There are new figures on the recent fungal meningitis outbreak that resulted from tainted steroid shots. Now it is believed that 13,000 people received the shot, though not all the shots were given in the back. The number of confirmed cases has now reached 105, with eight fatalities.
These growing numbers are causing renewed attention of these compounding pharmacies, which repackage or recombine medicines. These pharmacies are not regulated by the Food and Drug Administration, but some in Congress want the FDA to ensure that these compounded drugs meet the same safety standards as other drugs.
As it stands now, these pharmacies do not have to show that the drugs that they mix are safe or effective. But as the number of pharmacies performing this service increases, it is becoming more and more of a public health risk. Not only are more and more pharmacies performing this service, but they are also doing so on a large scale. With this particular example, the New England Compounding Center shipped over 17,000 vials of the tainted steroid to 23 different states.
On Saturday, the pharmacy issued a voluntary recall of all their products as a precautionary move. They claim however that they have no reason to think that any other product has been similarly contaminated.
It is possible that the Supreme Court of the United States will address these issues soon. If the FDA were able to regulate these pharmacies, their compounds would be treated as new drugs and be submitted to clinical trials before the drugs were allowed on the market. The FDA would also be able to inspect the facilities, hopefully preventing contaminations like this latest one.
Contact our attorneys at Kirkendall Dwyer to get more information on this or any other drug-related injury.
More at: http://www.foxnews.com/health/2012/10/09/meningitis-outbreak-stirs-calls-for-fda-pharmacy-oversight/