• HHS Secretary Robert F. Kennedy Jr. orders an FDA review of mifepristone after new data shows 11% of women experience severe complications, far higher than the 0.5% previously claimed.
• A study of 865,727 women revealed 1 in 10 suffered life-threatening issues like hemorrhaging and sepsis, contradicting the FDA’s long-standing safety assurances.
• Kennedy called the findings alarming, signaling potential label updates or stricter protocols, though abortion activists accuse the administration of attacking women’s rights.
• Critics argue the FDA ignored risks for years, expanding access under Obama and Biden, including mail-order distribution upheld by the Supreme Court.
• The debate now centers on patient safety versus reproductive freedom, with conservatives demanding transparency while the left dismisses concerns as political maneuvering.

In a move that has reignited the national debate over abortion access, Health and Human Services Secretary Robert F. Kennedy Jr. has ordered a full FDA review of the abortion pill mifepristone following disturbing new evidence that the drug may pose far greater risks to women than previously disclosed.

The decision, announced during a Senate hearing on May 14, comes after an analysis of insurance claims revealed that 11% of women who took the drug experienced serious adverse events. This is a staggering 22 times higher than the less than 0.5% rate reported in clinical trials.

Kennedy, appointed by President Donald Trump, told lawmakers that the findings were “alarming” and signaled that, at minimum, the FDA must update mifepristone’s labeling to reflect its true dangers. The review, led by FDA Commissioner Dr. Marty Makary, could pave the way for stricter safety protocols, although Kennedy emphasized no final decisions have been made. Predictably, pro-abortion activists have already framed the move as an attack on women’s rights, ignoring the mounting evidence that lax FDA policies have endangered countless lives.

The hidden risks of mifepristone

The bombshell study, published last month by the conservative Ethics and Public Policy Center (EPPC), analyzed insurance claims from 865,727 women who took mifepristone between 2017 and 2023. The results were damning: 1 in 10 women suffered severe complications, including hemorrhaging, sepsis, and life-threatening infections within 45 days of taking the pill. By contrast, the FDA’s current label—based on heavily sanitized clinical trials—claims the risk of serious adverse events is a mere 0.5%.

Critics argue the FDA, under both Democratic and Republican administrations, has long turned a blind eye to mifepristone’s risks. Originally approved in 2000 for use up to seven weeks of pregnancy, the agency later expanded its window to 10 weeks under President Obama. The Biden administration went further, eliminating critical safeguards like in-person dispensing requirements in a move the Supreme Court upheld last year, allowing the drug to be mailed without medical supervision.

A political firestorm ahead

Unsurprisingly, abortion advocates have dismissed the new data outright. The Center for Reproductive Rights, a radical pro-abortion group, blasted Kennedy’s decision on social media, claiming “President Trump should not be making decisions about our healthcare.” Yet their rhetoric ignores a fundamental question: If mifepristone is as “safe and effective” as they claim, why fear a review?

FDA Commissioner Makary, who testified in March that he had “no preconceived plans” to restrict the drug, has also acknowledged the need for scrutiny. “So if the data suggests something or tells us that there’s a real signal, we can’t promise we’re not going to act on that data,” he said during an April summit. That data is now impossible to ignore. The EPPC’s study—the largest of its kind—concluded that the FDA must “reconsider [mifepristone’s] approval altogether” unless it imposes stricter reporting requirements and ensures physician oversight.

Protecting women or “rolling back rights”?

The coming battle over mifepristone will hinge on a simple divide: Conservatives see this as a patient safety issue, while the left frames it as a war on reproductive freedom. But the facts are undeniable. The FDA’s own trials—conducted in controlled settings with rigorous medical oversight—never reflected the real-world harm now evident in post-market data.

This isn’t about banning abortion; it’s about ensuring women aren’t lied to. Mifepristone’s current label is a relic of pharmaceutical propaganda, downplaying risks to advance a political agenda. If the FDA revises its warnings or reinstates basic safeguards, it won’t be an assault on “choice”; it will be a long-overdue admission that corporate and government negligence has put women at risk.

As the review unfolds, expect hysterical claims from the left. But for the millions of women who’ve suffered in silence, the truth can’t come soon enough.

Sources for this article include:

TheEpochTimes.com

NYPost.com

Hawley.Senate.gov