Wednesday, December 5, 2012
It’s Time for FDA, States to Step Forward for Public Health
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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Reform is Coming::The Blog Has Accomplished One of It's Purpose
When I began this blog in March 2012, I was stunned at the lack of education and knowledge about compounding in the veterinary and medical world. I have learned so much since beginning this blog. I hope you have to. In the beginning of this blog, I could foresee a tragic event such as the NECC meningitis outbreak happening. I hoped it wouldn't. I hoped the worst of tragedies had already been seen in cases such as Franck's, and Apothecure and similar cases, but I knew the odds were great that something bad would happen based on the way things were done or not done in the compounding world and when it did happen it would be big. The one good thing that can possibly come out of that big bad thing is reform of the compounding world--better knowledge, better education, better procedures, better practices, better communication, better enforcement, better everything. It is not enough for organizations to point their finger at the federal government. All share in the blame. All must take responsibility and all must work together to improve the situation to make sure nothing like the NECC meningitis outbreak happens again. Whether the federal government passes some sort of legislation and takes over most of the jurisdiction of compounding or the states keep the jurisdiction and strengthen the teeth of the rules and regulations they have, reform is needed and I have no doubt reform is headed our way. There is much left for many to do. There is much knowledge to be gained. There is much education that still must be accomplish.
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