Combination Products Challenge Regulators and Manufacturers

combination-drug-product-postCombination drug products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen, and emerging cellular and gene therapies. Manufacturers complain of delays in decisions by FDA’s Office of Combination Products (OCP) about which FDA center should take the lead in evaluating a new combo. Medical device makers are particularly unhappy that most stents and transdermal patches are classified as drugs based on primary mode of action. At the same time, biopharma companies struggle with designing human-factors studies and evaluating risks related to intended use. A hot issue is how much the device portion of a generic drug–device combo has to be the “same” as the innovator product.

Industry concerns have generated efforts by FDA commissioner Robert Califf to streamline the OCP system for designating the lead center to regulate a new combination product. A newly formed Combination Products Council, composed of senior-level officials from OCP, the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices & Radiological Health (CDRH), was established in April 2016 to address cross-cutting issues and resolve disagreements.