What You Need To Know About The New FDA Label For Mifepristone And Abortion

by Meghan Sara

Just when it seemed as though women’s access to abortion was tied to the railroad tracks and screaming for help, the FDA rode up on a shining rainbow unicorn of hope.

Which is to say, on Wednesday, the FDA relaxed the guidelines for administering mifepristone, commonly known as “the abortion pill,” the drug taken alongside misoprostol to induce a medical abortion.

A lotta stuff has changed, so listen up!

1. Instead of 600 mg, the dosage was lowered to 200 mg, which the FDA believed was an effective dosage with less risk of adverse side effects.

2. Instead of three doctor visits, the FDA now recommends only two appointments for the mifepristone regimen.

3. The new FDA label permits use of mifepristone up to 70 days after the start of a woman’s last period, giving her up to ten weeks to opt for a medical abortion (up from 49 days, as per the prior label regulations).

The New York Times pointed out that “The original label on the drug was based on clinical evidence from the 1990s before the pill was approved in 2000.” In many cases, doctors have already been administering the drug according to the FDA’s new label restrictions, in what is called “off-label use,” when doctors administer drugs to the standard of common medical practice, even if it runs contrary to the FDA guidelines for that medication.

Many states have laws in place that prohibit off-label use of mifepristone. Texas, North Dakota, and Ohio required doctors to follow the old FDA label to the letter. Now, thanks to the FDA’s relaxed label restrictions, women can – under the law in these states – obtain easier, safer medical abortions with less hassle.

So I’m pretty happy, and guess who else is happy? The American Congress of Obstetricians and Gynecologists – the FDA has just validated what they’ve been saying for years! They issued a statement lauding the decision, saying that they were “pleased that the updated FDA-approved regimen for mifepristone reflects the current available scientific evidence and best practices.” That’s what practicing medicine should be about, people: scientific evidence and best practices. I mean, don’t you want your doctor to treat you using “scientific evidence and best practices”? That’s what I’m sayin’!

This was a huge win for reproductive rights — from a federal agency!  What’s more, this gives hope.  Hope that maybe the Supreme Court will follow suit in the many cases seeking to restrict access to abortion?  Hope that maybe the tide of excesssively punitive legislation is shifting?  Only time will tell, but tonight, let’s celebrate a win!

image via Mikayla Berry on flickr


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