Food and Drug Administration (FDA) announced a lift on restrictions on mifepristone, allowing doctors to issue online prescriptions for abortion pills and have them mailed to patients or local pharmacies.
pill—referred to as RU-486 or Mifeprex, or by its generic name mifepristone—is used to terminate early pregnancies up to 10 weeks after conception. It is also sometimes used for women who have miscarriages.
Chemical abortion involves a two-drug regimen, the first of which (mifepristone) blocks progesterone, which acts to deprive the unborn child of nutrients and stops the pregnancy from progressing, while the second (misoprostol) induces labor to expel the unborn child.
Since mifepristone’s FDA approval in 2000, the agency has required the drug to be physically dispensed by a doctor and for patients to retrieve it in person. That requirement was temporarily lifted in early 2021 by the FDA under the Biden administration, which cited the COVID-19 pandemic for doing so.
FDA’s rule change on Thursday makes that temporary change permanent, enabling women to have telemedicine health care consults and receive the pills by mail “via certified prescribers or pharmacies.”
Currently, 19 U.S. states have laws prohibit telehealth consultations or mailing of abortion pills, superseding the FDA rules.
Planned Parenthood and the American Civil Liberties Union (ACLU) praised the change, with both groups saying the in-person dispensing requirement was a “medically unnecessary restriction.”
“By eliminating medically unnecessary restrictions, patients in many states can access medication abortion in the privacy of their own home,” Planned Parenthood said on Twitter.
ACLU called the FDA’s move “critical progress,” although it said the agency was “falling short of repealing all unjustified restrictions on this safe medication.” group told Politico it was upset the FDA continues to require patients sign a special form to be prescribed the drug, and to require health care workers to pre-register with the drug manufacturer before prescribing it.
Pro-life think tank Charlotte Lozier Institute (CLI) warned against the FDA’s decision, calling it “dangerous.”
“FDA states on its website that Mifeprex (the abortion pill) should not be taken if a woman has an ectopic pregnancy. Without an in-person doctor visit, this could be missed, leading to severe complications or even death,” the group said on Twitter.
group added, “Abortion by mail eliminates the safe, confidential meeting with a doctor and puts women who do not want an abortion at risk from abusive partners, providing one more reason why mifepristone REMS are necessary and should be strengthened not weakened.”
CLI also noted in a separate statement that a large scale study of over 42,000 abortions in Finland found chemical abortion has four times greater a complication rate than surgical abortion, and that a fifth of all chemical abortions result in complications.
“Abortion activists’ longtime wish has been to turn every post office and pharmacy into an abortion center. y promote abortion drugs as easy, painless and private. Science says otherwise,” Sue Liebel, the state policy director of pro-life group Susan B. Anthony List, said in a statement. “Women who take chemical abortion pills are significantly more at risk of serious complications and more likely to require a visit to the emergency room. Some women even die.”
Lila Rose, president of pro-life group Live Action, called the FDA move “horrific” and a “revolting decision.” She lamented that the pill has killed “24 mothers and 3,700,000 children.” Rose said on Twitter, “Because of this reckless decision, more mothers will die, more kids will die, and the abortion pill will be more widespread than ever.”
According to the FDA (pdf), since 2000, “[t]he estimated number of women who have used mifepristone in the U.S. for the medical termination of pregnancy through the end of December 2018 is approximately 3.7 million women,” and there have been 24 U.S. deaths reported in people who used the drug, “regardless of causal attribution to mifepristone.”
Pezou : FDA Now Allows an Abortion Pill to Be Sent by Mail, Removing In-Person Dispensing Requirement