Thursday, November 15, 2012

Congressional Hearing on Deadly Meningitis Outbreak Wants Answers from FDA

The Commissioner of the FDA, Dr. Margaret A. Hamburg was called on the carpet at a congressional hearing yesterday after the FDA failed to take action to prevent a deadly meningitis outbreak throughout the country.

NECC (New England Compounding Company) made and distributed batches of a fungal contaminated medicine, which caused numerous deaths and serious illness throughout the country. The FDA had had a troubled past with NECC for over a decade. State agencies from several states had also reported unsafe practices by NECC to the FDA. Yet the FDA New England District office, headed by Capt. Mutahar Shamsi, did nothing to regulate NECC to prevent the manufacturing of tainted medicine which caused the meningitis outbreak.

Congressional members pelted FDA Commissioner Hamburg with questions about FDA's lack of oversight where she appeared evasive in most instances, yet was consistent in parroting for more laws and more money for the FDA due to lack of jurisdiction and resources. The FDA presently receives about 4.5 billion a year through tax payer’s money and user fees. Many congressional members did not buy into Commissioner Hamburg’s line.

What made it even more frustrating for many congressional members was that the FDA had failed to cooperate with congress in providing related internal documents from the FDA New England District, even when the documents had been requested a month earlier. The other red flag was that the FDA was well aware that the company was a manufacturer and not just a standard compounding pharmacy. This fact alone made it difficult for many congressional members to swallow Commissioner Hamburg’s answer that FDA had no jurisdiction over NECC.  Some members of congress believed that the FDA had to have had some form of authority to prevent the release of tainted medicine.  Yet, Hamburg could not address the issue of the FDA's lack of due diligence. Rep Cliff Stearns from Florida, who chaired the congressional hearing, said that someone in the FDA was not watching.

Distribution of the tainted drug has already resulted in 32 deaths and hundreds of serious illnesses. Many more deaths are expected since thousands of patients where exposed to the deadly fungus through injection of the medicine by physicians in at least 23 states.

Congress does well to demand more transparency and accountability to why the FDA failed in oversight and enforcement which led to distribution of an unsafe medicine and tragic deaths throughout the country.

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.