Anti-abortion activists sued in federal court in Texas last November, arguing in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration that the Food and Drug Administration (FDA)’s approval of mifepristone, one of two drugs used to provide medication abortions, should be revoked. On April 7, the case reached a troubling conclusion. Judge Kacsmaryk—who was appointed to the judiciary by President Trump—ruled in favor of the plaintiffs, ordering the FDA to rescind its approval for the drug. This unprecedented ruling will result in abortion care becoming even less accessible: medication abortions accounted for more than half of all abortions in the United States in 2020. In addition to its concerning implications for abortion access, this ruling also has the potential to undermine the need to reform how the FDA approves drugs.
Part of the plaintiffs’ arguments in this case rest on the false assertion that mifepristone was approved through the FDA’s accelerated approval process.
Part of the plaintiffs’ arguments in this case rest on the false assertion that mifepristone was approved through the FDA’s accelerated approval process. This commentary describes the FDA approval process for new prescription drugs, including the FDA’s accelerated approval process. After, it highlights how the inaccurate arguments and ruling in this case would undermine the need to reform these processes.
How does the FDA evaluate drugs?
The process for evaluating a new drug for approval is generally based on three features: safety, efficacy, and quality. Safety refers to evaluating the drug’s effects on the human body, and it is typically the first step a drug company takes in developing a new drug. Efficacy refers to the next two steps of the process. First, drug companies perform smaller studies to determine if a drug is effective at treating a given disease or condition, after which they perform larger studies to determine how well a drug works for different patient groups or at different dosages.
Throughout these studies, safety is continually evaluated to ensure that no dangerous side effects only emerge during long-term use. After drug companies submit clinical trial data to prove safety and efficacy, FDA officials inspect the manufacturing facilities to ensure the drug will be consistently and safely produced. These evaluations are all done by experts in drug safety and efficacy, and this process generally works to ensure that new drugs are safe for patients and effectively treat their health conditions.
Accelerated approval, however, is a more concerning process that contributes to wasteful health spending and exorbitant drug prices. Under this approach, the FDA approves drugs based on surrogate endpoints, rather than proven clinical benefit. An example of this is aducanumab, a drug approved in 2021 to treat Alzheimer’s disease. The drug was approved through the accelerated approval pathway based on evidence that it reduces plaques on nerve cells, and not on any evidence of improved patient outcomes.
The FDA first created the accelerated approval pathway in 1992 in response to the HIV/AIDS crisis, and Congress codified it into law in 2012. Over time, the process has become significantly more common: only four drugs were approved through the accelerated approval process in 2010, but forty-five drugs were approved through the pathway in 2020. This process allows drug companies to charge exorbitant prices for drugs with no proven benefit, taking advantage of vulnerable patients who are the most desperate for help.
The process also warps drug company incentives, encouraging them to focus research and development funds on high-profile diseases from which they expect to be able to extract a profit, rather than on the under-researched diseases that need this focus. This results in chronic underfunding for clinical trials into conditions that disproportionately impact women and people of color.
How are the FDA’s processes being represented in this case?
The plaintiffs in Texas argument relies in part on a claim that mifepristone was approved under the accelerated pathway—but this is inaccurate. The original application for mifepristone was filed in March 1996, and the drug was not approved until September 2000. The reality is that this approval included additional “restrictions to assure safe use” on the distribution of mifepristone to prevent its distribution outside of health care facilities. These restrictions originate from the same set of regulations that created the accelerated approval pathway, called Subpart H. A recent review of FDA processes for updating these restrictions by the Government Accountability Office did not identify any significant concerns.
In 2007, Congress passed the FDA Amendments Act, which allows the FDA to require a Risk Evaluation and Management Strategy (REMS) for drugs it deems have potential side effects that could outweigh the benefits. The same law required all drugmakers with existing Subpart H restrictions to submit a REMS plan, which mifepristone’s manufacturer did and which was approved in 2011. The REMS plan has been amended several times since, most recently in January 2023, loosening the restrictions and bringing them closer to reflecting the scientific consensus that these restrictions are not necessary.
The disingenuous and inaccurate claims brought by the lawsuit—and, more importantly, Judge Kacsmaryk’s acceptance of them—undermine the decades of clinical evidence and work by FDA experts that ensured mifepristone is safe and effective.
The disingenuous and inaccurate claims brought by the lawsuit—and, more importantly, Judge Kacsmaryk’s acceptance of them—undermine the decades of clinical evidence and work by FDA experts that ensured mifepristone is safe and effective. Meanwhile, they work to harm the FDA’s independence and detract from the real need to reform the accelerated approval process. Although there are meaningful issues to be addressed with the accelerated approval pathway, mifepristone’s approval is entirely unrelated.
Judge Kacsmaryk’s ruling would undermine the FDA’s authority, and without legal precedent.
Mifepristone was not approved through the accelerated approval process, and Judge Kacsmaryk’s acceptance of the assertion otherwise is troubling. Access to mifepristone is especially urgent in the aftermath of the Dobbs decision, and the FDA’s approval of the drug should not be revoked.
Rescinding mifepristone’s approval would undermine the ability of FDA experts to evaluate the safety and efficacy of prescription drugs without political interference, and would distract from other efforts to ensure that only drugs with a proven safety and efficacy record are approved by the FDA. If this ruling is permitted to stand, it would create a dangerous legal precedent, allowing other controversial treatments to be overturned by judges with no medical or scientific training based on false claims.