Even before [U.S. District Court Judge Matthew] Kacsmaryk’s decision, existing federal regulations on mifepristone also reinforced abortion stigma. The drug, which works by blocking a hormone needed to sustain pregnancy, held promise of improving access to abortion care when it was introduced over 20 years ago. Before mifepristone’s approval, most pregnancy terminations in the U.S. used vacuum aspiration, a brief and safe procedure with high patient satisfaction, but one that requires specific clinical training many clinicians do not have.
By contrast, medication abortion can be safely and effectively managed by any clinician who, once they’ve dated a pregnancy and ruled out very rare contraindications, can counsel patients on use of the medication. This, in theory, means more clinicians in more health care settings can provide abortion care.
In practice, many clinicians who want to offer mifepristone are unable to because of federal prescribing regulations that have existed in varying forms since mifepristone’s initial approval. Most notably, mifepristone is subject to the FDA’s Risk Evaluation and Mitigation Strategy (REMS), a highly restrictive set of regulations applied only to dozens of medications out of over 20,000 drugs currently approved for marketing in the United States. Other drugs needing REMS have side effects that can cause comas, or cause bones to break. People take mifepristone specifically to pass a pregnancy—a process that always involves cramping and bleeding. The drug also has a few side effects similar to those of thousands of drugs not subject to a REMS, such as nausea.
The FDA’s regulations are themselves both a product of and a means to perpetuate abortion stigma. The mifepristone REMS require that clinicians register with a drug distributor prior to prescribing the drug, that their patients sign a specific consent form mandated by FDA, and until recently, that mifepristone be dispensed directly by the care team in a health care setting. In January 2023, the FDA changed these regulations to permanently allow dispensing from certified pharmacies. But the pharmacy certification process itself is onerous, and the other requirements remain in place, making mifepristone difficult to access even before Kacsmaryk’s ruling.
The truth is that mifepristone should not only remain in use, but it should be easier to get—the FDA should remove the REMS completely. There is a strong consensus among scientific experts that mifepristone is safe, effective and superior to alternatives for both early abortion and early miscarriage care. In the 23 years since its initial approval in the United States, mifepristone has become more common worldwide. We now have research from tens of thousands of patients who received mifepristone in England and Canada showing it is extremely safe and highly effective without REMS-like restrictions. [Continue reading…]