WASHINGTON - 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.
Dr. Jesse Goodman, the FDA's chief scientist and deputy commissioner for science and public health, welcomed what appeared to be growing worker confidence in the FDA. In a blog item posted on the FDA website, he cautioned that the overall response rate was relatively low, making "definitive conclusions difficult."
Agencywide, 997 employees responded to the UCS survey, about 17 percent of those whose views UCS solicited. Of those, 158 survey participants worked in the center for devices.
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.
"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. "When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer."
Shaye Mandle of Life Science Alley, a trade association representing hundreds of Minnesota medical technology companies, said concerns about inappropriate influence from the industry are unwarranted.
"The FDA controls the approval process," said Mandle, a vice president at Life Science Alley. "There's very little industry can do to make the FDA make bad decisions. Industry wants to be partners with the FDA. We want to put devices out there that improve people's lives."
The survey's release coincides with efforts in Congress to balance patient access to new technology with patient safety. Several bills in the House and Senate, including legislation introduced by Sen. Amy Klobuchar, D-Minn., and Rep. Erik Paulsen, R-Minn., seek to speed up device approval. Meanwhile, advocates for patients hurt by malfunctioning medical devices approved by the FDA are urging the agency to spend more time reviewing implantable and life-sustaining devices.
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."
Jim Spencer • 202-408-2752
