USA TODAY: Some US women are taking reproductive matters into their own hands: They're ordering abortion pills by mail

by Elizabeth Lawrence

… "Medication abortion has an extensive safety record, and the evidence suggests that the restrictions placed on it by the FDA are unwarranted," said Megan Donovan, senior policy manager at the Guttmacher Institute. "Medical organizations have called for lifting the federal restrictions on medication abortion."

Ingrid Skop, an OB-GYN based in San Antonio and chairman-elect of the American Association of Pro-Life Obstetricians & Gynecologists, expressed concerns about women with ectopic pregnancies obtaining abortion pills from providers not meeting the FDA's criteria. 

"The first pill does nothing to end a tubal pregnancy, and tubal pregnancies rupture the tube," Skop said. "A woman who orders it online without the provision of a doctor is going to have no idea if she has an ectopic pregnancy."

Elisa Wells, co-founder and co-director of Plan C, said the reasoning behind restrictions of this method of abortion is political, not medical. 

"This is a very safe procedure that could be helping people," Wells said. "There’s no medical reason for why it can’t be more widely available than it is outside. It's purely political at this point. People need to know that these pills are so safe."

What are the downsides? 

Traffic on Plan C's website has grown significantly in recent years, Wells said.

It's not just the surge of restrictive abortion bills causing women to pursue other options but a steady legislative effort to limit access, she said.

"The more people are restricted, the more likely that they are going to try to manage an abortion on their own," said Gretchen Ely, an associate professor at the University at Buffalo specializing in access to abortion and contraception. "So instead of it being a pre-Roe situation with objects, they’re going to be looking to manage it with medication. More often, it will be unsupervised." 

Ely said more women turning to unsupervised means of managing their own abortions is a concerning trend. It's far preferable, she said, for women to get abortions with the advice of medical professionals.

Online medication abortions may put women's lives at risk, particularly those in rural areas with limited medical facilities, Skop said.

"We consider this is a human rights issue, because the fetus is a living human being," Skop said. "Rural women who are being primarily targeted by this, they’re not close to a good hospital. We’re running the risk with these mail-order abortions of increasing the mortality rate of the procedure."

The FDA advises against buying abortion pills off the internet because that would bypass FDA requirements.

Read the full article here. Defiance and Innovation Keep Abortion Available, If Not Legal


… Amidst the always heated debate over abortion, Aid Access isn't the only organization assisting women who want access to abortion pills from overseas suppliers. With Alabama and Georgia only the most prominent among the states approving draconian new restrictions on terminating pregnancies, plenty of outfits see both need and profit potential in the large numbers of women who lack easy, legal access to abortions. The same day that Aid Access received the letter in which "FDA requests that you immediately cease causing the introduction of these violative drugs into U.S. commerce," India-based pharmaceutical company Rablon received similar official hate mail.

In fact, there's enough competition in the abortion pills-over-the-Internet market that Plan C, a website sponsored by the National Women's Health Network, maintains an online report card comparing price, quality, and shipping speed. (Aid Access gets the only "A" grade, by the way.)

The drugs supplied by Aid Access, Rablon, and the other players in this gray market sector are mifepristone and misoprostol. Both are recognized by the American College of Obstetricians and Gynecologists (ACOG) as "safe and effective" means of ending pregnancies, especially when used together.

While legal in the United States, the drugs are subject to an FDA Risk Evaluation and Mitigation Strategy—tight restrictions on who can dispense them and where they can be used. Under the restrictions, mifepristone "may only be dispensed in clinics, medical offices, and hospitals by or under the supervision of a certified healthcare provider," among other limits on its availability.

Of course, as with so many restrictions on controversial goods and services, it's very likely the rules were put in place not to protect patients from especially dangerous medications but as barriers to access in lieu of an overt ban. That's what ACOG thinks, anyway.

"ACOG opposes regulations or restrictions that are inappropriately unique to the provision of abortion," the professional organization said last year. "ACOG recommends that mifepristone for reproductive health indications be made available in retail pharmacies like other prescription drugs and without unique provider certification or patient consent requirements."

But the barriers remain in place, and online suppliers based overseas continue to bypass those legal restrictions to reach customers who want what they have to offer.

