FDA warns against provision of abortion pills to women before pregnancy

Washington D.C., Nov 1, 2022 / 18:00 pm

The Food and Drug Administration (FDA) is warning about the dangers of health professionals prescribing an abortion drug to women before they are pregnant, after it had previously loosened restrictions on the drug.

Some abortion providers are participating in “advance provision” of these abortion drugs in response to state abortion restrictions following the Supreme Court’s recent decision to overturn Roe v. Wade. 

“The FDA is concerned about the advance prescribing of mifepristone for this use,” an FDA spokesperson told Politico on Friday. “Mifepristone is not approved for advance provision of a medical abortion.”

The agency’s comments come after it lifted restrictions on mifepristone distribution in December. The decision authorized doctors to prescribe the drugs online and mail the pills, allowing pregnant women to perform early abortions without leaving their homes. 

The FDA first approved mifepristone, which is paired with another drug called misoprostol, for earlier abortions in 2000. Taken by pill, this type of abortion — approved by the FDA for use up to 10 weeks of gestation — is also referred to as abortion with pills, chemical abortion, medication abortion, and telemedicine abortion.

This type of abortion accounts for more than half of all abortions in the U.S., according to the Guttmacher Institute, a reproductive research organization once associated with Planned Parenthood.

Dr. Ingrid Skop, senior fellow and director of medical affairs for Charlotte Lozier Institute (CLI), responded to the FDA’s new remarks.

“I was surprised to hear the FDA say this because last December, when they approved the provision of mifepristone without in-person prescribing, they set themselves up for this to happen,” she told CNA.

Politico reported that the FDA spokesperson condemned advance provision because it does not allow abortion providers properly to ensure safety and effectiveness. The outlet noted that the FDA expressed concern about pregnant women consuming mifepristone before a medical professional determines whether a pregnancy is intrauterine or ectopic, as well as the age of the unborn baby. 

Skop, who has more than 25 years of experience as an OB-GYN, expressed similar concerns about women using mifepristone when it is not handed to them directly by a prescriber.

“We don’t know for sure how far along she is [in her pregnancy]. We’re using her estimate, and many times that’s incorrect,” Skop said, “and the mifepristone-misoprostol does not work very well beyond about 10 weeks’ gestation.” 

She also pointed to the problem of ectopic pregnancy, a potentially life-threatening situation where an embryo implants outside the uterus or womb, usually in one of the fallopian tubes.

“Mifepristone does not work on an ectopic pregnancy,” she stressed. “That pregnancy can continue to grow, and the tube can rupture. And this is a fairly common cause of maternal deaths.”

Another concern is that the person requesting the abortion pills may not be the person taking them.

“This can leave the door open for coercion, it can leave the door open for other people to get ahold of the medicine and give it to a woman who may not necessarily desire an abortion,” she said.

As the FDA loosens restrictions on mifepristone, she cautioned that “we’re just seeing more and more potential for complications” and called for a different approach.

“Rather than prescribing a potentially dangerous medication that may be misused, this would be a perfect opportunity to have a proactive conversation about how to prevent an unintended pregnancy,” she said.

In anticipation of the FDA’s decision last year, CLI released a study authored by Skop and other experts finding increased access to abortion pills a public health risk.

“The rate of abortion-related emergency room visits following a chemical abortion increased over 500% from 2002 through 2015, according to an analysis of Medicaid claims data,” the press release read. “Over the same period, chemical abortions within the study population increased from 4.4% to 34.1% of total abortions.”

The study also found that the rate of abortion-related emergency-room visits is increasing faster for chemical abortions than for surgical abortions and that chemical abortion makes subsequent abortions more dangerous.

The FDA did not provide a comment by time of publication.