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Survey: Evidence of Political
Interference at FDA
Union of Concerned Scientists
July Survey/Posted August 21, 2006
The Union of Concerned Scientists (UCS) and Public Employees
for Environmental Responsibility (PEER) distributed a 38-question
survey to nearly 6,000 scientists at the U.S. Food and Drug
Administration (FDA) to obtain their perceptions about scientific
integrity in the agency. Nearly 1,000 scientists filled out and
returned the survey. Unless otherwise specified, the points
below refer to the percentage of scientists at the entire
agency who responded to the survey.
I. Interference with Scientific Determinations at the
FDA Large numbers of agency scientists reported
interference with their scientific work:
- 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
FDA scientists' responses suggest that the agency's ability to
fulfill its mission—protecting public health—is being
put at risk:
- 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 Agency scientists report being afraid to
speak frankly about safety concerns and feel constrained in their
roles as scientists:
- 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
FDA scientists reported that they have inadequate resources to
perform even the basic work of the agency. The lack of
resources and other pressures have strained scientists'
morale:
- 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 FDA scientists had strong opinions about
reforms that would address some of their concerns:
- 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."
Unless otherwise specified, the above percentages refer to
the FDA scientists who responded to the survey.
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