Concerns grow over stability and efficacy of mail-order abortion drugs

Even the media is growing concerned over the fact that a lack of climate-controlled delivery and extreme temperatures may negatively impact the stability and efficacy of mail-order drugs — including abortion pills.

KEY TAKEAWAYS:

• While the FDA regulates certain aspects of packaging and transporting drugs from manufacturers to wholesalers and pharmacies, they do not regulate the shipping of mail-order drugs (including abortion drugs) sent to customers’ homes.

• Mailed abortion pills often spend a great deal of shipping time in extreme temperatures. Experts note that this could cause the drugs to become compromised, unstable, and less effective.

• The lack of oversight and regulation in shipping and delivery could mean thousands of women obtaining the abortion pill by mail are receiving compromised, less effective drugs — potentially increasing the risk of incomplete abortion.

THE DETAILS:

Mifepristone 200mg (Mifeprex) and misoprostol are the two drugs that make up the Food and Drug Administration’s (FDA) approved abortion pill regimen.

Though the FDA’s 2023 mifepristone label is clear that the drug is to be stored at “25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F),” mailed abortion pills are often transported in extremely hot or cold conditions, before being placed inside mailboxes where they will likely sit for hours in potentially high heat or freezing weather.

Packaging inserts for both Danco and GenBioPro (GBP) show the same storage instructions. In addition, GBP states on its website that mifepristone should be protected from light.

The second drug in the protocol, misoprostol (Cytotec), also requires specific temperature controls. According to Pfizer and GBP, misoprostol should be stored “at or below 25°C (77°F), in a dry area.”

A study conducted between 2020 and 2021 by Concept Foundation and the International Planned Parenthood Federation (IPPF) concluded that “a significant problem still exists in relation to the quality of medical abortion drugs in low- and middle-income countries” and noted that “Misoprostol is a viscous oil at room temperature and is extremely unstable in the presence of moisture.”

Measuring possible impact

A heat map for May 15, 2025 (in neither the coldest nor the hottest season), reveals several states exceed the limits allowable by the drug’s labels for temperature excursions; this information suggests that mailed abortion pills could become compromised.

Interestingly, the drug’s Safety Data Sheet published at ChemicalBook.com tells those manufacturing the drug, “Do not let the chemical enter drains. Discharge into the environment must be avoided,” adding, “Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.” Yet DIY abortion pills are taken at home and sometimes ordered by “advanced provision” for a woman to keep on hand before she is even pregnant. In these situations, storage and disposal are unregulated.

According to a report published by the official journal of the American Association of Pharmaceutical Sciences, studies on drug stability are “conducted in temperature- and humidity-controlled environments,” to determine “shelf life and storage/shipping conditions,” which “follow[] guidelines set forth in International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q1A(R2) (1) and recommendations for good storage and transportation practices out lined in United States Pharmacopeia (USP).”

The Journal of Pharmaceutical Sciences claimed that “Instability within drug products can cause significant reduction in the potency of administered dose, loss of product performance (e.g. dissolution failure of solid product), formation of (geno-)toxic degradants, possibility of adverse events or side-effects, shortened shelf-life that can cause supply chain issues, batch variations and recalls, etc.”

Mailed abortion pills are on the increase, according to the pro-abortion #WeCount, which reported that “telehealth” abortions comprise a quarterly average of 20% of all abortions. It seems abortion pills are one of the more popular mail-order drugs; nationally in 2024, “just over 4% of the country’s prescriptions were delivered by mail” in comparison, according to KCUR.

In March of 2024, Guttmacher estimated that the abortion pill accounted for 63% of abortions in 2023, a 45% increase from 2017. And in February of 2025, Guttmacher estimated that 648,500 abortion pills were sold nationwide in 2023 (not including those that “take place outside of the formal health care system” or which are “mailed to people in states with total abortion bans”).

Therefore, it is likely that far more than 13,000 women received the abortion pill by mail, in conditions which could have compromised the drug’s effectiveness — possibly increasing the potential for incomplete abortions (requiring additional drugs or surgery) or more serious complications.

Potential compromise of all mail-order drugs

It isn’t just mailed abortion pills that are cause for concern; nationally, media has noted potential stability issues with all drug prescriptions sent by mail.

“Prescription medications usually come with package inserts that include storage requirements. If a medication doesn’t have specific storage requirements, the FDA says it may be stored at controlled room temperature. This is defined as 59°F to 86°F,“ GoodRX wrote, adding, “Mail-order pharmacies may use the U.S. Postal Services or companies like FedEx to deliver your medications. But they’re still responsible for putting processes in place to keep your medications at proper temperatures while in transit.”

But if not stored under the right conditions, GoodRX says those drugs “can change physically or chemically,” which can decrease effectiveness. “The same conditions apply if they’re shipped to your home. That’s why the FDA has strict rules for how pharmacies and distribution centers store them. Those same storage requirements should also be met during transit,” GoodRX added.

Even the New York Times noted in 2024 that “[m]illions of Americans now receive their prescription medications through mail-order shipments,” which is concerning, as “the temperatures inside the cargo areas of delivery trucks can reach 150 degrees Fahrenheit in the summer… far exceeding the range of 68 to 77 degrees recommended by the national organization that sets standards for drug handling.”

The Times pointed out that despite claims of “weather resistant” packaging, a study showed that “independent pharmaceutical researchers who embedded data-logging thermometers inside simulated shipments found that the packages had spent more than two-thirds of their transit time outside the appropriate temperature range, ‘regardless of the shipping method, carrier, or season.’” The outlet noted, “Extreme temperatures can alter the components in many medications…”

Local Missouri station KCUR likewise warned that pharmacists have said “extreme temperatures… can change the chemical makeup of medicine, often making it less effective.” Little “regulatory oversight” is happening in the transport and delivery process.

THE BACK STORY:

In 2000, following clinical trials by manufacturer Danco Laboratories, the FDA approved mifepristone as an abortion pill for use up to seven weeks of pregnancy in a regimen with the drug misoprostol. Changes were made in 2016, allowing the pill to be dispensed up to 10 weeks of pregnancy and removing requirements that the manufacturer report any adverse events other than death. In 2019, the FDA approved GenBioPro to become the generic manufacturer of mifepristone.

In 2021, the Biden FDA weakened the REMS safety regulations for the drug by eliminating the in-person dispensing requirement and enabled mailed abortion pills to be permanently shipped. It is important to note that the Federal Comstock Law prohibits the mailing of abortion drugs.

THE BOTTOM LINE: 

An FDA spokeswoman told the New York Times, “medicines that are not stored properly may not work as well or may cause harm, even if they are not expired.” Yet the Times noted that while the FDA has guidelines “for packaging and storing drugs and transporting them between manufacturers, wholesalers and pharmacies,” it is the states that have jurisdiction over the mail-order abortions.

“While the U.S. Food and Drug Administration regulates many aspects of medications, states deal with pharmacies,” wrote KCUR. “The ‘last mile’ when a medication is shipped by mail or commercial carrier directly to a consumer has had little oversight. Regulations generally lay out temperatures required for storing drugs, but not necessarily for shipping them.”

Judicial Watch has submitted yet-unanswered FOIA requests on this issue; the FDA appears uninterested in answering concerns about quality control mechanism for mailed abortion drugs.