On Sept. 30 as the government was about to shut down, the FDA silently issued a letter
to a company called Evita Solutions informing them their generic version of the abortion drug was approved. No press release. No tweet. No leak to the media. Two days later, Susan B. Anthony Pro-Life America became aware of the approval and sounded the alarm online.

The pro-life movement united in opposition. Fifty-one US senators joined a letter opposing the FDA’s approval and calling for action to protect pregnant women and their unborn children.

The administration’s response? HHS Secretary Robert F. Kennedy and his spokespeople said the FDA was bound by law to approve the drug.

The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap. Last month, I joined @DrMakaryFDA in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on… pic.twitter.com/G0eE4H4y42

— Secretary Kennedy (@SecKennedy) October 2, 2025

When asked at a White House press briefing, Karoline Leavitt reiterated the HHS talking point.

The White House press secretary says the FDA’s approval of a new generic abortion drug “does not address the merits of the current safety program.”

Mounting evidence shows abortion drugs are not safe for women, let alone for babies.

At a minimum, the FDA should reinstate… pic.twitter.com/djXotthmVl

— SBA Pro-Life America (@sbaprolife) October 3, 2025

So the question is: Were the FDA’s hands tied? Did they have to approve a new generic abortion drug created by a company that describes its mission as being to “normalize abortion” and make it “accessible to all”?

First, a Little About the Drugs

Abortion is the leading cause of death in America because of abortion drugs. The drugs now account for about two-thirds of abortions in the U.S. because they can be easily obtained through the mail. This is thanks to a Biden rule that ended the requirement of an in-person visit for mifepristone prescriptions – a rule the Trump administration has left untouched.

The drugs are not only deadly to babies, but to women as well. Two studies found that around 11% are going to the ER with serious side effects like hemorrhaging, infection, and sepsis. According to the Charlotte Lozier Institute, 75% of visits from women who went to the ER after taking abortion drugs were coded as severe or critical.

Tragically, a new form of domestic violence is on the rise thanks to the mail-order of mifepristone: the poisoning and coercion of women and girls with abortion drugs by abusive partners who obtain them through the mail. With a few clicks, bad actors can obtain these powerful drugs and use them to harm women and girls without their knowledge or consent.

HHS Says The Drug Is Under Review

During his confirmation hearing in January, Secretary Kennedy told senators that President Trump had asked him to study the safety of mifepristone and that he would ask the FDA to do that. In September, he told the Senate Finance Committee the Biden administration “twisted” abortion drug data “to bury one of the safety signals” for political reasons, and he cited the studies showing 11% of women suffering serious adverse events. His agency then sent a letter to state attorneys general confirming HHS will conduct a study as promised to review the safety of mifepristone for women.

Given the FDA’s mission of being “responsible for the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices” and its reservations about mifepristone, its decision to approve a new cheaper version of a drug that is sending droves of women to the ER is puzzling. Why put more of this drug that RFK suspects is seriously harming 1 in 10 women on the market?

The safety study itself would have justified holding the approval of Evita Solutions’ drug. Plus, the FDA has pulled drugs before when serious risks came to light. In fact, just this August, the FDA suspended a vaccine license and immediately halted distribution after reports of serious adverse events.

HHS Usually Takes Its Time To Review Generics

Abbreviated New Drug Applications, known as ANDAs, have a 180-day clock for approval, but according to HHS themselves, 79% of recent submissions missed the deadline. The Evita ANDA remained unapproved for 1,207 days under Biden and 253 additional days under Trump.

A document from the FDA spells out the process for approving a generic drug, showing approval is not an automatic process. Additionally, HHS says, “It should be noted that in many instances the failure to meet the 180-day statutory benchmark may have been justified and in such cases, was frequently the result of questions by the agency and responses by the applicant.”

This Is the Trump Administration We’re Talking About

As SBA Pro-Life America President Marjorie Dannenfelser told The Washington Post, “‘Powerless’ is an adjective no one uses to describe this administration when facing trouble.” The Trump administration is known for bucking the status quo to do the right thing. And they’re not afraid to defend their actions in court.

Take transgender-related litigation for example. On the AP’s Trump administration litigation tracker, there are 18 cases listed against the administration. The topics of the lawsuits range from President Trump’s executive order banning gender transitions for youth to the loss of education funds for letting boys compete in girls’ sports. There are dozens of other cases listed in categories like DEI, immigration, birthright citizenship, environment, federal funding and agency cuts.

Why in this instance did the FDA fail to take the Trump approach? How does the safety of pregnant women and the lives of their unborn children not rise to the level of delaying a bureaucratic process?

The FDA Must End Biden’s Mail-Order Abortion Rule

It’s not too late for the FDA to reverse course. Dannenfelser and leaders of the pro-life movement are calling on the FDA to end Biden’s mail-order abortion rule and reinstate basic regulations that were in place during Trump’s first administration. This is something the administration can do immediately.

Every day they wait, more unborn Americans die and more women and girls go to the ER with serious complications.