Thursday, November 15, 2012

Caution Urged in Meningitis Hearings


Gannett News Service
November 15, 2012
Rep. Marsha Blackburn says Congress needs to find out how meningitis-causing steroid drugs got through the nation’s pharmaceutical safety net but should refrain from attacking all compounding pharmacies.
Blackburn (R-Brentwood) made those comments in an interview as she looked forward to the start of congressional hearings on the contaminated steroids from the New England Compounding Center (NECC) in Framingham, MA, that are blamed for at least 438 illnesses and 32 deaths from fungal-meningitis nationwide. In Tennessee, there have been 81 cases and 13 deaths. The latter is the largest figure for any state.
The Oversight and Investigations Subcommittee of the House Energy and Commerce will hear from witnesses that include Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), and Barry Cadden, NECC owner. The subcommittee subpoenaed Cadden to appear. The Senate Health, Education, Labor and Pensions Committee, with Republican Sen. Lamar Alexander as a member, will follow with a similar hearing Thursday.
“This is the largest drug-related public health crisis in recent memory,” Rep. Edward Markey (D-Mass.) said Tuesday in a statement. Markey and Blackburn are both members of the Oversight and Investigations Subcommittee.
Blackburn said the panel is concerned “about what went wrong” and “where they (NECC) went wrong in their processes.” But she added it is too early to say what, if any, additional authority should be given to the FDA and that Congress “should not burden or hinder” the overwhelming majority of compounders, who fill a critical need in the nation’s medical system.
Compounding, as understood for decades, meant individual pharmacists in neighborhood drug stores mixing medicines to meet the needs of individual patients as prescribed by their doctors. But over the last two decades, many large-scale compounders such as NECC have emerged and escaped the regulations imposed on major pharmaceutical firms.
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