How the FDA is “Fundamentally Broken”
Filed under: Drugs & Medical Devices, FDA, FDA Center for Devices and Radiological Health
Photo by itchmo via Flickr
AP has run a story on FDA investigatory practices that lends additional credence to the assertions of a number of FDA scientists who have publicly claimed that the FDA is “fundamentally broken.”
The article focuses on a recent report by the Project on Government Oversight (POGO) which exposes a dramatic decrease in medical device lab inspections over the course of the last few years.
AP writes:
“Medical devices are overseen by an FDA division called the Center for Devices and Radiological Health. The center has been shaken by recent complaints from its own scientists that managers squelched debate, leading to the approval of devices that were of questionable effectiveness and perhaps not entirely safe.”
The Center has also been accused of allowing political influence to be a determinate factor in the approval process of medical devices.
The decline in laboratory inspections outlined by the POGO report is both precipitous and alarming. AP writes that the report shows that
“…the Food and Drug Administration has dramatically reduced inspections of “good laboratory practices” at facilities that do the earliest testing of medical devices. Such inspections declined from 33 in 2005, to seven in 2007, to just one last year, according to a report the group was releasing Wednesday. No inspections are planned for this year, the report said.”
Read the full POGO report here.
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