Republican Lawmakers Criticize FDA’s Approval of Generic Mifepristone

On Wednesday, Rep. Robert Aderholt and Rep. Barry Moore, both from Alabama, expressed their disapproval regarding the FDA’s recent nod to a generic version of the abortion drug mifepristone.

Used in combination with misoprostol, mifepristone is intended for terminating pregnancies within the first ten weeks. It’s been on the market, approved by the FDA, for about 25 years now.

Aderholt’s office released a statement against the FDA’s decision made on September 2, highlighting concerns that this drug poses risks to women’s lives due to severe side effects.

Twenty-two other House representatives from the Values Action Team joined Aderholt in voicing their opposition.

The representatives wrote, “The FDA’s approval of a new generic version of mifepristone compromises women’s health and disregards the sanctity of life. Prior versions of the drug have demonstrated dangerous side effects, including serious conditions like sepsis and severe bleeding.”

Aderholt and Moore also called on U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. to ensure that the concerns regarding the drug’s side effects were adequately addressed in a safety report he directed to the FDA regarding mifepristone.

Aderholt cautioned, “Re-approving this generic pill while a safety review is happening risks the health and safety of women nationwide. The FDA needs to adhere to its responsibility to protect public health and drug safety.” He reiterated his commitment to collaborating with colleagues in Congress to safeguard the lives of women and their unborn children from potentially harmful medications.

On September 24, President Kennedy announced that the FDA would reassess safety protocols for mifepristone following a letter sent in August by 22 Republican attorneys general, including Alabama’s Steve Marshall.

“I urge HHS to speed up a thorough inquiry into the adverse effects connected with mifepristone, as Secretary Kennedy has promised. Protecting women from the hazards of chemical abortions is crucial,” Moore stated.

Moore further stressed the need for HHS to conduct a prompt and transparent investigation into the drug’s effects, reiterating that it is portrayed as “safe” yet involved in serious complications.

He framed his opposition in both ethical and religious terms, asserting, “Each dose of mifepristone is an intentional act to end an innocent life, created in God’s image. We cannot ignore the damage done to mothers and the tragic loss of children. I will persist in advocating for truth, accountability, and the sanctity of life.”

Aderholt cited an FDA fact sheet indicating that 36 women have died and 97 experienced ectopic pregnancies following mifepristone use.

The FDA mentioned that reported deaths don’t necessarily imply a causal link to the drug. Among those deaths, some resulted from sepsis, while others were connected to various severe conditions, including septic shock and complications from toxic shock syndrome.

Yet, Aderholt pointed out that a study by the Ethics and Public Policy Center suggests that instances of hospitalization and fatalities due to mifepristone are significantly underreported.

This study has faced criticism from health professionals who assert that decades of reliable evidence indicates medical abortions are both safe and effective.

Many experts, including the 2024 ACOG President, Stella Dantas, have emphasized the reliability of peer-reviewed scientific data supporting the safety of medical abortion services.

Critics have also contested the links drawn between mifepristone and ectopic pregnancies, noting that follow-up visits to emergency rooms often pertain to ensuring the abortion’s completion rather than addressing severe side effects.

Overall, the dialogue surrounding mifepristone remains contentious, with varying perspectives on its safety and the implications of its approval.