Meningitis outbreak highlights failed oversight efforts

But according to Republicans, we need less regulation.

http://www.cnn.com/2012/10/10/health/meningitis-exposure/index.html?hpt=hp_c1

By Elizabeth Cohen. Danielle Dellorto and William Hudson, CNN
updated 5:46 PM EDT, Wed October 10, 2012

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.

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Currently, the FDA does not have jurisdiction over compounding pharmacies until there is a problem. FDA officials say they have been fighting to change that for more than 20 years.

The compounding pharmacy industry has challenged those efforts, and courts have ruled that individual state health departments are in charge.

"These facilities are inspected upon initial licensure and in response to complaints," said Alec Loftus of the Massachusetts Department of Public Health.