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I am pleased to submit the Food and Drug Administration’s Fiscal Year (FY) 2005 Annual Report to Congress for the Office of Combination Products (OCP). This report includes the second full year of data since OCP was established as mandated by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), enacted on October 26, 2002.
Combination products are therapeutic and diagnostic products that combine elements of drugs, devices, and/or biological products. The Food and Drug Administration (FDA) is receiving significantly more combination products for review as technological advances continue to merge product types and blur the historical lines of separation between FDA’s medical product centers. Because combination products involve components that would normally be regulated under different types of regulatory authorities, and frequently by different FDA Centers, they also raise challenging regulatory, policy, and review management issues. The differences in regulatory pathways for each component can impact the regulatory processes of all aspects of the product life cycle, including preclinical testing, clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, and post-approval modifications.
OCP continues to be actively involved in helping industry and FDA reviewers understand this complex regulatory area through a myriad of activities. OCP has made significant progress in enhancing the transparency and predictability of the process used to promptly assign combination products to a lead Center, facilitating interactions between industry and FDA to clearly delineate regulatory paths, and implementing processes to ensure the timely and effective review, and consistent and appropriate postmarket regulation of combination products.
In addition, OCP continues to engage stakeholders through various mechanisms, by seeking comments and providing clarification on a number of difficult issues surrounding the regulation of combination products. OCP co-sponsored a public workshop held in May 2005 to discuss the issue of mutually conforming labeling for combination products consisting of components developed and marketed by different manufacturers. OCP solicited stakeholder comment on options for determining the appropriate number of marketing applications for combination products and options for addressing the differences in drug, device, and biological product postmarket safety reporting regulations. Also, OCP published a guidance document providing mechanisms to reduce application user fees for certain innovative combination products, and a guidance document to explain the type of information sponsors should submit in a Request for Designation so OCP can make timely and appropriate product assignment decisions.
OCP closely monitored the timeliness of the consultation processes between Centers, offering advice and support to industry and agency review staff on challenging combination product issues. OCP’s efforts this year garnered the following comment in Medical Devices and Diagnostic Industry magazine, May 2005: “OCP is open-minded and flexible about many complex issues regarding the regulation of combination products. So, stakeholders should seek contact with OCP staff as a valuable and often-informal resource for information and guidance.” We look forward to continued success in meeting the unique challenges in the review and regulation of combination products.
Andrew C. von Eschenbach, M.D.
Acting Commissioner of Food and Drugs