The FDA has quietly approved another generic of the abortion pill mifepristone, even as it carries out a review of the drug that has raised concerns that it will result in restricted access.
The green light for Evita Solutions’ generic has stoked fury among anti-abortion groups, including the Family Research Council, which said the approval “should never have been granted” and is “undermining states” as well as the Supreme Court decision that overturned the constitutional right to abortion care in 2022.
Missouri Senator Josh Hawley, a Republican who is a fierce critic of abortion rights, said he has “lost confidence in the leadership at the FDA,” adding: “FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. The evidence shows chemical abortion drugs are dangerous and even deadly for the mother.”
The pushback overlooks the reality that the FDA is obligated to approve a generic medicine if the company sponsoring the application demonstrates the relevant level of safety, efficacy, and equivalence with the branded product, which in this case is Elanco’s Mifeprex. GenBioPro also sells a generic of the drug in the US.
Last week, the FDA announced a review of the safety of mifepristone on the back of a request from 22 Republican attorneys general, referring to a study by the Ethics and Public Policy Center (EPPC), a conservative and religious think tank, which claimed almost 11% of women experience sepsis or other serious complications within 45 days of taking it.
That study was not peer-reviewed or published in a medical journal and has been criticised for containing serious flaws, such as including ectopic pregnancies in the list of serious complications. These occur when an embryo implants outside the uterine lining and are not linked to mifepristone.
The EPPC has used its conclusions to criticise taking mifepristone “without sufficient medical support or supervision,” which is a clear attempt to overturn measures introduced by the FDA to enhance access to mifepristone after the right to abortion was overturned, including telehealth prescriptions, mail-order availability, and prescribing by certain healthcare professionals other than a doctor.
Pro-choice group Reproductive Freedom for All issued a statement saying: “This is exactly how our system is supposed to work, and it has worked this way for decades. Career scientists and civil servants at the FDA did their jobs – evaluating the evidence and approving a safe, effective medication.”
It continued: “The only reason this routine approval is making headlines is because anti-abortion politicians have turned health care into a political battlefield. We miss the days when this didn’t require a comment.”
For its part, Evita said that medical abortion care is “rife with medically unnecessary restrictions and social stigma in the US, [so] many people who choose to end a pregnancy may struggle to get the necessary care they need.”
The company added that it believes “all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live.”
Photo by Aiden Frazier on Unsplash
