Abortion Drug’s Adverse Event Reporting Should Be Cause for Concern at the FDA

Abortion is a very controversial topic, but drug safety isn’t.

Keeping America’s drug supply safe is a nonpartisan endeavor. Whatever one’s political leanings, everybody wants safe, effective drugs, and a full disclosure of known safety risks.

Because of that, the Food and Drug Administration is supposed to remain agnostic when it comes to politics, up to and including the politics of abortion, and base its decisions strictly on its mission of objectively making data-driven regulatory decisions based on safety and efficacy. 

Is the FDA Behaving Recklessly?

Congress has granted broad authority to the FDA to determine what drugs are safe and efficacious, but its discretion is not limitless. When it comes to mifepristone (for abortion), the FDA has abandoned appropriate drug-safety practices by not mandating that manufacturers collect all evidence of how the drug harms women. 

Questions typically arise from individuals or outside groups when it comes to controversial FDA drug approvals, but the agency prompted additional questions through regulatory actions years after it approved mifepristone. 

For the first time, the FDA, at manufacturers’ request, permitted epidemiologically unsound wording specifying that providers are only mandated to collect reports of deaths, but not any other adverse events (sometimes called side effects) following mifepristone administration.

Typically, manufacturers have responsibly proposed to collect all reported adverse events. However, the new wording in the FDA-approved Risk Evaluation and Mitigation Strategy only specifies that entities “[e]nsure that any deaths of patients who received Mifeprex are reported to [manufacturers] … .”  

The question here is: Why not “ensure” the collection of all adverse events for a drug taken by hundreds of thousands of women every year?

Are the FDA or manufacturers afraid of what they will find? If the answer to that question is “yes,” that’s all the more reason that women and abortion providers be made aware of all potential associated risks of the drug. 

The FDA’s death-only safety-collection language is unique compared with other Risk Evaluation and Mitigation Strategy products, which use substantively firmer language for adverse events, including: “… [medical providers] must: At all times report …” in reference to any adverse event that occurs.

Unlike mifepristone, other FDA Risk Evaluation and Mitigation Strategy sponsors seem to take forthright interest in protecting and informing their patients, and to that end, comprehensively collect all adverse events. 

Drug Safety Epidemiology Is More Than Deaths

Death is not the only adverse event of importance when it comes to evaluating the safety of drugs.

Analogously, if one were an automobile manufacturer proposing to collect safety information about its cars, only collecting reports of automobile-associated deaths would thereby exclude all nonfatal injuries, potentially hiding the true extent of any defects or dangers.

Consequently, consumers wouldn’t be informed about automobile failures resulting in serious injuries, such as dismemberment, burns, traumatic brain injury, or other permanent disabilities—which, although they might not ultimately result in death, are still critically important for safety assessments. 

Using the current FDA Risk Evaluation and Mitigation Strategy adverse-event collection language could mean that adverse events that occur might never be reported, and ultimately profit-driven manufacturers could capitalize on the lack of reported adverse events, and in turn advertise their drugs as having had a sterling “safety” record.

It’s not out of the realm of possibility that future television and other media advertisements would deceptively and falsely indicate the safety of at-home abortions, instead emphasizing convenience. 

Set Aside Abortion Politics and Protect Women

Regardless of one’s political stance on abortion, the at-home, unattended use of mifepristone does carry with it considerable, clinically significant risks—which is precisely why it was only approved via Risk Evaluation and Mitigation Strategy in the first place. 

Severe, life-threatening, disabling, and death adverse events have been reported, and are far more likely to be avoided if a surgical abortion is used instead of chemical abortion drugs. To the extent chemical abortion is used, it should be made as safe as possible for women and take place in a properly equipped clinic, under physician observation, and at least in accordance with the historical Risk Evaluation and Mitigation Strategy, Medication Guide, and Elements to Assure Safe Use requirements. 

In the name of women’s health, the FDA should demand the active solicitation and collection of all adverse events when mifepristone is used for abortion.

Manufacturers and the FDA cannot claim that a lack of evidence of mifepristone’s harms proves it’s safe—especially when the agency stopped requiring collecting evidence of harms.

Drug safety experts need all safety data mandated to be reported in order to do their jobs. The health of America’s women depend on it.