I am pleased to submit the Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2015 Annual Report to Congress for the Office of Combination Products (OCP). This report includes data from the 12th full year since OCP was established, as mandated by the Medical Device User Fee and Modernization Act of 2002, P.L. 107-250 (MDUFMA), enacted on October 26, 2002.
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Technological advances continue to merge product types and blur the historical lines of separation between FDA’s human medical product centers, which are made up of the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH). Combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, which raise regulatory, policy, and review management challenges. Differences in regulatory pathways for each component can impact the regulatory processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, user fees, and post-approval modifications.
OCP continues to enhance the transparency and predictability of the process for assigning combination products to the appropriate lead Center and for the review process. In this regard, OCP continues to facilitate interactions between industry and FDA to clearly delineate regulatory pathways, monitor and adjust processes to ensure timely and effective premarket review, and ensure the consistent and appropriate postmarket regulation of combination products. In addition to combination products, OCP also has classification and assignment responsibilities for non-combination drug, device, and biologic products.
Combination products are likely to become more complicated as new technologies emerge and existing technologies mature. Therefore, OCP will continue to focus on the most important issues relating to the regulation of combination products. OCP is committed to actively assisting industry and FDA reviewers in understanding the complexities of this regulatory area.
FDA looks forward to ensuring success in meeting the unique challenges in the review and regulation of combination products.
Robert M. Califf, M.D
Commissioner of Food and Drugs