The United States Food and Drug Administration on Thursday lifted a key restriction on the abortion pill, allowing it to be shipped to people’s homes instead of forcing patients to collect it from the doctor’s office.
The decision comes as the United States Supreme Court assesses the fate of legal abortion. Conservative justices signaled in arguments earlier this month that they were open to overturning the current protections established in Roe v. Wade. Overthrowing Roe would leave it up to the states to regulate abortion. A dozen have “trigger laws” that would immediately ban the procedure. Many also regulate the pill more – 19 require a clinician to be present when a woman takes it, according to the Guttmacher Institute, a reproductive health research group.
The FDA change will mean women won’t have to go to a clinic to get the drug. The agency requires pharmacies that dispense the pill to be certified. Almost 90% of American women currently live in counties without a clinic. Many of those who have abortions have low incomes and cannot afford to travel or take time off work.
The FDA said it made the change to “reduce the 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 increasingly early stages of pregnancy, it is all the more essential that the FDA remove medically unnecessary restrictions that reduce where and how patients can safely fill their prescription. mifepristone – and today’s decision is critical progress, although far from complete, “Julia Kaye, a lawyer with the ACLU Reproductive Freedom Project, said in an emailed statement. Georgeanne Usova ACLU’s senior legislative advisor added that the FDA “has failed” to repeal all medically unnecessary restrictions.
Currently, about 40% of abortions in the United States are performed using mifepristone, a drug that when combined with another pill causes an abortion. It can be used up to 10 weeks of pregnancy. The restrictions on mifepristone are known as the Risk Assessment and Mitigation Strategy, or the REMS program. These restrictions apply to approximately 60 of the 20,000 prescription drugs approved by the FDA.
Previously, regulations required patients to go to a doctor to get the pill – they couldn’t mail it to them or pick it up at a pharmacy.
US regulators first approved the drug in 2000 and immediately imposed restrictions that are usually reserved for drugs that carry serious risks. A growing body of evidence over the past two decades has shown that the pill is safe and effective. Research from Advancing New Standards in Reproductive Health of some 11,000 medical 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 female patients than commonly used drugs like Viagra and Tylenol. In an editorial in the New England Journal of Medicine, a panel of experts urged the FDA to reconsider the restrictions after studies had shown the pill to be “extremely safe and effective.”
During the pandemic, the Biden administration temporarily allowed the pill to be mailed. Now the FDA has made this permanent. The move follows a lawsuit brought 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 wouldn’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 came into effect that bans its use after seven weeks of pregnancy. The governor of South Dakota issued an executive order restricting access to the drug in September.