Making America healthy again requires restricting this drug

The U.S. Food and Drug Administration must quickly restore commonsense guardrails on the abortion pill to safeguard women’s health and save lives.

For years, activists on the Left claimed they were pro-abortion to protect “women’s health.” But the Biden administration’s FDA, in its push to promote more abortions at all costs, loosened safety restrictions on the abortion pill, harming countless women.

Today, more than half of abortions are completed with the abortion pill, a two-drug regimen administered to kill a woman’s preborn child. The first drug, mifepristone, blocks the pregnancy hormone progesterone, cutting off the blood supply and nutrients to the preborn child. The second drug, misoprostol, causes the woman’s body to expel her now dead baby.

In 2000, the FDA first approved mifepristone for use as a “medication” with severe restrictions, claiming it had a “meaningful therapeutic benefit.” But keep in mind, the abortion pill isn’t truly medication at all. Medicine is intended to cure or treat a disease or illness, and pregnancy is clearly not a disease. Therefore, mifepristione has zero therapeutic benefit, and should never have been approved in the first place.

In 2011, the agency formally placed a “REMS” designation, or Risk Evaluation and Mitigation Strategy designation, on the drug.

The REMS program is supposed to “help ensure the benefits of the medication outweigh its risks,” though the FDA acknowledges it is “not designed to mitigate all the adverse events of a medication.”

The agency reserves REMS designations for only the most dangerous drugs with “serious safety concerns.” Of the 20,000 prescription drugs approved by the FDA, just 67 — or 00.3% — have REMS designations.

As a part of the REMS designation, for years, the FDA maintained an “in-person dispensing requirement,” mandating women obtain mifepristone in-person from a licensed physician in a clinic, medical office, or hospital.

But in December 2021, the FDA temporarily halted enforcement of the requirement, ostensibly due to the COVID-19 pandemic, allowing women to obtain the abortion pill by mail for the first time. The FDA made this modification permanent in 2023.

In 2021, the FDA also added a new pharmacy certification process, permitting retail pharmacies nationwide — like Walgreens and CVS — to apply for permission to sell the drug.

Today, a woman can get a prescription for the abortion pill through a telehealth appointment, order the pill online at Walgreens, receive the pill in the mail, abort her child in the bathroom, and flush her human child down the toilet, never speaking to another human being in person about her decision.

This reality is bad for women. Bad for women’s health. And not only bad, but devastating for preborn children.

Our nation’s largest abortion provider, Planned Parenthood, still claims on its website that the abortion pill is “safer than Tylenol.” That isn’t remotely true.

Before he was nominated as the Deputy Director of the FBI, Missouri Attorney General Andrew Bailey filed a lawsuit demanding Planned Parenthood pay millions in damages for “spreading lies and disinformation” about mifepristone.

“The facts are clear: more than 4.5% of women who take this dangerous drug end up in the emergency room,” Attorney General Bailey said. “Yet Planned Parenthood compares it to Tylenol. This is a blatant violation of Missouri law.” The lawsuit is ongoing.

Even more strikingly, the Ethics and Public Policy Center released results earlier this year from the largest-known study of the abortion pill and its effect on women’s health. It found that the abortion pill is far riskier to women than previously known.

Based on analysis of 865,727 prescribed mifepristone abortions from 2017 to 2023, the study found that 10.93% of women experience sepsis, infection, hemorrhaging, or another serious adverse event following a mifepristone abortion. This is at least 22 times higher than the “less than 0.5%” previously reported in clinical trials.

Thankfully, following the release of the EEPC’s study, Health and Human Services Secretary Robert F. Kennedy Jr. promised the FDA would perform a “complete review” of the abortion drug in testimony before the Senate Health, Education, Labor and Pensions Committee. The secretary directed FDA Commissioner Marty Makary “to review the latest data on mifepristone.”

Subsequently, Commissioner Makary committed in a June 2 letter to Senator Josh Hawley that he would be “conducting a review” of the drug.

The FDA is right to do so. But this review must lead to action.

At a minimum, the FDA should revise its REMS designation and reinstate its 2000 safety protocols for mifepristone, as suggested by the EPPC. This includes requiring at least three in-person office visits by the patient; requiring mifepristone to be prescribed only by physicians; mandating mifepristone to be administered only in a clinic, medical office, or hospital; allowing mifepristone to be prescribed only to women in the first seven weeks of pregnancy; and requiring healthcare providers to report all serious adverse events to the FDA.

Such a move would go a long way towards protecting women’s health and informing them of the serious risks involved in aborting their child through a chemical abortion. One could even say this is required for women to exercise a real and informed “choice” about their pregnancy.

Alternatively, the FDA should rescind its approval of mifepristone altogether. Again, mifepristone is not a medication because pregnancy is not an illness. If the FDA had followed the law in the first place, mifepristone wouldn’t even be on the market today.

Secretary Kennedy and Commissioner Makary, the ball is in your court. The Make America Healthy Again movement requires mifepristone’s numerous safety risks be addressed. Fast.