Abortion Pills Will Be More Broadly Available Under New FDA Rules

Mifepristone (Mifeprex), one of the two drugs used in a medication abortion, is displayed at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, N.M., on June 15, 2022. Robyn Beck/AFP via Getty Images

The Food and Drug Administration (FDA) finalized a rule change on Tuesday that expands the availability of abortion pills at both physical and online pharmacies.

The new rules mean that any pharmacy can become certified via a short form to provide the abortion pill, not just a handful.

In December 2021, the FDA lifted restrictions on abortion drugs, allowing some doctors to issue telehealth or online prescriptions for the pills and have them mailed to patients or local pharmacies where allowed by law. That change to the regulations about 12 months ago meant that women no longer needed to pick up abortion pills in person from a doctor, as required before the pandemic.

The latest action on Tuesday formally updates the drug’s labeling, allowing many more retail pharmacies to dispense the pills if they complete a certification process. More doctors may now get certified to prescribe abortion pills because they won’t need to stock and dispense them.

Mifepristone is used to terminate early pregnancies up to 10 weeks after conception.

Used in a two-drug regimen as a chemical abortion, mifepristone blocks progesterone, acting to deprive the unborn child of nutrients and stop the pregnancy from progressing, while the second (misoprostol), taken 24 to 48 hours later, induces labor to expel the unborn child.

It’s also used sometimes for women who have miscarriages.

A woman looks at an abortion pill—RU-486, or mifepristone—displayed on a smartphone in Arlington, Va., on May 8, 2020. Olivier Douliery/AFP via Getty Images

Since the FDA approved mifepristone in 2000, patients have been required to retrieve the drug in person from a doctor and a subset of specialty offices and clinics. This rule was temporarily suspended during the COVID-19 pandemic under the Biden administration.

Later, the federal agency announced that a fresh scientific study done by agency personnel recommended relaxing access to the drug, agreeing with various medical associations that had long believed that the limitation was unwarranted.

The FDA has now sought to make the rule change permanent, enabling women to have telehealth care consults and receive the pills by mail “via certified prescribers or pharmacies” where allowed by law.

Currently, 19 U.S. states have laws prohibiting telehealth consultations or mailing of abortion pills, superseding the FDA rules.

Abortion Pill

Before modifying dispensing restrictions on drugs, a business must file an application with the FDA. Two pharmaceutical companies that produce both brand-name and generic abortion medicines requested the most recent FDA label change.

Danco Laboratories, which sells mifepristone branded as Mifeprex, said in a statement the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” with another option for prescribing the drug.

Pro-life think tank Charlotte Lozier Institute (CLI) said there had been an increase in emergency room visits linked to abortion pills.

“The abortion industry claims that abortion pills are safe for women (they are, of course, never safe for the unborn children they target),” the organization said on Facebook.

“Yet peer-reviewed science and data say otherwise. Research shows the rate of abortion pill-related emergency room visits has increased more than 500 percent over the past decade and a half, and that abortion pills put mothers at significantly greater risk for complications.”

In a fact sheet, the organization claimed that chemical abortion has a complication rate of four times that of surgical abortion.

“U.S. abortion data is generally very poor. A key analysis of abortion pill-related adverse events submitted to the FDA shows significant underreporting,” CLI stated. “Planned Parenthood independently reported over twice as many adverse events as the FDA in 2009–2010, despite the fact that FDA’s data is supposed to reflect complications from all abortion providers.”

“FDA’s data is missing as many as 95 percent of all serious adverse events,” CLI further stated. “Since 2016, FDA no longer requires abortion providers to report any complications other than death.”

According to the FDA (pdf), “[t]he estimated number of women who have used mifepristone in the United States for the medical termination of pregnancy through the end of December 2018 is approximately 3.7 million women,” and “regardless of causal attribution to mifepristone,” there have been 24 U.S. deaths reported in people who used the drug.