Citing “the deleterious and grossly underreported effects on women” of chemical abortion drug mifepristone, 175 Members of the U.S. House of Representatives wrote to HHS Secretary Robert F. Kennedy and FDA Commissioner Martin Makary asking that the promised FDA review of the drug’s safety be accelerated and the federal agency at least reinstate the in-person dispensing requirement that had been removed by the Biden administration.
The lawmakers request that mifepristone “be aggressively investigated and decisive action taken to protect women from harm.”
“We also urge that immediate action be taken to, at a minimum, reinstate the in-person dispensing requirement for mifepristone,” they said.
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The Nov. 20 letter was led by Reps. Chris Smith (R-NJ), co-chair of the Congressional Pro-Life Caucus, and Diana Harshbarger (R-TN), a pharmacist and vice chair of the House Energy and Commerce Subcommittee on Health. Among the 175 Republican Members of Congress who signed on to the letter were Speaker of the House Mike Johnson, Majority Leader Steve Scalise, Majority Whip Tom Emmer, and Republican Conference Chairwoman Lisa C. McClain.
The letter follows a similar letter signed by 51 U.S. Senators last month in response to the FDA approving a second mifepristone generic, and mounting evidence that the FDA-approved chemical abortion pill mifepristone poses significantly greater health risk to women than previously acknowledged.
“The need for urgent investigation and review of this drug comes in the wake of the Biden-Harris administration’s egregious action to remove critical safeguards that once applied to abortion drugs, and the FDA’s approval of a new abortion drug generic in September 2025,” the Nov. 20 letter states. “The previous administration claimed that these changes were in response to the COVID-19 pandemic, but in reality, COVID served as a smokescreen to accomplish its radical abortion agenda, which even now wreaks havoc across the nation.”
Tweet This: The need for urgent review of chemical abortion drugs comes in the wake of the Biden-Harris admin’s egregious removal of safeguards.
The Biden administration loosened regulations on the abortion pill, allowing it to be prescribed via telehealth and delivered by mail without an in-person clinic visit. The Trump administration has not reversed the Biden rules.
The GOP Representatives cite the Ethics and Public Policy Center (EPPC) study released earlier this year which found that serious adverse events from mifepristone are approximately 22 times more frequent than the FDA currently recognizes.
From the letter:
The study shows that, following a mifepristone abortion, 10.93 percent of women experience sepsis, infection, hemorrhaging, or another serious or life-threatening adverse event. That is, over one in ten patients experience at least one serious adverse event. This largest-ever study of the abortion pill is based on a HIPAA-compliant analysis of a health insurance claims database that includes 865,727 prescribed mifepristone abortions from 2017 to 2023.
Sec. Kennedy and Commissioner Makary sent letters to certain state attorneys general in July informing them that the FDA will be carrying out a full review of the safety of the abortion pill.
Kennedy revealed in September that the Biden administration misrepresented data on mifepristone to obscure safety issues with the drug.
Mifepristone is the first of two drugs in a chemical abortion, which has surpassed surgical abortion to be the most common in the U.S. through widespread ease of access and nominal oversight. The drug has been shown to be four times more dangerous than surgical abortion.
The FDA employs a drug safety program called REMS (Risk Evaluation and Mitigation Strategies) for medications “with serious safety concerns” to make certain the benefits of the drug outweigh its risks. Of the 20,000+ prescription drugs approved by the FDA, just 74 drugs have been deemed dangerous enough to merit a REMS restriction - and one of those is mifepristone.
Mifepristone was first approved in 2000 in a process that some argue was hurried, at odds with science and law, and encompassed by politics.
The FDA then loosened its own safety standards on the drug in 2016 under President Barack Obama and 2021 under President Joe Biden. Part of this reduction of safety standards has included eliminating the requirement that abortion providers report non-fatal adverse events to the FDA Adverse Event Reporting System.
The safeguards for mifepristone removed by the FDA over the last nine years include an initial in-person doctor visit to screen for ectopic pregnancy and other serious conditions, and a follow-up visit to check for life-threatening complications, such as internal bleeding and infection.
The FDA then further lessened its REMS requirements for chemical abortion drugs, permitting them to be dispensed by pharmacies and delivered via mail. The Biden administration made access to the drug without in-person dispensing permanent in 2023.
FDA data shows that between the drug’s approval in 2000 and 2022 at least 32 women have died following mifepristone use.
