Paper Answers Common Questions Regarding FDA Decision
WASHINGTON, D.C.—On Thursday, March 2, National Right to Life released a white paper in a question-and-answer format addressing common concerns regarding the Food and Drug Administration’s (FDA) decision to update labeling for mifepristone (generic for Mifeprex) that would allow pharmacies to dispense the drug.
“More than two dozen deaths and thousands of complications are associated with the use of the mifepristone/misoprostol chemical abortion method,” said Randall K. O’Bannon, Ph.D., director of education and research for National Right to Life and author of the white paper. “With these safety concerns, it is not surprising that questions have arisen regarding the FDA’s decision to allow pharmacies to dispense the abortion drug combination.”
O’Bannon continued, “Thousands of ‘adverse events,’ on record with the FDA include serious infections, severe hemorrhaging, and the rupture of previously undiscovered ectopic pregnancies.”
Mifepristone is used in combination with misoprostol, a prostaglandin, to cause an abortion. Mifepristone blocks progesterone, leading to the death of the unborn baby, while the second drug, misoprostol, causes powerful, painful uterine contractions to expel the dead or dying baby.
The FDA’s revised Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex would require that the drug only be dispensed by pharmacies that have completed certification. Only those pharmacies, once certified, could dispense the drug prescribed by certified prescribers who have pledged to follow FDA guidelines regarding the screening and counseling of patients to ensure they know the risks and dangers.
Questions & Answers: FDA’s Latest Decision to Allow Pharmacies to Stock and Sell the Abortion Pill Mifepristone can be accessed here.