YOUR EDITORIAL "Too confident in the FDA" (Feb. 28) misses the mark on the safety of medical devices.
Patient safety and the effectiveness and reliability of medical devices are not enhanced by patients' ability to sue device manufacturers, but rather by the strict oversight provided by Food and Drug Administration scientists and physicians.
The FDA is responsible for the review and approval of thousands of medical devices each year - a figure that dwarfs the small number of products subject to corrective actions.
There are a host of civil and criminal penalties that manufacturers are subject to for failing to follow FDA requirements. The contention that some people have made that FDA approval gives companies "blanket immunity" is not true.
By reaffirming that the FDA, not state courts, is solely responsible for the approval of safe and effective medical technologies, the Supreme Court's ruling is a victory for patients and public health and safety.
The FDA's science-based approach to medical device approvals has served patients well for more than 30 years, and has prevented inconsistencies in standards and delays in patient access to products that would occur if state regulations or multiple jury verdicts were to impose additional regulatory hurdles.
STEPHEN J. UBL
President and CEO
Advanced Medical
Technology Association
Washington
