On Sept. 30, hours before the federal government shut down, the U.S. Food and Drug Administration had a baffling act to fit in. The FDA stealthily approved a new generic version of the abortion drug mifepristone.

Mifepristone, a drug the FDA itself admits sends as many as 1 in 25 women to the emergency room even under strict use conditions, is not only responsible for the deaths of countless unborn children, but also has taken the lives of too many mothers along with it.

Ironically, the approval came barely a week after the administration warned pregnant women to reconsider taking Tylenol to avoid harm to their unborn children.

Dangerous medication abortions now even easier to get

Evita Solutions, which describes its mission as being to “destigmatize abortion” and make abortions accessible "for all,” submitted its application to produce generic mifepristone in October 2021 ‒ 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.

No doubt a profitable opportunity was in sight. Today, there are at least 1.1 million abortions a year in America, and more than 60% are carried out using drugs.

Taking doctors out of the equation, the abortion industry will happily sell dangerous drugs to anyone over the internet, completely free of face-to-face interaction with a clinician. Lack of access is clearly not a problem.

Sixty-three percent of Americans, including about the same percentage of women, oppose mail-order abortion drugs with no in-person doctor visit because they know it’s not safe.

These sensible Americans can be forgiven for having whiplash. Just recently, Health and Human Services Secretary Robert F. Kennedy Jr. said Biden’s FDA “twisted” data on mifepristone to bury safety signals as it stripped away safeguards and opened the floodgates to unaccountable mail-order drugs.

Kennedy cited data from the Foundation for the Restoration of America and the Ethics & Public Policy Center showing that 11% of women experience severe adverse events like hemorrhaging, infection and sepsis.

Kennedy and FDA Commissioner Marty Makary assured Republican attorneys general that HHS was going to conduct a study incorporating the real-world experiences of women harmed by the drug. State leaders see the deadly impact up close as these drugs invade even the most pro-life states, despite their valiant efforts to combat them and enforce the law.

“New data show that the problem far outpaces individual enforcement efforts,” Louisiana Attorney General Liz Murrill explains in a new lawsuit. “Pro-abortion states have refused to enforce judgments or extradite mail-order abortion drug providers. … A growing number of states have also started anonymizing abortion drug prescriptions ‒ making enforcement at this granular level all but impossible."

Food and Drug Administration needs to reverse course

HHS also needs to hear from survivors of the abortion drug, like Rosalie Markezich, who is speaking out about being pushed by her boyfriend to take abortion drugs.

Markezich called out the Biden mail-order policy for enabling 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 stakes and urgency are greater than ever now. The new generic was approved under an abbreviated new drug application, which means Evita Solutions didn’t have to provide independent clinical trials to establish safety and effectiveness. It just had to prove the drug delivers the same amount of active ingredients to the bloodstream in the same time frame.

Presumably, the new drug has all the same problems as the old drug and is no less harmful to women or their babies.

Is this the “gold standard science” we were promised?

The FDA must reverse course. Cooperating with pharmaceutical companies to bring new life-ending drugs to market doesn’t make America greater or healthier.

This reckless decision undermines the right of states to protect their most vulnerable from harm. It is emphatically not what millions of pro-life Americans who support President Donald Trump voted for.

Women and children can’t wait. We call on the administration to immediately reinstate commonsense safeguards on abortion drugs that were in place during President Trump’s first term.

Ultimately, there should be no drugs approved for the purpose of killing Americans. They must be pulled off the market.

Marjorie Dannenfelser is president of Susan B. Anthony Pro-Life America, a network of more than 1 million pro-life Americans nationwide.

This article originally appeared on USA TODAY: FDA's abortion pill approval is reckless decision that will harm women and babies | Opinion

Reporting by Marjorie Dannenfelser / USA TODAY

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