SURVEY OF SCIENTISTS DEPICTS A STRUGGLING FDA

The FDA is in disarray, beset by political and industry influences and hampered by insufficient funding to protect public health, a study of agency scientists concludes.

This study, released July 20 by the Union of Concerned Scientists (UCS), is just the beginning, as the group will soon seek out former FDA officials to get their recommendations for changes with an eye toward the Prescription Drug User Fee Act negotiations as the vehicle for reform.

UCS surveyed nearly 1,000 FDA scientists to determine their views of how independent and candid agency researchers are allowed to be in assessing the health and efficacy of drugs and devices. According to the study, "Voices of Scientists at FDA: Protecting Public Health Depends on Independent Science," FDA staff see an agency that is in decline.

The study, which is the latest is a flurry of attacks on the agency, finds that 47 percent of respondents believe the agency is less effective than it was five years ago. Half of the staffers surveyed, including consumer safety officers, chemists and other specialists, also believed that the FDA was heading in the wrong direction.

At least one-third of the 997 respondents believed that their work was interfered with by outside political and industry influences, that retaliation for their views hampered scientific candor and that the FDA is failing to protect human health, the study said. The report also noted that morale at the agency is increasingly poor.

However, many times an equal or greater number of respondents reported that they were independent and were not worried about being candid with their findings. For instance, 67 percent of the scientists said that they had never been asked explicitly to provide incomplete, inaccurate or misleading data, and 60 percent said they never faced implicit pressure to do so. Furthermore, 77 percent said that the FDA's scientific documents and reports rely on the best available science.

The FDA rejected the report, calling it "highly unscientific," and based on "leading questions and innuendo. FDA would expect more rigor to support more far-reaching allegations and conclusions," the agency said in a release.

The FDA also criticized the scientists who cooperated with the survey for going outside normal channels to "try and impose their views through the media. This is unfortunate because it undermines the scientific decisionmaking process and devalues the many contributions made by other FDA staff who do work within the established framework."

The report is available at www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html (http://www.ucsusa.org/scientific_integrity/interference/fda-scientist-survey.html). (http://www.fdanews.com/did/5_142/)