Are warning letters the FDA’s carrots?
This week Ed Silverman over at Pharmalot asked whether the FDA needed to get tough on some foreign active pharmaceutical ingredients (API) suppliers, citing some pretty hairy findings from inspections of Canadian and Indian factories that triggered the ol’ Warning Letter Machine.
The FDA does need to get tougher, using the authorities it has (seizure, shutting down a plant) and gaining new ones (recall and subpoena are two) to crack down on problem suppliers, since it seems that many manufacturers can’t or aren’t willing to.
As we’ve said here here and oh here, a more splintered supply chain means more places for things to go wrong, and with the number of GMP violations and recalls on the rise, it’s clear that plenty does. (And it’s not just suppliers: see the quality meltdown at GSK’s flagship plant.)
In a recent Pew Prescription Project survey 93 percent of Americans said they favor country of origin labeling on drugs—and the majority had little confidence in drugs coming from major overseas manufacturing hubs like India and China. Recently, drugmakers haven’t given them good reason to. FDA can do its part to change that by taking “louder” actions against suppliers in flagrant violation of safety and quality standards, and use its admittedly limited resources as a megaphone/stick to other suppliers, distributors and drugmakers, and less of a warning-letter/carrot.
Congress can also pass bills before it to bolster the FDA’s authorities and resources. A stronger FDA that can do timely inspections and subpoena documents when asking a company nicely doesn’t work could encourage some members of the supply chain to comply, or at least make it easier to keep them out of the chain when they don’t.
–Kate Petersen, PostScript blogger