FDA Approves Generic Abortion Pill, Drawing Conservative Outrage
Federal health officials approved multiple generic versions of the abortion pill mifepristone, including one from Evita Solutions, sparking widespread criticism and outrage from conservatives and anti-abortion groups.
'SHOCKING': FDA Approves New Abortion Drug
Daily Signal
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Washington Examiner
Overview
- The FDA approved multiple generic versions of the abortion pill mifepristone, with Evita Solutions being the second company to receive such approval, aiming to increase accessibility.
- This approval sparked significant outrage and backlash from conservatives, including Republican Sen. Josh Hawley and anti-abortion advocates, who criticized the FDA's decision.
- Critics, such as Kristan Hawkins and Marjorie Dannenfelser, raised concerns about the safety of mifepristone and questioned the thoroughness of the FDA's review process.
- The FDA, along with HHS spokesmen, emphasized its limited discretion in approving generic drugs, stating the new version is therapeutically equivalent to the brand-name pill.
- Mifepristone, used for pregnancies up to 70 days, accounts for nearly two-thirds of U.S. abortions, though access remains restricted in some states due to existing laws.
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Analysis
Center-leaning sources cover the FDA's generic abortion pill approval neutrally by presenting a balanced array of perspectives. They detail the approval, the company's mission, HHS's legal explanation, and reactions from both anti-abortion and pro-abortion rights groups. The coverage also includes scientific context on mifepristone's safety and addresses the conservative think tank report with counter-arguments, avoiding loaded language.
"Approval of a second generic is unlikely to affect access to the pill, which is typically taken with another drug, misoprostol."
ABC News"Approval of a second generic is unlikely to affect access to the pill, which is typically taken with another drug, misoprostol."
CBS News"The Food and Drug Administration has approved a new generic version of the abortion drug mifepristone, as conservatives slammed the decision as a stab in the back to the anti-abortion movement."
USA TODAY"The approval of a second generic drug for mifepristone underscores what research has shown for decades: medication abortion is safe, effective, and essential health care, used by millions with proven efficacy."
NBC NewsArticles (11)
FAQ
The generic version must comply with all REMS (Risk Evaluation and Mitigation Strategy) requirements before entering interstate commerce, including Elements to Assure Safe Use and a shared implementation system.
The approval aims to increase access to medical abortion by introducing competition, potentially lowering costs and expanding availability; however, access remains restricted in some states due to existing laws.
Conservatives, including Sen. Josh Hawley and anti-abortion advocates like Kristan Hawkins and Marjorie Dannenfelser, have criticized the approval, raising concerns about the drug's safety and questioning the thoroughness of the FDA's review process.
The FDA has confirmed that the generic product is bioequivalent and therapeutically equivalent to the brand-name Mifeprex, indicating no differences in safety or effectiveness.
The FDA generally has limited discretion in approving generic drugs, requiring them to be therapeutically equivalent to already approved brand-name drugs, whereas new brand-name drugs undergo a more extensive original approval process.
History
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