Deadly Drug Errors: Regulate Lethal Compounds

If Congress wants to investigate the need for federal regulation of the booming U.S. drug-compounding-lab industry, Ocala in North-Central Florida would be the logical place.

 in 2009, when 21 polo ponies perished after ingesting a mineral supplement mixed by an Ocala compounding lab. This year, the same lab came under new scrutiny when 33 cases of a rare fungal eye infection were reported across seven states, leading to blindness in some of the victims.

Now comes the fungal meningitis outbreak emanating from the New England Compounding Center in Framingham, Mass., which, reports the Centers for Disease Control and Prevention, has claimed at least 233 victims, including 15 deaths in 15 states. Three of those deaths occurred in Marion County, the home of Ocala.

No more evidence should be necessary for Congress to move to put compounding labs under the regulatory eye of the U.S. Food and Drug Administration.

Former FDA Commissioner David Kessler warned Congress in 1996 that, left unregulated, small drug-compounding outfits could morph into "a shadow industry" producing untested and unsafe drugs that "could result in serious adverse effects, including death."

His warning was on target. Congress should give the FDA the power to oversee compounding labs.

Read More: http://www.theledger.com/article/20121023/EDIT01/121029776?Title=Deadly-Drug-Errors-Regulate-Lethal-Compounds