FDA neglected environmental concerns with abortion pill approval, petition claims
As the legal battle over the U.S. Food & Drug Administration's approval of the abortion pill mifepristone continues, a new citizen's petition demands that access to the drug be prohibited until the FDA can determine the threat it poses to the environment.
A petition submitted to the FDA last week by the national pro-life activist group Students for Life of America and 150 student groups nationwide argues that approval of the abortion pill must be revoked in "light of the FDA's failure to comply with the requirements of the Endangered Species Act (ESA) when taking these actions."
The petition contends that the FDA failed to assess the environmental impact of women using pills to end their pregnancies at home and flushing their unborn children's remains down the toilet when it approved the abortion pill in 2000.
"Indeed, the FDA did not conduct an environmental study regarding the potential impact Mifepristone could have on the nation's wastewater," the petition reads. "The problem with the FDA's assessment is that it only reviewed the impact that packaging, partially empty packaging, production waste, and pharmaceutical waste would have on the environment, and underestimated the impact the excretion of Mifepristone would have on the environment."
The organization claims the FDA underestimated the frequency of chemical abortions, which now account for the majority of abortions in the country.
"This Petition makes one request. We request that the FDA revoke its actions to approve Mifepristone and modify the associated regimen (including the REMS) until the agency conducts the required consultation with the United States Fish and Wildlife Service ('FWS') and National Marine Fisheries Service ('NMFS') (collectively, 'the Services') as compelled by the ESA," the document continues.
The FDA must file a consult with the services to determine the effects of mifepristone on endangered species or designated critical habitats in the agency's action area, which includes the entirety of the United States and its territories, according to SFLA.
"When the FDA made significant changes to the Mifepristone regimen and REMS in 2016, 2019, 2021, and 2023, the agency simply failed to conduct any ESA consultation or environmental assessment," the petition argues.
Previously, the Risk Evaluation and Mitigation Strategies (REMS) protocol for the abortion pill mandated that the drugs be dispensed in a healthcare setting until the FDA permanently lifted those requirements in 2021.
"This failure flies in the face of the ESA and must be corrected immediately — especially in light of the FDA's removal of the in-person dispensing requirement, which opened up the floodgates to do-it-yourself abortions at home and disposal of Mifepristone directly into our nation's water supply," the petition states.
SFLA President Kristan Hawkins contends that the FDA has disregarded the Endangered Species Act by approving mifepristone in 2000.
"FDA officials never checked whether government-sanctioned, corporate dumping of medical waste was hurting our environment," Hawkins said in a statement. "The Pro-Life Generation demands environmental justice for the aquatic, animal, plant, and human lives put at risk by the FDA's neglect."
The petition comes as the U.S. 5th Circuit Court of Appeals will weigh the merits of a lower court ruling restricting access to the abortion pill.
Last Friday, the U.S. Supreme Court allowed the abortion pill to stay on the market until appeals against a Texas judge's suspension of the FDA approval of mifepristone can be adjudicated.
On April 12, a three-judge panel of the 5th Circuit agreed to stay a decision by U.S. Judge Matthew Kacsmaryk of the U.S. Northern District of Texas earlier this month that suspended the FDA's approval of mifepristone.
Kacsmaryk granted the request of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians & Gynecologists, the Christian Medical & Dental Associations, and four individual doctors to suspend the FDA's approval of the drug.
The appellate court temporarily overruled the district court's suspension of the FDA's approval of mifepristone while the case's merits can be weighed. However, the court upheld the part of the ruling that struck down the FDA's relaxation of requirements for the distribution of mifepristone, including in-person visits and allowing the drug to be distributed through the mail.
FDA also eased the limits on when the abortion pill can be prescribed, changing it from 10 weeks of pregnancy to seven weeks.
As CP reported, the FDA previously rejected another SFLA petition related to the abortion pill. The Red Bag Medical Waste citizen's petition drew attention to the environmental impact of flushing human remains down toilets or sinks and called for the FDA to reinstate safety standards for the abortion pill.
On Jan. 3, the FDA announced that it had modified existing protocols on mifepristone, allowing certified pharmacies to dispense the drug. Several retail pharmacies, including Walgreens and CVS, announced they had taken steps to begin the process of receiving approval to dispense mifepristone.
Following threats of legal action from multiple Republican state attorneys general, Walgreens announced that it would not dispense mifepristone in over 20 states, as it would be illegal under those states' laws.
Samantha Kamman is a reporter for The Christian Post. She can be reached at: [email protected]. Follow her on Twitter: @Samantha_Kamman