Meningitis outbreak highlights failed oversight efforts

By Elizabeth Cohen. Danielle Dellorto and William Hudson, CNN

updated 3:13 PM EDT, Wed October 10, 2012

Contamination warnings were ignored

STORY HIGHLIGHTS

• There are no federal sterility guidelines for compounding pharmacies
• The FDA has no jurisdiction until there is a problem
• Two lawmakers are introducing legislation to strengthen the FDA's oversight
• 12 people have died in a meningitis outbreak linked to a steroid

Framingham, Massachusetts (CNN) -- If Sarah Sellers' warnings had been taken seriously 10 years ago, 12 people might be alive today.

Sellers, a pharmacist and expert on the sterile compounding of drugs, testified to Congress in 2003 about non-sterile conditions she'd witnessed.

"Professional standards for sterile compounding have not been consistently applied," she told the Senate Committee on Health, Education, Labor, and Pensions. "The absence of federal compounding regulations has created vulnerability in our gold standard system for pharmaceutical regulation."

Nearly 10 years later, there are still no federal sterility guidelines for compounding pharmacies that make and distribute drugs all over the country.

Now, 137 cases and 12 fatalities nationwide are blamed on a rare, noncontagious form of meningitis linked to contaminated steroid injections made by the Massachusetts-based New England Compounding Center.

The pharmacy announced Wednesday it has established a recall operations center to manage the removal of all its products from circulation.

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