Illinois lawmaker calls FDA hormone therapy reversal ‘overdue’

By Catrina Barker | The Center Square contributor
The Center Square

(The Center Square) – An Illinois lawmaker and practicing physician weighs said U.S. Health and Human Services Secretary Robert F. Kennedy Jr.’s announcement that the FDA will lift a long-standing safety warning from hormone-based menopause drugs is long overdue, noting it is a move that could reshape how millions of women view mid-life treatment.

During a news conference, Kennedy said for more than 20 years, the nation’s medical establishment has largely ignored the needs of women navigating menopause.

“Millions of women were told to fear the very therapy that could have given them strength, peace, and dignity through one of life’s most difficult transitions. That ends today,” said Kennedy.

State Rep. Bill Hauter, R-Morton, an emergency physician and anesthesiologist, said the decision was overdue and reflects how science and medicine evolve over time.

“I think that, overall, it was kind of an over-warning by the FDA at the time, and it probably needed to be reviewed,” Hauter said. “They didn’t account for all types of administration, whether it’s a patch, vaginal, or oral form, and that overgeneralization dissuaded a lot of women from taking something that could have been beneficial.”

Kennedy argued the original warning, a “black box” label added in 2003, was based on incomplete and poorly interpreted data from the Women’s Health Initiative study published the year before.

“That study was not statistically significant, but it triggered a media frenzy,” Kennedy said. “The FDA reacted out of fear, not gold-standard science. The consequences have been devastating. More than 50 million American women have been scared away from treatments that could have eased their suffering and extended their lives.”

Hauter said it’s not unusual for federal health agencies to take years to revisit medical guidance, but such reversals often spark political backlash regardless of the science behind them.

“It’s a new administration with new people, and they’re challenging some of the conventional wisdom,” Hauter said. “That can be good and bad in medicine, but in this case, it was probably due. Unfortunately, everything gets politicized now, so you’ll have some people criticizing this just because it came from Secretary Kennedy.”

Federal officials say updated evidence shows early, properly prescribed hormone therapy can reduce risks of heart disease, Alzheimer’s, and bone loss while improving overall well-being.

Supporters call it a long-overdue correction, and Hauter notes most specialists already tailor treatment to individual risk rather than the FDA’s old warning.

“I don’t think there’s going to be a huge change in practice,” he said. “Doctors who actually specialize in this already knew the data, knew their patients’ risk tolerance, and have been giving sound advice all along. This is more of a change for the general public than for the medical community.”