Regulatory Focus™ > News Articles > Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

Posted 18 October 2012 | By Alexander Gaffney, RAC

What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy.

The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus far killed 19 patients and sickened hundreds in dozens of states around the US. Federal officials, including those at FDA, the Center for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA) have been scrambling to track patients and secure supplies of all drugs manufactured at the pharmacy, some of which are contaminated with fungal meningitis.

Letter: Give us all the Information you have

The letter requests, "All documents related to FDA's oversight of the NECC dating back to 2004"-a marked escalation in the scope and depth of details sought by the committee. Previously, members of the committee had asked for summary information regarding the agency's activities and whether it required additional authority to regulate compounding pharmacies such as NECC.

In their 17 October letter to FDA Commissioner Margaret Hamburg, E&C Chairman Fred Upton (R-MI) and Ranking Member Henry Waxman (D-CA) called for three specifics from FDA: all inspection reports and records pertaining to NECC, all communications between NECC or the Massachusetts Board of Registration in Pharmacy or other inspectors and all information about briefings with individuals in the Office of the Commissioner about NECC.

The letter could mark the start of an investigation into FDA's handling of NECC. The representatives noted FDA had issued a warning letter to NECC in 2006 after a two-year-long investigation into its manufacturing facility.

Upton and Waxman said they were troubled by FDA's inability to, "Confirm whether any subsequent inspections were conducted to validate that the Food, Drug and Cosmetic Act violations [identified in the warning letter] were corrected."

"Given the risk to public health posed by this outbreak, the Committee expects the FDA to comply with this request promptly," they concluded.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe