(Bloomberg) -- The U.S. Food and Drug Administration on Thursday removed a key restriction on the abortion pill, allowing it to be sent to people’s homes instead of requiring patients pick it up at the doctor’s office.
The decision comes as the U.S. Supreme Court weighs the fate of legal abortion. The conservative justices signaled in arguments earlier this month that they were open to rolling back current protections established under Roe v. Wade. Overturning Roe would leave it up to states to regulate abortion. A dozen have “trigger laws” that would immediately ban the procedure. Many also further regulate the pill — 19 require a clinician to be present when a woman takes it, according to the Guttmacher Institute, a reproductive health research group.
The FDA’s change will mean women don't have to travel to a clinic to get the drug. The agency is requiring that pharmacies that dispense the pill be certified. Almost 90% of American women currently live in counties without a clinic. Many who get abortions are low-income and can't afford to travel or take time off of work.
The FDA said it made the change to “reduce burden on patient access and the health care delivery system” and because the benefits of the drug outweighed the risks.
“With states banning abortion at earlier and earlier points in pregnancy, it is all the more essential that the FDA remove medically unnecessary restrictions that reduce where and how patients can safely fill their mifepristone prescription — and today’s decision is critical progress, though far from complete,” said Julia Kaye, a staff attorney with the ACLU Reproductive Freedom Project, in an emailed statement. Georgeanne Usova, senior legislative counsel at the ACLU, added that the FDA “fell short” in repealing all the medically unnecessary restrictions.
Currently, some 40% of abortions in the U.S. are done using mifepristone, a drug that when combined with another pill induces an abortion. It can be used up to 10 weeks of pregnancy. The restrictions on mifepristone are known as a Risk Evaluation and Mitigation Strategy, or REMS program. Such restrictions apply to around 60 of the 20,000 prescription drugs approved by the FDA.
The regulations previously required patients to go to a doctor’s office to get the pill — they couldn’t get it sent to them in the mail or pick it up at a pharmacy.
U.S. regulators first approved the drug in 2000 and immediately imposed restrictions that are generally reserved for drugs that carry serious risks. A growing body of evidence over the last two decades has shown the pill is safe and effective. Research from Advancing New Standards in Reproductive Health looking at some 11,000 medication abortions in California showed that only 0.3% of women had a serious adverse event after taking it. The group said the abortion pill is safer for patients than commonly used drugs like Viagra and Tylenol. In an editorial in the New England Journal of Medicine, a group of experts urged the FDA to reconsider the restrictions as studies had demonstrated the pill was “extremely safe and effective.”
During the pandemic, the Biden Administration temporarily allowed for the pill to be sent by mail. Now, the FDA has made that permanent. The move comes as a result of a lawsuit filed by a family doctor in Kauai, Hawaii represented by the ACLU. He wanted to be able to prescribe the pill to his patients so they didn’t have to take a flight to another island to get the drug.
States can still pass laws to further regulate the pills. This month, a Texas law went into effect that bans its use after 7 weeks of pregnancy. South Dakota's governor issued an executive order curbing access to the drug in September.
©2021 Bloomberg L.P.
RECOMMENDED FOR YOU
POPULAR