The safety of medication abortion got a contentious Senate hearing Wednesday as Republican lawmakers put pressure on the FDA to return to in-person prescribing requirements for mifepristone.
Republicans and anti-abortion rights witnesses at the Senate Health, Education, Labor, and Pensions (HELP) Committee hearing argued that medication abortion is unsafe and that the Biden administration's efforts to relax prescribing were "illegal" and made safety worse. Democratic members, meanwhile, charged that their Republican colleagues don't actually care about protecting women.
HELP Committee Chair Bill Cassidy, MD (R-La.), argued that medication abortion can lead to potential complications.
According to one study he cited, nine in 10 women who had a medication abortion described the pain as "moderate to severe." And Cassidy also cited a contested study suggesting that one in 10 women who took the abortion pill experienced serious adverse events, including hemorrhage, sepsis, or infection.
Nisha Verma, MD, MPH, a fellow with Physicians for Reproductive Health in Atlanta, countered that "over the past 25 years, medication abortion using mifepristone and misoprostol has been rigorously studied and proven safe and effective in over 100 high-quality, peer-reviewed studies."
She noted that two of the 10 "deeply flawed" studies that purported to show harm have been retracted.
"As a person of science, I think any person can say the science is settled," Verma said.
FDA Commissioner Marty Makary, MD, MPH, was not at the hearing, but Sen. Jim Banks (R-Ind.) pressed for the commissioner to testify in order to clear up "rumors" that the agency is "intentionally slow-walking" a safety review of mifepristone.
Cassidy said the committee would host Makary "very soon."
Louisiana Attorney General Liz Murrill charged that the Biden administration's "illegal" actions provided an end-run around Louisiana law, which banned abortion following the Supreme Court decision overturning Roe v. Wade, including those using medications.
In 2023, the FDA amended the risk evaluation and mitigation strategies (REMS) program for mifepristone, eliminating the requirement that the drug be dispensed in person at a clinic, medical office, or hospital, opening the door for telehealth prescribing and the distribution of the drug by mail.
"This was not a medically informed decision, but a purely political one," Murrill argued.
Consequently, she said, 900 "illegal abortions" occurred each month in Louisiana last year, along with multiple instances of partners or parents coercing women into ending wanted pregnancies. Murrill called for the 2023 REMS changes to be "vacated."
Louisiana has gone after multiple out-of-state doctors who allegedly prescribed abortion medications to individuals in the state, testing the limits of shield laws enacted in blue states to protect the practice.
Sen. Jon Husted (R-Ohio) said he spent his early childhood in foster care and was later adopted. "My birth mother was under a lot of pressure to have an abortion, and thankfully for me, she didn't," he said.
But there have also been alleged instances of women forced to end pregnancies against their will, said Husted, who asked witnesses whether reinstating in-person visits would help prevent these scenarios.
"We absolutely believe that putting the in-person dispensing requirement back in place would substantially protect women," Murrill said. To that end, Louisiana placed mifepristone on the state's controlled substances list to help track who is prescribing the drug and increase accountability, she said.
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