{"id":35053,"date":"2025-10-08T16:14:23","date_gmt":"2025-10-08T16:14:23","guid":{"rendered":"https:\/\/cincinnatirighttolife.org\/?p=35053"},"modified":"2025-10-08T17:22:47","modified_gmt":"2025-10-08T17:22:47","slug":"after-promising-review-of-deadly-abortion-pill-fda-greenlights","status":"publish","type":"post","link":"https:\/\/cincinnatirighttolife.org\/after-promising-review-of-deadly-abortion-pill-fda-greenlights\/","title":{"rendered":"After Promising Review Of Deadly Abortion Pill, FDA Greenlights A Copycat Version"},"content":{"rendered":"\n

By: Jordan Boyd, originally published October 2, 2025, The Federalist<\/a><\/em><\/strong><\/p>\n\n\n\n

The generic mifepristone manufacturer Evita Solutions wants to \u2018normalize abortion\u2019 and make it \u2018accessible to all.\u2019<\/strong><\/p>\n\n\n\n

Twenty-five years after the U.S. Food and Drug Administration bypassed safety concerns<\/a> to approve what has become the most popular abortion method<\/a> on the market, the agency greenlit a generic version of mifepristone manufactured by a company committed to \u201cnormalizing\u201d abortion for all.<\/p>\n\n\n\n

The news broke mere weeks after the FDA formally committed to re-examining the factors that could prompt it to limit, if not revoke, permission for mifepristone\u2019s prevalence in the U.S.<\/p>\n\n\n\n

Health and Human Services Secretary Robert F. Kennedy Jr. confirmed<\/a> to the Senate Finance Committee on Sept. 4 that the FDA was evaluating \u201cnew data\u201d on mifepristone.<\/p>\n\n\n\n

\u201cWe know that during the Biden administration, they actually twisted the data to bury one of the safety signals with a very high safety signal, around 11 percent,\u201d Kennedy added.<\/p>\n\n\n\n

In a joint letter<\/a> to 22 Republican attorneys general on Sept. 19, Kennedy and FDA Commissioner Marty Makary both reiterated that the federal regulators planned their \u201cown review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy.\u201d<\/p>\n\n\n\n

On Tuesday, however, the FDA sent a letter<\/a> to Evita Solutions permitting it to begin selling and distributing an off-brand abortion pill.<\/p>\n\n\n\n

For more than two decades, Danco Laboratories\u2019 Mifeprex<\/a> has been the go-to abortion pill brand in the U.S. It works by severing the hormones<\/a> babies in utero require to grow and flourish \u2014 essentially starving them to death. That mifepristone-induced process is followed by misoprostol pills, which cause a woman\u2019s body to expel the deceased infant by inducing contractions.<\/p>\n\n\n\n

Evita Solutions\u2019 compliance with the conditions outlined in the FDA\u2019s Sept. 30 approval message, however, ensures yet another, presumably more affordable version of the chemical abortion drug mifepristone will be available for sale sooner rather than later.<\/p>\n\n\n\n

Both the Danco and Evita drugs will share the same label, per FDA policy for generic drugs.<\/a><\/p>\n\n\n

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As Susan B. Anthony Pro-Life America\u00a0noted in its statement condemning the approval<\/a>\u00a0that Evita Solutions \u201cdescribes its mission as being to \u2018normalize abortion\u2019 and make it \u2018accessible to all.\u2019\u201d<\/p>\n\n\n\n

\u201cThis reckless decision by the FDA to expand the availability of abortion drugs is unconscionable. These dangerous drugs take the lives of unborn children, place women and underage girls at serious risk, empower abusers, and trample the pro-life laws enacted by states across the nation,\u201d SBA Pro-Life America President Marjorie Dannenfelser said.<\/p>\n\n\n

\n
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The\u00a0Virginia-based<\/a>\u00a0drug company also referred to mifepristone on its website as \u201can effective, safe way to terminate early pregnancy,\u201d even though evidence strongly suggests otherwise. It also\u00a0laments<\/a>\u00a0pro-life policies as \u201cmedically unnecessary restrictions\u201d and complains about the \u201csocial stigma\u201d they put on abortion.<\/p>\n\n\n

