Republican senators demand answers from Trump FDA on abortion pill approval

Senate Republicans, who voted unanimously in support of Makary’s confirmation in March, have expressed mistrust following the covert announcement of the approved application for telehealth provider Evita Solutions to begin production of its generic formulation of mifepristone.

Both Makary and Health and Human Services Robert F. Kennedy Jr. promised GOP senators during their confirmation hearings that the FDA would conduct a wholesale safety review of mifepristone, which was deregulated under the Biden administration to remove in-person screening requirements before prescribing the medication.

Anti-abortion advocates argue that the FDA’s decision in 2016 to no longer require physicians to report nonfatal adverse complications has led to skewed safety statistics for the drug.

Mifepristone opponents contend that the FDA’s 2021 decision to no longer require in-person screening requirements, based on safety data collected since 2016, endangers women, as ultrasounds are necessary to determine the gestational age of the fetus and to rule out ectopic pregnancy, a life-threatening emergency.

Two April studies using the same insurance claims data, one published by the Ethics and Public Policy Center and one by the Restoration of America Foundation, found that 11% of patients who are prescribed mifepristone experience severe complications within 45 days of a medication abortion.

That’s roughly 22 times higher than the 0.5% complication rate listed on the medication packaging. 

Abortion opponents also point to abusers taking advantage of telehealth prescribing to force women into unwanted abortions. In Cassidy’s home state of Louisiana, where abortion is illegal, Attorney General Liz Murrill is attempting to prosecute a New York doctor for telehealth prescribing abortion pills to a mother who coerced her pregnant teenage daughter to abort.

“To be clear: this approval fails to mitigate the risks to women that have been identified and fails to protect women from the coercive use of the drug,” the senators wrote in the letter. “It also flies in the face of President Trump’s strong statement that he is ‘the most pro-life president’ in history and his dedication to protecting the lives of unborn children and keeping women safe.”

Other signatories on Cassidy’s letter include Sens. Lindsey Graham (R-SC), Tommy Tuberville (R-AL), Rand Paul (R-KY), Josh Hawley (R-MO), Pete Ricketts (R-NE), Mike Lee (R-UT), James Risch (R-ID), John Cornyn (R-TX), James Lankford (R-OK), Ted Budd (R-NC), John Cornyn (R-TX), Marsha Blackburn (R-TN), Roger Wicker (R-MS), Jon Husted (R-OH), Steve Daines (R-MT), Tim Scott (R-SC), and Mike Rounds (R-SD).

All but two Senate Republicans signed a different letter written by Graham and sent to Kennedy last week, calling on HHS to “take decisive action to reevaluate whether this generic version of mifepristone is suitable to enter the market.”

However, Cassidy’s letter asked more pointed questions about the nature of the approval, highlighting portions of the statute that govern the FDA’s approval processes.

Specifically, Cassidy highlighted a section of the Food, Drug, and Cosmetic Act that allows the agency to require drugmakers to submit an assessment or proposed modification to safety protocols if the FDA believes it is necessary to evaluate the risks and benefits of the medication.

Cassidy also highlighted the section of the legal code on generic drug approvals that requires the FDA to make a decision to approve or deny the new drug within 180 days of the company filing the application, or an extended period of time mutually agreed upon by the FDA and the applicant. 

In this case, Evita Solutions filed its application for generic mifepristone in October 2021, but it was not approved until Sept. 30, 2025.

Cassidy asked whether the FDA had any agreements with Evita Solutions to extend the approval timeline and asked why the FDA approved the generic application “before completing its review of mifepristone’s safety data.”

HHS did not respond to the Washington Examiner‘s request for comment, but agency spokesman Andrew Nixon previously said it “has very limited discretion in deciding whether to approve a generic drug.”

“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,” he said earlier this month. 

The GOP letter also asks for specific data and studies regarding the safety concerns resulting from the removal of in-person screening requirements.

Doug Truax, founder of the Restoration of America Foundation, told the Washington Examiner prior to Cassidy’s letter that the Trump administration has not contacted his organization regarding its April study on the higher-than-previously estimated complication rates, including sepsis and hemorrhaging. 

“We were happy to hear that it would be studied, but it’s been going on for a while, and the generic thing came out,” said Truax, adding that it’s “not ideal timing, given the fact that we know this drug is very dangerous.”

SBA Pro-Life America President Marjorie Dannefelser said in a statement on Cassidy’s letter that her organization is “deeply grateful” for the oversight letter to the FDA.

SENATE GOP CALLS ON RFK JR. TO REVOKE GENERIC ABORTION PILL APPROVAL

“The lawlessness surrounding the distribution of these drugs — kicking the physician out of the doctor-patient relationship — has put drugs in the hands of abusers of underage girls and women,” she said. “The horror stories and facts roll in daily, yet the response from the FDA was to approve a cheaper version of a drug that ends unborn lives and sends women to the ER.”

Cassidy, whose committee has oversight authority over the FDA, requested a response to all questions by Oct. 30.