"As it is generally accepted that the FDA has no authority over the practice of medicine by licensed doctors in the U.S., it is surprising that the FDA would now be claiming to have authority over the practice of medicine by a licensed doctor in Austria," Aid Access's attorney, Richard A. Hearn, wrote to the FDA in a May 16 response. "When U.S. women seeking to terminate their pregnancies consult Dr Gomperts, she will not turn them away."

Aid Access continues to consult with American patients via telemedicine from overseas and issue prescriptions to be filled by pharmacies on the other side of the planet, no matter what U.S. officials may think of the situation.

Read the full article here.

East Idaho News: Pocatello attorney defending European doctor who is defying FDA orders to stop sending abortion pills to US women

by Jessica Ravitz, CNN

Why Aid Access

Gomperts suggested in an email that the federal restrictions amount to hypocrisy.

“In direct opposition to its mission — to protect the public health by ensuring the safety, efficacy, and security of drugs — the FDA has so severely restricted access to these safe and effective pills that few doctors are willing or able to prescribe mifepristone and misoprostol,” she wrote.

So through Aid Access, she began prescribing abortion medication to women in the United States last year. It was an outgrowth of her 13-year-old program Women on Web, which offers this kind of service to women in countries where abortion is illegal. The nearly 1,000 emails she’d received from people in the United States seeking help, some so desperate that they threatened to harm themselves, she said, prompted her to broaden her outreach.

“I realized it was time,” she said last fall. “Something had to be done.”

She has consulted “with women in all 50 states and the District of Columbia,” attorney Hearn said in his letter to the FDA. “Of the 11,108 women who consulted with Dr. Gomberts in 2018, 2,581 were prescribed medicine approved by the FDA to induce a medical abortion during the early stages of their pregnancies.”

Of those she’s served, Hearn said, Gomperts is “not aware of a single death, hospitalization or serious complication attributed to the prescriptions she prescribed for her patients in the U.S.”

There are other ways to get abortion pills by mail in the United States, for women who can’t get to or afford clinic visits, but Aid Access is the most affordable option at $95, according to the grassroots group Plan C, which aims to educate women about self-managed abortion. Aid Access also offers the possibility of financial help, according to its website.

Plus, it’s the single source to offer physician oversight, according to a Plan C report card.

Aid Access is the only one of eight suppliers to receive a grade of A.

What happens next

A 2015 study showed abortions by medication to be about 97% effective. Interest in self-managing or self-inducing abortions is on the rise, according to reports.

In a one-month period in 2017, research published last year showed, there were nearly 210,000 US Google searches for information about self-abortion. This indicates a demand for alternatives, perhaps driven by barriers to clinic access due to financial hardship, geographic distance, fear of being publicly shamed or other reasons.

Read the full article here.

Medium: Trendy Health Startups Still Don’t Offer What Women Need

by Lux Alptraum

… “We need innovation in abortion care,” says Elisa Wells, co-founder and co-director of Plan C, an advocacy organization that provides information about access to medication abortion. Even in states like New York, where there are few legal restrictions to providing abortion care, people seeking out the service are limited to a handful of clinics mostly based in major cities. Wait times can be long and appointments limited and at inconvenient times. Even something as simple as increasing the number of abortion providers could have a dramatic impact on women’s access and experience — and yet fewer than 2,000 doctors in the U.S. provide abortion services.

If so many reproductive health care startups recognize and understand that abortion is an essential component of women’s health, why are so few stepping up to disrupt abortion access and make the service effortless to obtain?

Abortion providers in the U.S. face a number of challenges, including the punitive legal restrictions, which are on the rise across the country. While the laws passed by Georgia and Alabama are often difficult to enforce (if not outright unconstitutional), onlookers say the restrictions have a chilling effect on doctors and clinics that might otherwise offer abortion services.

Providers also face a business model that requires them to provide a high-cost service to an often low-income client base. On top of that, providing abortion is still stigmatized work — work that can put a physician in the crosshairs of potentially violent anti-abortion zealots. “Why does anyone do this work?” says Melissa Grant, co-founder and COO of the abortion provider Carafem, with a laugh.

Carafem is an anomaly. It’s a new health care company that’s investing in and streamlining reproductive health care using modern technology. Abortion is their primary service.

