On Thursday, 51 Republican senators sent a letter to Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty McCully, urging a reassessment of the FDA’s approval of a new generic abortion pill.
The FDA recently approved this new generic version of mifepristone, which is the first drug used in a two-drug abortion regimen. Following a troubling study indicating a significantly higher complication rate than earlier suggested, the agency, which operates under the Department of Health and Human Services (HHS), re-evaluated the drug’s safety. In response to criticism from conservative and pro-life advocates, HHS stated to Breitbart News: “If the generic drug is identical to the original, it has to be approved.”
Senators, led by Lindsey Graham (R-S.C.), called on the FDA to rethink its decision and reinstate safety protocols for mifepristone that had been lifted by the Biden administration as safety evaluations continue.
In their letter, the senators expressed appreciation for the administration’s commitment to addressing policies impacting the most vulnerable, namely the unborn. They noted, “We recognize your concern regarding FDA approval and oversight of abortion pill prescriptions and your willingness to prioritize the science to ensure both women and fetuses are safe. However, there’s still a lot to do.”
The lawmakers continued, “The culture of ‘abortion on demand’, facilitated by the Biden administration’s removal of essential safeguards for the FDA-approved abortion therapy, poses the largest threat to unborn children in America currently.” They pointed out that existing FDA regulations permit these drugs to be acquired via mail without adequate medical consultation or verification of the purchasers’ intent.
Specifically, the senators requested that the agencies halt approval for other generic abortion medications until safety assessments are completed, include mifepristone generics in those reviews, reinstate the requirement for in-person dispensing of mifepristone, and withdraw FDA guidance that allows pharmacies to distribute the drug.
The senators commented, “Easy access to abortion pills undermines state rights and contradicts pro-life laws. Every month, numerous abortion pills are sent to states with limited post-operative abortion options. Dobbs has weakened pro-life laws at the state level across the nation.”
They also emphasized that the agency has sufficient information to override the prior administration’s abortion drug regulations while a comprehensive review is conducted.
The FDA has approved a generic version of the abortion pill made by Evita Solutions LLC, which aims to “normalize abortion” and “ensure abortion is accessible for everyone.” The agency determined that this drug is “bioequivalent and therapeutically equivalent” to the brand-name mifepristone, Mifeprex, and thus meets the necessary requirements for approval.
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According to statistics from the pro-abortion Guttmacher Institute, in 2023, medical abortions constituted 63% of all abortions carried out in the U.S. health care system, translating to an estimated 642,700 fetal deaths from medical abortions. This percentage has risen from around 53% in 2020 and 39% in 2017. It’s worth noting that this does not encompass abortion medications obtained through underground networks that send pills to women in restrictive states.
In the medical abortion process, mifepristone blocks the action of progesterone produced by the mother, which is vital for sustaining the pregnancy. When progesterone is blocked, it leads to the degradation of the mother’s endometrial lining, effectively cutting off nutrients to the developing fetus, resulting in its demise in the womb. Following that, another drug called misoprostol (or Cytotec) induces contractions and bleeding to expel the fetus.
