The FDA: Are they dropping the ball regarding laboratory practices?

Major concerns about the Food and Drug Administration (FDA) practices have risen as facts surrounding the recent peanut butter salmonella outbreak in Georgia and dirty syringes in North Carolina unfold.   People began getting sick from the peanut butter salmonella outbreak in September of 2008.   Thus far, the 2,200 recalled peanut butter products have caused nine deaths and sickened over 600 infected people.  The incident regarding the dirty syringes has caused five deaths and sickened hundreds other patients.  As can be expected, questions of mandatory testing procedures and proper laboratory conditions ensue from both the federal and state level as well as whether the FDA could have or should have prevented this from occurring. 

Currently, federal law requires no reporting of contaminants if private companies perform testing.  Instead, state law drives many of the testing and laboratory requirements with guidance from the FDA and Center for Disease Control (CDC).   Mandatory testing is not required in all states.  Neither is testing for all strands of particular diseases.   As a result, these outbreaks occur and people must suffer for things that might be avoidable. 

However, the FDA remains a target for disapproval associated with these two major recent health emergencies.   Facts related to FDA’s involvement in these two catastrophes have surfaced and turned many heads towards criticism.  Regarding the salmonella outbreak, the FDA received reports that the Georgia peanut plant had positive test results for salmonella in the peanut products as far back as 2007, but later shipped out products following negative tests.  Reports of missed inspections by federal officials and failure to obtain licensure can also be linked to the peanut company.  Moving to the incident in North Carolina, several complaints were filed with the FDA as far back as 2005 stating that hospitals were receiving dirty syringes.  It took until December of 2007 for the FDA to finally pull the drug off the market following the infections being linked to those syringes.  In addition, law mandates that the FDA inspect facilities like the one in North Carolina every two years.  However, the actual inspections only occur about once every five years for these types of facilities.

All of these reports force people to wonder if the FDA is really doing their job and whether tighter legal standards need to be both imposed and enforced against them and the state counterparts.  Additionally, requiring uniform testing and laboratory practices across the states seems like a necessary step to prevent future incidents like these two recent emergencies.  Without uniform testing and tracking systems, it seems as though the FDA and state officials cannot have a concerted effort for disease prevention and maintaining sufficient health protection.  Until stricter standards and procedures are in place, the public will not know which products they can trust to be safe and which products may have been sent produced in unsafe or unclean facilities.

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