FDA Quietly Approved New Abortion Drug After Promising Safety Investigation

The Food and Drug Administration (FDA) approved a new generic version of mifepristone on Tuesday.

Weeks after confirming a review of the abortion pill was underway, the FDA approved the application of a new mifepristone producer, Evita Solutions, LLC, according to a letter sent to the company.

“Evita Solutions believes that all people should have access to safe, affordable, high-quality, effective, and compassionate abortion care, regardless of their race, sex, gender, age, sexuality, income, or where they live,” the company’s website states. “We know that you can make the best choice for your body.”

The FDA has “very limited discretion in deciding whether to approve a generic drug,” HHS Communications Director Andrew Nixon told the 🏢Daily Caller News Foundation, adding that the agency “does not endorse any drug product and directs prescribers to follow all labeling.”

“By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” Nixon said.

“Generic applicants are not required to submit independent evidence proving safety and effectiveness,” he continued. “HHS is conducting a study of the reported adverse effects of mifepristone to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”

The company submitted its application in 2021, according to the approval letter.