Trump FDA Approves Generic Abortion Pill Amid Safety Probe (3)

The Food and Drug Administration this week approved a new generic version of the abortion pill mifepristone, as the Trump administration undertakes a broader safety review of the drug.

The drug will be made available by Evita Solutions LLC, according to an FDA filing approving a 200 milligram oral tablet of the abortion medication.

The FDA’s Sept. 30 approval is the latest development in an ongoing fight over access to mifepristone. Opponents say FDA decisions made before the Trump administration have expanded access to mifepristone in ways that violate red-state restrictions on abortions and endanger patients, while proponents view the drug as crucial to women’s health.

The approval follows a letter from FDA commissioner Marty Makary and US Department of Health and Human Services Secretary Robert F. Kennedy Jr. stating they would open an investigation into safety and efficacy of the abortion pill mifepristone.

That investigation came after a controversial study from the faith-based group Ethics and Public Policy Center found potential adverse effects from using the drug.

Kennedy told lawmakers at a Sept. 4 Senate Finance Committee hearing that the Biden administration “twisted the data” on the safety of mifepristone. Kennedy said the Trump administration was committed to reviewing mifepristone safety and keeping politics out of his approach.

“The FDA has very limited discretion in deciding whether to approve a generic drug,” HHS spokesperson Andrew Nixon said in an email Thursday. “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.”

“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,” Nixon said.

Kennedy echoed that in his own post on social media site X Thursday.

“The Biden administration removed mifepristone’s in-person dispensing rule without studying the safety risks. We are filling that gap,” he said. The FDA “only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”

Evita Solutions said in a statement: “Availability of our product will expand patients’ options for medication abortion with an affordable product backed by decades of safe use.”

Anti-abortion conservatives criticized the FDA for the approval.

“This reckless decision by the FDA to expand the availability of abortion drugs is unconscionable,” Marjorie Dannenfelser, president of Susan B. Anthony Pro-Life America, said in a statement.

“The FDA must, at a minimum, immediately reinstate the commonsense safeguards that were in place during President Trump’s first term. In particular, the Biden-era policy of removing doctors by allowing mail-order abortion drugs without in-person medical oversight must be reversed without delay,” Dannenfelser said.

Sen. Josh Hawley (R-Mo.) posted on X that the FDA’s approval was “shocking.”

“FDA had promised to do a top-to-bottom safety review of the chemical abortion drug, but instead they’ve just greenlighted new versions of it for distribution. I have lost confidence in the leadership at FDA,” Hawley said.

Also on X, Mike Pence, who served as vice president in the first Trump administration, called the FDA’s decision a “a complete betrayal of the pro-life movement” that elected the president.

“President Trump must immediately reverse this decision. RFK must resign and give President Trump the opportunity to appoint a new Secretary of HHS who will protect the sanctity of life,” Pence said.