February 6, 2012 ~ Consumers Union is bringing eight patient activists to Washington, D.C. to meet with lawmakers and press for strengthened medical device oversight. The timing is important. The Food and Drug Administration’s budget will be determined by the Medical Device User Fee Act (MDUFA) and the medical device industry is pushing for faster and more streamline medical device reviews.
See a news release from the group here.
Consumers Union is concerned that patient safety provisions are missing from the FDA budget proposal which it says is more focused on better serving industry than patients.
Consumers Union would like Congress to adopt patient safety reforms (here) including:
Recommendations to improve the processes for device approval:
- Require all permanently implantable devices and all life-sustaining devices to go through the Pre-Market Approval (PMA) process, requiring more stringent review, including safety and effectiveness testing, rather than the expedited 510(k) process.
- Exclude pre-1976 devices from serving as predicates, so devices being submitted for approval have to show substantial equivalence to a more current device.
- Once a device is found to be unsafe (either recalled or when FDA issues a warning), that device should no longer be allowed to be used as a predicate for device makers in the 510(k) clearance process. Devices cleared based on a recalled predicate should be reviewed for similar problems.
- Eliminate the “least burdensome” requirement when the FDA asks for additional information in its review of medical devices.
- Raise the standard for PMA approval of devices from “reasonable assurance” of safety to “substantial evidence” of safety to bring it in line with the standard for drugs.
- Give the FDA adequate resources for thorough review of the increasing number and complexity of device applications.
Among the eight is Steven Baker who experienced complications from an elbow implant, and Dan Walter, whose wife, Pam, nearly died from a medical device to treat a heart condition. #