Can Old FDA Regulatory Structure Cope With New Technologies?
June 25, 2001
Innovation in medical technology could slow unless the U.S. Food and Drug Administration (FDA) reorganizes to better handle emerging technologies and new "hybrid" products, warns a report by the Lewin Group for the Advanced Medical Technology Association (AdvaMed). Hybrids are products that combine device and drug technology into one treatment -- such as a laser-activated drug or an inhaler that delivers insulin.
The products can pose regulatory difficulties because their components must undergo review by different centers of the FDA. The report calls on the agency to improve collaboration and communication between the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).
- The Lewin report notes FDA review times for new medical devices -- so-called 510(k) and PMA submissions -- have been getting consistently shorter since 1994.
- And it found that innovation in medical technology has remained healthy thus far, with research and development funding jumping from 5.4 percent of sales in 1990 to 12.9 percent in 1998.
- However, despite important improvements in FDA productivity and processes, total review times for breakthrough technologies are still averaging about 12 months -- twice the statutory deadline of 180 days.
The FDA should set up a system for tracking the progress of hybrid products throughout the review process, the authors say. They also called on the FDA to develop and maintain state-of-the-art staff expertise to review medical devices, make better use of outside expertise when needed and encourage reviewers to consider innovative scientific approaches to evaluate new technologies.
Source: "Report Finds FDA Unprepared to Regulate New Technologies," Reuters Health, June 18, 2001.
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