The Biden administration on Thursday relaxed restrictions around an abortion pill that had prevented women from getting the medication without first making in-person visits to pick up the prescriptions at medical offices.
The Food and Drug Administration decision to allow patients to get the drug mifepristone, sold under the brand name Mifeprex and sometimes known as RU-486, without a visit to a hospital or doctor will help pave the way for the drug to be available for ordering online and delivery by mail, according to groups that support abortion access.
The FDA said in a document posted on its website that it was ending a requirement restricting where mifepristone could be dispensed to certain healthcare settings, such as clinics, medical offices and hospitals.
The agency said it also was adding a requirement that pharmacies that dispense the medication be certified.
Organizations that support abortion rights applauded the action, which follows a lawsuit brought by the American Civil Liberties Union challenging the in-person requirement.
“This decision follows the science, something we could only hope for from our nation’s regulatory body on medications,” said Dr. Jamila Perritt, president and chief executive of Physicians for Reproductive Health. “And the science shows that medication abortion care is safe to administer via telehealth.”
Other groups, including organizations that oppose abortion, said the FDA decision ignored data that mifepristone leads to more emergency room visits.
“Today’s FDA decision ignores several sets of much more substantial data which confirms the abortion pill is a significant public health threat, and the real-world data suggests that threat is growing,” said Dr. James Studnicki, vice president of data analytics at Charlotte Lozier Institute, a group that opposes abortion.
The New York Times earlier reported the FDA action.
Mifepristone, used up to the first 10 weeks of pregnancy, works by halting the supply of hormones that maintain the interior of the uterus, according to the Mayo Clinic.
During the Trump administration, the FDA responded to the pandemic by relaxing certain requirements for drugs, and encouraged telemedicine, to help prevent transmission. However, the FDA didn’t relax the restrictions requiring in-person pick up for the drug mifepristone.
The American College of Obstetricians and Gynecologists, an organization of women’s healthcare physicians, and other groups sued the FDA over its exclusion of mifepristone.
The Supreme Court in January, however, agreed with the Trump administration on excluding the drug.
In May, the FDA said it would review the restrictions around the medication, which is used in abortions and miscarriages.
Write to Stephanie Armour at [email protected]
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Appeared in the December 17, 2021, print edition as ‘FDA Eases Abortion-Pill Restriction.’
https://www.wsj.com/articles/fda-allows-women-to-get-abortion-pill-by-mail-11639698022
