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.