In this 2-part special edition of Derms and Conditions, host James Q Del Rosso, DO, sits down with David Light, cofounder and president of Valisure, and Christopher Bunick, associate professor of dermatology and translational medicine at Yale University and medical and dermatologic advisor for Valisure, to shed light on Valisure’s recent Citizen Petition to the US Food and Drug Administration regarding findings of high levels of benzene in benzoyl peroxide-containing products.
In Part 1, Dr Del Rosso interviews David Light, cofounder and president of Valisure, an independent quality assurance company that aims to address a critical gap in the health care supply chain. Dr Del Rosso and Mr Light delve into the details regarding how a product review gets initiated, the financial source of such reviews, and the important differences between Valisure’s work and that of Good Manufacturing Practice (GMP) testing facilities. Finally, they address the impact that manufacturing issues have on the increasing incidences of drug shortages in the United States.
In Part 2, Dr Del Rosso continues his conversation with David Light to discuss stability testing—what it is, why it’s important, and how Valisure undertook stability testing on products containing benzoyl peroxide. Mr Light details the rationale for conducting accelerated stability testing at elevated temperatures to evaluate the safety of the products across their entire lifecycles. Dr Bunick also joins the conversation to comment on the misperceptions about FDA-allowable limits of benzene in consumer products and the urgent need for change in how products are evaluated and formulated to ensure patient safety first and foremost. Lastly, Dr Del Rosso and Dr Bunick discuss how dermatologists should counsel patients in the short term on minimizing the risk of benzene exposure while we await further testing, external validation, and regulatory guidance.