--- title: "When Off-Label is Safer for Women: The Politics of Medication Abortion" date: 2013-12-17T23:11:09-05:00 author: OBOS Admin canonical_url: "https://ourbodiesourselves.org/blog/when-off-label-is-safer-for-women-the-politics-of-medication-abortion" section: Blog (Archive) --- [Donate](https://ourbodiesourselves.org/donate) [From the Archives of Our Bodies, Our Blog](/blog)# When Off-Label is Safer for Women: The Politics of Medication Abortion By Rachel Walden • December 17, 2013 Please note: This entry -- originally posted at [Our Bodies, Our Blog](https://ourbodiesourselves.org/blog) -- has not been updated since the publication date listed above. Among the numerous tactics used to restrict abortion access, [several states](http://www.guttmacher.org/statecenter/spibs/spib_MA.pdf "Guttmacher State Policies in Brief - Medication Abortion") have proposed or implemented laws that impose unnecessary restrictions on medication abortion. These restrictions interfere with evidence-based practices that are considered safer for women's health. Some states are requiring that medication abortions follow the exact regimen approved by the FDA back in 2000, though research has since proven that lower doses are safer and just as effective. (The FDA has approved updated labeling since 2000, but these updates have not addressed the commonly used lower-dose regimen; it is not clear whether the drug company plans to submit new data and request these changes.) The FDA protocol calls for a clinician to provide 600 mg of the first drug, mifepristone, for the patient to take orally, followed 48 hours later by 400 mcg of oral misoprostol. More modern, evidence-based regimens call for only 200 mg of mifepristone, followed later by 800 mcg of misoprostol that is held in the cheek until it dissolves instead of swallowed. The newer regimen also allows for the misoprostol dose to be taken at home. [![Guttmacher Institute: State Policies on Medication Abortion](https://assets.ourbodiesourselves.org/images/blog-archive/guttmarcher-state-medication-abortion-299x300.jpg "Guttmacher Institute: State Policies on Medication Abortion")](http://www.guttmacher.org/statecenter/spibs/spib_MA.pdf)But states looking to make abortions more difficult for women to obtain are requiring physicians to administer the second dose in person. This mean women are forced to make an additional clinic visit -- a significant hardship for many patients. It's common practice for doctors to prescribe drugs "off-label," which means in a different way or for a different purpose than what the FDA has specifically approved. This allows doctors to use the most current evidence and their own judgment. Indeed, a [new study](http://www.contraceptionjournal.org/article/S0010-7824(13)00743-9/abstract "Reduction in Infection-Related Mortality since Modifications in the Regimen of Medical Abortion") accepted for publication in the journal Contraception illustrates how the practice of medicine can change to improve patient safety after a drug has been approved by the FDA. The researchers reviewed Planned Parenthood data from the five years prior to 2006 -- the year Planned Parenthood clinics changed their protocol for medication abortion from vaginal to oral administration of misoprostol, and added additional steps (such as STI testing and routine antibiotics) to reduce infection risk -- and the five years after. They found three deaths out of 218,928 abortions *before* the change, and no deaths among 711,556 abortions *after* the change. The Planned Parenthood study used the common reduced dose regimen of 200 mg mifepristone followed by 800 mcg of misoprostol. [Other studies](http://www.ncbi.nlm.nih.gov/pubmed/22898359 "First-trimester medical abortion with mifepristone 200 mg and misoprostol: a systematic review.") have also demonstrated the safety and effectiveness of the reduced mifepristone dose. When politicians insist on the outdated FDA-approved regimen, they are prohibiting the use of the safer approaches. The outdated FDA regimen, [says Rachael Phelps](http://www.slate.com/articles/news_and_politics/jurisprudence/2013/09/oklahoma_and_mifiprex_supreme_court_considers_law_about_fda_approved_medical.html "The Cleverest New Anti-Abortion Law"), medical director for Planned Parenthood in Rochester and Syracuse, is "dramatically less effective, has more side effects, is harder for women to use, and increases the likelihood of an additional invasive procedure compared to the evidence based regimen. Mandating the FDA regimen forces doctors to provide substandard medical care and is just plain bad medicine." A case challenging such a law in Oklahoma [had been set](http://thinkprogress.org/health/2013/09/11/2606261/supreme-court-abortion-explainer/ "Everything You Need To Know About The Abortion Case That’s Headed To The Supreme Court") to go before the Supreme Court, but [was dismissed](http://www.scotusblog.com/2013/11/court-wont-rule-on-ru-486-abortion/ "Court won’t rule on RU-486 abortions") following a [state Supreme Court ruling](http://www.nytimes.com/2013/11/05/us/justices-decide-not-to-hear-oklahoma-abortion-case.html "Justices Decline an Appeal on Abortion") that the law would [effectively ban](http://thinkprogress.org/health/2013/10/30/2858291/supreme-court-abortion-pill-stealth/ "The Abortion Case Making Its Way To The Supreme Court Is A Stealth Attack On Your Reproductive Rights") all medication abortion in the state. Texas's controversial HB 2 law [also requires adherence](http://rhrealitycheck.org/article/2012/12/19/texas-abortion-drug-bill-could-mean-more-side-effects-and-higher-costs/ "Texas Abortion Drug Bill Could Mean More Side Effects and Higher Costs") to the outdated FDA-approved regimen. For a quick guide to additional states with restrictions requiring the old regimen or barring remote doctors from supervising medication abortion via telemedicine, view this [fact sheet from Guttmacher Institute](http://www.guttmacher.org/statecenter/spibs/spib_MA.pdf "Medication Abortion"). The federal Women's Health Protection Act ([S1696](http://hdl.loc.gov/loc.uscongress/legislation.113s1696 "S 1696 bill summary and status") / [HR 3471](http://hdl.loc.gov/loc.uscongress/legislation.113hr3471 "HR 3471 bill summary and status")) introduced this year would prohibit such restrictions. Among provisions addressing telemedicine abortion, hospital admitting privileges, and other targets of recent legislation, the bill would forbid any "limitation on an abortion provider's ability to prescribe or dispense drugs based on her or his good-faith medical judgment, other than a limitation generally applicable to the medical profession." Contact your [senator](http://www.senate.gov/general/contact_information/senators_cfm.cfm "Senators of the 113th Congress - contact info") or [representative](http://house.gov/representatives/ "Directory of Representatives - there's a find your rep tool on the site, too") to support this Act. --- #### 0 Response Our Bodies Ourselves is no longer able to accept comments. ![](/assets/img/monogram.webp)Topics - [Abortion & Reproductive Rights](https://ourbodiesourselves.org/blog/topic/abortion-reproductive-rights) - [Drugs & Pharmaceutical Companies](https://ourbodiesourselves.org/blog/topic/drugs-pharmaceutical-companies) - [Politics](https://ourbodiesourselves.org/blog/topic/politics) - [Research & Studies](https://ourbodiesourselves.org/blog/topic/research-studies) ![](/assets/img/monogram.webp)### *Why You Can* **Trust Us** - We rigorously evaluate all content - We embrace a reproductive justice framework - We don’t accept ads or sell products - We reject funding from the pharmaceutical industry - We counter misinformation and disinformation - We address the social, political, and economic factors that affect health and sexuality [read more](https://ourbodiesourselves.org/why-you-can-trust-us) Share [](javascript:void();)[](javascript:void();)[](javascript:void();)[](javascript:void();)