FDA Initiative to Speed Availability of Innovative Medical Devices

Originally Published MDDI March 2003

NEWSTRENDS

Gregg Nighswonger

Access to advanced medical devices is key to ensuring that the nation's healthcare system keeps pace with a population that is growing and aging. Associations such as Advamed and MDMA have long emphasized the benefits of healthcare innovations, including improved outcomes, error reduction, and lower costs. But questions have also been raised regarding FDA's ability to adequately review submissions that involve advanced technologies. 

In January, FDA announced a new initiative that would "help make innovative medical technologies available sooner," according to the agency. The program is also intended to reduce development costs for new products and will involve all of FDA's product review centers.

The agency intends to take action in three areas to implement the initiative. First, FDA plans to reduce delays and avoidable product-development costs by avoiding multiple review cycles. This will be done through early communication and other steps that improve the quality of applications. Second, the quality and efficiency of the review process will be improved by adopting a quality system approach. Third, new product development will be facilitated by providing up-to-date guidance for diseases and for emerging technologies.

In addition to FDA's efforts to streamline reviews, the agency intends to help speed "potentially important emerging technologies to the market by reducing regulatory uncertainty and increasing the predictability of product development." To achieve this goal, FDA will clarify the regulatory pathways for three emerging areas of technology. These include cell and gene therapy, pharmacogenomics, and novel drug-delivery systems.

In the area of cell and gene therapy, for example, FDA hopes "to enable sponsors to focus studies to yield maximum information during product development," according to the agency. Within the next 18 months, FDA will sponsor a series of conferences and workshops in an effort to design standards for the human studies and the manufacture of these potentially vital new technologies.

FDA also views pharmacogenomics and pharmacogenetics as promising new technologies that will "combine drug therapies and diagnostic devices to treat the patient, as well as identify certain critical needs of the patient." But the regulatory pathway for such products has been uncertain, the agency explains. Over the next 18 months, guidance documents will be issued on when and how to submit pharmacogenomic information to FDA during drug development. 

In addition, an agency workshop will address issues involved in codevel-opment of a pharmacogenomic test and a drug, and joint guidance will be issued for sponsors of these products that guides them through the regulatory process. Noting the importance of novel drug-delivery systems and citing drug-coated stents as an example, FDA says it plans to seek assistance from the academic, patient, and industry communities to develop the best methods for animal and human testing of these systems. 

The agency provided details of its initiative in a report, "Improving Innovation in Medical Technology: Beyond 2002," which was released on January 31.

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