ALBANY, N.Y. (WTEN) — More than twenty years ago, the FDA approved a drug called Mifepristone as part of a two drug regimen to end an early pregnancy. A group of physicians filed a lawsuit in November claiming the FDA improperly approved the drug and a federal judge in Texas agreed, suspending Mifepristone beginning Friday. The order was met with a dueling lawsuit out of Washington state to ensure the abortion pill remains accessible.
The lawsuit coming out of Texas tells the FDA to go back to the drawing board and gives them a week to appeal the order. “This is completely unprecedented, and yet Texas has come up with this ruling that we are now taking it to the Court of Appeals and we really don’t know what is coming next,” said Chelly Hegan, President and CEO of Upper Hudson Planned Parenthood. Hegan said mifepristone has proven to be safe and effective, but Compass Care Care CEO, Jim Harden, disagrees, “To say that this drug is perfectly safe is not just a lie, but it’s fraudulent.”
The lawsuit pointed to a 2019 citizen petition challenging the approval of Mifepristone by the American College of Pediatricians. In part, it asked the FDA to limit mifepristone’s use to 49 days gestation rather than 77, required the drug be administered under doctoral supervision, and required reporting of certain adverse side events to the FDA.
“The standard of care for women’s health has gone down dramatically, Judge Rice’s ruling out of Washington state, represents a reckless reduction in the basic standard of women’s reproductive health care,” said Harden.
Misoprostol, the second drug that’s part of the abortion pill regimen will still be available. Hegan said it’s 95% effective in ending a pregnancy, but without mifepristone it could be more painful. “I think that women who are seeking abortions in the early stages will continue to have access, the Miso only protocol works, but it is more uncomfortable…simply because someone made a political choice about what was or wasn’t approved for a drug.”