STAT+: FDA protocols originally intended to be extra conservative are now heralded as evidence of mifepristone’s risk
Decisions made by the FDA more than 20 years ago have come under heightened scrutiny thanks to a lawsuit calling for increased restrictions around the abortion pill mifepristone.
Decisions made by the Food and Drug Administration more than 20 years ago have come under heightened scrutiny thanks to a lawsuit calling for increased restrictions around the pregnancy-terminating drug mifepristone. The Alliance of Hippocratic Medicine, a recently formed umbrella organization composed of several anti-abortion groups, has argued the protocols first adopted to safeguard mifepristone are indicative of the drug’s danger. Yet these measures, according to those involved in the original FDA decision along with regulatory scholars, were originally put in place in an effort to be especially cautious, given the political controversy around the pill.
It was a “risky policy,” said Holly Fernandez Lynch, professor of medical ethics and law at University of Pennsylvania, who signed an amicus brief of food and drug law scholars submitted to the Supreme Court regarding the mifepristone case. Those initial protocols inadvertently implied heightened risk around mifepristone, she added: “That’s being leveraged by the Alliance of Hippocratic Medicine — in that way it seems to have backfired.”
Those tasked with reviewing the FDA application for approval of mifepristone were sensitive to the potential controversy around any abortion medication. Michael Greene, professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and chair of the reproductive drugs committee that advised the FDA on mifepristone approval in 2000, said members of the advisory committee were escorted to and from the first meeting venue under security, and the discussion took place in a windowless cinderblock room for fear of attack.
“Of course, you don’t live in a black box, you know that’s a controversial product,” said Jane Henney, commissioner of the FDA at the time mifepristone was approved. “What you’re asked to do is look at the evidence presented to you and make a decision.”
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