FDA Workers Say Outsiders Influence Medical Device Decisions

Lots of people are unhappy with the process by which the FDA approves medical devices, including patients who’ve suffered harm from deficient products and manufacturers who claim burdensome bureaucracy stands between them and profit.

Congress has acknowledged that the process is less than ideal, and supposedly is trying to establish fair access to safe new technology. Pending legislation includes efforts to speed up device approval, many of which we recently suggested were tainted with lobbying dollars. Patient advocates want the FDA to spend more time reviewing implantable and life-sustaining devices.

Now, a survey by the Union of Concerned Scientists (UCS) captures the conflicted feelings of some FDA employees. Many believe that political and corporate interests wield too much influence when the agency is considering the value and marketability of medical devices.

According to a story in the Minneapolis Star Tribune, some employees feel pressured to approve devices despite misgivings they might have about their safety.

Survey participants were 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 in 4 said yes.

The results were decidedly more cynical than a similar poll in 2006. At that time, most employees of the FDA’s Center for Devices and Radiological Health trusted agency leadership and felt it was headed in the right direction.

This time around, as the Star Tribune reported, “dozens of employees reported experiences in the past year where they believe the medical device industry hurt public health by withholding information or by forcing changes in FDA policy.”

Dr. Jesse Goodman, chief scientist and deputy commissioner for science and public health, applauded the growing worker confidence to be candid, then undercut the survey’s message by saying that the survey’s response rate was low enough to make “definitive conclusions difficult.”

But maybe he did get the message. He also told the Star Tribune that some things in the survey “should still concern us. … some scientists still fear retribution for sharing concerns about the FDA. Some believe that business interests frequently influence science-based regulatory decisions.”

UCS got responses from 997 employees across the agency-17 percent of those asked. Of the respondents, 158 worked in the center for devices.

Some respondents reported experiences within the last year in which they lacked complete scientific data to make conclusions about outcomes for devices seeking approval.

In addition to expressing concern about undue influence for approvals, some survey participants called into question the FDA’s ability to monitor the performance of medical devices once they were on the market. Again, 1 in 4 said they lacked confidence that the FDA had enough authority to assure patient safety for available devices. Many members of the medical profession share this concern.

“When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer,” said Francesca Grifo, director of the Scientific Integrity Program for UCS.

To voice concern about malfunctioning medical devices and for guidance where to register your beliefs about the process, visit the website of the Consumer Union’s Safe Patient Project.

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