FDA Updates Abortion Pill Label Despite Political Games

This article by carafem’s Vice President, Melissa Grant, originally appeared on the Huffington Post Blog

Recently the FDA updated the label for the drug Mifepristone, which is also known as the abortion pill. This update eased many of the restrictions that had been unnecessarily placed on this medication, which is great news for American women, but also highlights the needless restrictions placed on abortion access by abortion opponents.

Mifepristone was first approved for use in the United States over 15 years ago and since that time, over two million American women have it used it to safely end an early pregnancy. Medical science has learned a great deal about these medications and as with other areas of medicine, physicians have used this evidence-based research to provide a better experience for their patients. Now, over a decade and a half later, the FDA has updated their labeling to be more consistent with the medical evidence.

So what does this mean in practice? In most places not all that much. The label now reflects basic facts that have been in practice for some time, including that women were taking three times more medication than was necessary to be effective and how letting the second medication, Misoprostol, dissolve in your cheeks (vs. swallowing) increased overall effectiveness, and lessened side effects like nausea and vomiting. The old regimen also required up to three visits to a doctor’s office to receive this medication, when most physicians were able to provide the same level of care with only one or two visits.

SO — if medical research and physicians providing this medication were already in agreement that there were better and more effective ways of using a medication for their patients, then why create an issue where there isn’t one?

This is because certain politicians decided to insert themselves into medicine with seemingly no agenda other than to restrict access to a legal medication and a more effective way of using it. Six states attempted to pass legislation requiring doctors to provide Mifepristone in a way they knew to be less effective and with more unpleasant effects only because it was consistent with the original outdated label. Three states were successful in passing these antiquated restrictions; North Dakota, Ohio and of course, Texas, where lawmakers are quite confused about the actual abortion procedure.

Changing FDA labeling is a slow and expensive process in the United States. For this reason, many doctors prescribe according to a medically accepted regimen, despite the fact that the label says otherwise. This common practice is known as “off-label” use. Restricting the use of Mifepristone to the outdated FDA regimen did nothing to make abortion safer, but it did make it more expensive and less available, something that was already an issue of great concern in those affected states.

So, while it is good news for women that the FDA has changed its labeling to be consistent with actual best medical practices, there are still restrictions on this medication that are more stringent then those placed almost any other medication in this country. The label still requires a special registration of providers who wish to use it and Mifepristone will still not be available for purchase in pharmacies in the U.S., as it is in many other countries around the world.

The question remains, will this label change make medication abortion more feasible in states facing medically unnecessary, politically motivated restrictions or will politicians with the goal of limiting abortion access just continue to find new ways to restrict access? Time will tell, but this new action from the Food and Drug Administration seems to be a step in the right direction.