This is probably a good idea in theory, but once every 2 years won't cut it...and how often and what portions are inspected should be formally addressed...and I would think the inspections should be on a non-notify basis, in other words no prior notification, or on the other hand, do you place an inspector on premise at all times? We can't operate like we have in the past with overseas manufacturing and with today's technology changes in formularies, procedures, etc. can be changed rather quickly..retooling can be accomplished much faster than it has been done in the past. Somebody along the line has to pay for our safety with pharmaceuticals and re-establish some type of "trust" system in light of current events....BD
Three big trade groups (Pharmaceutical Research and Manufacturers of America, the Generic Pharmaceutical Association and the Biotechnology Industry Organization) yesterday told Congress they may be willing to pay new “user fees” so the FDA can beef up its overseas inspections, the Newark Star-Ledger reports.
The user fee model is already well established, with drug makers funding much of the FDA’s work reviewing applications for new drugs. Industry officials said yesterday they’d be open to adding new fees, as long as Congress also appropriates more money toward the same end and the fees go to inspect higher-risk overseas manufacturers, the article says.