From a recent study:
A damning report on the many shortcomings on the creaky old house that is the FDA. It's a grossly underfunded, undermanned, and mess of an agency. It's decades away from repair, and this report shows that perhaps it's time to dismantle it and start anew:
Our preliminary findings suggest that shortcomings in FDA’s oversight of the medical device recall process may limit the agency’s ability to ensure that the highest-risk recalls are being implemented in an effective and timely manner. These shortcomings span the entire range of the agency’s oversight activities—from the lack of a broad-based program to systematically assess trends in recalls, to inconsistencies in the way FDA ensures the effective completion of individual recalls.
and this:
Although FDA’s recall data system contains numerous data elements that would allow for analyses of recall data, our preliminary findings suggest that FDA is not using this system to effectively monitor and manage its recall program.
When it came to recalls that were audited:
Our analysis of 2,196 audit check forms associated with the class I recalls we reviewed found a variety of inconsistencies in how the audit checks were implemented and documented for nearly 90 percent of these recalls. For each of these recalls we found inconsistencies in how different investigators determined whether a recall was effective or ineffective when conducting their audit checks of recalls.
To citizens, the FDA is as useful as FEMA was during Katrina.
