“Amid Covid-19, a Call for M.D.’s to Mail the Abortion Pill” From The New York Times

In this post I link to and excerpt from the New York Times‘* May 13, 2020 article, Amid Covid-19, a Call for M.D.’s to Mail the Abortion Pill, by Patrick Adams.

* I recommend everyone subscribe to the New York Times [Not an affiliate link – I just think it is a worth it]. It is critically important to those who which to stay informed.]

Here are excerpts:

Last fall, months before America’s first outbreak of the coronavirus, Francine Coeytaux and Elisa Wells, co-founders of the abortion rights advocacy group Plan C, were reaching out to doctors with a question they said was urgent:

“Would you be willing to mail the ‘abortion pills’ to women in their homes?”

For millions of women across America, abortion access was already severely limited — the result of restrictive new laws that have forced dozens of clinics to close their doors. Now, with the spread of Covid-19, some states have classified abortions as “nonessential,” putting access to the procedure even further out of reach.

But the pandemic has also shone a spotlight on what’s known as “medication abortion,” or the use of pills to terminate an early pregnancy. And Ms. Coeytaux and Ms. Wells say that has only broadened support for their efforts to make the medicines available by mail.

The medicines are mifepristone and misoprostol. Mifepristone blocks the effects of progesterone, a hormone without which the lining of the uterus begins to break down, while misoprostol, to be taken 24 to 48 hours later, induces contractions of the uterus that expel its contents. Both drugs are approved by the Food and Drug Administration for use up to 10 weeks into pregnancy.

With its approval in 2000, mifepristone promised to substantially expand access to abortion care in the United States. (Misoprostol, which had been developed as anti-ulcer therapy, was already in use.) Suddenly, what had previously required a surgical procedure could be done safely and effectively anywhere a woman chose.

But approval came with stringent restrictions on mifepristone’s distribution.

Regulated under what’s called a “risk evaluation and mitigation strategy,” or R.E.M.S., mifepristone can be dispensed only in clinics, medical offices and hospitals; only by, or under the supervision of, a doctor certified to prescribe the drug; and only to patients who have signed an F.D.A.-approved patient agreement.

Abortion rights advocates have long held that there is no medical justification for applying that regulation to mifepristone, the safety of which has been well established, and that the decision to do so was politically motivated. And for years, leading medical societies and reproductive health experts have petitioned the F.D.A. to loosen the restrictions or lift them altogether.

Now, as stay-at-home orders further impede access to clinic-based abortions, prominent voices — including those of attorneys general from 21 states, a former F.D.A. official, and The Times editorial board — have joined calls for the F.D.A. to act.

But what if the consensus understanding of the regulation is wrong? What if it doesn’t actually prohibit doctors from mailing mifepristone?

It’s a question at the heart of the debate around abortion access and one that has not been considered by a court. And for that reason, Ms. Wells and Ms. Coeytaux feel they are on firm legal ground in assembling what they envision as a national network of new providers — those who, like them, embrace a broader interpretation of the rules.

“Most U.S. providers have taken the R.E.M.S. to mean that mifepristone cannot be mailed,” Ms. Wells said. “We disagree. We think providers have clear latitude to ‘dispense’ the drug from their offices and then ship it to patients, and we’re hearing from more and more of our colleagues who see it the same way.”

“I strongly believe that the R.E.M.S. does not limit the ability to send mifepristone by mail,” said Dr. Mitchell Creinin, a veteran medical researcher and professor of obstetrics and gynecology at the University of California, Davis, who is not affiliated with Plan C.

“It says you have to dispense the drug to the patient in the clinic,” Dr. Creinin added. “But the act of distribution — by mail, by overnight delivery, whatever — is different than dispensing.”

In early March, Plan C called on doctors across the country to take the first step for mailing mifepristone: registering with Danco Laboratories or GenBioPro, the only F.D.A.-approved manufacturers.

Already, Ms. Wells said, dozens of doctors have responded. “And we know of several who have started shipping the pills or are planning to soon,” she added.

A family physician, who spoke on condition of anonymity out of fear of harassment, said she had never provided abortion care when a friend introduced her to Plan C in early April. After confirming that her malpractice insurance covered abortion by medication and reviewing the guidelines for managing patients, she enrolled in GenBioPro’s provider program and filled out a prescriber agreement attesting to the R.E.M.S.

“It says all of the things you would want it to say, like that there has to be a doctor-patient relationship, that you have to educate the patient and obtain consent, and that you have to log and label the drug correctly,” she said. “But how you deliver it to the patient — by hand? By mail? By throwing it over a fence? It says nothing about that.”

The paperwork took her less than a day, she said. “And I thought, oh my God, why didn’t I do this a long time ago? Honestly, I’m a little ashamed that I didn’t.”

When they started Plan C in 2016, Ms. Wells and Ms. Coeytaux — who in the late 1990s was instrumental in making emergency contraception available over the counter — set out to raise awareness about self-managed abortion through a grass-roots approach. They held meetings in their homes, trained groups of millennial “ambassadors,” and put out a report card ranking the various vendors offering pills online.

While Plan C was getting the word out, the nonprofit research group Gynuity Health Projects was gathering evidence for advocacy efforts aimed at removing the regulation. In 2016, the group launched a direct-to-patient telemedicine abortion service as part of a study in four states, with pills shipped to women in their homes.

Gynuity secured special permission from the F.D.A. under the Obama administration to mail mifepristone and its program, called TelAbortion, has been allowed to continue ever since. Over the past year, TelAbortion added eight new states and now operates in a total of 13. But in terms of the number of patients served, the program’s impact has been modest: It has shipped just 841 packages containing abortion pills over a four-year period.

One reason is that the F.D.A. approved the study on the condition that all patients arrange an in-person visit for an ultrasound to gauge their gestational age. A routine ultrasound is not considered medically necessary for a first-trimester abortion; research shows that most women can accurately recall their last menstrual period; and new medical protocols are now changing the standard of care. But barring exceptions made for the pandemic, the TelAbortion study can only serve patients who are able to come in for a test.By comparison, the website Aid Access, which does not require an ultrasound, was serving almost 800 patients a month before the pandemic began.

Founded in 2018 by the Dutch physician and activist Rebecca Gomperts, Aid Access offers women in America who are less than nine weeks pregnant the ability, for the first time, to obtain abortion pills by mail with a prescription from a licensed physician. After writing the prescription, Dr. Gomperts provides patients with instructions for how to request the pills from an exporter in India.

Within its first year, Aid Access was contacted by more than 21,000 women in America, as requests for consultations flooded in from across the country. The F.D.A. took notice. Last year, the agency accused the organization of violating federal law and ordered it to stop distributing the drugs in the United States. Dr. Gomperts responded by suing the F.D.A., claiming federal officials had seized medications prescribed to patients through her website.

Amid the pandemic, demand for Dr. Gomperts’ services has surged. Since late March, she says, “approximately 3,000 women living in the U.S. have requested my help.” For a time, Dr. Gomperts had to suspend operations; after India closed its airspace to international traffic, shipments from the pharmacy she works with were halted. But with Plan C’s network, she was able to find American providers registered with GenBioPro and ready to mail.

“This is why I went to med school,” said a doctor in upstate New York who is mailing the abortion drugs on behalf of Aid Access and also spoke on condition of anonymity. “If there’s one thing I hope we can learn from life under Covid, it’s to trust and empower women to take care of themselves, and this is one way of doing that.”



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