DECEMBER 5, 2012 BY LEAVE A COMMENT
Patrick Stone, President, TradeStone QA
It’s clear that the FDA should have more compounding pharmacy oversight but how long will it take them to make other important decisions on public health?
The recent news is troubling.
Example: According to state and federal records, it took FDA approximately 684 days to issue a warning letter that may have saved lives and time. Usually it should only take 90 days for compliance branch a local district directors to decide on a firm’s regulatory outcome. The FDA mandates strict 483 fifteen day response letter times and should also be held to a 60 or 90 day turnaround.
As a former FDA inspector, I’ve been there. Some of the cases I was involved with took 24 months to get a final warning letter decision. This is unacceptable because there is a 6 month follow up that should be conducted.
But if regulators give the regulated industry time to make more lethal products who is to blame? Usually FDA gets local state authorities involved for immediate detention and embargo of harmful products. Each state has unique authority over products made within it’s borders if they are held for interstate trade. The New England region was also involved with the FDA inspections. The state could have stopped many products from interstate trade before the situation escalated.
The FDA’s initial inspection on this product began in September 2004 and ended on January 19, 2005. In the Dallas district an Investigator would be reprimanded for taking five months on an inspection. It does not take that long to conduct a compound pharmacy inspection or to collect product samples. It usually takes two or maybe three weeks for this type of inspection. Each district has time limits that can be spent on any one assignment. There seems to be a pattern of errors here that could have prevented lives from being lost with much time wasted.
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