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Should the FDA Continue Restricting an Abortion Pill?

by Countable | 10.7.17

What’s the story?

The American Civil Liberties Union is suing the Food and Drug Administration over its restrictions on the abortion pill Mifeprex.

The FDA has stipulated that Mifeprex can only be dispensed at medical facilities by certified providers — and providers must pre-register with the drug manufacturer and be capable of performing surgical abortions if complications arise.

The ACLU is arguing that the drug – which can used during the first 10 weeks of pregnancy – should be made available by prescription in pharmacies.

"The abortion pill is safe, effective and legal. So why is the FDA keeping it locked away from women who need it?" said Julia Kaye, an attorney with the ACLU Reproductive Freedom Project. "The FDA's unique restrictions on medication abortion are not grounded in science—this is just abortion stigma made law."

Why does it matter?

As the Chicago Tribune reported, "The FDA issued new guidelines for the use of Mifeprex last year, and said at the time that the restrictions continue to be necessary to ensure safe use of the drug."

However, the FDA also said last year that the drug had an excellent safety record, writing in 2016 that Mifeprex "has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare."

This has been the experience of Graham Chelius, a physician who’s part of the ACLU lawsuit. Chelius works in Waimea, Hawaii, and says that when a women comes to his practice seeking an abortion, his only option is to advise her to get on a plane.

"There are no abortion providers on our island," Chelius told NPR, "so if one of my patients wants to end her pregnancy, she has to fly to a different island 150 miles away to get this care."

Chelius said not all his patients can afford the trip, and that similar financial constraints affect women across the nation. "The FDA restrictions create delays that often push medication abortion out of reach of my patients," he said. Lifting the FDA’s restrictions on Mifeprex would mean women who wanted abortions could get them, and not be "forced to carry a pregnancy to term against their will."

About one third of abortions in the U.S. are medication induced. Mifeprex is taken at home, and the drug causes cramping and bleeding, terminating the pregnancy. According to the New England Journal of Medicine, Mifeprex-induced abortions carry a lower risk of death than childbirth.

The ACLU argues that the FDA restrictions "impose significant burdens on women seeking abortion with no medical basis, violating federal constitutional guarantees of privacy and equal protection." They cite the recent Supreme Court decision Whole Woman’s Health v. Hellerstedt, where the court ruled, as ACLU summarizes, “that health regulations must in fact serve patient health and cannot burden access to abortion without proof of a valid medical justification.”

The lawsuit is supported by the American Congress of Obstetricians and Gynecologists, which has described medication abortions as a "safe, effective option."

That’s the majority opinion among OB-GYNs. But Dr. Donna Harrison, executive director of the American Association of Pro-life Obstetricians and Gynecologists, questions the safety of "abortions without supervision."

"Is the pharmacist going to answer her call at 5 in the morning when she's suffering or needs some help? The pharmacist is not going to be there," Harrison told NPR.

But Kaye, the ACLU attorney, counters:

"The idea that the regulation of medical care must be based on scientific evidence is not controversial — unless the care in question is abortion."

What do you think?

Are Mifeprex restrictions "abortion stigma made law"? Or are you also concerned about “abortions without supervision”? Is the FDA too politicized? Hit Take Action, tell your reps, then tell your fellow citizens below.

—Josh Herman

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(Photo Credit: Lalocracio* / iStockphoto)*


Written by Countable

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