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FDA Faulted Again on Medical Device Oversight

Feb 18, 2009 | Parker Waichman LLP

Labs that develop medical devices haven't been receiving adequate scrutiny from the Food & Drug Administration (FDA), a new report says.  According to the Project on Government Oversight (POGO), the FDA's Center for Devices and Radiological Health (CDRH) allows manufacturers and testing facilities  to monitor their own compliance with federal regulations meant to insure the safety of medical devices.

According to a press release issued by the POGO, the FDA apparently decided to ignore the federal Good Laboratory Practice (GLP) regulations.  The GLP was issued in 1979 protect patients from unsafe drugs and devices by no longer allowing manufacturers to set their own standards of laboratory testing.  According to the Associated Press, the regulations were written after a leading medical lab was found to have fabricated data later submitted to the government.

POGO  called the FDA's decision to ignore the GLP regulation " stunning in its contempt for the protection of patients and its indifference to standards that comply with federal regulations."  The decision to ignore the regulations was made over the strong objections of CDRH scientists, the group said.  To prove this point, POGO released  a 2006 internal FDA memo in which scientists argued unsuccessfully for continued enforcement of the lab standards.

"There are many insiders who are deeply concerned that real harm is being done.  Such a decision affecting public health should not have been made behind closed doors,"  Danielle Brian, Executive Director of POGO, said in the group's press release.

This is not the first time the FDA has been criticized for its oversight of medical devices.  Last month, the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews.

That some month, a group of FDA scientists wrote then President-elect Obama imploring him to reform the agency, which they characterized as corrupt.  The letter explained that  that FDA's regulation of  medical devices was “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”  The letter also provided specifics about how scientists who differed in opinion from FDA management were threatened with disciplinary action.

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