The Food and Drug Administration said Thursday it would permanently remove a key restriction on drugs 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 drug to be available in such methods after a federal judge ordered it due to the COVID-19 pandemic and concerns about exposure to the virus in healthcare 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, has always required that the pills can only be prescribed after an in-person visit with a doctor. Women who are up to 10 weeks pregnant might receive the drug.
FDA officials said scientific review supports expanding access, including no longer limiting distribution 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 need to be certified.
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There are two FDA-approved pills for terminating a pregnancy, mifepristone and misoprostol, as a safe alternative to a medical procedure. When a person is prescribed a medical abortion, they first take mifepristone, which blocks the body’s ability to absorb its own progesterone, a hormone necessary for the growth of a pregnancy. Then the person will take misoprostol up to 48 hours later, which will cause cramping and bleeding as the uterus empties. Medical providers said the process resembled a miscarriage.
Although the drug’s use has grown steadily since its first approval in 2000, surgical abortions have remained more popular in part because medical abortions are generally more expensive and can only be performed during the early months of pregnancy.
But an onslaught of new regulations, shuttered abortion clinics and Supreme Court rulings could leave people seeking to terminate a pregnancy with no other options.
In May, Texas banned abortions after heart activity is detected in the embryo, usually around six weeks. Another Texas state law that took effect Dec. 1 prohibits anyone from prescribing abortion medication through telehealth or mail. Mississippi’s law banning most abortions after 15 weeks of pregnancy was debated in the US Supreme Court recently, with a majority of high court justices signaling they could uphold the law.
This decision would weaken the landmark 1973 Roe v. Wade, who established a constitutional right to abortion that can be exercised until a fetus can live outside the womb, around 24 weeks.
The American Civil Liberties Union welcomed the elimination of the stricter requirements, but said regulators should have gone further and allowed for prescription by any physician and broader dispensation.
“The FDA’s decision to permanently remove the requirement for in-person pill pickup is a major step forward that will allow many more patients to get this safe, time-saving medication when they are ready, without travel costs or delays. .,” said Georgeanne Usova, Senior Legislative Counsel at the ACLU.
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Other reproductive rights advocates applauded the decision. Planned Parenthood, one of the strongest proponents of abortion rights in the country, calling it a “victory.”
“By eliminating medically unnecessary restrictions, patients in many states can access medical abortion in the privacy of their own home,” the group said.
Abortion advocates said the move could mean more mothers hurt and more lives lost to abortions.
Jeanne Mancini, president of the education and advocacy fund March for Life, said the move allows a “dangerous regimen of pills available without the supervision of a physician,” noting that the FDA has documented adverse drug reactions.
“It’s well documented that chemical abortion is much harder on women’s health than surgical abortion, and today the FDA lowered women’s health standards in the name of greater abortion access. , a truly political decision that will have serious consequences,” she said. . “Today’s decision will result in more lives lost to abortion and increase the number of mothers who suffer physical and psychological harm from chemical abortions.”
Although medical abortions are legal, almost every state has some form of restriction.
An analysis by the Kaiser Family Foundation, a nonprofit healthcare-focused research institute, found that only licensed physicians can prescribe abortion drugs in 33 states, unlike advanced practice clinicians such as nurse practitioners. , medical assistants or nurse midwives.
The FDA’s latest scientific review of the drug stems from a 2017 lawsuit filed by the ACLU, which argued the agency’s restrictions block or delay medical care, especially for low-income people and rural communities.
Contributor: Romina Ruiz-Goiriena, USA TODAY; Associated press