The Biden administration on Tuesday formalized a process to allow retail pharmacies to join the abortion-pill business.
The policy change—originally announced more than a year ago—is the latest example of President Joe Biden doing the bidding of the abortion industry at the expense of women’s health and safety.
Here’s what you need to know about the Food and Drug Administration’s latest move and what it means:
Ever-Changing Regulatory Process
The first pill in the process, mifepristone, kills the unborn child by cutting off a hormone called progesterone, which is required to sustain a pregnancy. The second pill, misoprostol, causes contractions to empty the uterus. Together, this regimen is approved to be used up to 70 days (10 weeks) into pregnancy.
The FDA has a safety program called a Risk Evaluation and Mitigation Strategy (REMS) for certain drugs to ensure that the benefits outweigh the risks. Mifepristone has needed such a strategy since its original approval in 2000. These specifics have weakened over the years, but one constant was a requirement that mifepristone be dispensed in person by a qualified prescriber in certain health care settings, such as a clinic or hospital.
That means abortion pills weren’t treated like typical prescription drugs. Abortion providers would affirmatively “opt in” to be able to prescribe them. For many years, that largely contained abortion-pill provision to abortion clinics, not rank-and-file primary care doctors or OB-GYNs.
In December 2021, the FDA weakened the REMS, opening the door to telemedicine abortion and abortion pills by mail. The agency signaled it would create a policy for retail pharmacies to become certified to distribute abortion pills.
A year later, that process is finally in motion.
New Policy, Same Risks
The new REMS describes the administrative and compliance requirements for the pharmacy certification process.
In practice, it means that a woman can have a telemedicine chat with an abortion-pill prescriber, then fill the prescription at a local pharmacy without being seen in person by a health care provider before obtaining the pills.
The consequences are dire.
Abortion pills aren’t safe. Mifepristone is associated with 28 deaths, thousands of serious adverse events, and more than 500 life-threatening complications—that we know of, due to weak state and federal reporting requirements.
The complication rate from abortion pills is four times that of a first-trimester surgical abortion. One recent study found that between 2002 and 2015, emergency room visits following a chemical abortion increased by more than 500%.
FDA Having It Both Ways
The FDA’s own mifepristone Q&A shows how ideology is driving decision-making.
In one Q&A, the FDA says abortion-pill prescribers “must have the ability to date pregnancies accurately and the ability to diagnose ectopic pregnancies.” Why does this matter?
Mifepristone is approved up to 10 weeks. According to the American College of Obstetricians and Gynecologists, half of women will incorrectly recall the date of their last menstrual period. In one study, 40% of women who had a first-trimester ultrasound had their estimated due date adjusted by more than five days. Without an ultrasound, there’s no way to know if a woman is definitely within the 10-week window.
And the only way to rule out ectopic pregnancy (where the egg has implanted outside of the uterus) is to perform an ultrasound.
In the very next Q&A, the FDA says that the “REMS program does not require patients to see a health care provider in person before obtaining mifepristone,” and that “it is not necessary for the REMS to mandate how providers clinically assess patients for duration of pregnancy and for ectopic pregnancy.”
The FDA can’t have it both ways.
An ultrasound is necessary to accurately date a pregnancy and rule out ectopic pregnancy—full stop. But under the new REMS, the FDA will allow your local pharmacy to give women abortion pills without actually knowing if she’s eligible to take them in the first place.
What Now?
Time will tell if pharmacies will get in on the abortion business. In states with strong pro-life laws to protect women and unborn children, the FDA’s latest action will have no effect. But in many states, the prospect of your local pharmacy turning into an abortion clinic is a very real possibility.
Pharmacies must say “no” to the FDA’s latest reckless action, and Americans should avoid doing business with those that decide to profit from the deaths of unborn children.
In the meantime, policymakers at the state and federal level must act. That includes prohibitions on telemedicine and mail-order abortions, heightened informed-consent requirements, and reporting requirements to better track complications.
Congress should also conduct robust oversight of the Biden administration and the FDA to hold officials accountable for endangering women and girls.
Abortion pills are a matter of life and death for women and unborn babies. Policymakers at every level of government can’t afford to stay on the sidelines of this battlefield.
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