But abortion opponents weren’t finished. The FDA placed mifepristone in the most restrictive drug category, a controversial decision the anti-choice movement would soon abuse. The FDA recommended a very large dosage and placed limitations on who could prescribe the medication, which was out of line with recommendations for drugs with similar safety and efficacy profiles. Using the medical studies that led to the drug’s approval, doctors and researchers quickly developed a more modern, evidence-based regimen than the original FDA-approved label. It lowered the dosage and allowed pregnant people to complete the process at home. It was proven to be just as effective with lessened side effects and fewer barriers to patients seeking care.
Under normal circumstances, FDA guidelines are treated by clinicians as a recommendation. The medical community uses scientific evidence to adapt these recommendations, often finding off-label uses and or updated regimens for drugs. Even as early as 2001, 84% of physicians providing medication abortions followed the revised regimen for mifepristone instead of the guidelines on the FDA label.
Ignoring this medical expertise, however, anti-choice politicians used the overly-cautious FDA label to restrict abortion services. They passed laws claiming to “protect” women from the potential harm of a “dangerous drug,” but it was just another way to decrease access to the safe and effective medication abortion pills. Not only were these laws medically unnecessary, they actually put women’s health at risk.
Examples of current laws:
- Thirty-four states only allow licensed physicians to give mifepristone to patients. The World Health Organization recommends that mid-level healthcare professionals like physician assistants and nurse practitioners be trained to administer medication abortions. These laws restrict the capacity of facilities offering abortion services and mean pregnant people often wait longer for an appointment.
- Seventeen states require a physician to be physically present when the patient swallows the mifepristone tablet, preventing the use of telemedicine (despite medication abortion being simple and safe enough to be taken at home). These laws are more than just a hassle; they make a safe, simple treatment inaccessible for many people, and particularly harm pregnant people living in rural areas, who must travel long distances and pay for hotels.
- Anti-choice laws on the books in several states require physicians to follow the FDA label for mifepristone exactly. Prior to the 2016 FDA updated label, this meant pregnant people in these states took three times the amount of mifepristone administered in other states for political, not medical, reasons. These laws worsened side effects and increased cost, hurting access to medication abortion.