Combination drug products (i.e., products that are a combination of a medical device and/or a drug and/or a biologic) are inherently complex to manage, particularly due to regulatory approval processes. Three different FDA centers—the CDRH, the CBER, and the CDER—are involved in regulating these products, and although a lead center is assigned to a specific drug, the needed coordination and knowledge base required to manage the process is not easy.
In April 2016, the FDA announced its first Combination Products Policy Council. The Combination Products Policy Council will include senior-level team members who will focus on holding agency-wide discussions and making decisions on issues related to combination drug products. This council will “have decision-making authority on issues relating to combination products, cross-labeled products, and medical product classification.”
A lead center will still be designated based on the combination product’s determined primary mode of action (PMOA), but it appears the Combination Products Policy Council will take a more hands-on role in tapping required resources and expertise across the agency as the complexity of combination products increases. Ultimately, the goal is to increase efficiency in line with the agency’s announced dedication to lean process mapping initiatives.
This new organization will not replace or override existing processes for the review and approval of combination products. However, the council will have the authority to resolve any issues and conflicts that often arise between CDRH, CBER, or CDER regarding the review, classification, and clearance or approval of combination products.
Per the FDA’s efficiency goals mentioned earlier in this post, the formation of the Combination Product Policy Council will hopefully improve the delays that often occur in reviews of combination products. In fact, the Combination Products Coalition (CPC), an industry group that the FDA regularly consults, states that 70 percent of innovators experience delays as a result of problems during combination product reviews. Of greater concern, up to 85 percent of respondents stated that when a combination product-related conflict arose, the lead center communicated its position without offering scientific and regulatory support for its position.
Given the senior-level resources being assigned to the council, it is expected that many more strategic, scientifically grounded decisions will be facilitated. In addition, discussion, guidance, and insight will be facilitated if needed. This move is much needed since combination drugs will only increase in complexity as new technologies and innovations come online.