Advocates say FDA guidelines far too lax

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For those who don’t know how the agency works, the following may come as a surprise, but it’s indeed the way the FDA does business.  While most state and federal agencies rely on regulations, and in most cases get really nasty when those regs aren’t followed, the FDA issues “guidance.”

We’re talking voluntary guidance, not the “safe harbors” agencies issue which allow healthcare organizations to avoid otherwise stiff penalties. And safety advocates say that it’s about time the FDA get tougher on the organizations that it regulates.

Take a quick look at how pharma manufacturing guidance works, and you’ll see what we mean. The current guidance from the FDA on finding drug contamination by a toxic lumber preservative (halogenated phenolic preservative) is to give wooden pallets supporting the product a simple “sniff test.

Apparently, halogenated phenolic preservative by-products are incredibly easy to smell, producing a musty or moldy odor which stands out even to non-professionals. In fact, consumers can detect them at the parts-per-billion level.  So in theory, a smell test maybe as good as any method for detecting the presence of this toxin while the product is in process.

The thing is, even so simple a test of this is at the discretion of the drugmaker.  Safety advocates argue that as long as testing is voluntary, biopharma firms aren’t going to play nice and be thorough.

“Guidelines are just guidelines,” safe food advocate Nancy Donley told Food Safety News. “They don’t have any teeth…FDA has been operating under guidance documents for years, and it hasn’t worked. Nothing has changed.”

Perhaps it’s just a matter of throwing a switch and turning guidance in to must-follow regulation — after all, it does seem to work. Pfizer, for example, was able to detect problems at its Freiburg, Germany plant last March when quality impectors smelled the musty/moldy odor of possible contamination.

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