In a recent interview, Dr. Sean Hennessy discusses how citizens, healthcare professionals, and organizations can petition the FDA to update drug labels, including removing boxed warnings—the strongest safety warnings on medications. These petitions must present strong scientific evidence showing that a warning is unnecessary or harmful. For example, metformin, a common diabetes drug, once carried a boxed warning against use in patients with kidney disease, based on outdated concerns. After new data showed it was safe, a citizen petition led the FDA to update the label in 2016, expanding access for millions of patients.
Successful petitions often come from experts without financial conflicts and require clear evidence that the change will improve public health. While the process can be slow, it has led to major regulatory changes, such as removing certain drugs from the market or updating warnings on others. Ultimately, citizen petitions are a powerful tool for improving drug safety and access through advocacy and real-world data.