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In response to The Federalist\u2019s questions about the approval, HHS Communications Director Andrew Nixon claimed in an email that the FDA \u201chas very limited discretion in deciding whether to approve a generic drug.\u201d<\/p>\n\n\n\n

\u201cBy law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,\u201d he wrote.<\/p>\n\n\n\n

He emphasized that the FDA \u201cdoes not endorse any drug product and directs prescribers to follow all labeling\u201d and noted that \u201cgeneric applicants are not required to submit independent evidence proving safety and effectiveness.\u201d<\/p>\n\n\n\n

\u201cHHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA\u2019s risk mitigation program for the drug is sufficient to protect women from unstated risks,\u201d Nixon concluded.<\/p>\n\n\n\n

A Bitter Pill<\/h2>\n\n\n\n

For more than two decades<\/a>, pro-life doctors tried via citizen petition to convince the FDA that the agency<\/a> violated federal law by approving Mifeprex. Instead of fulfilling its legal requirement to address these concerns, the FDA repeatedly stonewalled<\/a> the petitioners and repeatedly changed the rules on mifepristone use to accommodate abortion activism.<\/p>\n\n\n\n

By the end of the Obama administration<\/a>, the FDA had expanded when girls and women could take the pill, changed its dosing, reduced the required number of doctor visits to obtain the drug, allowed more people than licensed doctors to prescribe it, and eliminated the reporting of non-fatal complications that resulted from taking the drug.<\/p>\n\n\n\n

The Biden administration\u2019s radically relaxed abortion pill policies<\/a> compounded on those changes by sanctioning DIY at-home abortion dosing via mail order<\/a> or sale in pharmacies like Walgreens and CVS<\/a>. The results of that expansion were countless losses of unborn life and a steady<\/a> stream<\/a> of stories<\/a> about women<\/a> who were injured and even died<\/a> as a result of the abortion drug.<\/p>\n\n\n\n

The Supreme Court had a chance to judge the legality of those expansions but chose to punt the case by claiming the plaintiffs lacked adequate legal standing<\/a>. The majority opinion left the door wide open for a stronger challenge to make its way to the high court.<\/p>\n\n\n\n

It wasn\u2019t until the Trump administration and its Make America Healthy Again allies took back the administration, however, that movement on mifepristone\u2019s approval status was officially back on the table.<\/p>\n\n\n\n

Multiple new studies showing the life-threatening consequences of chemical abortion \u2014 especially without supervision \u2014 have since made their debut.<\/p>\n\n\n\n

One particular analysis found<\/a> that the rate of serious complications after mifepristone abortion is at least 22 times higher than what the FDA and Danco Laboratories, manufacturer of the pill commonly referred to as Mifeprex, suggest. Another study determined the abortion lobby\u2019s attempts to paint abortion pills as less harmful than over-the-counter painkillers such as Tylenol are rooted in activism instead of scientific fact.<\/a><\/p>\n\n\n\n

Despite the dangerous and sometimes deadly effects of mifepristone, the abortion drug is literally celebrated<\/a> by abortion giants such as Planned Parenthood, which is partially responsible for its popularity<\/a>, and defended by Democrats, such as the numerous blue party attorneys general who falsely claim the dangerous drug combination is \u201csafe and effective.\u201d<\/a><\/p>\n\n\n

\n
\"\"<\/figure><\/div>\n\n\n

Jordan Boyd is a staff writer at The Federalist and producer of The Federalist Radio Hour.<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

By: Jordan Boyd, originally published October 2, 2025, The Federalist The generic mifepristone manufacturer Evita Solutions wants to \u2018normalize abortion\u2019 and make it \u2018accessible to all.\u2019 Twenty-five years after the U.S. Food and Drug Administration bypassed safety concerns to approve what has become the most popular abortion method on the market, the agency greenlit a generic version of mifepristone…<\/p>\n","protected":false},"author":2,"featured_media":35054,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-35053","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"\nAfter Promising Review Of Deadly Abortion Pill, FDA Greenlights A Copycat Version - Cincinnati Right to Life<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cincinnatirighttolife.org\/after-promising-review-of-deadly-abortion-pill-fda-greenlights\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"After Promising Review Of Deadly Abortion Pill, FDA Greenlights A Copycat Version - 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