FIRST ON FOX: Sen. Josh Hawley, R-Mo., is introducing a new bill to strip FDA approval from the popular abortion pill mifepristone. The new bill builds upon proposed legislation Hawley introduced last year that would ban mifepristone and allow women to sue manufacturers profiting off of what the lawmaker deems an "inherently dangerous" drug.
The Safeguarding Women from Chemical Abortion Act was introduced in the Senate Tuesday and would prohibit the use of mifepristone for ending pregnancies.
"The science is clear: The chemical abortion drug is inherently dangerous to women and prone to abuse. Yet major companies like Danco Laboratories are making billions off it," Hawley told Fox News Digital in a statement. "That's why I am introducing new legislation to ban the use of mifepristone for abortion and empower women to sue its manufacturers. Congress must act now to protect the health and safety of women."
If passed, the legislation would withdraw FDA approval for the drug and classify its distribution for abortion as a violation of federal law. In 2023, mifepristone was used in 63% of all abortions in the U.S., according to data from the Guttmacher Institute.
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The Guttmacher Institute, a nonprofit research organization formerly affiliated with Planned Parenthood, also estimates there were 1,038,100 clinician-provided abortions in 2024. However, that figure accounts only for states without abortion bans and does not include abortions performed outside the formal healthcare system or in states where abortion laws differ.
Hawley raised concerns about the abortion pill last May when he introduced a separate bill that would direct the FDA to create safeguards on mifepristone, allowing women who suffered complications the right to sue telehealth providers and pharmacies for damages.
Research by the Ethics and Public Policy Center (EPPC) in Washington, D.C., showed the rate of side effects when using mifepristone is 22 times higher than indications from the FDA-approved drug label.
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The study revealed more than 1 in 10 women have reported experiencing "infection, hemorrhaging, or another serious or life-threatening adverse event."
EPPC assessed 865,727 insurance claims between 2017 and 2023 for women who used the medication to terminate early pregnancy. The pill can be taken up to "70 days since the first day of their last menstrual period," according to the FDA.
During the Biden administration, the FDA revised rules allowing mifepristone to be prescribed via telehealth, meaning patients would not have to physically go to the doctor to receive the abortion drug.
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In 2024, the Supreme Court unanimously rejected an Alliance for Hippocratic Medicine challenge that was brought to reverse the FDA’s approval and expansion for access to the drug. The ruling allowed mifepristone to remain available through telehealth and mail.
The Supreme Court’s rejection was based on the group’s inability to bring a lawsuit, saying Alliance for Hippocratic Medicine lacked the legal standing to challenge FDA approval. The merits of the abortion drug were never discussed or questioned in the ruling.
Last May, Hawley sent a letter to FDA Commissioner Marty Makary, whom Hawley questioned during Makary’s Senate confirmation hearing last year.
"[D]uring your confirmation hearing, you pledged to me that you would ‘review the totality of the data and ongoing data’ to inform action on the drug," Hawley's letter to the FDA chief states. "I urge you to follow this new data and take all appropriate action to restore critical safeguards on the use of mifepristone.
"The health and safety of American women depend on it."
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