FDA backed off device lab inspections

In the ever-growing roll call of shame at the FDA, a government watchdog group is preparing to release a report showing the agency deliberately backed off of "Good Laboratory Practice" requirements for medical device makers. In doing so, the agency allowed device companies to test their products on humans without proving that the tests adhered to standards observed for three decades. All device makers had to do was file paperwork asserting that their labs met standards; the agency stopped inspecting the facilities prior to human studies, the report states.

FDA's Casper Uldriks, head of regulatory guidance for the agency's medical devices division, said that regardless of the changes, the oversight was adequate. FDA requires documentation at three stages of the approvals process, he told the Project on Government Oversight, which authored the report. According to the report, inspections declined from 33 in 2005 to seven in 2007 to just one in 2008, the Associated Press reports.

POGO released a 2006 internal memo in which agency scientists argued for continued enforcement of the lab standards. They were unsuccessful. The decision to scale back inspections was made behind the scenes around that time. "The decision ... to not enforce (lab standards) is stunning in its contempt for the protection of patients," the oversight project, a nonpartisan group that exposes problems in government, said in its report.

As you know, scientists from the FDA's device division have been up in arms in recent weeks, alleging that science took a back seat to politics at the agency in recent years. The FDA employees are asking Congress and the Obama administration to intervene. President Obama has promised a top-to-bottom review at the agency.

- read the AP story
- see the McClatchy Newspapers' take

Related Articles:
GAO: FDA's device review too slack
Obama says FDA due for 'complete review'
Acting FDA chief promises science, not politics
FDA scientists plea for agency reform
Sweep the FDA clean, Stupak says