Consumer Watchdog Asks FDA to Revisit Compounders
WASHINGTON - A government watchdog group is calling on the Food and Drug Administration to re-inspect more than a dozen specialty pharmacies with prior records of violations, in light of a recent deadly outbreak tied to compounded drugs.
Contaminated pain injections from a Massachusetts compounding pharmacy have been blamed for fungal meningitis that has killed 36 people and sickened more than 500, according to federal health officials.
In a letter to the FDA sent Thursday, Public Citizen asks the agency to revisit 16 compounding pharmacies that received warning letters from the agency between 2003 and 2009.
Compounding pharmacies traditionally mix customized medications based on doctors’ instructions, turning out a small number of specialized products for patients with unusual medical needs. However, some pharmacies have grown into much larger businesses in recent years.
Congressional investigators recently reported that the FDA inspected the New England Compounding Center three times before the outbreak, and issued the company a warning letter in 2006. The letter cited the company for several violations, including mass-producing drugs without doctors’ prescriptions and repackaging FDA-approved drugs into smaller doses.
Public Citizen notes that the agency often does not follow up on warning letters to see if the problems have been corrected.