Posted by: Dan | July 20, 2006

FDA Interference: Intimidation of science

From the Union of Concerned ScientistsFDA Scientists Pressured to Exclude, Alter Findings; Scientists Fear Retaliation for Voicing Safety Concerns. I don’t need to comment much on this, the data speaks for itself:

I. Interference with Scientific Determinations at the FDA

  • Almost one in five (18 percent) responded, “I have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or my conclusions in an FDA scientific document.”
  • More than three in five (61 percent) knew of cases in which “Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions.”
  • Three in five (60 percent) also knew of cases “where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” Fifty percent also felt that non-governmental interests (such as advocacy groups) had induced or attempted to induce such changes.

II. Negative Effect on Public Health

  • Only half (51 percent) feel the “FDA is acting effectively to protect public health.”
  • Less than half (47 percent) think that the “FDA routinely provides complete and accurate information to the public.”
  • Less than half (49 percent) agree that “FDA leadership is as committed to product safety as it is to bringing products to the market.”

III. Chilling Effect on Scientific Candor

  • One-fifth (20 percent) say they “have been asked explicitly by FDA decision makers to provide incomplete, inaccurate or misleading information to the public, regulated industry, media, or elected/senior government officials.” In addition, more than a quarter (26 percent) feel that FDA decision makers implicitly expect them to “provide incomplete, inaccurate, or misleading information.”
  • Two in five (40 percent) said they could not publicly express “concerns about public health without fear of retaliation.” More than a third (36 percent) did not feel they could do so even inside the confines of the agency.

IV. FDA Scientists Face Immense Pressures

  • Nearly 70 percent do not believe the FDA has sufficient resources to effectively perform its mission of “protecting public health . . . and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”
  • Less than half (44 percent) say they “respect the integrity and professionalism of FDA leadership.”
  • Two in five (40 percent) describe their morale as poor to extremely poor, while a mere four percent rate their morale as excellent.
  • More than half (52 percent) say their personal job satisfaction has decreased over the past few years, while only 18 percent say their job satisfaction has increased.
  • Less than a third (32 percent) think the agency “is moving in the right direction.”

V. Scientists Recommend Changes at the Agency

  • Nearly two in three (63 percent) said that the “laws and regulations that govern FDA, including the agency’s structure, need change for the agency to better serve the public.”
  • More than four in five (81 percent) agreed that the “public would be better served if the independence and authority of FDA post-market safety systems were strengthened.”

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