Normally, I spend my days chatting with scientists, poring over papers, and organizing pages of notes to craft compelling stories. But a few months ago, I found my attention drawn to a federal courtroom in Texas where a group of abortion opponents argued that the Food and Drug Administration (FDA) should not have approved the drug mifepristone 23 years ago.
Mifepristone, which is often used in combination with misoprostol, terminates pregnancies and aids miscarriage management. By questioning the FDA's authority to regulate mifepristone, this case undermines the ability of the FDA to regulate all drugs, potentially damaging public trust and obstructing the path to new drugs.
Translational researchers are well acquainted with the “Valley of Death” in drug development. Of all drugs that enter clinical trials, 90 percent fail. For the remaining 10 percent that seem promising, a team of multiple scientists at the FDA rigorously evaluates the clinical trial data to decide whether to issue an approval. But the FDA’s work doesn’t end there. The scientists at the agency regularly monitor the scientific literature regarding approved drugs and investigate any instances of adverse events. In fact, the FDA has a reporting and recall system in place to remove drugs from the market if they prove dangerous or ineffective.
The problem with the Texas case, which as of this writing is working its way through appeals in the courts, is that a single judge with no scientific expertise was asked to decide whether or not the drug is safe. Leaving regulatory decisions up to one person or even to a panel of judges with no scientific background or public health experience undermines the expertise of the researchers who developed the drug, the clinical trial administrators who tested it, and the FDA scientists who reviewed the data.
If the Texas judge’s original decision against the FDA is allowed to stand, it sets a dangerous precedent for challenging the FDA’s approval of any drug — past, present, or future. With decisions based on politics rather than safety and efficacy data, any politicized medications could be targeted next.
In a recent Amicus Brief, pharmaceutical companies and investors argued that the specter of legal challenges will slow the development of new drugs, “causing widespread harm to patients, providers, and the entire pharmaceutical industry.” Many pharmaceutical industry leaders have also spoken out in support of the FDA in a statement published soon after the Texas judge’s decision.
We will have to wait and see how this court case plays out, but it certainly feels like the drug discovery and development field is at a tipping point. Will decisions about what makes a safe and effective medication stay in the hands of scientific experts or slide into the clutches of those pursuing their own personal agendas? The answer will have a profound impact on all of us who want to see the development of new drugs and therapies to help people live healthier lives.