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U.S. Congressman Chris Smith Representing New Jersey's 4th District

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Press Release

New report shines light on FDA’s cover up—gross failure to protect women from significant harms caused by chemical abortion pill

Smith says FDA’s removal of needed safeguards under Biden ignored real dangers and misled women

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Washington, May 2, 2025 | Jeff Sagnip (202-225-3765) | comments

     Following a report published by the Ethics and Public Policy Center (EPPC) finding that one in 10  women who take the chemical abortion pill mifepristone experience a serious adverse event, Rep. Chris Smith (R-NJ), Co-Chair of the House Pro-Life Caucus, called on the Food and Drug Administration (FDA) to rescind its approval of the drug.  He also today submitted a letter urging the House Appropriations Committee to nullify the FDA’s irresponsible actions with regard to mifepristone—baby poison that significantly harms women as well. Rep. Smith said:

     “In addition to killing an unborn child by starving the baby to death, which is an outrage in itself, this new data exposes the significant health risks mifepristone poses to pregnant mothers—a glaring fact the abortion lobby and the FDA has tried to hide and ignore—a massive cover-up.

     One out of every 10 women who take this drug experience sepsis, infection, hemorrhaging, or other serious complications—according to the detailed report released by EPPC.

     
This is an astonishing 22 times higher than the adverse event rate referenced by the FDA. 

     
By contrivance and design, the FDA under Presidents Clinton, Obama and Biden prioritized their radical abortion agenda over the safety of women.  The Obama and Biden FDA deliberately promulgated regulations that encouraged non-reporting of adverse events, turning an intentional blind-eye to the impact on women. How can the FDA credibly suggest the drug is safe when regulations exclude the reporting of adverse events experienced by women?  This is gross negligence and a massive cover up of mifepristone’s harmful effects on women.”

     
As a first step, the EPPC report calls on FDA, at a minimum, to reinstate the earlier, stronger patient protections around mifepristone. The report also urges FDA to use objective safety criteria to further investigate the irreparable harm mifepristone causes women and reconsider the drug’s approval status completely.

     By way of background, in 1993, President Bill Clinton signed an executive order directing his FDA Commissioner David Kessler to bring mifepristone to the United States; the FDA Commissioner lobbied French pharmaceutical company Roussel-Uclaf to import its baby poison. By 2016, the Obama FDA weakened safety regulations, including pushing usage to a 10-week pregnancy, requiring only one doctor visit, and no longer requiring prescribers to report all serious complications. In 2021, Biden’s FDA eviscerated even the requirement for an office visit, which can lead to life-threatening complications for women, including undiagnosed ectopic pregnancy.

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    1005 Hooper Avenue
    Toms River, NJ 08753
    Tel.: (732) 504-0567

  • Monmouth County
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    Middletown, NJ 07748
    Tel.: (732) 780-3035

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Washington DC Office Washington DC Office

2373 Rayburn House Office Building
Washington, D.C. 20515

Phone:
(202) 225-3765
Ocean County District Office Ocean County District Office

1005 Hooper Avenue
Toms River, NJ  08753

Phone:
(732) 504-0567

*Please call for an appointment.

Monmouth County District Office Monmouth County District Office

1715 Highway 35 North, Suite 303
Middletown, NJ 07748

Phone:
(732) 780-3035

*Please call for an appointment.

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