Friday, November 2, 2012

Will New Laws Prevent Future Meningitis Outbreaks?

Legislators Should Examine FDA before Creating New Laws

Today an article from the Wall Street Journal reports that Rep Edward J. Markey (D., Mass) and Rep Rosa De Lauro (D., Conn) plan to introduce a bills that would “give the FDA clearer authority to regulate large pharmacies that mix customize drugs like the one tied to a deadly meningitis outbreak”.

But legislators may be on the wrong track. Prior to the outbreak, the FDA had sufficient jurisdiction to inspect NECC, the compounding pharmacy who manufactured in bulk, injectable medicines that caused the meningitis outbreak.

Mutahar Shamsi, the District Director for the New England FDA Office of Regulatory Affairs, during an October 2012 press conference, however, was quoted as stating that an inspection occurred on October 1st, 2012, only after the outbreak. No other inspectional information on NECC has been released by the FDA depite the fact that this company was on the FDA's inspection list. The big question is why did the FDA fail to perform at least minimal oversight of NECC where they had jurisdiction to do so?

The lack of oversight of NECC by the FDA raises questions to the possibility of either incompetence or conflicts of interests within FDA leadership in the New England Boston district. Conflicts of interests can  undermine enforcement of laws since FDA regulators can pick and choose whom they inspect or regulate.  

Excuses to a lack of jurisdiction or lack of resources are often made to cover up inadequacies, unethical standards or poor leadership within government agencies. 

Making new laws will not protect the public when regulators act in capricious ways to favor industry and are not held accountable to uphold current law.The New England Boston District FDA office needs to be thoroughly examined regarding their prior oversight of NECC or their lack there of. The public should have transparency as to the real reason why the FDA did not properly inspect NECC prior to the meningitis outbreak that caused 28 deaths, when in fact, they had jurisdiction to do so, and when in fact, NECC had a history of prior complaints.

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