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FDA Workers Pressured to Approve Unsafe Medical Devices

FDA's Medical Device Approval Lab

FDA's Center for Devices and Radiological Health

Some workers in the medical device review department of the U.S. Food and Drug Administration (FDA) say they feel pressured to approve devices that they are not sure are safe, according to a new survey reported in the Minneapolis Star Tribune.

When asked “Have you ever been pressured to approve or recommend approval for a device or product despite reservations about the safety, efficacy or quality of the product?” one-quarter of the respondents answered “yes.”

The survey was conducted by the Union of Concerned Scientists (UCS), and the participants were employees of the FDA’s Center for Devices and Radiological Health.

Device Approval Process Viewed with Skepticism

Almost 1,000 FDA employees — 17 percent of the total solicited — took the survey. Of those, 158 survey participants worked in the center for devices.

Among the respondents’ concerns:

** The FDA’s inability to monitor the performance of medical devices once they have been approved for use.

** The FDA’s use of incomplete scientific data to justify specific outcomes in device approval.

** The excessive influence of political and corporate interests over FDA policy.

The results were more negative than a similar poll in 2006, which found most employees of the FDA’s Center for Devices and Radiological Health trusted the agency’s  leadership.

Inappropriate Interests Cloud Judgement

“Despite the Obama administration’s improvements in scientific integrity, political and corporate influence over the FDA’s scientific work persist,” Francesca Grifo, director of the Union of Concerned Scientists’ Scientific Integrity Program, said in a statement to the Star Tribune.

“When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer.”

This year, Congress must reauthorize laws that determine how medical devices are approved and monitored, and lobbyists are lined up to have their interests heard.

The second Medical Device User Fee and Modernization Act (MDUFA II), which is one of the key pieces of legislation, expires on Sept. 30. After more than a year of negotiations, the FDA has reached a tentative agreement with the medical-device industry. The industry is seeking quicker review times in exchange for funding 200 additional scientists at the FDA.

Financially Advantageous Move may Endanger Consumers

The deal that AdvaMed (Advanced Medical Technology Association), the Medical Device Manufacturers Association and the Medical Imaging and Technology Alliance agreed to would give the FDA $595 million over five years. In return, the FDA promises to expedite review periods for 510(k) applications and others, with increasing productivity throughout the five years.

The new deal almost doubles fees, which totaled $287 million for the last 5 years.

But are quicker review times in the best interest of patients? Surely that, too, is a concern of employees in the FDA’s Center for Devices and Radiological Health.

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