July 20,2006

Sen. Grassley Comments on Union of Concerned Scientists’ Survey of FDA Scientists

M E M O R A N D U M

TO: Reporters and Editors
FR: Jill Kozeny, for Sen. Grassley, 202/224-1308
RE: Union of Concerned Scientists Survey of FDA Scientists
DA: Thursday, July 20, 2006

Sen. Chuck Grassley commented today on survey results reported by the Union of
Concerned Scientists. The survey presents the responses of 998 scientists for the Food and Drug
Administration. Among those participating in the survey, 81 percent agreed that the “public
would be better served if the independence and authority of FDA post-market safety systems
were strengthened.” Less than half of respondents said the “FDA routinely provides complete
and accurate information to the public.”

Sen. Grassley began conducting oversight of the Food and Drug Administration in early
2004, when the drug safety agency tried to keep a lid on information about the dangers of
antidepressants when used by children and teenagers. He chaired a Senate hearing later that year
on how the Food and Drug Administration handled risk information about the drug Vioxx. Since
then, the senator has coauthored bipartisan legislation to improve post-market surveillance of
drugs by the Food and Drug Administration (S.930) and to require that information about clinical
trials be publicly available (S.470). He also has urged the agency to make administrative reforms
aimed at transparency and respect for the scientific process.

Sen. Grassley’s comment on the survey of the Union of Concerned Scientists:

“The leaders of the FDA would be well-served to listen to what FDA scientists are saying
in this survey. It echoes the sentiments and allegations that some stalwart scientists report to
Congress on a regular basis. However, concerns are even more often whispered in hallways and
behind closed doors. Whistleblowers, like Dr. David Graham, who will stand firm and not bow
down in the face of tremendous pressure and even retaliation, are few and far between.

“The Union of Concerned Scientists’ survey is important because it gives a public voice
to scientists who aren’t in a position to place their jobs on the line, to suffer retaliation for
speaking the truth, and to potentially jeopardize their families. The responses of these scientists
reinforce the findings of the independent Government Accountability Office, which said the
process for reviewing drugs on the market is deeply flawed. The FDA needs a major overhaul
and a culture change at the highest levels in order to continue meeting its mission. In particular,
the FDA needs to re-establish its relationship with its own scientists and distance itself from the
drug industry. The FDA needs to get rid of its mindset that it’s a facilitator for the drug industry
and become regulator once again. The FDA’s focus should be only on science and the public
good.”