New survey shows FDA employees’ medical device approval concerns

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The NPR “Shots” blog and the Star Tribune were the only mainstream news organizations I saw that reported on a new survey by the Union of Concerned Scientists (opens as pdf file).

Under the headline, “FDA Survey uncovers concerns over influence,” the Strib reported:

Some workers in the medical device approval section of the Food and Drug Administration feel pressure to approve devices even when they have doubts about their safety, a new survey reveals.

The revelations were among the results of a 2011 survey released Wednesday by the Union of Concerned Scientists (UCS). One in four participants answered yes 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?”

The survey showed employees in the FDA’s Center for Devices and Radiological Health had much more trust in leadership than in a UCS poll taken in 2006. The workers were generally convinced that the agency was headed in the right direction.

At the same time, many participants said political and corporate interests have too much clout in the decisionmaking process. 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.

Some respondents worried about the FDA’s ability to monitor the performance of medical devices once they hit the market. One in four survey participants was not confident that the FDA had enough power to assure patient safety from medical devices that malfunction after manufacturers offer them for sale.

Others said they had experienced a situation in the past year where the FDA used incomplete scientific data to justify specific outcomes in device approval.

The FDA’s Goodman acknowledged there were findings within the survey that “should still concern us.” In particular, Goodman noted, “some scientists still fear retribution for sharing concerns about the FDA. Some believe that business interests frequently influence science-based regulatory decisions.”

The paper reminded its Minnesota readers that Minnesota legislators have recently been trying to speed up device approval.  Minnesota is home to hundreds of medical technology companies, include giants like Medtronic.


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