Comment from Anonymous
AnonymousOpposeAdvocacy
Summary: The American College of Obstetricians and Gynecologists opposes the current FDA regulations regarding mifepristone, arguing that the drug's real-world adverse event rate is significantly higher than previously reported. They call for the FDA to reinstate original safeguards, including mandatory in-person physician examinations, prescription requirements, and strict follow-up protocols.
A report released by the Ethics and Public Policy Center (EPPC) has caused quite a stir. It is the largest-known study of the abortion pill Mifepristone. The revelatory report reviewed commercial insurance claims data from 865,727 prescribed chemical abortions between 2017 and 2023 showed 94,605 women suffered serious adverse events, including sepsis, infection, hemorrhage or another serious adverse event within 45 days of taking the drug. That is 11 percent of women taking the drug. This real-world rate is 22 times greater than the rate claimed by the FDA in approving mifepristone. In their approval, the FDA relied on limited data which has put women's lives at risk. Having blinded their eyes to oversight, the FDA claimed it was no longer necessary for a doctor to even be involved in the process – removing protections like requiring a doctor to examine the patient in-person before prescribing the drug to rule out dangerous conditions like ectopic pregnancies or follow up on the patient’s condition after she ingests mifepristone. The FDA must, at minimum, reinstate these protections for women. The FDA should immediately reinstate the safeguards it originally put in place for this drug and begin studying the adverse effects highlighted in these reports. The FDA should resume its requirement that all adverse events are reported, so we can have all the information needed to ensure safety. The safeguards include requiring physicians to prescribe, requiring in person visits, limiting its use to seven weeks and requiring all adverse events to be reported (one for full evaluation before the drug is dispensed and two follow up visits to screen for and treat any complications).