Too few FDA tests of high-risk devices, activists say

The Project on Government Oversight (POGO) called on Wednesday for an investigation into the U.S. Food and Drug Administration’s early laboratory inspections of high-risk medical devices, faulting the agency for conducting too few.

The watchdog 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 on Wednesday.

POGO said in the report that in 2007, an FDA official said it was not feasible for companies to follow the agency’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 and 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 that the Government Accountability Office (GAO), the investigative arm of Congress, or the inspector general of the Department of Health and Human Services should examine the FDA’s records and look at when and why the agency started paring back its 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.

Last month, the GAO said the process used by the FDA to approve riskier devices was incomplete and called on the FDA to act to ensure that such products go through the most stringent review possible.

FDA scientists complained to lawmakers last year about the lack of laboratory compliance. In January, FDA staffers expressed concern that their complaints were sparking retribution from FDA managers.

“It is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress,” the FDA staffers wrote in a January 26 letter to U.S. President Barack Obama.

WASHINGTON (Reuters)