FDA Can’t Inspect Its Way Out Of Import Safety Problems – Schultz, Sharfstein
Full article reprinted from "The Gray Sheet" - June 8, 2009
Increasing the number of foreign device facility inspections alone will not dramatically improve FDA import safety, agency leaders say. Read more....
Increasing the number of foreign device facility inspections alone will not dramatically improve FDA import safety, agency leaders say.
Rather, FDA must rely more on foreign regulatory authorities to certify the safety and effectiveness of products made in their countries, agency and device center managers agree.
"Congress, if you ask them what the problem is, the problem is not enough inspections," CDRH Director Dan Schultz said May 26 at an industry meeting in Rome.
FDA is gradually increasing the number of foreign inspections it performs, he said, but doing so "is obviously very expensive and very time-consuming and requires a lot of resources."
"The key is, we can't inspect our way out of this problem."
In January 2008, the Government Accountability Office reported that FDA had inspected only about 5% of foreign Class II and III device manufacturing facilities in the previous few years ("The Gray Sheet" Feb. 4, 2008, p. 6).
Members of Congress blamed a lack of foreign inspections, in part, for problems such as last year's appearance on the U.S. market of products made with contaminated heparin. The Drug and Device Accountability Act of 2009, a bill recently introduced by Sens. Chuck Grassley, R-Iowa, and Ted Kennedy, D-Mass., attempts to address import safety problems primarily by boosting FDA's foreign and domestic inspection resources ("The Gray Sheet" April 27, 2009, p. 10).
But Schultz said more inspections cannot be the sole solution. "What we really need to do is think long and hard about where we need to be sending these inspectors and what kinds of products they need to be inspecting, because the numbers themselves clearly are not going to make much difference."
At a May 21 House hearing to discuss FDA's proposed budget for the upcoming year, agency Deputy Commissioner Joshua Sharfstein also questioned whether testing and inspections are appropriate measures of safety.
