The FDA Fails Its Own Drug Test

The FDA is required by federal law to ensure that drugs are “safe and effective.” Under the Food, Drug, and Cosmetic Act, the FDA must reject an application or modification for a drug unless “adequate tests,” test “results,” and “sufficient information” demonstrate that the drug is safe for use “under the conditions … in the proposed labeling.”

But when it comes to abortion drugs, the FDA has continued to illegally remove—without adequate justification—the few critical safety standards it had originally implemented. This erosion of safety standards has harmed women, and that is why Alliance Defending Freedom is at the U.S. Supreme Court challenging the FDA’s reckless actions.

What safety standards has the FDA removed?

In 2000, the FDA approved the drug mifepristone for chemical abortions. Mifepristone is used in tandem with misoprostol to complete a chemical abortion. When originally implemented, special measures were required so that the drugs could be “safely used.” Some of the most significant are listed below.

• The drugs may only be prescribed up to seven weeks’ gestation.
• A licensed doctor who can diagnose ectopic pregnancies and accurately determine gestational age must be the one to prescribe the drug.
• That doctor must see a woman at three in-person office visits before, during, and after the chemical abortion to ensure she does not have any life-threatening conditions and serious complications.
• The prescribing doctor must report all serious complications women suffer from the drugs.

Because of the risks that came with taking these drugs, the safety standards were considered necessary to protect women’s health. Yet the FDA has since weakened or removed these bare-minimum safety measures.

In 2016, upon request from Danco Laboratories (the drugs’ manufacturer), the FDA increased the gestational age from seven to ten weeks, reduced the number of in-person visits from three to one, and no longer required the drugs to be prescribed by a physician.

Another significant requirement the FDA eliminated was for prescribing physicians to report all serious adverse events to the FDA. After eliminating many safety standards in 2016, the FDA decided that it didn’t want to know if these changes increased harms to women taking abortion drugs. So long as the drugs did not lead to a woman’s death, these prescribers no longer needed to report serious complications like severe bleeding, life-threatening infections, and emergency medical treatment.

In 2021, during the COVID-19 pandemic, the FDA further undercut its safety standards by allowing mifepristone to be dispensed by mail, concluding any in-person visits were “no longer necessary.” Now, the FDA no longer requires a prescriber, let alone a doctor, have any direct contact with a woman before giving her these abortion drugs—drugs that carry considerable risk, especially for women with ectopic pregnancies. What’s more, since 2016, the FDA has warned that roughly one in 25 women will end up in the emergency room after taking these drugs.

Why the FDA’s removal of the safety standards is wrong

Both the 2016 and 2021 removal of safety standards were unlawful and unjustified for several reasons. Here are just two:

Incomplete FAERS data

As discussed above, prior to 2016, the FDA required that prescribers report all serious adverse events resulting from the use of these drugs to the FDA Adverse Event Reporting System (FAERS). But the FDA’s decision in 2016 to switch from mandating the reporting of all adverse events to the reporting of only fatal events made the data more incomplete and couldn’t adequately capture how further changes to the safety standards would affect women’s health.

Even under normal circumstances, the FDA considers FAERS data unreliable, saying “the FAERS data by themselves are not an indicator of the safety profile of the drug.” Ironically, however, the FDA’s proposed changes in 2021 were based largely on this inherently unreliable FAERS data. It’s even worse here because the FDA created a situation in which adverse event data was less likely to be reported but then cited the lack of adverse events in its justification for further removing safety standards. As the U.S. Court of Appeals for the Fifth Circuit said last April, “It’s unreasonable for an agency to eliminate a reporting requirement for a thing and then use the resulting absence of data to support its decision.”

Misapplying the scientific literature

In addition to the FAERS data, the FDA claimed that multiple studies “supported” its decision in 2021 to remove the initial in-person office visit—which provided the only opportunity to identify whether a woman has life-threatening conditions.

But the FDA conceded that these studies were “not adequate on their own to establish the safety of … dispensing mifepristone by mail.” The best the FDA could say was that the studies were “not inconsistent with [its] conclusion” that removing the last remaining in-person visit was safe. In other words, these studies did not disprove the FDA’s apparently predetermined belief that eliminating this crucial office visit was safe. That’s cold comfort to women taking high-risk drugs without the safeguards the FDA once declared necessary.

Women deserve better

To summarize, the FDA relied on A) FAERS data it conceded cannot be used to show the safety of a drug, and B) studies that it admitted were “not adequate” to establish safety. Despite neither source being able to independently support the FDA’s decision, the agency has nevertheless cobbled together two insufficient rationales to support an unjustified conclusion. According to the FDA’s math, zero plus zero equals one. That’s not just wrong but also unlawful.

The FDA has shown a callous disregard for women’s health by ending the safety standards it once provided to those using abortion drugs. Women deserve better.