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Monday, April 04, 2016

The FDA Just Removed One Of Anti-Abortion Lawmakers’ Favorite Talking Points

BY TARA CULP-RESSLER MAR 30, 2016 10:05 AM

Thanks to a policy change from the Food and Drug Administration announced on Wednesday, it may get harder for anti-choice lawmakers to rely on unscientific information to restrict women’s access to the abortion pill.

The FDA intends to change its years-old label for the abortion pill, medically known as mifepristone. Wednesday’s move will update the agency’s previous guidelines for mifepristone — which were first issued back in 2000 and have since become outdated.

“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.

In the years since mifepristone was initially approved by the FDA, doctors learned more about how it works. Medical professionals quickly confirmed that it’s just as safe and effective when prescribed at lower dosages and later in pregnancy. In practice, this expands access the abortion pill because it allows patients to take the pill at a lower price and during a bigger window of time.

In light of that information, abortion doctors stopped following the official FDA label and started prescribing mifepristone differently than directed. As far back as 2001, more than 80 percent of providers were no longer using the FDA-approved protocol for medication abortion.

This type of evolving medical practice is very common. The FDA is often slow to update its official guidance, and it can be costly for drug manufacturers to complete the complicated process of re-labeling. So it’s not unusual for drugs to be prescribed for off-label use. In fact, thanks to the emerging scientific evidence in the field, major medical groups like the American College of Obstetricians and Gynecologists have for years opposed using the outdated FDA protocol.

Read more
http://thinkprogress.org/health/2016/03/30/3764742/fda-label-change-abortion-pill/

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