Distributing abortion pills

FDA loosens rules for distributing abortion pills, opening new battle fronts

Heightening the stakes is the Supreme Court’s pending decision on Mississippi’s 15-week abortion ban.

By ALICE MIRANDA OLLSTEIN

The Food and Drug Administration on Thursday said it's lifting longstanding restrictions on abortion pills, clearing the way for doctors to prescribe the drugs online and have them mailed to patients or sent to local pharmacies.

Enforcement of the agency’s decades-old rules requiring the pills to be physically handed out by a physician was suspended earlier this year following a lawsuit from the ACLU arguing that the risks of traveling to a doctor’s office during the Covid-19 pandemic outweighed any potential harms from having the drugs delivered. Now, the agency says it will move to make the looser distribution rules permanent.

While Planned Parenthood and other abortion-rights groups celebrated the decision, calling it “long overdue,” the ACLU told POLITICO they were upset that the FDA kept a requirement that patients sign a special form in order to be prescribed mifepristone, as well as a requirement that clinicians pre-register with the drug manufacturer before they prescribe the pills.

Julia Kaye, an attorney with the ACLU's Reproductive Freedom Project, said the remaining restrictions are "an unnecessary hurdle that prevents many abortion and miscarriage patients from accessing this safe, time-sensitive medication from their own qualified health care providers."

Patrizia Cavazzoni, the Director of the FDA's Center for Drug Evaluation and Research said in a letter to the ACLU on Thursday that their review of the drug's safety data found that the restrictions "must be modified to minimize the burden on the healthcare delivery system." But the agency argued for maintaining some of the restrictions the group had challenged, saying that physicians prescribing the drugs need to "have the ability to date pregnancies accurately and to diagnose ectopic pregnancies" and "be able to provide any necessary surgical intervention, or have made arrangements for others to provide for such care" in the event of a complication.

FDA also preserved previous administrations' warning against buying the pills online, telling patients Thursday that doing so will "bypass important safeguards designed to protect your health." Online pharmacies that source the pills from overseas are popular with activist groups that are working to get the drugs to people in states that may move to ban them.

The FDA’s move is set to open a new front in the ongoing battle over abortion rights, with activists and lawmakers on the right pushing national and state restrictions on the pills while their counterparts on the left work to get information out about where people can obtain the drugs no matter where they live or what bans are enacted.

Heightening the stakes is the Supreme Court’s pending decision on Mississippi’s 15-week abortion ban that people across the political spectrum anticipate will give states permission to sharply roll back access to the procedure.

"People think that Roe v. Wade being overturned means our work is done. That’s not true. It will become a 50-state battle, and that’s where we’re going to be fighting," Kristan Hawkins, the president of the anti-abortion-rights group Students for Life of America, said Thursday during a press conference, stressing that pushing state and federal restrictions on the pills will be one of the movement's top priorities.

Anti-abortion-rights groups said Thursday they are also working to counteract what they anticipate will be a "great backlash from the other side” should Roe fall, and are investing millions to elect politicians in 2022 and 2024 who will sign restrictions on the pills into law.

"We have to have the presidency. We have to have the U.S. Senate and, most importantly, we have to have governorships all over the country," Susan B. Anthony List President Marjorie Dannenfelser told reporters Thursday.

The FDA reviewed mifepristone — one of two drugs used to end a pregnancy in the first 10 weeks — because of several lawsuits, including one filed in 2017 that challenged the regulations and argued the pills are just as safe whether distributed in person or by mail.

Xavier Becerra, the former California attorney general and current HHS secretary, also sued the Trump administration in 2020, leading several of his fellow Democratic attorneys general in petitioning the FDA to suspend enforcement of the restrictions during the pandemic because they put patients at unnecessary risk from the virus.

The Trump administration’s FDA initially refused, saying in 2018 that it carried “substantial health risks … including incomplete abortion or serious bleeding that can cause death and requires surgical intervention.”

A lower federal court sided with the groups challenging the rule, but the Supreme Court threw out that decision in January of this year, clearing the way for the Trump administration to reinstate the restrictions.

The Biden administration moved to allow telemedicine prescription and mail delivery of the pills as long as the public health emergency lasted, and in May FDA officials announced they were reviewing the permanent rules around the drug’s distribution.

The pills — which are far cheaper than a surgical abortion — were growing in popularity before Covid-19, and now comprise more than 40 percent of all the country’s abortions prior to 8 weeks of pregnancy. Their use is expected to grow significantly following today’s federal rule change. Yet access to the drugs already vary widely by state, disparities set to widen if the Supreme Court chips away at or overturns Roe v. Wade.

Many Republican-led states have rushed to limit who can access the pills, when and where, with many more states likely to follow in 2022.

Activists are devising ways to help people in those red states get around the bans, raising money to help them cross state lines, directing them to sites like Aid Access and Plan C where they can order the pills, and creating grassroots organizations modeled on those that helped people terminate a pregnancy before Roe v. Wade.

“As we see more of these restrictions set in, the type of networks that our parents and grandparents had in place to support each other to get women access to safe abortion will have to get built again,” said Kristin Mink, an activist with the Center for Popular Democracy Action. “But this time, with an online component.”