November 30, 2012

Group calls on FDA to re-inspect compounders with past violations

The push to ensure 16 such pharmacies have acted to fix problems comes after a deadly meningitis outbreak.

The Associated Press

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.

"By not fully investigating what could potentially be deadly violations of the law, the FDA is disregarding its primary purpose, which is to protect the lives of citizens," Dr. Michael Carome, deputy director of Public Citizen's health unit, said in a written statement.

The consumer advocacy group wants the agency to follow up on warning letters issued to pharmacies in 15 states for a variety of violations, including:

Producing compounded drugs without a doctor's prescription.

Producing copies of drugs already approved by the FDA.

Making drugs from non-FDA-approved ingredients.

Public Citizen notes that five of the warning letters, which are available on the agency's website, identified injuries or deaths allegedly associated with the pharmacies' products.


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