“The Biden-Harris administration’s blatant disregard for the innumerable health risks and complications caused by mifepristone—the baby poison pill—has been the status quo for far too long,” Rep. Smith said in a statement. “The carelessness of Biden’s FDA has taken and harmed thousands of lives, the unborn and their mothers alike.”
Rep. Harshbarger said, “As a pharmacist, I’ve always believed women deserve the full truth when it comes to their health. Recent findings raise real questions about the safety of chemical abortion pills like mifepristone, and Americans deserve straight answers about the risks involved.”
In addition to Smith, Harshbarger, Johnson, Scalise, Emmer, and McClain, the letter to Kennedy and Makary was signed by Reps. Andy Harris, M.D., Kat Cammack, Michelle Fischbach, Robert F. Onder, Jr., Robert B. Aderholt, Brett Guthrie, Tom Cole, Jim Jordan, Brian J. Mast, Claudia Tenney, Harriet M. Hageman, Mary E. Miller, Sheri Biggs, Virginia Foxx, Stephanie Bice, Ashley Hinson, Beth Van Duyne, Carol D. Miller, Celeste Maloy, Erin Houchin, Lauren Boebert, Julia Letlow, Ph.D., Nicole Malliotakis, Laurel M. Lee, Ann Wagner, Mariannette J. Miller-Meeks, M.D., Marjorie Taylor Greene, Blake D. Moore, Clay Higgins, David Rouzer, Michael Cloud, Earl L. "Buddy" Carter, Barry Moore, Tim Walberg, Eric A. "Rick" Crawford, Chip Roy, Mike Rogers, French Hill, Marlin A. Stutzman, Wesley Hunt, Glenn Grothman, Mike Kennedy, M.D., William R. Timmons, IV, Robert E. Latta, Mike Flood, Jeff Crank, Brandon Gill, Gary J. Palmer, Andrew S. Clyde, Andy Biggs, Derek Schmidt, John Rose, Joe Wilson, Mark Harris, Scott Fitzgerald, Ronny L. Jackson, Lloyd Smucker, Julie Fedorchak, Julie Fedorchak, Cliff Bentz, Brad Knott, Gregory F. Murphy, M.D., Ben Cline, Michael K. Simpson, Nicholas A. Langworthy, Mark B. Messmer, Keith Self, John J. McGuire III, Jack Bergman, Rudy Yakym III, Mike Ezell, Adrian Smith, Charles J. "Chuck" Fleischmann, John H. Rutherford, John H. Rutherford, Vince Fong, Nathaniel Moran, Riley M. Moore, Dale W. Strong, Craig A. Goldman, Randy Feenstra, Tony Gonzales, Richard Hudson, Tim Burchett, Ralph Norman, Bill Huizenga, Andy Ogles, Michael A. Rulli, Russ Fulcher, Ron Estes, Addison P. McDowell, Josh Brecheen, Mike Bost, John R. Carter, Aaron Bean, David J. Taylor, Kevin Hern, Brian Jack, Glenn "GT" Thompson, Mark Alford, Jefferson Shreve, Tracey Mann, Byron Donalds, Guy Reschenthaler, W. Gregory Steube, Daniel Webster, Randy Fine, Randy Fine, Lance Gooden, Roger Williams, Mike Collins, John Joyce, M.D., Mark E. Amodei, Neal P. Dunn, M.D., Warren Davidson, Michael R. Turner, Brian Babin, D.D.S., C. Scott Franklin, Dusty Johnson, Dan Crenshaw, Brad Finstad, Randy K. Weber, Sr., Michael Guest, Rich McCormick, MD, MBA, Bruce Westerman, Pat Fallon, Trent Kelly, Jason Smith, August Pfluger, Mike Haridopolos, Mike Carey, Paul A. Gosar, D.D.S., Doug LaMalfa, Steve Womack, David Kustoff, Dan Meuser, Troy Downing, Tom Barrett, Tim Moore, Jodey C. Arrington, Jodey C. Arrington, John R. Moolenaar, Mike Kelly, Barry Loudermilk, Victoria Spartz, Austin Scott, Darrell Issa, Michael Baumgartner, Don Bacon, Burgess Owens, Jimmy Patronis, Russell Fry, Pete Stauber, Sam Graves, Mario Diaz-Balart, Elijah Crane, Darin LaHood, Gus M. Bilirakis, Jake Ellzey, Andy Barr, John James, Frank D. Lucas, Cory Mills, Vern Buchanan, Thomas Massie, James R. Baird, PhD, H. Morgan Griffith, Scott Perry, and Anna Paulina Luna.
