FDA chief calls for Congress to act over tainted drugs
April 02--The U.S. Food and Drug Administration is asking Congress for authority to effectively regulate firms such as the one that Mount Pleasant resident Bob Ross said sickened him with their product.
"The deadly outbreak of fungal meningitis associated with a compounded medication was a horrible tragedy, and I've asked myself many times if and how it could have been prevented," FDA Commissioner Margaret Hamburg said in her latest blog post.
"I speak for everyone at FDA when I say that our hearts go out to the many victims, including those still struggling with this devastating infection, and their loved ones."
Ross said he was injected with a suspected fungus-tainted steroid shipped from New England Compounding Center. Under current law, such compounding pharmacies fall in a regulatory gray area, according to experts.
The pharmacies are supposed to mix prescriptions one at a time, on a per-patient basis. But demand for special formulations is so high that hundreds of compounders have started large-scale production. They closely resemble drug manufacturers, but without the very strict oversight and long list of sterility requirements that manufacturers must follow, officials said.
"There should be legislation that establishes appropriate, minimum federal standards for firms that compound sterile drug products in advance of or without a prescription and ship them interstate," Hamburg said.
Ross was among 14,000 patients who received an injection of a suspected fungus-tainted NECC steroid.
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