Amid Review Of Deadly Abortion Drug, FDA Greenlights Copycat
this article discusses the FDA’s recent approval of a generic version of the abortion pill mifepristone, produced by Evita Solutions, a company openly committed to normalizing abortion access. This approval comes 25 years after the FDA originally approved mifepristone despite safety concerns. The move follows the FDA and the Department of Health and Human Services’ announcement that they are reviewing new safety data on the drug, amid accusations from Health Secretary Robert F.Kennedy Jr.that previous administrations manipulated data to downplay serious risks.
mifepristone, often followed by misoprostol, is the leading method for medical abortion in the U.S. Critics-including pro-life groups-condemn the FDA’s decision, arguing the drug endangers women and unborn children, undermines state pro-life laws, and is backed by companies and advocates that dismiss safety concerns and oppose restrictions.
Over the past two decades, the FDA has eased regulations on mifepristone’s use, allowing broader access including at-home dosing and sales through retail pharmacies.These policy changes have coincided with reports of injuries and deaths linked to the drug, fueling ongoing legal and political battles. Even though the Supreme Court declined to rule on the legality of these expansions due to procedural grounds,the Biden management has further relaxed policies,increasing availability.
Despite mounting evidence suggesting higher complication rates and serious risks than previously acknowledged, mifepristone remains widely promoted by organizations like Planned Parenthood and defended by many Democratic officials as safe and effective. Simultaneously occurring, the FDA continues to study the drug’s safety profile and has limited discretion in approving generic versions if they are identical to the brand-name drug.
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 manufactured by a company committed to “normalizing” abortion for all.
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’s prevalence in the U.S.
Health and Human Services Secretary Robert F. Kennedy Jr. confirmed to the Senate Finance Committee on Sept. 4 that the FDA was evaluating “new data” on mifepristone.
“We 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,” Kennedy added.
In a joint letter to 22 Republican attorneys general on Sept. 19, Kennedy and FDA Commissioner Marty Makary both reiterated that the federal regulators planned their “own review of the evidence, including real-world outcomes and evidence, relating to the safety and efficacy.”
On Tuesday, however, the FDA sent a letter to Evita Solutions permitting it to begin selling and distributing an off-brand abortion pill.
For more than two decades, Danco Laboratories’ Mifeprex has been the go-to abortion pill brand in the U.S. It works by severing the hormones babies in utero require to grow and flourish — essentially starving them to death. That mifepristone-induced process is followed by misoprostol pills, which cause a woman’s body to expel the deceased infant by inducing contractions.
Evita Solutions’ compliance with the conditions outlined in the FDA’s 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.
Both the Danco and Evita drugs will share the same label, per FDA policy for generic drugs.
As Susan B. Anthony Pro-Life America noted in its statement condemning the approval that Evita Solutions “describes its mission as being to ‘normalize abortion’ and make it ‘accessible to all.’”
“This 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,” SBA Pro-Life America President Marjorie Dannenfelser said.
The Virginia-based drug company also referred to mifepristone on its website as “an effective, safe way to terminate early pregnancy,” even though evidence strongly suggests otherwise. It also laments pro-life policies as “medically unnecessary restrictions” and complains about the “social stigma” they put on abortion.
In response to The Federalist’s questions about the approval, HHS Communications Director Andrew Nixon claimed in an email that the FDA “has very limited discretion in deciding whether to approve a generic drug.”
“By 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,” he wrote.
He emphasized that the FDA “does not endorse any drug product and directs prescribers to follow all labeling” and noted that “generic applicants are not required to submit independent evidence proving safety and effectiveness.”
“HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks,” Nixon concluded.
A Bitter Pill
For more than two decades, pro-life doctors tried via citizen petition to convince the FDA that the agency violated federal law by approving Mifeprex. Instead of fulfilling its legal requirement to address these concerns, the FDA repeatedly stonewalled the petitioners and repeatedly changed the rules on mifepristone use to accommodate abortion activism.
By the end of the Obama administration, 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.
The Biden administration’s radically relaxed abortion pill policies compounded on those changes by sanctioning DIY at-home abortion dosing via mail order or sale in pharmacies like Walgreens and CVS. The results of that expansion were countless losses of unborn life and a steady stream of stories about women who were injured and even died as a result of the abortion drug.
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. The majority opinion left the door wide open for a stronger challenge to make its way to the high court.
It wasn’t until the Trump administration and its Make America Healthy Again allies took back the administration, however, that movement on mifepristone’s approval status was officially back on the table.
Multiple new studies showing the life-threatening consequences of chemical abortion — especially without supervision — have since made their debut.
One particular analysis found 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’s attempts to paint abortion pills as less harmful than over-the-counter painkillers such as Tylenol are rooted in activism instead of scientific fact.
Despite the dangerous and sometimes deadly effects of mifepristone, the abortion drug is literally celebrated by abortion giants such as Planned Parenthood, which is partially responsible for its popularity, and defended by Democrats, such as the numerous blue party attorneys general who falsely claim the dangerous drug combination is “safe and effective.”
Jordan Boyd is a staff writer at The Federalist and producer of The Federalist Radio Hour. Her work has also been featured in The Daily Wire, Fox News, and RealClearPolitics. Jordan graduated from Baylor University where she majored in political science and minored in journalism. Follow her on X @jordanboydtx.
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