At Hearing, Senator Questions FDA Inconsistencies in Regulating Abortion Pill vs. COVID Vaccines
U.S. Senator Cindy Hyde-Smith (R-Miss.) today continued a push for the Food and Drug Administration (FDA) to conduct a thorough review of the risks to women’s health from a chemical abortion pill made more widely available during the pandemic.
During a Senate Agriculture Appropriations Subcommittee hearing to review the FY2022 FDA budget request, Hyde-Smith questioned FDA regulatory inconsistencies regarding the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone, the chemical abortion drug.
In April, Hyde-Smith led a bipartisan, bicameral letter to the FDA that expressed concerns about the agency’s decision not to enforce the mifepristone REMS during the pandemic and requested the agency mandate complete reporting of adverse effects of the drug on women.
“The FDA decision is alarming because this drug is dangerous. The limited data we do have shows unacceptable rates of complications for women and girls,” Hyde-Smith said.
“I am particularly struck by the inconsistency of FDA’s actions. For instance, the FDA and CDC imposed a pause on the Johnson and Johnson COVID vaccine after reports of blood clots in some women. At the same time, FDA is expanding the approval for chemical abortion pills that have much, much higher risks of blood clots than the J&J vaccine,” she said.
More than 20 percent of reported complications from mifepristone use were life threatening or resulted in death, and over 70 percent of reported complications required follow up surgery, including total hysterectomy, Hyde-Smith reported.
Acting FDA Commissioner Dr. Janet Woodcock, in her response at the hearing and in a letter, said the agency will undertake a review of the REMS for mifepristone.
“I will have to look at the conditions of the REMS. All serious events need to be reported to the FDA. So let me look into that, but it may well be that if a person has a headache after using this drug that that may not have to be reported because it’s a non-serious, self-limited event,” Woodcock said.
Hyde-Smith responded, “Twenty percent, though, that’s pretty serious for life threatening or resulting in death.”
In January, Hyde-Smith and Congressman Bob Latta (R-Ohio) introduced companion legislation, the Support and Value Expectant (SAVE) Moms and Babies Act of 2021 (S.78 and HR.554), to prevent labeling changes for already-approved abortion drugs; prevent providers from dispensing these drugs remotely, by mail, or via tele-medicine; and prevent FDA approval of new chemical abortion drugs.