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# Physicians Want Mifeprex REMS Removed
- URL: https://www.fdaweb.com/physicians-want-mifeprex-rems-removed/
- Published: 2017-02-23T12:00:00.000Z
- Updated: 2026-09-14T22:08:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138058

A group of physicians under the Mifeprex REMS Study Group are calling for FDA to withdraw a risk evaluation and mitigation strategy (REMS) program for the medical abortion drug Mifeprex because they say it no longer makes clinical sense. The distribution of Mifeprex “remains substantially and unnecessarily encumbered by a \[REMS\], the group wrote in a *New England Journal of Medicine* [article](http://www.nejm.org/doi/full/10.1056/NEJMsb1612526?rss=searchAndBrowse&ref=fdaweb.com).

The physicians noted that REMS programs are intended for drugs that are known or suspected to cause serious adverse effects that cannot be mitigated simply by the label instructions. The Mifeprex REMS requires that the drug be dispensed to patients only in clinics, medical offices, and hospitals by or under the supervision of a certified prescriber. To prescribe the drug, a health care provider must become “certified” by completing and sending a form to the drug distributor attesting that he or she can assess pregnancy duration, diagnose ectopic pregnancy, and provide surgical intervention if needed, either personally or by referral.

  
“Given the data and experience that have been accumulated since the initial FDA approval, the Mifeprex REMS no longer makes clinical sense,” the group wrote. “The provider certification criteria can technically be met by any health care professional with the ability to read an ultrasound report and familiarity with emergency services, and thus the certification process itself — which is a self-certification without any validation component — is, in essence, an empty formality. Serious complications of mifepristone treatment are uncommon and are very familiar to clinicians who provide care to women of reproductive age; these risks should be manageable through routine labeling and standard clinical counseling.”