The US Food and Drug Administration (FDA) announced the display of a proposed rule discussing how FDA proposes to assign a lead center with responsibility for premarket review and regulation of a combination product.
Combination products, those containing a combination of a drug, a device, or a biological product, represent a growing category of products incorporating cutting edge, novel technologies that hold great promise for advancing patient care. Products, such as drug-eluting stents (which combine a drug with a medical device), orthopedic implants with genetically engineered human protein, and antibiotic bone cement, often do not fit neatly into traditional categories of FDA-regulated items. But such innovative combination products have the potential to make treatments safer, more effective, more convenient or more comfortable for patients.
The purpose of the proposed rule is twofold: (1) to codify the definition of "primary mode of action" (PMOA), the criterion the agency has used for more than a decade when assigning combination products to a particular Center within the agency for review; and (2) to simplify the assignment process by providing a defined framework that sponsors may use when recommending and/or considering the PMOA and assignment of a combination product to a FDA Center.
Traditionally, FDA has required sponsors submitting a request for assignment of a combination product to identify the PMOA of the product and recommend a center within FDA to take the lead in the product review. Today's proposed rule will streamline and clarify the process for assigning these products because it will provide an expanded regulatory definition.
Under the proposal, the "primary mode of action" would be defined as "the single mode of action (e.g., drug, device, biological product) of a combination product that provides the most important therapeutic action of the combination product." This would be the mode of action that is expected to make the greatest contribution to the overall therapeutic effects of the combination product.
In certain cases, it is not possible for either FDA or the product sponsor to determine, at the time a request for assignment is submitted, which mode of action of a combination product provides the most important therapeutic action. In those cases, the agency would assign the combination product to the FDA Center that regulates other combination products presenting similar questions of safety and effectiveness with regard to the combination product as a whole.
When there are no other combination products that present similar questions of safety and effectiveness with regard to the combination product as a whole (for example, when it is the first such combination product, or when differences in its intended use, design, formulation, etc. present different safety and effectiveness questions), the agency would assign the combination product to the agency component with the most expertise to evaluate the most significant safety and effectiveness questions presented by the combination product.
This proposed action is consistent with FDA's ongoing innovation initiative and recently-announced 'Critical Path' initiative, in its emphasis on further clarifying the complex therapeutic development process and helping to speed innovation.
More information on the proposed rule can be found here: http://www.fda.gov/OHRMS/DOCKETS/98fr/oc03366.pdf.