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Abortion Pill Label Change: A Legal Overview

By Ephrat Livni, Esq. on April 06, 2016 | Last updated on March 21, 2019

Last week, the Food and Drug Administration (FDA) announced revised labeling for what is commonly called the "abortion pill." The new label acknowledges the use of the pill in a manner that doctors have long been prescribing it, and may undermine legislation based on the old labeling.

The "abortion pill" is medically known as mifepristone, and since 2000 it has been prescribed "off-label." Now the FDA is acknowledging with the revised label that the drug is safe and effective when prescribed at lower dosages than initially recommended and later in a pregnancy. This expands the window of time for women to terminate a pregnancy using the pill and makes early stage abortions less expensive. But the pill's label is a political issue too.

Safety First

The FDA label change was met with enthusiasm by pro-choice activists, according to Think Progress. "We are delighted that the FDA has approved a label change, which brings the label for mifepristone in line with scientific research and evidence-based practice," Vicki Saporta, the president of the National Abortion Federation, said in a statement.

Saporta is delighted for a number of reasons. First, the FDA's acknowledgment of the pill as safe and effective for terminating pregnancies up to 70 days after gestation, up from 49 days. extends the time in which women will have access to less invasive abortions that are less costly than surgery.

The label change is also said to undermine legislation promoted and supported by anti-abortion activists, which made it illegal for doctors to prescribe the abortion pill off-label, even though it was known to be a common practice. That's the political part.

Politics Also

Some believe that the laws requiring only on-label use of the pill were not about safety. They see the adherence to on-label prescription in the law as a way that anti-abortion activists could limit access to abortions in their states.

"Now that the protocols have changed, those legislators' intentions will be put to the test," writes the Los Angeles Times. "If they are serious about protecting women's health, then the laws they wrote enshrining the FDA guidelines shouldn't need to be changed. But if they try to amend them to reflect the older, more cumbersome protocols, it will be clear their aim was never to protect women."

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