PHILADELPHIA The pandemic is helping U.S. abortion-rights advocates achieve a long-standing goal: Make it easier for women to use pills to end pregnancies up to 10 weeks.

Federal and state regulations have restricted access to medication abortion ever since the Food and Drug Administration approved it two decades ago. Nonetheless, use of the two-drug regimen has grown steadily, accounting for at least 40% of all abortions, even as the national abortion rate has fallen to historic lows, data show.

Before the coronavirus made seeking medical care in person risky for both patients and providers, efforts were well underway to expand access to abortion pills through telemedicine and mail-order pharmacies. Now, those efforts are accelerating and multiplying because suddenly a divisive political issue is also a matter of public health.

For patients seeking abortion, urgent modifications of current protocols are needed to ensure that patients can continue to obtain this time-sensitive treatment while limiting transmission of infection, 11 prominent reproductive health experts wrote last month in the journal Contraception.

The group, led by obstetrician-gynecologist Elizabeth Raymond, proposed reducing in-person clinic visits by eliminating ultrasounds and other tests that research shows are unnecessary for a safe, effective pill-induced abortion.

Planned Parenthood Southeastern Pennsylvania, which adopted the test-less approach in mid-March, quickly saw a shift. Although the total number of medication and surgical abortions remained about 800 a month, the proportion that used pills increased from 55% before the pandemic to 65% now.

We wouldnt be offering it if it werent safe, said Dayle Steinberg, president and CEO of the Southeastern Pennsylvania affiliate. The pandemic is showing us that we have to be nimble and adapt.

WHEN PRECAUTIONS BECOME DANGERS

Some background: Medication abortion starts with a pill called mifepristone, which blocks a hormone vital to pregnancy. That is followed 24 to 48 hours later by at least two misoprostol pills, which induce contractions. (Misoprostol is also used to treat stomach ulcers.)

In 2000, when the FDA made the controversial decision to approve mifepristone, it imposed stringent safety requirements. The drug can be dispensed only by specially certified health-care providers and only in clinics, hospitals, and medical offices not pharmacies like most prescription drugs.

Medical societies and public health experts have called on the FDA to remove the restrictions. Physician Jane E. Henney, FDA commissioner when mifepristone was approved, added her voice last year. Last month, so did Democratic Sens. Elizabeth Warren and Patty Murray, urging a reevaluation in light of the growing coronavirus disease pandemic.

The FDA has not budged, even though its own review says medication abortion has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.

Advocates have not been deterred by the FDAs inflexibility.

Over the last year, Gynuity Health Projects a New York City-based nonprofit that Raymond joined in 2010 has expanded its FDA-approved study of medication abortion via telemedicine from five states to 13. It enables women to have video conferences with certified doctors, then get the pills mailed to them to take at home.

Still, Gynuitys TelAbortion has served fewer than 1,000 women over more than three years. Partly, thats because the FDA requires all study participants to have an initial in-person visit and an ultrasound to make sure they are no more than 10 weeks pregnant.

BENDING THE RULES

Studies have shown an ultrasound is unnecessary; only 1% of women do not accurately recall the date of their last menstrual period, and medication abortion still works for the vast majority of them. Other parts of the typical medication abortion protocol a pelvic exam, blood tests, and a return visit to confirm the termination are also unneeded, research shows.

Thats why Raymond and her 10 colleagues wrote the Contraception article, which laid out a protocol for evaluating, treating, and following up with patients in a way that would bend but not break the FDA rules.

Although FDA-imposed restrictions on mifepristone may require patients to present to the abortion facility to obtain the drug, this protocol would enable every other part of the medication abortion process to be implemented without any in-person encounter, they wrote.

Nothing like an epidemic to accelerate innovations, Raymond said in an interview.

Abortion foes denounce such innovations as endangering womens health. So far, 18 states have enacted various laws designed to ban the use of telemedicine in medication abortion. More recently, several states have tried to ban all abortions under pandemic emergency orders restricting elective medical procedures.

While the political divide is wider than ever, even abortion-rights activists dont agree on how much medical support women seeking medication abortion need or how best to provide it.

Numerous international websites ship abortion pills without prescription or any medical oversight to women who self-manage the termination in secret. Recognizing that the internet makes such uncounted abortions virtually unstoppable, public health researcher Elisa Wells cofounded Plan C, a website with a report card that rates such websites on product quality, price, and shipping time.

In early March, as the pandemic deepened, Plan C took another step toward helping women self-manage: It asked doctors across the country to register with one of the two FDA-approved manufacturers of mifepristone so they can obtain pills to mail to women in their homes.

FDA regulations say mifepristone must be dispensed in a facility, but Plan C maintains that dispensing is different than delivering.

Most doctors read the (FDA regulations) to say the pills cant be mailed, Wells said, adding that a handful of doctors have joined the new initiative. We disagree.

Aid Access, a mail-order abortion-pill service overseen by Dutch physician Rebecca Gomperts, has already been ordered to cease and desist by the FDA.

Gomperts set up Aid Access last year using the model of her first abortion-pill service, Women on Web, which serves women in countries were abortion is illegal. Basically, the pregnant woman consults online with the prescribing doctor, then gets a script to email to an Indian company that ships the pills. Instructions explain how to use the drugs, what to expect, and when to see a doctor if problems occur.

Although Gomperts didnt respond to a request for comment, she was recently quoted in the New York Times saying that the pandemic has fueled demand, with about 3,000 women requesting help from Aid Access since late March.

As for the FDA, Gomperts has a complaint against the agency pending in federal court. The FDA, she maintains, is trying to deny the constitutional right to abortion.

Dr. Gomperts has standing to assert the constitutional rights of her patients seeking medical abortions in the U.S., her legal brief says.

2020 The Philadelphia Inquirer

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