Reacting to a lawsuit brought by conservative pressure group Alliance for Hippocratic Medicine, seeking not only to shoot down OTC sales but the regulator’s original approval in the year 2000, the agency now says said it’s too late for litigation. The statute of limitations has expired. 

The loosening of regulations, initially planned for late 2021 but postponed for over a year, initially came at the request of HRA Pharma, which owns the rights to the drug Mifeprex (mifepristone) approved by the agency more than two decades ago.

Under the new rules finalized after the health agency reviewed supplemental applications from US drugmakers Danco and GenBioPro, pharmacies will be able to dispense mifepristone and misoprostole (both must be taken together) directly to patients who present a prescription from a certified prescriber.

In this respect, the US still lags its neighbor Mexico, which allows abortifacients to be dispensed without a prescription.

There is still a chance that a US court will allow the lawsuit to proceed and block direct sales. The administration of US president Joe Biden for its part is urging a judge due to hear the litigation to dismiss it.

While the plaintiffs contend that abortifacients can endanger the lives of women using them, the American College of Obstetricians and Gynecologists and the American Medical Association said in a joint letter to Biden “robust evidence” suggests they are safe.

According to figures published by The New York Times, inducing abortion with mifepristone is cheaper, less invasive and offers more privacy than surgery.

Author: Dede Williams, Freelance Journalist