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Questions & Answers on the FDA’s Latest Decision to Allow Pharmacies to Stock and Sell the Abortion Pill Mifepristone

by | Feb 15, 2023

Part Three: Pushing against remaining legal limits on mifepristone

By Dave Andrusko

The Biden administration has greatly expanded the conditions under which abortion pills may be prescribed and sold, but abortion advocates clearly wish to take things further. Today, in our final segment, Dr. Randall K. O’Bannon, who has followed the issue of chemical abortion for nearly thirty years for National Right to Life, answers additional questions about how far abortion advocates and the federal government mean to go.

Q. Why are abortion advocates complaining?  Didn’t the FDA give them everything they wanted?

The abortion pill’s promoters envision a time when women can simply buy these online or pick these up at their local pharmacy any time they want without any testing, screening or formal prescription, the way one picks up cold or flu medications at the grocery store. Although having greatly relaxed requirements, this is not what the U.S. Food and Drug Administration (FDA) has authorized with these latest changes.

The FDA has gradually whittled down regulations on drug over the years. It has changed doses, extended recommended gestational cutoffs (originally seven weeks after a woman’s last menstrual period or LMP, now ten weeks), dropped the number of required visits from three down to zero, and expanded the pool of prescribers to include any certified health care provider. But the FDA has long maintained that because of certain inherent safety issues with the drugs, the distributor and authorized prescribers need to follow certain guidelines regarding the abortion pill’s distribution, prescription, and delivery.

Those include the prescriber’s certification that he or she is qualified to accurately assess the duration of the pregnancy (as the “effectiveness” of these pills diminishes, while risks of complications increase, the farther along the woman is); an ability to diagnose ectopic or tubal pregnancies (which these pills do NOT treat); and an ability to provide “surgical intervention” in cases where the pills do not complete the abortion or cause severe bleeding.

If they cannot provide that needed “surgical intervention,” they must have in place plans for their patient to receive that care from others.  They must also assure that their patient has access to medical facilities equipped to provide blood transfusions or resuscitation if these are needed.

They must sign a Prescriber Agreement Form agreeing to the above and prescriber and the patient must sign a separate Patient Agreement Form which reviews and explains the risks of the “mifepristone treatment regimen.”

The abortion industry considers these conditions and the involved paperwork cumbersome and unnecessary. But the FDA continues to maintain that these are necessary to “mitigate the risk of serious complications associated with mifepristone.”

Q. Is the FDA now authorizing women to buy abortion pills directly from online foreign groups and pharmacies?

In the last few years, thanks to the abortion industry’s endless self-promotion, there’s been a lot in the news about “self-managed” chemical abortions.  Alongside those stories, plenty of websites have sprung up selling foreign-made “abortion pills” that can sometimes be had at fraction of the cost being charged by America’s leading abortion chains.  

Many, if not most of these, are from foreign manufacturers whose drug formulation, purity, and effectiveness is of dubious quality. The only distributors whose chemical formulations, manufacturing processes, and drug purity have been tested by the FDA are Danco Laboratories, out of New York, which sells mifepristone under the trade name Mifeprex, and GenBioPro, a distributor of generic mifepristone out of Nevada.

Danco’s pills were originally produced by pharmaceutical firm in China, though more recent news stories say they are currently manufactured in Europe (ABC News, 6/24/22).  Assurances have been given that both facilities passed full U.S. federal inspections of their drugs and manufacturing processes.

We do not know at this point who manufactures GenBioPro’s pills, but to obtain FDA marketing approval for their drug, their manufacturer, foreign or domestic, would have had to pass FDA chemical analysis or their drugs and formal inspections of their manufacturing processes.

Groups obtaining and promoting pills from elsewhere are selling drugs of unproven purity, safety, or efficacy, even if they use the same names and claim to be identical formulations.

In the wake of the FDA’s loosening of mifepristone regulations, particularly the dropping of required office visits, many independent companies sprung up offering some telemedical version of mifepristone. Those attempting to operate within the law likely relied on one or more certified prescribers who somehow oversaw the online screening process and assured compliance with all state and federal regulations. One assumes they will now adjust their business and delivery models to comply with the FDA’s new regulations.

Others, like international abortion activist Rebecca Gomperts and her U.S. group, Aid Access, ignored relevant state laws and made no commitment to follow the FDA’s rules. They decided for themselves how much or how little screening to do, how much follow up, how to deal with complications, and relied on uninspected foreign suppliers to provide and ship their pills in a safe and timely fashion.

Gomperts and Aid Access have published assurances of their patients’ safety and success, but the reliability of their data, given the quality of their follow-up, is questionable.

Q. Will the FDA’s new authorization override my state law protecting unborn children or otherwise limiting chemical or telemedical abortion? What about the Biden administration legal opinion saying that a long-time federal law prohibiting the mailing of abortion drugs can simply be set aside?

The Biden administration has taken a number of actions to assure its pro-abortion constituency that it means to guarantee women’s access to the abortion pill. 

On the day that the Supreme Court announced its Dobbs decision overturning Roe, Biden’s Attorney General Merrick Garland went out of his way to note that “States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”

In addition to actions by the FDA allowing both health care providers and pharmacies to dispense and deliver mifepristone by mail, the Biden administration’s Office of Legal Counsel issued a memo. This memo declared that, in spite of an 1873 federal law specifically and directly prohibiting the mailing of abortifacients, the Justice department was of the opinion that the Comstock act–despite being reaffirmed multiple times and still in force–“does not prohibit the mailing, or the delivery or receipt by mail, of mifepristone or misoprostol…”because the shipper’s and recipient’s intentions cannot be presumed.

Meanwhile, lawsuits have been brought in federal court against limits imposed on the sale and prescription of mifepristone in West Virginia and North Carolina. GenBioPro is arguing, as Attorney General Garland asserted in June of 2022, that state law prohibiting the use of mifepristone as part of a larger ban on abortion conflicts with a federal determination of the abortion pill’s safety by the FDA. Similarly, a doctor in North Carolina says that a state law requiring the abortion pill to be dispensed in person goes beyond regulations the agency says are sufficient for safe use. In each case, plaintiffs argue that the issue for the courts is whether the state or the federal government is entitled to declare what constitutes safe use of the drugs.

All these matters will eventually be resolved in court, but legal experts say the Biden administration’s case is weak. The Comstock Law is pretty direct in its prohibition on the mailing of abortifacients. Mifepristone mailers rely on the Justice department’s novel reading of the law at their own legal peril. Anyone mailing these pills and counting on the Biden administration’s declaration as their defense will have nowhere to turn if and when a court rejects that argument or when a new administration takes office.

Much the same can be said regarding the upcoming tussle between federal and state governments over safety measures limiting the availability of mifepristone.  States can and have had different laws and opinions regarding the safety of different drugs, products, and practices than the federal government and these have generally been allowed to stand in the name of state sovereignty and the Constitution’s 10th amendment.

Furthermore, even though the state may raise several demonstrated safety issues associated with use of the mifepristone-misoprostol combination, the 2022 Dobbs decision allows the state to ban or regulate abortion as it sees fit, in the interest of protecting nascent human life (or any other reason), regardless of whether chemical abortion is or is not proven to be safe.

Editor’s Note: Part One of this Q&A series can be found here. Part Two can be found here.

Categories: Abortion Pill