coded as miscarriages. (8) Better quality, international records-linkages studies, and meta-analyses document far higher rates of complications and mortality from abortion, casting doubt on the validity of the reported data by which United States public health decisions are made. (9) Independent systematic analysis of adverse event reports submitted to the Food and Drug Administration (FDA) between 2000 and 2019 revealed approximately 3,000 United States adverse events out of an expected 185,000 adverse events based on the known and published complication rate after mifepristone misoprostol abortions. Thus, the Adverse Event Reporting System of the FDA captured only 1.7 percent of the actual adverse events occurring in United States women, the majority of which occurred prior to 2016 when mifepristone prescribers were required to report adverse events as part of the risk evaluation and mitigation strategy. (10) In 2016, the FDA relaxed the gestational age dispensing from a limitation of 7 weeks gestation to a limitation of 10 weeks gestation, and at the same time the FDA no longer required mifepristone prescribers to report adverse events other than death. These simultaneous changes ensured that there would be no way to capture the increased adverse events resulting from the relaxation of the gestational age requirements. (11) In order to fulfil the statutory requirement of the FDA to oversee and evaluate the safety of mifepristone use as an abortifacient, substantial changes in the adverse event reporting for mifepristone must be implemented to obtain an accurate evaluation of the impact of mifepristone-related adverse events on United States women. 3. Accurate reporting on chemical abortion and related adverse events (a) Reporting requirements The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall require any abortion drug, including any abortion drug approved by the Food and Drug Administration before the date of enactment of this Act, to have a risk evaluation