List of Issues House Plans To Address During Hearing

IV. ISSUES
The following issues will be explored at the hearing:
 Both State and Federal inspectors documented a number of deficiencies and violations at NECC since as early as 2002, many of which are similar to those at issue in the ongoing meningitis investigation. Were the FDA’s and the Massachusetts Board of Pharmacy’s enforcement actions appropriate?
 Why didn’t FDA pursue any enforcement actions against the NECC despite having emphasized in 2003 the potential for serious public health consequences if the company’s compounding practices, in particular those relating to sterile products, were not improved?
 Prior to this outbreak, the Massachusetts Board of Pharmacy had investigated at least twelve separate complaints relating to NECC and its management. While many of these complaints covered NECC’s sales and marketing tactics, several were associated with serious adverse events and uncovered deficiencies with NECC’s compounding operations. How was NECC able to maintain its pharmacy license despite repeated violations?
 What did State and Federal authorities do to confirm that sufficient corrective measures were taken after these inspections? How did they communicate with each other to ensure such responses were adequate to protect the public health?