US Edition
U.S. Bishops: FDA Approval of Generic Abortion Drug Is a ‘Shocking Inconsistency’
Senator Hawley and U.S. Catholic bishops oppose FDA's generic mifepristone approval amid safety concerns, citing an 11% serious adverse event rate among users.
- On September 30, the Food and Drug Administration quietly approved a second generic form of mifepristone, notifying Evita Solutions LLC that its 2021 application met approval requirements shortly before last week’s federal government shutdown.
- With a safety study already under way, the Food and Drug Administration approved the generic despite ongoing mifepristone safety review, and HHS said federal law requires such approval, a claim the Washington Post challenged.
- Senator Josh Hawley demanded answers from the Food and Drug Administration, calling the decision shocking and asking Marty Makary, FDA Commissioner, if adverse events were evaluated and if the drug would remain on the market during the review.
- A group of senators on Thursday urged Robert F. Kennedy Jr. and Marty Makary to reevaluate the approval and suspend further generic approvals, while 51 Republican senators and state attorneys general filed lawsuits against mail-order distribution.
- With telemedicine and mail-order distribution active, Evita Solutions expects the generic to be available in January 2026, potentially increasing access as chemical abortions already account for about 63.
17 Articles
17 Articles
Trump's abortion pill approval shatters his pro-life facade
In Focus delivers deeper coverage of the political, cultural, and ideological issues shaping America. Published daily by senior writers and experts, these in-depth pieces go beyond the headlines to give readers the full picture. You can find our full list of In Focus pieces here. Trump administration officials say their hands were tied over the Food and Drug Administration’s decision to greenlight a generic version of the abortion drug mifeprist…
Commissioner Makary’s FDA Makes a Fatal Mistake Approving Evita Solutions’ Generic Abortion Drug
Concerned Women for America (CWA) has been on the front lines of the fight against chemical abortion drugs for decades. In 2011, we sued the FDA over its approval of the abortifacient contraceptive pill “Ella.” In 2020, we urged the Biden Administration to reinstate commonsense safety regulations on Mifeprex. In 2023, we submitted a brief […]
Reps. Aderholt, Moore condemn FDA approval of generic abortion medication
U.S. Representative Robert Aderholt, R-Ala., and U.S. Representative Barry Moore, R-Ala., criticized the Food and Drug Administration on Wednesday for approving a generic version of abortion drug, mifepristone. Mifepristone is a drug prescribed in combination with misoprostol to terminate a pregnancy within the first ten weeks of gestation. The medication has been FDA-approved for 25 years. The representatives released statements opposing the ap…
Meanwhile, at the FDA: Menopause Progress, Abortion Gaslighting
The FDA caused a stir last week when it approved a new, generic version of mifepristone—the abortion medication that has safely, effectively and privately ended pregnancies for 25 years. Many mainstream outlets made it sound like a dramatic policy reversal, but really it was a procedural box check. Meanwhile, the Trump administration is already laying the groundwork to undermine access, announcing a so-called “safety review” based on flawed data…
Senators urge HHS, FDA to reevaluate approval of a new generic version of mifepristone
The FDA sent a letter approving the drug to its manufacturer, Evita Solutions LLC, last week stating that it has reviewed the drug and found that it meets the requirement for approval under the Federal Food, Drug, and Cosmetic Act.
Coverage Details
Bias Distribution
- 84% of the sources lean Right
Factuality
To view factuality data please Upgrade to Premium
