FDA Deception Exposed...Meningitis Death Toll now at 53

by Bill Faloon

The House Energy and Commerce Committee today released a majority staff report citing internal documents from the Food and Drug Administration chronicling the agency's numerous opportunities over the years to address warning signs about the pharmacy that produced and distributed the contaminated drugs that led to the deadly meningitis outbreak, the New England Compounding Center (NECC).

The outbreak has resulted in 53 deaths and over 700 individuals sickened. In October 2012, the Oversight and Investigations Subcommittee launched an investigation to examine the deadly outbreak and determine whether this tragedy could have been prevented. The investigation revealed what FDA Commissioner Margaret Hamburg did not disclose during the November 2012 hearing: FDA received a litany of complaints about NECC and its sister company, Ameridose, right up until the 2012 outbreak.

On March 11, 2013, a 60 Minutes report described an unscrupulous manufacturer of contaminated drugs that has caused 53 deaths and over 700 serious illnesses. I revealed how 60 Minutes omitted the fact that the FDA knew about this disaster-waiting-to-happen as far back as 2002, but failed to stop it until Americans started dying in 2012. I was outraged that the FDA commissioner was given free rein on national TV to blame this tragedy on a lack of regulatory authority. On April 16, 2013, the FDA was subpoenaed to appear before Congress to account for these contaminated drugs. According to the House Committee investigative report:

• "The investigation revealed what FDA Commissioner Margaret Hamburg did not disclose during the November 2012 hearing: FDA received a litany of complaints about NECC and its sister company, Ameridose, right up until the 2012 outbreak."

• "These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about."

• "After reviewing more than 27,000 documents, we found a dramatically different picture than the one painted by the FDA during our initial hearing in November. We now know that doctors, patients, providers, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manufacturers and marketing their products nationwide without patient prescriptions."

• "The FDA was also warned about sterility and safety issues with the companies' products. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act."

You can review the House Committee's summary and entire report about the FDA's numerous failures in this case by clicking here.

The FDA pretends to protect the health of the American public. The sordid facts instead expose a pattern of failure and deception.