New FDA Rule Lets Pharmacies Dispense Abortion Pills – Under Certain Conditions

By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research

The media has read all the abortion industry’s press releases and is anxious for you to know that the U.S. Food and Drug Administration (FDA) has now made abortion pills available at your local neighborhood pharmacy.  

Well, sort of. And maybe sort of not.

What the FDA has done is to set up a regulatory system whereby certain pharmacies—if they agree to comply with certain rules and conditions, if they commit to filling out and maintaining certain records for every pill they dispense–can fill prescriptions from doctors (or other health care professionals) if those prescribers have undergone their own certification process and agreed to follow guidelines the FDA set for the pill’s distribution and prescription.

This is clearly not something every retail pharmacy will do. They may lack the staff, they may despise the extra paperwork, or they may not want to be linked in documentation to women who are injured or killed by the deadly drugs. They may not wish to work with abortionists, or they just may not want to be involved in any way with the killing of unborn children.

A lot of your mom and pop local pharmacies will simply say “no way.” However CVS and Walgreen’s have said they will participate.

According to Reuters, Walgreens and CVS Health Corp “said on Wednesday  they plan to offer abortion pills following the U.S. Food and Drug Administration’s (FDA) decision to allow retail pharmacies to offer the drug in the country for the first time”[1/4].If these drugstore chains follow through, and the new rule encourages and enables new prescribers to sign up, it could be devastating.

The ones most immediately affected will probably be the online pharmacies that were explicitly set up with the idea of being able to sell abortion pills over the internet and ship them to women’s homes. The new FDA rules make that possible, so long as everyone complies with the new regulations

Part of the abortion industry’s long-term plans

Even before the mifepristone-misoprostol combination was first approved for sale in the U.S. in September of 2000, abortion advocates have been pushing to have abortion pills available to women with as few limits as possible. In the beginning, the pills were approved with a multi-step procedure that involved three separate visits to the clinic.  

In her first visit, a woman was screened for certain medical conditions that might make the drug dangerous or ineffective for her. Her gestational age was determined (the pill’s effectiveness begins to drop off after the seventh week LMP [pregnancy measured from a woman’s Last Menstrual Period], and her doctor checked to see whether she might have an ectopic pregnancy. The abortion pills do not work in the 1-2% of pregnancies where the baby implants outside of the womb.

If she passes those hurdles, she was to be told what to expect with the drugs, how to recognize signs of problems (e.g., excessive bleeding), and then given the mifepristone to take there in the office. Over the next few hours, mifepristone acts to block the signal of progesterone, essentially shutting down the life support system for the tiny embryo.

Two days later, she was to return to be administered the misoprostol, a prostaglandin which stimulates powerful uterine contractions to expel the dead child.

A third visit at two weeks confirmed whether or not the abortion was complete or further actions were required.

Right away, the abortion industry did not like all the visits and began recommending its own protocol where women simply took the prostaglandin home with them at the first visit and self administered it later, skipping visit two.

In 2008, some Planned Parenthoods in the Midwest began experimenting with abortions by telemedicine, eliminating the need to visit the clinic for the first visit. 

The required patient screening and counseling were then done by a Planned Parenthood clinician, who, miles away on his own webcam, after getting satisfactory responses from the patient, clicked his computer mouse, triggering the opening of a locked drawer at the patient’s location where the abortion pills were waiting. She took those while the prescriber watched.

The FDA eventually agreed to reduce the visits for standard chemical abortions from three to one, extend the deadline until 10 weeks, broaden the pool of prescribers to include any certified health care provider, as well as other demands of the abortion industry. But advocates were still not satisfied.  

They sought full telemedicine, where appointments could be handled entirely online and pills could be shipped to women by overnight mail. They wanted these available through online pharmacies. There were no required visits, and women might never have to even leave their homes. This was authorized in the FDA’s latest revision of regulations.

New FDA regulations still likely to be a hurdle for many pharmacies

This is still not the industry’s endgame. They would like to get rid of the FDA’s special regulations entirely. They want any doctor, any nurse, and any healthcare worker to be able to prescribe these drugs without any sort of special certification or tracking. They also want pharmacies everywhere to keep these in stock and sell these to anyone who asks, maybe even without a prescription.

In that regard, the FDA’s latest regulations are still a bit of a disappointment to the abortion industry.  

The FDA still requires that prescribers be certified. They must sign paperwork assuring the distributor that they have read and understood materials on the drug’s operation; that they will date a mother’s pregnancy; that they will ascertain whether or not she has an ectopic pregnancy; that they will give her due warning about the risks and the danger signs; and that they will keep records of the pills and monitor their patient’s outcome.

While it used to be the case that the prescriber had to order the abortion pills directly from the distributor, the new FDA relations now allow the doctor, nurse or clinician to simply write a prescription and have a separate pharmacy stock the pills and fulfill those orders. That pharmacy, however, must have on file the completed “prescriber agreement forms” from any would-be prescriber. The pharmacy must also be able to fully track all abortion pill shipments, and have someone on staff who will be responsible for the pharmacy’s compliance with the FDA’s certification process.

The regulations require this pharmacy employee being familiar with the same prescribing information as the prescriber. He or she must complete and maintain files of the pharmacy and prescriber forms, ensure and monitor timely delivery of the pills, track shipments, and report any patient deaths to the distributor.

While doctors and clinics will welcome the chance not to have to order or store abortion pills at their offices, it remains to be seen how many pharmacies will be willing to take on the burdens of the FDA certification process, much less risk the ire of other customers who don’t want to buy their drugs from a pharmacy involved in the killing of unborn children in their community.