensed in a medical clinic. That paved the way for telemedicine start-ups like Hey Jane in New York, California and Washington; Choix in California and Illinois; Just the Pill in Minnesota and Montana; and Abortion on Demand in many other states to mail abortion drugs to patients after a consultation via telemedicine.

Yet in the 19 states that require a clinician to be physically present with the patient when administering mifepristone, Aid Access is still the only option for physician-supervised medication abortion by mail. Dr. Gomperts consults with patients online from her office in Austria, writes a prescription and provides instructions on how to request the pills from a pharmacy in India — a process that generally takes up to three weeks. The cost, including shipping, comes to $110. Patients who cannot afford that amount are asked to pay what they can.

While importing drugs from abroad is illegal in most cases, the F.D.A. typically does not go after individuals who purchase medicines online for their personal use. And though a few states — South Carolina, Oklahoma, Idaho and Nevada — explicitly criminalize self-managed abortion, Texas does not outlaw terminating one’s own pregnancy, and S.B. 8 exempts abortion patients in the state from being sued. (People in any state seeking legal advice on these matters can consult the hotline run by the group If/When/How.)

Yet even more important than the access to medication abortion afforded by Aid Access may be what Dr. Gomperts’s move signals to health care providers in America. Indeed, some reproductive rights experts argue that not only can American health care providers follow her lead and prescribe abortion pills in advance — they have a responsibility to do so. Doing so would be just one way of helping patients access care, but it could be significant.

“What I’m saying to clinicians is, if you believe people should be able to have an abortion when they want one and that early abortions can be safely self-managed with pills, then understand that it’s in your hands to make that happen,” said Francine Coeytaux, a co-founder of the advocacy group Plan C, which has worked to raise awareness about the safety of self-managed abortion and to educate the public about how to acquire abortion pills online. “I think many of them are now realizing they can do this — that it’s legal and within their scope of practice.”

Some experts caution that state medical boards could view prescribing abortion medication in advance as being out of step with standards of practice. But others argue that it would merely constitute the off-label use of a drug — a use other than what it was approved for — which is common in medicine.

“It seems like it would be very reasonable to provide the medications in advance and strongly encourage the patient to call the clinician before they actually take it,” said Dr. Daniel Grossman, a professor of obstetrics and gynecology at the University of California, San Francisco, whose research has demonstrated broad demand for such a service. “I think it makes sense for people living in places where there’s no access to care or where there’s a narrow window of time to seek it out.”

Dr. Grossman and his colleagues at U.C.S.F. had planned to conduct a study last year aimed at demonstrating the safety and effectiveness of advance provision of abortion pills, but the F.D.A. under the Trump administration declined to approve it.

Still, he and others point to plentiful evidence in support of the strategy pursued over the course of the pandemic. That includes the findings of a study comparing thousands of medication abortions in Britain before and after the government began allowing health care providers to administer medication abortion by telemedicine, with pills mailed to patients’ homes. The study, led by Dr. Abigail Aiken at the University of Texas at Austin, found that the two groups were able to complete their abortions at equally high rates, with similarly low rates of significant complications.

“I think that doctors do have an obligation to make pills available in advance, particularly when they know that people will encounter obstacles when they need a procedure,” Dr. Gomperts said. “Advance provision still means the doctor is the gatekeeper. It’s not over-the-counter, which is the ultimate goal. But it’s a step closer. And it allows pregnant people to take the medicines the moment they have a positive pregnancy test.”