House E&C subcommittee posts background memo on outbreak
Pharmacists may be interested in document as source of information
A surprisingly long list of pre-2012 investigations of the New England Compounding Center (NECC) are detailed in a background memo on the fungal meningitis outbreak in preparation for a congressional hearing tomorrow at 10:00 am.
On letterhead from the Energy & Commerce (E&C) Committee in the U.S. House of Representatives, Subcommittee on Oversight and Investigations staff prepared a majority memorandum for the November 14 hearing, The Fungal Meningitis Outbreak: Could It Have Been Prevented?
According to the memo, the first hearing of two scheduled for this week (the other, on the U.S. Senate side, is set for November 15) will “examine the facts” surrounding the outbreak of meningitis and other infections linked to contaminated injectable products made and distributed by NECC, and also “examine the history of complaints” about NECC and its affiliated entities as well as “related inspections and actions” taken by FDA and the Massachusetts Department of Public Health.
Pharmacists following the tragedy as it unfolds may be interested in the background information provided by this memo. The 25-page memo’s five sections included 4 pages about “Background—The Current Outbreak” and 19 pages devoted to “History of State and Federal Investigations of NECC.”
Issues that will be explored at tomorrow’s hearing, according to this memo, include the following:
- 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 related to sterile products, were not improved?
- Before this outbreak, the Massachusetts Board of Pharmacy had investigated at least 12 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?
Tomorrow at 9:00 am, 1 hour before the Energy & Commerce hearing, Rep. Ed Markey (D-MA) will hold a news conference outside the U.S. Capitol building with a Baltimore-based patient who suffered severe adverse reactions after receiving two steroid injections from NECC and a patient advocate from the National Research Center for Women & Families, Cancer Prevention and Treatment Fund.
As reported on pharmacist.com, Markey introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act (H.R. 6584) on November 2. He issued a report, Compounding Pharmacies, Compounding Risk, on October 29.