Editor's Note: The column is co-authored by John Mize and Brick Lantz, M.D.
In 1994 James W. Johnston, the CEO of R.J. Reynolds, boldly proclaimed under oath in front of a congressional committee that “cigarette smoking is no more ‘addictive than coffee, tea, or Twinkies.” Fortunately, that despicable lie didn’t last, and neither will the lie that chemical abortion is “safe and effective” for women.
Recently, The Ethics and Public Policy Center (EPPC) published a detailed analysis on the largest ever commercially available real-world claims dataset that rips wide open the lie that mifepristone is safe. This analysis of 865,727 women who had been prescribed mifepristone, the first pill of the chemical abortive cocktail, showed they were 22 times more likely to experience a medical emergency or serious adverse event within 45 days compared to the rate claimed on the FDA-approved drug label. According to the claims data, more than 1 in 10 women will experience a serious adverse event compared to the lower 1 in 200 rate as reported by Danco Laboratories, the manufacturer of mifepristone.
There is no other FDA approved drug on the market that has such a high percentage of serious adverse events.
Mifepristone, subject to continuous debate since FDA approval in 2000, has become emblematic of a larger trend where bureaucratic safeguards are sidelined in favor of market expediency and political experience. The non-randomized, limited studies used by Danco to justify FDA approval of the drug were conducted on healthy young women without comorbidities using the guidelines as approved in 2000. Those guidelines included three in-person visits, maximum gestational age of 7 weeks, physician-required prescription, in-office medication dispensing, with required in-office follow-up, and reporting of adverse events.
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In 2016, the Obama administration reduced the number of in-person visits to one, increased the gestational age from 7 weeks to 10 weeks, eliminated the physician-only prescribing requirement along with the requirement for the drugs to be administered in office, and the need for an in-person follow-up visit. Importantly, the Obama Administration also removed the requirement for adverse event reporting, which makes it much more difficult to accurately assess the prevalence of serious adverse events.
Finally, in 2023, leveraging the COVID pandemic as justification, the Biden administration removed the requirement for an in-person consultation. Now, a woman can be prescribed mifepristone without ever consulting a physician in person. The lack of an in-person encounter eliminates the opportunity to confirm gestational age and evaluate the women for potential abuse or coercion, along with other complications like ectopic pregnancy.
Big abortion has shoved this pill down the throats of American women, leaving a trail of despair and serious health risks, including death, all in the name of reproductive freedom. Doctors have long witnessed the dangerous and life-altering effects of chemical abortion in the ER, and now the truth can no longer be ignored: a drug designed to end the innocent life of a baby cannot be safe for a woman to ingest. The American public has no reason to trust a government that ignores scientific data and risks the welfare of its people in the name of a political agenda.
What has been incredibly interesting since the release by EPPC, is the speed at which pro-abortion forces have dismissed the analysis. If they truly cared about the health and safety of women, wouldn’t it be prudent to, at a minimum, ask the FDA to conduct a thorough evaluation and cross-reference of the data?
The Trump administration, through the FDA, can correct these wrongs and help rebuild the public trust that has been eroded over several decades. If the Trump administration believes in transparency and the widely touted mantra of “Make America Healthy Again,” now is the time to rethink the reckless and greedy overreach by big abortion to expand access to these dangerous drugs.
At a minimum, the FDA has a responsibility to reinstate the commonsense safety standards under the Risk Evaluation and Mitigation Strategy program that is expected of any other FDA-approved drug with proven serious complications, including expanding documentation and data requirements to report not only deaths, but all adverse effects. The Trump administration should also be urged to audit the original approval of mifepristone to determine the cause of such serious discrepancies between the purported complication rate and the new analysis that reflects the lived experience of real women.
Americans United for Life and Christian Medical & Dental Associations are dedicated to holding this and all future administrations accountable for public welfare and to ensure no more women are harmed by political deregulation. If America is to restore the trust of the people, it can no longer ignore the truth that has faced us for so long. “Safe and effective” has cost our country too many lives.
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