The Food and Drug Administration said Thursday that it would permanently remove a key restriction on medication used to terminate pregnancies, allowing so-called “abortion pills” to be available by mail and prescribed through telehealth medical consultations.
The FDA had temporarily allowed the medication to be available in such methods after a federal judge ordered it due to the COVID-19 pandemic and concerns about virus exposure in health care settings. Now, the agency says it will leave those new policies in place – a key move by the Biden administration as the Supreme Court considers monumental cases that could limit abortion rights across the country.
The FDA, which first approved medical abortion in 2000, had always required the pills could only be prescribed after an in-person visit with a doctor. Women who are up to 10 weeks pregnant could received the medication.
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FDA officials said a scientific review supported widening access, including no longer limiting dispensing to a small number of specialty clinics and doctor’s offices. But prescribers will still need to undergo certification and training. Additionally, the agency said dispensing pharmacies will have to be certified.
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There are two pills approved by the FDA to end a pregnancy, mifepristone and misoprostol, as a safe alternative to a medical procedure. When a person has been prescribed a medication abortion, they will first take the mifepristone, which blocks the body’s ability to absorb its own progesterone, a necessary hormone for a pregnancy to grow. Then the person will take the misoprostol up to 48 hours later, which will cause cramping and bleeding emptying the uterus. Medical providers have said the process is similar to a miscarriage.
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While the use of the medication has steadily increased since it was first approved in 2000, surgical abortions have remained more popular in part because medication abortions are typically more expensive and can only be performed during the first few months of pregnancy.
But an onslaught of new regulations, shuttered abortion clinics and rulings by the Supreme Court could leave people looking to terminate a pregnancy with no other option.
A doctor holds a handful of mifepristone pills, a drug that causes abortion when taken early in pregnancy.
In May, Texas banned abortions after cardiac activity can be detected in the embryo, usually around six weeks. Another Texas state law that began Dec. 1 makes it illegal for anyone to prescribe abortion medication via telehealth or postal mail. Mississippi’s law barring most abortions after 15 weeks of pregnancy was debated recently at the U.S. Supreme Court, with a majority of the high court’s justices signaling they might uphold the law.
The move would weaken the landmark 1973 Roe v. Wade decision, which established a constitutional right to abortion that can be exercised up to the point when a fetus can live outside the womb, about 24 weeks.
The American Civil Liberties Union hailed the elimination of the strictest requirements but said regulators should have gone further and allowed prescribing by any physician and broader dispensing.
“The FDA’s decision to permanently remove the in-person pill pick-up requirement is a major step forward that will enable many more patients to get this safe and time-sensitive medication as soon as they are ready, without travel-related expenses and delay,” said Georgeanne Usova, a senior legislative counsel at the ACLU.
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Other reproductive rights advocates applauded the decision. Planned Parenthood, one of the nation’s strongest supporters of abortion rights, calling it a “win.”
“By eliminating medically unnecessary restrictions, patients in many states can access medication abortion in the privacy of their own home,” the group said.
Anti-abortion advocates said the move could mean more mothers harmed and more lives lost to abortions.
Jeanne Mancini, president of the March for Life education and defense fund, said the move allows a “dangerous pill regimen available without a physician’s oversight,” noting the FDA has documented adverse reactions to the medications.
“It is well documented that chemical abortion is much harder on women’s health than surgical abortion, and today the FDA has lowered the standards for women’s health in name of greater access to abortion, a truly political move that will have grave consequences,” she said. “Today’s decision will lead to more lives lost to abortion, and will increase the number of mothers who suffer physical and psychological harm from chemical abortions.”
Although medication abortions are legal, nearly all states have placed some form of restriction.
An analysis by the Kaiser Family Foundation, a nonprofit research institute focused on health care, found that only licensed physicians can prescribe abortion medication in 33 states as opposed to advanced practice clinicians such as nurse practitioners, physician assistants or nurse-midwives.
The FDA’s latest scientific review of the medication stems from a 2017 lawsuit by the ACLU, which argued the agency’s restrictions block or delay medical care, especially for people in low-income and rural communities.