Hawley introduces bill to remove FDA approval for Mifepristone

 Sen. Josh Hawley (R-Mo.) on Wednesday unveiled legislation to remove Food and Drug Administration (FDA) approval for the use of mifepristone to end pregnancies, a bill that has quickly gained the support of major anti-abortion groups.

The legislation is an ambitious undertaking given the drug’s widespread use in the United States, where an estimated 7.5 million women have used it to terminate pregnancies since the FDA approved its use in 2000. It accounted for 63 percent of all abortions in the U.S. in 2023.

But mifepristone, which when combined with the drug misoprostol can end pregnancies at up to 70 days of gestation, has become a major target of the anti-abortion movement. President Trump has sought to satisfy those anti-abortion voices by launching an FDA review of the drug, which has not been completed.

Hawley says the ability of doctors to prescribe the drug across state lines has led to rampant abuse and alleges that incidences of adverse health effects are far more common than the drug’s maker, Danco Laboratories, has acknowledged.

“We’ve known for years that mifepristone is risky but it’s really just in the last few years that we’ve learned that this drug is inherently dangerous and it is inherently prone to abuse,” he said, citing a study of 875,000 mifepristone prescriptions showing that in 11 percent of cases in which women take the drug to end a pregnancy, there are “serious adverse health” effects.

“What it means in practice is internal infections, sepsis, a trip to the emergency room, a life-threatening condition — in 11 percent of cases,” he said.

That study, from the Ethics and Public Policy Center, has been the subject of numerous fact checks disputing its findings. The FDA puts the rate of serious adverse effects at 0.5 percent, and KFF notes other studies have come to similar conclusions.

Still, Hawley says those numbers hide the true number of injuries caused by the medication.

“This is a drug that is incredibly widespread and is inherently dangerous, it is also inherently prone to abuse,” he said, noting that about a dozen men have been charged around the country with using mifepristone to force on girlfriends or female acquaintances abortions they didn’t want.

The Supreme Court decision overturning the federal right to an abortion, combined with the COVID-19 pandemic prompting the FDA to ease some restrictions, led to an increase in the use of the medication.

Hawley said the looser regulations mark a major departure from the guidelines the FDA implemented when it first approved the drug more than 25 years ago.

“Because the drug comes in capsule form and because it is at this juncture almost completely unregulated, it is inherently prone to abuse,” he said.

“Over the years, one liberal administration after another, President Obama and then President Biden, removed almost all of the safety protocols around mifepristone such that today it is almost wholly unregulated,” he said. “They did it because of abortion politics. They did it because they wanted to turn mifepristone into the driver of abortion on demand.”

His bill would ban the sale of mifepristone for use in abortions but would still allow it to be prescribed to treat Cushing’s syndrome, a rare disorder associated with high cortisol levels for prolonged periods of time.

The legislation would also give women who suffered because of the drug the right to sue its makers in court.

Hawley called on Senate Republicans to unify behind the legislation, but it could be hard to round up the support of other Republicans such as Sens. Susan Collins (R-Maine) and Lisa Murkowski (R-Alaska).

“This is something for Congress to do. Congress needs to act,” he said. “Only Congress at this stage can withdraw the certification for abortion for mifepristone in an effective way. Only Congress can do it and make it permanent.”

“I’m going to make that case to my colleagues,” he added.

He held a press conference in the Senate Judiciary Committee’s hearing room Wednesday to present the stories of several women who suffered serious health consequences or experienced profound feelings of loss and remorse after using the drug.

One of the women Hawley introduced at the press conference, Shanyce Thomas, a nursing student attending school in Maryland, described the serious infection she suffered after taking mifepristone that resulted in a partial hysterectomy.

“I developed a severe infection behind my uterus that went undetected until it became life-threatening. My condition deteriorated so rapidly that I was rushed into the ICU,” she said. “I was [in a] medically induced coma for a month. During this time, I required several blood transfusions.”

https://thehill.com/homenews/senate/5779756-hawley-fda-approval-mifepristone/