The job of the U.S. Food and Drug Administration (FDA) is to ensure that drugs on the market are effective and safe: that drugs do what they’re meant to do, and that their health benefits outweigh their risks.
As a “science-led organization,” the FDA claims it carefully deliberates—using the best information available—to make unbiased decisions, and follows its scientific-method-based process when evaluating new drugs. The FDA can also pull drugs deemed to be unsafe off the market if it was wrong about the initial approval. This may occur, for instance, if the FDA acquires new knowledge about the safety profile of a drug.
So, what does the FDA approval process look like? And more importantly, did the agency follow that process when it approved the chemical abortion drug called mifepristone?
The FDA approval process
The FDA doesn’t perform its own tests when evaluating new drugs, but as part of the approval process, it inspects manufacturing and testing facilities and guides later stages of testing. Drug companies work with the FDA on testing and submit evidence that drugs are safe and effective for their intended uses. The intended use is important: a drug can be considered “new” for purposes of treating a particular condition even if it’s already been approved and marketed with a different dosage for treating another condition.
The FDA follows a carefully structured drug approval process before giving the green light for a drug maker to begin marketing a new drug to the public.
- The FDA’s approval process turns in large part on its evaluation of data submitted by the sponsoring drug maker. This data is generated by the drug maker in cooperation with the FDA. The drug company starts with lab or animal tests. Then, the FDA and a local review board decide whether to test the drug in people. Studies on humans are called clinical trials.
- In the FDA approval process, the agency must ask if a drug’s benefits outweigh the risks as demonstrated in at least two well-designed clinical trials. In addition, the FDA is required to assess the safety of new drugs on persons under 17 years of age, and may only waive this separate requirement if it provides a justification for doing so.
- The FDA also must develop risk management for the drug, ranging from a label to a strategy that drug makers must implement to ensure safe use of the drug.
Accelerated approval process for drugs that treat serious or life-threatening illnesses
Sometimes, the FDA approves a drug without the same clear measurements of benefit that would usually be required. In 1992, largely to address the surge in HIV/AIDS, the FDA created the Accelerated Approval program for promising treatments for “serious or life-threatening illnesses” if those treatments “provide meaningful therapeutic benefit” beyond what is already available.
A treatment for a disease with a long course that ends in death and for which there are no other treatments can be a good candidate for Accelerated Approval. After Accelerated Approval, the drug manufacturer must conduct further trials to ensure the promised benefit actually follows.
Does the FDA follow its own rules?
Unfortunately for Americans, when it comes to the FDA’s approval of the abortion drug mifepristone, the agency fell prey to political pressure. The FDA approved the drug in 2000 under the Clinton administration, but it could only do so by twisting its own rules.
Unscientific categorization of pregnancy
Before President Clinton left office, the FDA approved mifepristone under the Accelerated Approval program—which was the only option that allowed the FDA to require safeguards for dangerous drugs. To fit mifepristone within the Accelerated Approval program, however, the FDA had to call pregnancy a “serious or life-threatening illness.”
Pregnancy is no illness, of course, and the drug sponsor knew it. The Population Council initially objected, stating that “[n]either pregnancy nor unwanted pregnancy is an illness” or even “a ‘serious’ or ‘life-threatening’ situation as that term is defined” in the regulations.
Pregnancy is the result of the reproductive system functioning correctly; it’s certainly not an illness and is not even in the same category as a condition such as cancer or HIV/AIDS.
Dangers, not benefits
Simply declaring pregnancy to be an illness was just the first step. To make any pretext of upholding its standards, the FDA had to argue that chemical abortion drugs provide benefits over existing “treatment.” According to FDA regulations, that meant that chemical abortion had to possess the “ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy.”
The other available “therapy” for ending a healthy pregnancy is surgical abortion. So the FDA had to assert that chemical abortion is safer than surgical abortion.
But the questionable studies used for comparison in the FDA approval process showed more adverse events, incomplete abortions, and excessive bleeding rates for chemical abortion than for surgical abortion. Instead of heeding these warning signs, the FDA justified its decision by saying that the “meaningful therapeutic benefit” provided by mifepristone was simply … no surgery. Under this backward logic, the “benefit” of mifepristone was the mere fact that women could take it even if it was riskier than surgery.
The FDA’s failures didn’t stop there. The clinical trials the FDA depended on included safety requirements that, without any explanation, the FDA didn’t require when the drug regimen was approved. In other words, it did not test the drugs under their conditions of use.
For one, the physicians administering the drugs during the trial were trained and licensed physicians with experience and admitting privileges at hospitals. Yet this precaution was not required upon approval.
The U.S. trial also required an ultrasound to confirm gestational age and ensure that the pregnancy was not ectopic. But ultrasounds were not required upon approval either. An ultrasound is an essential safety precaution: the risk of complication for chemical abortion increases the longer the pregnancy, and the early symptoms of an ectopic pregnancy can be mistaken for a completed chemical abortion.
The FDA also pressed on without knowing what chemical abortion drugs would do to young girls. It depended on three flawed studies of young girls, none of which considered the possible long-term effects of the drugs on developing reproductive systems—a more than reasonable concern for drugs affecting hormone balances.
One study noted that for women under 18, up to 20 percent of young girls had not had a follow-up appointment, resulting in a lack of data on whether these girls had any serious adverse events. The second found dangerous rates of complications in all populations, but since these numbers were similar for teenagers and adults, they made nothing of it. The third study included only 28 participants.
After the FDA approved mifepristone, it continued to gather data showing the drug to be more dangerous to women than surgical abortion.
A long-term study that spanned 17 U.S. states counted emergency room visits after abortions from 1995-2015. It showed that a chemical abortion is 50 percent more likely to result in an emergency room visit within 30 days of taking the drugs than surgical abortion. The number of visits after chemical abortions increased by over 500 percent between 2002 and 2015.
Beyond this, the restrictions on the label weren’t being followed. Abortionists were neglecting the gestational age limits and ignoring the three required in-person visits. But the FDA has done nothing to counter these deficiencies.
In fact, it has gone the other direction. During the Obama and Biden administrations, the FDA removed safeguards, including approving sending the drugs by mail—without doctor visits.
Suing the FDA
From 2000 to today, concerned medical professionals and organizations, seeing the results of the drugs in the ER, have pleaded with the FDA to withdraw approval of chemical abortion drugs after the agency initially abused its approval process. But instead, the FDA stonewalled them for decades and removed critical safeguards protecting women. ADF is standing up for the health and safety of women and girls by suing the FDA, asking the court to hold the agency accountable and take these dangerous drugs off the market.