U.S. group decries fewer FDA device inspections

WASHINGTON (Reuters) - The Project on Government Oversight (POGO) on Wednesday called for an investigation into the U.S. Food and Drug Administration''s dwindling number of early laboratory inspections for high-risk medical devices.

The group urged lawmakers to give the FDA more funding to hire and train additional inspectors to monitor laboratories before manufacturers begin clinical trials.

FDA records show that early lab inspections dropped to 1 in 2008 from 33 in 2005, POGO said in a report released today.

The report said that in 2007, an FDA official said it was not feasible for companies to follow the FDA''s lab regulations and that most do not.

POGO''s Executive Director Danielle Brian said it was not clear whether the decline in inspections was because of budget issues or other pressures, possibly from companies.

"What we see this as is a case study of a bigger, more endemic problem with the FDA, where they are simply incapable of functioning the way they are intended to function," Brian told reporters.

A number of FDA scientists have complained that the agency''s Center for Devices and Radiological Health (CDRH) stopped requiring device makers to undergo FDA preclinical lab inspections.

Under FDA regulations, companies must submit a safety study of their device and show compliance with the FDA''s Good Laboratory Practices guidelines before getting approval to start clinical trials.

Such preclinical inspections look at equipment maintenance, record keeping, training, personnel and animal care. These inspections are particularly important for more complex devices, such as stents, used to open clogged arteries, and heart pacemakers, POGO said.

POGO said in its report that in 2006, a group of FDA staff scientists urged FDA officials to better enforce early testing requirements, saying nonclinical information could shed light on a product''s safety, especially if serious complications occurred during development.

The report said the Government Accountability Office (GAO), the investigative arm of Congress, or the inspector general of the Department of Health and Human Services should examine FDA records to learn when and why the agency started paring back early device investigations.

Congress should also look at why the FDA has curbed inspections and increase funding for the agency. "This is a case where you need to throw money at the problem," Brian said.

The FDA said in a statement that it has not conducted as many laboratory inspections as it has in the past.

"We continue to review our inspectional plans, and CDRH maintains the authority to request additional information on GLP adherence from a manufacturer and inspect any facility for GLP compliance," the agency said.

The Advanced Medical Technology Association (AdvaMed), an industry group representing device manufacturers, called the report flawed and said FDA''s device oversight was rigorous.

"Manufacturers comply with regulatory requirements not because of the threat of inspections. They do so because it is in the best interests of patients to consistently manufacture safe and effective devices," AdvaMed Executive Vice President Janet Trunzo said in a statement.  Continued...