Fifty-one U.S. senators wrote to Health Secretary Robert F. Kennedy Jr., and Food and Drug Administration Commissioner Marty Makary Thursday urging suspension of the recently approved generic chemical abortion drug and reinstatement of prior safety standards for mifepristone.
“The “abortion-on-demand” culture enabled by the Biden-Harris administration’s removal of critical safeguards on the only FDA-approved abortion regimen (mifepristone and misoprostol) is currently the biggest threat to unborn life in America today,” the senators said in the letter.
Led by South Carolina Republican Sen. Lindsey Graham, the group commended the federal agencies’ acknowledgement and commitment to reevaluating the standards for chemical abortion drugs but also called for specific action to keep women safer.
“Under current FDA regulations, these drugs can be obtained via mail order without meaningful consultation with a medical professional and without any confirmation of who is purchasing them or for what purpose,” the senators’ letter said. “These policies have enabled abortion pills to be obtained by abusers, traffickers, and even minors.”
Late last month the FDA had sent a letter to Evita Solutions, LLC, approving its application for a new generic version of mifepristone to the great consternation of pro-life groups who have been seeking reinstatement of safety protocols for mifepristone which had been reduced or removed during the Obama and Biden administrations. This marked the third company after Danco and GenBioPro authorized to distribute chemical abortion drugs in the United States. HHS had said it would study the effects of the abortion drug and a review has been underway.
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Safety concerns have surrounded chemical abortion drugs for the entirety of the approval of mifepristone in 2000. This concern has heightened with the rollback of some of the safety protocols with the drug. Abortion proponents continue to float the idea that no such safety issues exist.
“Contrary to the narrative peddled by the media that taking abortion pills is “safer than taking Tylenol,” evidence shows that the risk of serious medical complications after taking mifepristone is at least twenty-two times higher than reported on the drug label,” the senators continued in their letter. “In fact, more than 1 in 10 women who take mifepristone will experience a serious adverse event.”
Tweet This: In fact, more than 1 in 10 women who take mifepristone will experience a serious adverse event.
The figures they cite come from the Ethics and Public Policy Center study from earlier this year of more than 800,000 women who were prescribed mifepristone abortions from 2017 to 2023.
The senators go on to detail how pro-life states are being undermined by abortion pill companies shipping the drugs into pro-life states.
The group of senators recommended the following actions to Kennedy and Makary:
- Suspend the approval of any new generic versions of mifepristone pending the outcome of the REMS safety review;
- Commit to ensuring that all generic versions of mifepristone are included in the ongoing reevaluation of prior REMS approvals;
- Reinstate the in-person dispensing requirement for mifepristone and all its generic versions;
- Suspend the distribution of mifepristone and all generic versions as an “imminent hazard” under Section 505(e) of the Federal Food, Drug, and Cosmetic Act (FDCA); and
- Withdraw FDA guidance permitting pharmacy distribution of mifepristone and all its generic versions.
The White House had said that the FDA’s approval of Evita Solutions’ abortion drug was legally required because it is chemically equivalent to existing mifepristone drugs and no new safety studies were required.
Still, this moment of great concern for the safety of women and their unborn children is an opportunity for education, according to Heartbeat International, the largest network of pregnancy help organizations in the U.S. and the world.
Heartbeat noted that Evita’s own FDA labeling still has warnings of hemorrhage, sepsis, ectopic pregnancy complications, and even maternal death. This is a reminder that chemical abortion remains dangerous, especially when taken without medical supervision.
“We continue to urge the FDA to reinstate the full REMS safeguards to help protect women and ensure real medical oversight,” the group of senators said in a statement.
The REMS are Risk Evaluation and Mitigation Strategies reserved for the drugs of utmost safety concern.
Heartbeat said, “this moment offers a critical opportunity for pro-life advocates and pregnancy help centers to educate communities that FDA approval does not equal safety, advocate for reinstating in-person dispensing and full REMS enforcement, and serve women compassionately when chemical abortion fails, harms, or traumatizes them.”
The letter from the senators to the HHS and the FDA shared first with Just The News is available HERE.
Senators signing on to the letter:
Lindsey Graham, John Thune, John Barrasso, Tom Cotton, Shelley Moore Capito, James Lankford, Tim Scott, Jim Banks, James Risch, John Cornyn, Jim Justice, Pete Ricketts, Ted Budd, Steve Daines, Cindy Hyde-Smith, Roger Marshall, Tim Sheehy, Rick Scott, Kevin Cramer, Bernie Moreno, Todd Young, Bill Hagerty, Deb Fischer, Marsha Blackburn, Mike Lee, Ted Cruz, Roger Wicker, Markwayne Mulin, Josh Hawley, Mike Rounds, Joni Ernst, John Boozman, Jon Husted, Ashley Moody, Charles Grassley, John Hoeven, Rand Paul, Tommy Tuberville, Katie Boyd Britt, John Kennedy, Jerry Moran, Cynthia Lummis, Ron Johnson, Bill Cassidy, Mike Crapo, Thom Thillis, Eric Schmitt, John Curtis, Dan Sullivan, Mitch McConnell, David McCormick
Editor's note: Heartbeat International manages Pregnancy Help News.
