Twenty lives have now been lost due to a meningitis outbreak that is sweeping our nation. Now members of Congress are investigating whether federal regulators did enough to prevent this tragedy.
Members of the House Energy and Commerce Committee are questioning whether federal regulators did enough to prevent the major outbreak of meningitis Nine lawmakers wrote to the Food and Drug Administration (FDA) on Wednesday October 17, 2012 asking how it handled regulatory violations at the New England Compounding Center (NECC) in 2004 and 2005.
The NECC is responsible for the tainted injections tied to at least 19 deaths around the United States.
In their letter, lawmakers implied that the FDA had not pushed the NECC to correct its code violations, which amounted to “significant public health concerns” in the committee’s view.
In 2004, the FDA was concerned about the potential for “microbial contamination” of the NECC’s injectable products, the letter noted.
“FDA officials could not confirm whether any subsequent inspections were conducted to validate that the … violations were corrected,” lawmakers wrote following a briefing with regulators.
Congress has been pushing for action on the outbreak for weeks. Several members have called for a range of investigations, and introduced bills that would strengthen FDA oversight of operations like the NECC, a compounding pharmacy.
The Framingham, Mass.-based company reprocesses drugs on a large scale to fit patients’ needs, such as dividing standard medications into doses fit for children.
As a compounding pharmacy, it is not obligated to follow certain federal guidelines that apply to drug makers.
So, how exactly did this all happen?
The Food and Drug Administration has announced that it has confirmed the presence of Exserohilum fungus in one of three lots of steroids used for pain injections from the pharmacy at the center of the widespread meningitis outbreak. That confirms the link between the contaminated drugs and the infections found in most of the afflicted patients.
Testing on the other two implicated lots of the steroid methylprednisolone acetate and other injectable drugs from the New England Compounding Center continues, the agency said.
The CDC said there was no firm evidence of infection in any patients beyond those exposed to the contaminated lots. However, FDA officials warned doctors earlier this week to reach out to patients who received any drugs from NECC to check their health status because the agency could not assure that any of the products were sterile.
To date, the number of deaths from fungal meningitis linked to potentially contaminated steroid injections has risen to 20 and the outbreak has reached 16 states the Centers for Disease Control and Prevention has stated. The number of people that have contracted the meningitis is 254 nationally.[hr]