The FDA unveiled the new Combination Products Policy Council, which will have decision-making authority on issues relating to combination products, cross-labeled products and medical product classification.
Under the current regulatory scheme, the Office of Combination Products determines the lead center for the investigation of a combination product by what’s called the primary mode of action of the medical product. In most cases, the type of investigational application is that typically required by the lead center. For example, if the device is the PMOA, the lead center would be CDRH, and the investigation would be under an IDE that includes the drug information.
But this system has met with increasing criticism as the number of combination products in development have escalated. Although OCP is charged with coordinating pre- and post-market review of combination products to ensure consistency, critics have asserted that this effort often has fallen short.
In making its announcement, FDA specifically noted that the council was being formed to resolve differences and inconsistencies “in statutory and regulatory requirements for different application types, including evidentiary standards, data requirements and review limitations.”
The council will be housed in the Office of the Commissioner as part of a concerted effort to develop a unified FDA position on combination products. In addition to serving as a communications hub, the council will be involved in developing agency-wide and external communications, such as draft guidances and publications. — Michael Levin-Epstein