Lawsuit: Let Pharmacists Dispense Medication Abortion

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Lawsuit: Let Pharmacists Dispense Medication Abortion

Nicole Knight

“The abortion pill is safe, effective, and legal. So why is the FDA keeping it locked away from women who need it?”

A lawsuit filed Tuesday that argues medication abortion should be offered by prescription at the local drugstore could amount to a seismic shift in abortion access.

The lawsuit, filed in U.S. District Court in Hawaii, challenges a restriction imposed by the Food and Drug Administration (FDA) on one of the pills used in medication abortion, mifepristone, known by the brand name Mifeprex. Unlike most other drugs, the FDA requires Mifeprex to be dispensed in clinics, doctors’ offices, and hospitals—rather than a pharmacy.

Kauai Doctor Graham Chelius, who brought the suit with the American Civil Liberties Union (ACLU) and several health-care associations, called the restriction medically unnecessary and burdensome. Because Kauai lacks a single abortion clinic, Chelius said he’d like to stock mifepristone, but cannot because of the FDA restriction.

“So if one of my patients wants to end her pregnancy, she has to fly to a different island 150 miles away to get this care,” the family medicine doctor told NPR.

Roe is gone. The chaos is just beginning.

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Medication abortion is a two-drug regimen taken up to ten weeks’ gestation; the other drug, misoprostol, is regulated differently by the FDA and can be dispensed at pharmacies with a prescription. Medication abortion accounted for nearly one-third of abortions in the United States in 2014, according to the Guttmacher Institute. But 39 percent of U.S. women of reproductive age live in a county without an abortion clinic, meaning they have no access to any abortion services. Lifting the FDA restriction on Mifeprex would increase access for these people because they could go to the drugstore for medication abortion, advocates said. 

“The abortion pill is safe, effective, and legal. So why is the FDA keeping it locked away from women who need it?” said Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project, in a statement

The FDA regulates Mifeprex under a set of rules called Risk Evaluation and Mitigation Strategy (REMS). Because of these mandates,  only health-care providers who have pre-registered with the manufacturer of Mifeprex, and stocked the abortion pill in their health-care facility, may hand patients the medication.

In a paper titled “Sixteen Years of Overregulation: Time to Unburden Mifeprex,” published in April in the New England Journal of Medicine, leading clinicians and public health experts argued the FDA restriction was medically unnecessary. ACLU attorneys noted that leading medical groups, including the American Congress of Obstetricians and Gynecologists, support making the abortion pill available by prescription at pharmacies. 

“Overwhelming medical evidence and decades of clinical experience show medication abortion to be a safe and effective method to end a pregnancy,” Dr. Paul Blumenthal, director of the Gynecology Service at Stanford University, said in a statement. “There is simply no medical justification for these restrictions, and they create a needless and harmful burden for women seeking this care.”