The Union of Concerned Scientists (UCS) recently conducted a follow-up study to their 2006 survey regarding scientific integrity in the FDA in which FDA scientists pointed to several unsettling issues including the influences of political and special interests in scientific work being conducted.

Nearly 1,000 FDA scientists responded to the recent follow-up survey and although responses made it clear problems still persist,there has been a marked internal improvement in the scientific integrity of the Agency.  For example, among the 33 questions posed by the survey, one asked “Is the FDA acting effectively to protect public health?” to which 25% more scientists responded in the affirmative than in 2006.

The 2011 survey produced the following take-away points for FDA’s continued efforts toward integrity:

  • Leadership at FDA is stronger than it was 5 years ago
  • Communication and controversial publication are still discouraged
  • Science-based decision making is inefficient, complex, and slow
  • Political and industry influences persist, despite improvements

Across the boards, the outlook of 2011 responses is more positive than those from 2006. It is clear that FDA has taken strides to reduce external influences and enhance its support of scientists pursuing and discussing controversial or politically unpopular topics.  However, it is also evident that there is a great deal of room left for improvement:  55% of respondents feel FDA decisions are overly-influenced by political interests; and 40% feel the same about business interests.  Most concerning, over 1/3 of all respondents claimed to have firsthand experience of interference by one of these interests in their own work in the past year.

FDA Chief Scientist Dr. Jesse L. Goodman responded to the survey on his blog, saying, “While there may be differing views of what we can or cannot conclude from the science and data on which we rely, and while there are often multiple options that can be considered in developing a policy approach or making regulatory decision, FDA’s scientific decision-making on difficult issues must always be the product of an open and honest debate by the agency’s well-qualified employees. It is for these reasons that we stood up two new offices within the Office of the Chief Scientist whose missions explicitly include supporting Scientific Integrity (OSI) and Scientific and Professional Development (OSPD).”

To read more about UCS’ follow-up survey of FDA scientists and the responses that ensued, click here.