Recently, over 100 members of both the House and Senate sent a letter to FDA Commissioner Robert Califf calling on him to restore oversight regulations on chemical abortions, which were rescinded last December. The letter, led by Sen. Cindy Hyde-Smith (R-MS) was dated February 18, 2022. Dr. Califf, as Spencer highlighted, was confirmed last month thanks to Republican support, by a vote of 50-46.
"Removing the in-person dispensing requirements from the drug's Risk Evaluation and Mitigation Strategy (REMS) and permitting mail-order dispensing of this drug will increase risks to women. This action recklessly ignores the clear data showing the dangers of chemical abortions and abandons FDA's responsibility for ensuring safety of drugs," the letter charges.
The December decision to permanently remove commonsense safety regulations means that a woman will no longer need to go in for an in-person visit to confirm she is even pregnant, how far along in her pregnancy she is, or to ensure she is not experiencing an ectopic pregnancy. Chemical abortions are only approved for up to 10-weeks of pregnancy. The FDA made the decision to increase it from seven weeks to 10 in 2016, when Dr. Califf was the commissioner in the Obama administration.
The letter also goes into detail of the safety risks of a chemical abortion procedure, which entails a woman taking mifepristone to cut off nutrients from her unborn child. She then later takes misoprostol to induce contractions to expel the dead child.
As the letter warns:
In addition to the loss of the unborn child, chemical abortion drugs present serious risk to the health of the mother, including severe bleeding, infection, the need for surgical intervention, and even death. In fact, chemical abortions are four times more dangerous than surgical abortions. These health risks necessitate, at minimum, in-person screening by a physician. Pregnant mothers need to be screened in-person for contraindications like an ectopic pregnancy and the age of their baby to prevent life-threatening complications. They should also be tested for blood type and Rh factor to protect their fertility, examined after taking the drugs because of the risk of infection from an incomplete abortion. Furthermore, allowing these drugs to be dispensed without physician oversight makes it easier for the drug to fall into the hands of abusers who may give them to pregnant women without their knowledge and consent.
Recognizing these grave risks, FDA put in place rules to protect the women who take these drugs by implementing a REMS for mifepristone. FDA can require a REMS when a drug has "serious safety concerns” and the REMS are necessary to address the specific serious risk associated with the drug.
Under the mifepristone REMS, the drug had to be ordered, prescribed, and dispensed by a qualified healthcare provider in a clinic, medical office, or hospital. FDA's action to indefinitely repeal basic, commonsense safeguards is reckless and exposes women to unnecessary risks.
The etter goes on to mention a study conducted last November by the Charlotte Lozier Institute (CLI), which showed that between 1999-2015, emergency room visits went up 507 percent following women undergoing this method. It's worth keeping in mind that this study does not include data for ER visits after the approved timeframe was expanded. Thus, the numbers may paint an even more dangerous picture.
And, as I covered later in December, after the Biden administration made the move to permanently do away with the safety regulations, there's an issue of incomplete data and abortion advocates spreading lies to promote the dangerous method.
"The FDA decision ignores these studies, which all confirm the risks from mifepristone are serious and increasing," the letter from lawmakers also charges.
In an opinion piece published in Newsweek last month, shortly before the lawmakers sent their letter to Dr. Califf, Drs. James Studnicki and John W. Fisher of CLI, who participated in the study mentioned above, similarly called out the FDA.
"The Abortion Industry, Like Big Tobacco Before It, Undermines Science," their headline charged. In their piece, they also refer to the study, specifically as it applies to the FDA's ignoring it:
To get a more complete picture of national abortion incidence, the CDC defers to abortion patient and provider surveys conducted periodically by Guttmacher, which include every state but are not taken every year. The most recent survey dates to 2017. Similarly, the FDA recently relied on data from the abortion industry—abortion providers and the manufacturers of abortion pills—in its decision to eliminate longstanding patient safeguards on the abortion pill. As in the days of the [Tobacco Industry Research Committee (TIRC)], the FDA and abortion industry studiously avoid independent research findings that the rate of U.S. abortion pill-related emergency room visits increased more than 500 percent from 2002 through 2015 (the most recent data available).
The strongly-worded letter from lawmakers turns the pro-abortion argument about the procedure being a matter of "women's health" on its head:
Make no mistake: the relaxation of these requirements will hasten a new regime of mail order abortion, where women ingest these dangerous medications alone without any meaningful oversight from a doctor. Without physician involvement and the associated quick access to care in the case of adverse events, women are likely to face additional complications from these do-it yourself chemical abortions.
Indefinitely eliminating the REMS in-person requirement eliminates the minimal guardrails established to protect women's health. This action promotes mail-order abortion-on demand and disregards the growing threat to women's health posed by chemical abortion drugs. Further, the agency abandons vulnerable pregnant women to the reckless and predatory actions of the abortion industry. In light of comprehensive data showing increasing risks to women, the FDA should strengthen the REMS, rather than loosen them. Therefore, we call on FDA to immediately rescind its removal of the in-person dispensing requirement and to strengthen the REMS in order to protect women's health.
Since then, chemical abortion has remained a hot topic in the news. As Madeline reported last week, a study from the Guttmacher Institute found that chemical abortions accounted for 54 percent of abortions in 2020.
Abortion rates have gone up over the years due to chemical abortions.
It's not merely the Biden administration and FDA making abortion further unsafe for women by loosening these regulations. As I covered in December, Dr. Daniel Grossman, who performs abortions, has heavily promoted this method, to the point of calling for the falsification of medical records when it comes to their safety. He has written pieces and tweeted incessantly for years promoting this method, encouraging women to store it as a backup.
Dr. Grossman isn't the only one who promotes chemical abortion with such recklessness. Bloomberg published and heavily promoted a shocking claim from Cynthia Koons that "The Abortion Pill Is Safer Than Tylenol and Almost Impossible to Get."
Carole Novielli quickly responded in a piece for Live Action News.
Where the federal government under the pro-abortion Biden administration is failing women's health and safety, states are stepping in. Madeline's coverage references efforts in Alabama to outlaw the method.
Other states, including Kentucky, South Dakota, Wyoming, and Tennessee are also looking to regulate or ban the method in some way.