Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to email@example.com so that we can defer those challenges. Your health and safety are paramount to us.
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.
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."
Tags: Crisis, Meningitis, Legislators, Compounding, Upton, Waxman, Letter, Scandal, Latest News, Congress