Grant came to Carafem after years of working with family-planning organizations across the U.S. As she worked to connect people to abortion providers, she became frustrated with the barriers to access, and she wanted to figure out a way to make it easier to get an abortion. Her co-founder, Christopher Purdy, came from a more international background — as CEO of DKT International, he spent his career improving contraceptive marketing and messaging in the developing world — and the job left him befuddled about the state of abortion access in one of the richest countries in the world. “He pondered out loud why it was possible that in some areas of the U.S. it was more challenging to get an abortion than to get one in Ethiopia,” Grant says. (While Ethiopian law places some restrictions on who can have an abortion, the service is available at the majority of venues that are capable for providing abortion, including 98% of the country’s public hospitals.)

Read the full article here.

Fast Company: The wave of restrictive abortion bans may force telemedicine providers to get more creative

by Pavithra Mohan

… What many people don’t realize is that medication abortion pills were approved by the FDA nearly 20 years ago—albeit with a number of restrictions—and are much more common in other countries. “Abortion pills themselves are not very well known in the U.S., and the use is very low when compared to other countries,” says Elisa Wells, the cofounder of Plan C, a platform that provides detailed information on medication abortions and reviews on abortion pill providers. “So you wonder, why is that? Why is it such a popular method elsewhere? And I think it’s in part because of the restrictions that have been placed on medication abortion.” Those regulations include not selling the abortion pill as an over-the-counter medication and requiring that providers register with a distribution company to carry the drug.

Many are now turning to online pill providers, which allows them to take charge of their bodies—and don’t require any in-person consultations or medical tests. For people in states with three or fewer abortion clinics, or who are far from healthcare of any kind, telemedicine options like TelAbortion may not be realistic (or available anytime soon). What many of them can benefit from, however, is the freedom to purchase safe, legitimate abortion pills online—something countless individuals are already doing through Aid Access, an organization selling abortion pills run by a physician named Rebecca Gomperts. (It’s also the online provider with the highest rating, according to Plan C, and offers the option of an online medical consultation.)

Read the full article here.

Ageist: Francine Coeytaux francine coeytaux, 64, public health specialist, los angeles

by Andreas Tzortzis

… Coeytaux’s journey to social scientist and advocate began in rural California, where her French father moved the family after the independence movement in Tunisia forced a change.

“If you ask me where I was born, I was born in Switzerland. If you ask me where I grew, I would say Tunisia. If you ask me what I am, it’s French,” she says. “If you ask me where I’ve lived most of my life? It’s California.”

While studying at Stanford, she spent a semester working at a pediatric clinic in the slums outside Lima, Peru. The stream of women who came with multiple children and questions as to how to avoid future pregnancies made Coeytaux realize that the greater issue — that of family planning — wasn’t being properly addressed in third world countries.

When she moved to New York with her husband in the 1980s and joined the Population Council, that realization became the foundation of her work. Starting with work in Tunisia, she criss-crossed Africa conducting research and helping put family planning programs in place.

Read the full article here.

OneZero - Medium: Telemedicine Will Change How Underground Abortions Work

by Lux Alptraum

…In order to make use of TelAbortion’s services, one has to be able to conduct an online consultation and receive mail within the borders of one of its approved states — simpler and less stressful traveling to an abortion clinic in another state, especially when pills alone are often significantly cheaper than a surgical abortion.

Additionally, online abortion services offer scheduling flexibility rarely afforded by clinics, where abortions may only be available one day a week when providers happen to be on site. “The nice thing about the TelAbortion project is that women are able to obtain the service at a time that’s convenient to them,” says Inga Platais, a program associate for Gynuity.

Easy access to self-managed abortion in some states is hardly a panacea for regressive abortion laws in others.

But even as telemedicine has the potential to radically change our understanding of abortion access, the promise of projects like TelAbortion is currently stymied by FDA regulations. Since its debut on the U.S. market in 2000, mifepristone has been governed by an additional set of restrictions known as Risk Evaluation and Management Strategies (often referred to as the REMS), which severely curtail when, how, and under what circumstances the drug can be dispensed.

Most notably, the REMS requires mifepristone to be dispensed at a clinic, hospital, or medical office — a restriction that makes distribution by mail potentially in violation of FDA policy. As a research project, TelAbortion is given some leeway with regards to the REMS, but until the REMS is overturned, it’s unlikely that we’ll see other U.S.-based telemedicine abortion projects following in its footsteps. Even if it is, it’s possible that states may decide to curtail the expansion of telemedicine abortion, through restrictions that discourage pregnant people from self-managing their procedures at home.

And while the combination of telemedicine and self-managed abortion has the potential to provide an appealing alternative to unsafe back-alley abortions or lengthy trips to the lone abortion clinic in a neighboring state, it’s still far from a perfect solution for people living in anti-abortion states. Easy access to self-managed abortion in some states is hardly a panacea for regressive abortion laws in others.

Read the full article here. Online supplier of abortion pills defies FDA order to stop providing them in U.S.

by Marie McCullough

..Aid Access resumed service the next day.

The FDA declined to discuss its next step. “We cannot comment on a potential future action at this time,” the agency emailed, “but we remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women’s health.”

The abortion-pill regimen, which is effective through the first nine weeks of pregnancy, actually involves two drugs. Mifepristone, sold in the U.S. by Danco Laboratories and branded Mifeprex, disrupts the pregnancy, then misoprostol triggers uterine contractions and expulsion of the grape-size fetus.

The FDA requires women who want the regimen to make two visits to the doctor, and they can’t get mifepristone from pharmacies. It can only be dispensed in clinics or medical offices by specially certified health-care providers.

Aid Access, in contrast, provides pills after a woman consults online with the prescribing doctor and gets a blood test. She receives instructions for taking the drugs, what to expect, and when to see a doctor if a problem occurs.

Numerous other international websites ship abortion pills — without prescription or any medical oversight. That’s why a group of researchers who support abortion rights created Plan C, a website with a “report card” that rates such websites on product quality, price, and shipping time.

"The combination of very safe and effective medication abortion, and the pervasiveness of global commerce, make Internet access virtually unstoppable,” said public health researcher Elisa Wells, codirector of Plan C.

Read the full article here.

The Cut: Is This the Biggest Threat to the Anti-Abortion Movement?

Rebecca had expected anti-abortion backlash when she started working in America. But getting a letter from the FDA was weird. The FDA doesn’t regulate doctors — and they definitely don’t regulate doctors in Austria, where Rebecca is now based.

Rebecca: I’m a doctor. I work under my jurisdiction. I’m allowed to write these prescriptions and the women can fill these prescriptions by a pharmacy where that can be done. And actually it’s my duty as a doctor when people in need of care and medical care reach out to me. I have the duty to help them if I can. And that’s what I’m doing. That’s that’s what I will continue to do and that’s what I’m doing.

Rebecca has continued her work. When we asked the FDA whether they were going to do anything about it, they told us they couldn’t comment on potential future actions, but that they remained concerned that Aid Access was bypassing, quote, “important safeguards designed to protect women’s health.”

A little while after the FDA sent their letter to Rebecca, 118 members of Congress sent a thank-you note to the FDA commissioner. All but one of them were Republicans. And only ten of them were women … or, fewer than the total number of Jims, Mikes, and Steves.

Read the full article here.

New Statesman: Why so many American women are ordering abortion pills online

by Sophie McBain

…Meanwhile, another American non-profit, Plan C, which was founded in 2015 by two public healthcare experts, Elisa Wells and Francis Coeytaux, is also trying to plug the gaps in American abortion provision by providing women the information they need to obtain an abortion with pills.

It directs women who live in Georgia, Washington State, Maine, Oregon, New York, New Mexico, Hawaii and Colorado to a pilot “TelAbortion” project, which will mail abortion pills to a woman’s home following an online medical consultation.

For others, it offers information on how to safely self-administer a medical abortion. Knowing that many women have already tried to order abortion pills online, without knowing whether they are being scammed, Plan C compiles and regularly updates a “report card” that rates different websites from which you can buy abortion pills.

Wells told me that traffic to Plan C’s website keeps increasing, too. They now average around 40,000 hits a month.

“If the worst-case scenario happens [and Roe v Wade is overturned], there will be more need than ever for groups like Plan C, that are providing information for people to make their own decisions about the medical care they need, and to gain access to that medical care,” says Wells. “There’s no stopping people from accessing information and medications, we have a global economy and a global information system.”

Read the full article here.