Headline: Sen. Hawley Calls for Tighter Regulations on Abortion Pill Following Study of Unseen Risks
Senator proposes new law to limit use of commonly employed, contentious abortion medication
Digital catches up with the Director of Legal Affairs at SBA, Katie Glenn Daniel, to discuss a study exposing the hidden dangers of the commonly used abortion drug, mifepristone.
Last Tuesday, Sen. Josh Hawley (R-Mo.) presented the Restoring Safeguards for Dangerous Abortion Drugs Act in an effort to protect women from the drug's potential side effects.
In a recent study by the Ethics and Public Policy Center (EPPC), it was found that 10.93% of women suffer severe health complications linked to mifepristone, such as sepsis, infections, hemorrhaging, and visits to the emergency room.
The study analyzed 865,727 insurance claims from 2017 to 2023 for women who had undergone mifepristone-assisted abortions. The Food and Drug Administration (FDA) allows the pill to be taken up to 70 days since the first day of a woman's last menstrual period.
While the exact number of women affected by mifepristone since its FDA approval in 2000 remains ambiguous, some pregnancies are terminated without medical supervision. According to the Guttenmacher Institute, a non-governmental organization (NGO) once affiliated with Planned Parenthood, just under a million clinician-provided abortions occurred in 2024. However, this figure does not account for illegal or underreported abortions.
The Obama administration loosened various FDA requirements regarding mifepristone use in 2016 by reducing the need for in-person visits, removing prescription requirements, and abolishing non-fatal adverse event reporting.
Sen. Hawley directly questioned then-FDA commissioner, Dr. Marty Makary, during his confirmation hearing about addressing concerns linked to mifepristone. In response to these new findings, Hawley wrote to Makary, urging him to consider the data and make necessary safety adjustments.
The Restoring Safeguards for Dangerous Abortion Drugs Act would also grant women who have suffered complications from mifepristone the authority to sue telehealth providers and pharmacies for damages and prohibit foreign companies from mailing and importing mifepristone to the US.
Hawley believes that the FDA must take immediate action to safeguard women's health, stating, "The data shows 1 in 10 women who take mifepristone experience adverse health effects... The FDA needs to act to protect women now."
Key Proposed Safeguards:- Reinstating in-person consultation: Mandating that healthcare professionals directly monitor patients during the abortion process, eliminating reliance on telehealth and mail-order distribution.- Thorough adverse event reporting: Requiring healthcare providers to submit comprehensive reports on mifepristone-related complications (hemorrhage, sepsis, etc.).- Reevaluating drug approval: Halting mail-order distribution and tightening prescriber requirements due to safety concerns surrounding mifepristone.
- Sen. Josh Hawley presented the Restoring Safeguards for Dangerous Abortion Drugs Act to protect women from potential mifepristone side effects, such as sepsis and hemorrhaging.
- In a recent study by the Ethics and Public Policy Center, it was found that 10.93% of women who took mifepristone experienced severe health complications.
- The study analyzed insurance claims from 2017 to 2023 for women who underwent mifepristone-assisted abortions, with the FDA allowing the pill to be taken up to 70 days since the first day of a woman's last menstrual period.
- While the exact number of women affected by mifepristone since its FDA approval in 2000 remains ambiguous, some pregnancies are terminated without medical supervision, and just under a million clinician-provided abortions occurred in 2024.
- Sen. Hawley questioned then-FDA commissioner, Dr. Marty Makary, about addressing concerns linked to mifepristone during his confirmation hearing and wrote to Makary urging him to consider the new data and make necessary safety adjustments.
- As part of the Restoring Safeguards for Dangerous Abortion Drugs Act, healthcare professionals would be required to report comprehensive information on mifepristone-related complications, and the FDA would be encouraged to reevaluate the drug's approval.
- The proposed legislation also aims to reinstate in-person consultations for healthcare professionals during the abortion process, eliminating reliance on telehealth and mail-order distribution.
- Sen. Hawley argued that the FDA must take immediate action to safeguard women's health by reinstating in-person consultations, thoroughly reporting adverse events, and reevaluating mifepristone's approval.
