Thursday, April 25, 2013

FDA Wants Stronger Authority Over Compounding Pharmacies

The House of Representatives met on April 16th to address concerns from the FDA and their desire to have more regulatory authority over compounding pharmacies. Late last year, many cases of meningitis broke out due to non-sterile compounding practices by the now closed New England Compounding Center (NECC). Many people died and even more fell ill.  Since this tragedy, the FDA has been pushing for stricter, more powerful authority over compounding pharmacies. Hospitals have begun to rely on these pharmacies to produce many of their sterile products.  As a result, hospitals are buying their needed compounded medications from anywhere in the United States. This has led to an increase in the need for federal regulation due to the states' limited authority.
The FDA stated that the need for increased legislation is obvious and needed if they are to do their job properly.  The Democrats seem to be on the side of the FDA while the Republicans are not so convinced. A Republican from Texas stated that " new legislation takes a lot of time....especially with the current political environment. Don't blame your tools. Do your work."  The FDA commissioner fired right back saying, " We need new tools."
As of right now, it remains unclear whether new legislation will be passed, but I think one thing is clear- Americans can't afford another tragedy like this one.

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