What the New FDA Label Means for Medication Abortion

The U.S. Food and Drug Administration has finally changed the drug label for the abortion drug mifepristone, more closely aligning official dosage now with the medical best practices recommended by doctors who have long been using the drug. For those who oppose any form of accessible, safe abortion, that new label change has them worried that their longstanding legislative efforts to block medication abortion may be coming to an end.

Previous FDA instructions regarding the use of RU-486 cautioned that the medication should only be used in the first seven weeks of pregnancy, and recommended that the mifepristone be given at three times the dosage that most doctors say is actually necessary. The new recommendations change this, as well as advocate that patients using the medication return repeatedly to a clinic in order to obtain the pills.

“The new labeling for the drug is in line with what medical professionals who dispense the drug say they have known for years: that mifepristone is just as effective, and has fewer negative side-effects, when patients take a smaller dose than was originally recommended by the FDA,” reports The Guardian. ”The FDA now instructs clinicians to prescribe just 200mg of mifepristone, down from 600mg, and a higher dose of misoprostol, a drug that causes the uterus to expel its contents after the mifepristone takes effect. Most abortion doctors have already been following this dosage regimen for years.”

Abortion rights activists are excited about the new label, which will offer the opportunity for providers in states which have passed “FDA protocol” bills regarding abortion (but not FDA protocol only for other drugs) to now be able to use the medicine in a way consistent with best practices.

“The FDA’s approval of a label reflecting a more updated, evidence-based protocol for medication abortion has the potential to expand women’s options for safely ending a pregnancy in the earliest weeks,” said Nancy Northup, the president and CEO of the Center for Reproductive Rights, according to the Associated Press.

“This label change underscores just how medically unnecessary and politically motivated restrictions on medication abortion in states like Texas and Oklahoma truly are, and demonstrates the lengths politicians will go to single out reproductive health care to restrict women’s rights.”

According to the AP, abortion providers in North Dakota, Texas and Ohio – which have all passed FDA protocol bills – will now all start to offer the medication with the newly approved regime.

“Today, medication abortion care is once again a real option for Ohio women,” NARAL Pro-Choice Ohio executive director Kellie Copeland told Politico. “Ohio physicians no longer have to follow an outdated, draconian protocol enacted by anti-choice politicians, which forces women to take more medication and make more trips to the clinic than is medically necessary.”

Unsurprisingly, anti-abortion activists accused the FDA of play politics and putting the health of pregnant patients at risk.

“We all agree that the FDA should be looking out for the best interests of American health care consumers, but in this case, they’re serving the interests of the abortion industry and Danco Laboratories, the sole provider of mifepristone in the U.S.,” said Eric Scheidler, executive director of the Pro-Life Action League, in a written statement.

“At least eight deaths have been documented of women using mifepristol for abortion, all of them using the off-label protocol that the FDA has just approved. While this change is unlikely to impact abortion rates, it will improve the bottom line for abortion providers, who charge as much for a medical abortion as for a surgical one, despite the cost being much lower to them. And should the abortion pill fail, as often happens, abortion providers profit again with a backup surgical abortion.”

He added, “With this deplorable decision, the FDA has abdicated its responsibility to safeguard women’s health and defend human life.”

Photo credit: Thinkstock


Jim Ven
Jim Venabout a year ago

thanks for sharing.

Siyus Copetallus
Siyus Copetallus1 years ago

Thank you for sharing.

Danuta Watola
Danuta Watola2 years ago

Thank you for sharing

Marie W.
Marie W2 years ago

FDA approved oxycodone drugs to be handed out like candy.

ERIKA S2 years ago


Trish K.
Trish K2 years ago

New label for medication abortion means fewer murders of some other mothers baby.

Janet B.
Janet B2 years ago


pam w.
pam w2 years ago

Ann Moran....does a cancerous tumor have ''life?" Because, there's no difference from an embryo at conception and a tumor. Neither have sentience, or anything other than the ability to grow.

ERIKA S2 years ago


Janis K.
Janis K2 years ago

It doesn't matter what anyone else believes or thinks, it is only up to the woman who has to deal with her pregnancy. And all women should be able to sympathize with that one woman who must make her own choice, about her own body. We should support her right to choose, as we would support our own right. We must ensure that we will have that choice and stop letting old white politicians legislate about a condition, they will never understand! We must support choice and vote the GOP OUT, and elect more women in all levels of politics!