As the Senate considers Dr. Martin Makary’s nomination to lead the Food and Drug Administration, the safety of all Americans — especially women and children — must be a top priority. For far too long, the FDA has been grossly negligent regarding essential safeguards surrounding the abortion-inducing drug mifepristone. Dr. Makary’s initial hearing provided a glimpse into his commitment to data-based approaches to providing the best care for our patients. I’m hopeful that this expected confirmation will stand as a first step to the FDA reprioritizing the health and safety of women and children.
Despite the common refrain that abortion should be a decision “between a woman and her doctor,” doctors are too often left out of the picture by what has become a highly politicized and aggressively pro-abortion FDA. To the detriment of women’s health and safety, the FDA has for too long made women’s health a pawn in abortion politics by promoting drug-induced abortions as safe and recklessly ignoring the necessity of proper medical oversight.
Due in large part to the Biden-era FDA’s gutting of the requirements necessary to take mifepristone, women today are denied crucial medical care in life’s most vulnerable moments. In fact, the FDA has recklessly removed its requirements that women meet with a doctor before taking abortion drugs, thereby denying women the chance to be screened for life-threatening conditions like ectopic pregnancy or to confirm how far along she is in her pregnancy.
My 20 years of caring for women as an OB/GYN have affirmed what the medical literature shows — the only way to ensure accurate dating of a pregnancy is to examine a woman in person, ideally with an ultrasound. This is crucial, because an error of just a couple of weeks could mean a significant increase in risk for the woman if she takes these drugs.
To be clear, I would never recommend dangerous drug-induced or surgical abortions to any woman or teen who comes to me for care, especially when so many life-affirming alternatives exist to effectively care for both mother and child.
The FDA also shamefully fails to require any follow-up visits, even though their own label on mifepristone states roughly one in 25 women who take it will end up in the emergency room. Selling women the lie that these drugs are safe, especially without the benefit of ongoing care with a doctor, is unethical.
With the urging of abortion advocates, and without appropriate evidence to support it, the FDA has also allowed abortion drugs to be shipped to women by mail, delivered straight to their doorsteps. This move not only puts women in danger of taking counterfeit drugs that could cause them harm, but it also makes them vulnerable to coercion and abuse.
The new FDA leadership must prioritize women’s health by implementing key reforms.
First, they should reinstate the requirement for in-person doctor visits so women can receive individualized counseling and fully informed consent, along with being adequately screened for potentially life-threatening conditions. It’s a simple but essential principle of medical ethics that patients have a right to informed consent before taking these high-risk drugs — something that can only happen with an in-person visit and individualized counseling. Even the pro-abortion American College of OB/GYNs (ACOG) notes that an adequate informed consent process is one where patients are “free to ask questions” and make a choice about their care, including refusing treatment. It’s impossible to have this tailored conversation when abortion drugs are dispensed online with no in-person interaction with a medical professional.
Next, should a woman choose to pursue a drug-induced abortion, the FDA should restore the seven week gestational age limit (currently 10 weeks) to decrease the risks associated with these drugs, as well as require abortion providers to see a woman for a follow–up visit to ensure her abortion is complete and to evaluate for and treat any complications she might be experiencing. This would be consistent with what was originally recommended when the drug entered the market and would reduce risks to women. With these protections in place, our federal leaders, regardless of their personal position on induced abortion, can at the very least reduce the risk of women dying from complications of abortion drugs and ensure that all women are receiving fully informed consent before taking them.
Reinstating the FDA’s original safety regulations for mifepristone is an essential first step toward protecting the health and safety of women across the nation. Women and girls seeking an induced abortion are often in a vulnerable and uncertain time of their lives. Rather than ensuring that they receive accurate information and ongoing medical care, the FDA has sold them a lie and denied them appropriate care. We all should work together to bring this negligence to an end.
Women and girls deserve the best medical care possible that is individualized and evidence-based. I’m hopeful that with Dr. Makary’s leadership the FDA will restore safety as the priority for American women and girls. Our patients deserve nothing less.
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Christina Francis, MD is a board-certified obstetrician-gynecologist practicing as an obstetric hospitalist. She also serves as CEO of the American Association of Pro-Life Obstetricians and Gynecologists.
The views expressed in this piece are those of the author and do not necessarily represent those of The Daily Wire.
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