Sen. Josh Hawley (R-MO) said Friday that he believes Food and Drug Administration Commissioner Marty Makary “misled” him regarding his commitment to President Donald Trump’s anti-abortion agenda after the agency approved a new generic version of an abortion pill.
Hawley was one of the first senators on Thursday to criticize the FDA for approving the new generic version of the pill mifepristone, which will be produced by the company Evita Solutions. He said he has “lost confidence” in the agency.
Both Makary and Health and Human Services Secretary Robert F. Kennedy Jr. promised during their Senate confirmation hearings this spring that they would conduct a safety review of the abortifacient mifepristone following new data indicating that 11% of women have life-threatening complications from the at-home abortion protocol.
When asked by the Washington Examiner on Friday whether he was misled by either of the Trump nominees, Hawley said he believes he was misled by Makary but not Kennedy.
“I don’t think [Kennedy] has to do with this, but the commissioner, yeah, I do,” Hawley said.
Hawley described the situation as “broken trust and faith” and “quite egregious.”
“The whole premise of the review is, ‘gee, this drug might be unsafe. We might need to change the safety protocols,’ and then they approve the same drug with no new safety protocols and no review done,” he said. “That just tells me they’re not interested in the review.”
When asked whether there would be an oversight investigation of the FDA’s decision, Hawley said it would be “up to the chairman,” referring to Sen. Bill Cassidy (R-LA), chairman of the Senate health committee.
Cassidy posted on X on Thursday evening that the FDA’s “approving one more tool to kill babies is a betrayal.”
“This is not what Commissioner Makary and Secretary Kennedy indicated they would do in their confirmation hearings,” he wrote.
In early September, Kennedy, during a Senate Finance Committee hearing, was asked by Sen. James Lankford (R-OK) about the status of the review, and Kennedy assured him that it was ongoing.
During his testimony, Kennedy also referenced the 11% complication statistic and the fact that the FDA removed the requirement for physicians to report nonfatal adverse complications in 2016.
Abortion opponents also claim that the FDA’s 2021 decision to remove in-person screening requirements for dispensing mifepristone endangers women, as an ultrasound is necessary to determine the gestational age of the fetus and rule out the risk of ectopic pregnancy.
Lankford, on Friday, in response to the news of the generic approval, called on the FDA to “prioritize women’s health by returning to the safety protocols that preceded the activist Biden administration.”
“The FDA’s move to approve a generic version of mifepristone while a safety review of the drug is ongoing puts women at risk,” Lankford said on X. “Chemical abortion carries serious and well-documented dangers for mothers.”
Later Friday afternoon, Hawley sent an oversight letter requesting information about the timing of granting the approval for Evita Solutions’s generic product.
Evita Solutions first submitted its generic drug approval request in 2021, during the Biden administration.
Federal statute governing the agency requires that the FDA either approve or deny a company’s application within 180 days of submitting the application “or within such additional period as may be agreed upon by the Secretary and the applicant,” in this case Evita Solutions. Neither HHS nor Evita Solutions answer specific questions related to the timing of the approval process when asked by the Washington Examiner.
A group of 13 House Republicans on Friday, led by Rep. Mark Harris (R-NC), sent a letter to Kennedy demanding that he fire the director of the Office of Generic Drugs, the director of the Center for Drug Evaluation and Research, and other bureaucrats involved in the decision.
Harris and his colleagues wrote that the generic approval “not only contradicts the announced review but also runs directly counter to this administration’s stated pro-life agenda.”
“It is clear that rogue actors within the FDA are working to undermine both the sanctity of life and the administration’s commitment to protecting it,” they wrote.
Other signatories on the letter included Reps. Josh Brecheen (R-OK), Keith Self (R-TX), Eli Crane (R-AZ), Paul Gosar (R-AZ), Chip Roy (R-TX), Mary Miller (R-IL), Andy Biggs (R-AZ), Barry Moore (R-AL), Scott Perry (R-PA), Ralph Norman (R-SC), Sheri Biggs (R-SC), and Ben Cline (R-VA).
HHS spokesman Andrew Nixon told the Washington Examiner on Thursday that the FDA “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. Generic applicants are not required to submit independent evidence proving safety and effectiveness,” Nixon said.
Kennedy later posted a similar message to X, noting that “[r]ecent studies already point to serious risks when mifepristone is used without proper medical oversight.”
TRUMP FDA APPROVES NEW GENERIC ABORTION PILL, ANGERING CONSERVATIVES
Neither HHS nor the White House responded to the Washington Examiner‘s request for comment.
Senate reporter Ramsey Touchberry contributed to this report.
