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Senate panel expands meningitis probe as illness spreads
The Senate Health, Education, Labor and Pensions (HELP) Committee is demanding a slew of documents in light of a deadly meningitis outbreak that has spread to 18 states.
Pressure has been mounting from Congress, now in recess, for answers on the spate of illnesses. Most have been tied to tainted steroid injections administered for back pain. The injections came from the New England Compounding Center (NECC), a Framingham, Mass.-based company that remixes drugs to fit patients' needs.
The NECC has recalled all of its products and surrendered its state license. But its role in the outbreak has raised questions about rules that govern so-called compounding pharmacies. The operations are not obliged to follow many of the regulations that apply to drugmakers, and several Democratic lawmakers have called for new laws that would enable stricter oversight.
The senators noted that 14,000 patients may have been exposed to the deadly fungus since May. More than 300 have been sickened and 24 have died.
House lawmakers are pushing hard for more details from the NECC. Earlier in the week, leaders with the House Energy and Commerce Committee complained that no one affiliated or formally affiliated with the company had agreed to brief committee staff.
Those lawmakers expressed specific interest in code violations by the NECC that may have foreshadowed the fungal contamination behind the meningitis outbreak.
"On December 4, 2006, the FDA sent the NECC a warning letter detailing significant violations of the Food, Drug and Cosmetic Act witnessed by the investigators," lawmakers wrote to an NECC lawyer, Paul Cirel.
"Included in the list of violations was the NECC's manipulation of a sterile injectable product, which caused the FDA to be 'especially concerned about potential microbial contamination,' " the leaders wrote.
