The FDA announced Thursday it will no longer require in-person doctor visits for women who want the chemical abortion pill, a move some physicians say will endanger women across the country.
The agency temporarily lifted the requirement in April so doctors could prescribe the pill after a virtual visit. Unlike morning-after pills, which are available over the counter and aim to block fertilization, chemical abortion pills terminate a developing fetus in the uterus. Chemical abortion pills have four times the complication rate as surgical abortions and are more likely to send women to the emergency room. Physicians recommend in-person exams prior to prescribing abortion pills because ultrasounds can help minimize harm to the mother.
"If you can't tell a woman how far along she is you also can't tell her what her risks are," Dr. Donna Harrison, the chief executive officer of the American Association of Pro-Life Obstetricians and Gynecologists, told the Washington Free Beacon. Women often misdate their pregnancies and taking the abortion pill too late could prove deadly. Harrison also noted that virtual visits would make it easier for men to force women to take the abortion pill.
"There is no way to know what abusers, what pimps, what disgruntled boyfriends will do with this drug," Harrison told the Free Beacon. "It's bad for women."
Pro-choice activists are pushing to expand access to chemical abortions as states pass laws restricting surgical abortions. Plan C, a website that details how to illegally purchase chemical abortion pills online, said it has seen a significant increase in web traffic, especially in Texas, which enacted a six-week abortion ban in September. States have placed restrictions on chemical abortion pills such as requiring they be purchased in-person and through a provider, but pills not approved by the FDA have continued to sell online with ease. The FDA sent a cease and desist letter in 2019 to the top illegal supplier in the country, Aid Access, but no action has been taken to stop its sales.
The FDA announced in April 2021 that doctors could prescribe chemical abortion pills with virtual visits for the duration of the pandemic, but did not specify when that rule would lapse. Thursday's announcement makes this move permanent. It also removes mifepristone from the FDA's Risk Evaluation and Mitigation Strategy program, which imposes tight regulations on drugs determined to have serious health risks. Removing mifepristone from this program could clear the way for chemical abortion pills to be made available over the counter.
More than 70 Democratic politicians signed onto a resolution in August calling on the FDA to deregulate mifepristone, the active ingredient in abortion pills. The resolution was backed by Planned Parenthood Federation of America, NARAL, and the American College of Obstetricians and Gynecologists, the leading membership organization for OBGYNs. Rep. Carolyn Maloney (D., N.Y.) earlier this month called for the FDA to make chemical abortion pills available over the counter.
Dr. Tara Sander Lee, a senior fellow at the Charlotte Lozier Institute, said the next logical step in this push for abortion is to make abortion pills available over the counter.
"As states themselves decide to put safeguards in place to protect these women, I know there is a real danger that women are being encouraged to stockpile these chemical abortion drugs before they even get pregnant," Sander Lee told the Free Beacon.
The FDA has worked to deregulate abortion pills in recent years. In 2016, the agency stopped requiring drug makers to report adverse events in women who took abortion pills.
A federal judge lifted the in-person requirement in July 2020 amid the pandemic, but the Supreme Court ruled in January that a physical checkup is still required. The FDA responded to the decision by lifting the in-person appointment requirement in April for the remainder of the pandemic.
Tessa Longbons, a senior research associate at the Charlotte Lozier Institute, says that because drug makers only have to report deaths, it allows regulators to pretend abortion pills are safe.
"In the real world," Longbons told the Free Beacon, "multiple peer-reviewed studies show that real women are suffering a significantly greater risk of complications from chemical abortions than surgical abortions."
Mifepristone is sold under the brand name Mifeprex by Danco Laboratories. In the 1990s, Danco took millions of dollars from foundations run by Warren Buffett, George Soros, and David Packard to help it gain FDA approval. These foundations donate tens of millions annually to abortion groups, including Planned Parenthood and NARAL.
Mifeprex is Danco's only drug. The Packard and Buffett Foundations funded a 2018 study on the safety of the drug. The American College of Obstetricians and Gynecologists cited the study to support deregulating chemical abortion pills. The report's authors included former employees of Planned Parenthood, NARAL, and the Later Abortion Initiative.