Hours before a federal government shutdown on Sept. 30, the FDA approved a new generic version of the abortion drug mifepristone. The approval comes amid scrutiny over safety concerns raised by HHS leadership, lawmakers and state attorneys general—and at a tim
Hours before the federal government shut down on Sept. 30, the FDA approved a new generic version of the abortion drug mifepristone—an action critics describe as both abrupt and dangerous.
The FDA’s decision to “stealthily approve” the generic. according to the account driving this dispute. arrived despite the agency admitting that mifepristone. even under strict use conditions. sends as many as 1 in 25 women to the emergency room. The same passage argues the drug has been associated with deaths of unborn children and also “too many mothers.”.
The approval is being challenged not just for what it changes. but for how it fits into a broader shift that critics say accelerated access. The generic application was submitted by Evita Solutions in October 2021. and the criticism points to its timing—“mere months after then-President Joe Biden’s FDA used COVID-19 as an excuse to ditch the safeguard of in-person doctor visits to obtain abortion drugs.” Evita Solutions describes its mission as “destigmatiz[ing] abortion” and making abortions accessible “for all.”.
For critics, the practical impact is straightforward: with doctors “taken out of the equation,” they argue the abortion industry can sell “dangerous drugs to anyone over the internet,” free of face-to-face clinician interaction.
The debate extends well beyond one approval. The piece cites figures that there are at least 1.1 million abortions a year in America. and that more than 60% are carried out using drugs. It also points to public resistance. saying 63% of Americans—including about the same percentage of women—oppose mail-order abortion drugs when there is no in-person doctor visit.
The argument hinges on safety and the speed of regulatory change. The account recalls that the administration recently warned pregnant women to reconsider taking Tylenol to avoid harm to unborn children, then notes the FDA moved to broaden access to a drug critics say poses risks.
HHS Secretary Robert F. Kennedy Jr. is cited as saying Biden’s FDA “twisted” data on mifepristone to bury safety signals as safeguards were stripped away and mail-order access opened up. Kennedy referenced data from the Foundation for the Restoration of America and the Ethics & Public Policy Center. saying 11% of women experience severe adverse events such as hemorrhaging. infection. and sepsis.
Kennedy and FDA Commissioner Marty Makary are also said to have assured Republican attorneys general that HHS would conduct a study incorporating the real-world experiences of women harmed by the drug. But state officials and critics say enforcement has not kept pace with the scale of access.
Louisiana Attorney General Liz Murrill is quoted describing what she argues is a mismatch between the problem and the response. She says “New data show that the problem far outpaces individual enforcement efforts. ” adding that “Pro-abortion states have refused to enforce judgments or extradite mail-order abortion drug providers.” She also argues that “A growing number of states have also started anonymizing abortion drug prescriptions. ” making “enforcement at this granular level all but impossible.”.
At the center of the dispute is not only regulatory process but how harmed patients are treated once the rules change. The piece points to testimony from Rosalie Markezich, who says she was pushed by her boyfriend to take abortion drugs. Markezich’s account says the mail-order policy enabled her abuse: “Had the FDA required an in-person visit with a doctor before dispensing the drugs. my boyfriend would never (have) been able to obtain the drugs that he made me take … and I would have told the doctor that I wanted to keep my baby.”.
The federal review itself is described as moving quickly. The new generic was approved under an abbreviated new drug application. meaning Evita Solutions “didn’t have to provide independent clinical trials to establish safety and effectiveness.” Instead. it was required only to prove that the drug delivers the same amount of active ingredients to the bloodstream in the same time frame. according to the account.
Critics argue that this kind of shortcut cannot meaningfully change safety outcomes. The piece says the new drug likely has “all the same problems as the old drug and is no less harmful to women or their babies,” questioning whether it matches the “gold standard science” promised in public debate.
The editorial stance in the source is explicit: the FDA “must reverse course,” and cooperation with pharmaceutical companies to bring “new life-ending drugs” to market is framed as neither health-focused nor aligned with voters’ expectations.
The passage argues the decision undermines the rights of states to protect vulnerable residents. and it calls for the administration to reinstate safeguards that were “in place during President Trump’s first term.” It also urges that “there should be no drugs approved for the purpose of killing Americans. ” and that the drugs “must be pulled off the market.”.
Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America—a network of more than 1 million pro-life Americans nationwide—puts the call for action squarely on the federal government, asserting that “women and children can’t wait.”
FDA mifepristone generic mifepristone abortion pill abbreviated new drug application mail-order abortion Evita Solutions Marty Makary Robert F. Kennedy Jr. Liz Murrill federal shutdown