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Survey: FDA Scientists (2006)

The U.S. Food and Drug Administration (FDA) is responsible for protecting and advancing public health through the regulation of drugs, food, medical devices, cosmetics, and the blood supply—including products that, according to the FDA, account for 25 cents of every American consumer dollar spent.  
 
In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA's scientific work, compromising the agency's ability to fulfill its mission of protecting public health and safety. 

The National Academies Weigh In
In September 2006, the National Academies Institute of Medicine released a report critical of the FDA and its ability to protect the public from unsafe drugs.  In a section discussing the poor handling of scientific disagreement, the report mentioned the UCS survey result indicating that hundreds of agency scientists had been pressured to approve a drug despite reservations about safety. 

The report describes the acknowledgment of these concerns by acting FDA commissioner Andrew von Eschenbach when questioned about the UCS survey at his Senate confirmation hearing and in a separate meeting with UCS about scientific integrity at the FDA.

"Scientific discourse is strongly discouraged when it may jeopardize an approval. . . . Whenever safety or efficacy concerns are raised on scientific grounds . . . these concerns are not taken seriously."

"First class scientists are leaving the FDA, and recruiting new ones will be very difficult."

—selected FDA survey essay responses

Returning to its Scientific Mission
The FDA mission statement calls for "helping the public get the accurate, science-based information they need to use medicines and foods to improve their health." Unfortunately, scientists at the agency are concerned that science no longer plays this crucial role in the FDA’s regulatory decisions.

Independent science must be the driving force for decisions made by the FDA. Based on the survey responses from FDA scientists, it is clear that the agency needs to demonstrate a greater respect for independent science and improve both the transparency and accountability of its decisions.

For this to occur, both the FDA leadership and Congress must act swiftly to pursue reforms. Without real leadership to defend impartial science, the FDA cannot do its job—and public health and safety will suffer.

This survey is one in a series of surveys designed to explore the level of political interference in science at federal agencies. Explore all survey results and learn more about the UCS Scientific Integrity Program by exploring the links below and to the right.

Main FDA Survey Documents
   Brochure containing survey summary, methodology, and demographics (pdf)

Supporting FDA Survey Documents
   Survey questions and responses (pdf)
   Selected essay responses (pdf)
   All essay responses (pdf)
   Abuses of science at the FDA (pdf)
   Survey demographics (pdf)
   Survey methodology (pdf)
   FDA center-specific questions and answers (pdf)
   FDA centers response analysis (pdf)
   Comparison of 2006 UCS survey to 2002 inspector general survey (pdf)

Other Documents and Resources
   Summary of the 2002 inspector general survey of FDA scientists
   General Accountability Office report on the FDA's decision process related to Plan B emergency contraception (pdf)
   Institute of Medicine assessment of the U.S. drug safety system (report forthcoming)
   Prescription for Harm: The Decline in FDA Enforcement Activity (a June 2006 report from the House Committee on Government Reform Minority Office)
   Harris poll: 82 percent of Americans believe FDA decisions are influenced by politics
   Statements about the FDA survey from Senator Grassley (R-IA), Representative DeLauro (D-CT), and Representative Hinchey (D-NY)

About the FDA
   FDA homepage
   FDA history

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