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Lawmakers Say FDA Better Clean Up Its Act

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For six years, the Bush administration has placed pharmaceutical industry interests ahead of public interest by appointing persons with strong ties to drug companies to high level positions at the FDA, and as a result, Congressional investigations and a recent survey indicate that the health and safety of all Americans is being compromised.

On July 20, 2006, the Union of Concerned Scientists published the results of a survey that showed an insidious political influence of science within the FDA. According to the UCS press release, the survey was co-sponsored by Public Employees for Environmental Responsibility (PEER), and was sent to 5,918 FDA scientists.

The survey found that 61% of the responding scientists knew of cases where the "Department of Health and Human Services or FDA political appointees have inappropriately injected themselves into FDA determinations or actions."

In responding to the survey, one scientist wrote: "Over the last several years I have noticed a significant increase in the number of decisions that have become politicized (e.g., increasing requests to review even simple regulations and changes, both by Congress and the Commissioner's office and to make apparently politically-motivated changes in language and sometimes to alter bottom line results), and I think the integrity of scientific work could be improved by minimising the 'politics' of the process."

Out of the nearly 1000 scientists who responded, close to one-fifth or 18.4%, said they had "been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document."

In addition, 40% of the scientists said they fear retaliation for voicing safety concerns in public and more than one-third said they did not feel they can express safety concerns even inside the agency.


The survey also found that only 47% think the "FDA routinely provides complete and accurate information to the public," and 81% agreed that the "public would be better served if the independence and authority of FDA post-market safety systems were strengthened."

In a complaint aimed at the FDA's Office of Regulatory Affairs, one scientist said it should "not ostracise scientists or black ball them because their foresight sees a problem with a drug, device, food, biologics, etc. that possess a potential hazard to health now or in the future."

In response to the concerns raised by FDA scientists, the UCS recommends:

Accountability: FDA leadership must face consequences if they side with commercial or political interests and not with the American people.

Transparency: Scientific research and reviews should be open so any undue manipulation is immediately apparent.

Protection: Safeguards must be put in place for all government scientists who speak out.

"These disturbing survey results make it clear that inappropriate interference is putting people in harm's way," said Dr Francesca Grifo, Senior Scientist and Director of UCS's Scientific Integrity Program, in the press release.

"All federal scientists," he said, "need protections so they can speak out when their science is manipulated, and all federal agencies need fully functioning independent advisory committees."

"FDA leaders," Dr Grifo noted, "should act now to improve transparency and accountability and renew respect for independent science at the agency."

"FDA leadership," he stated, "must understand and support independent science and it is up to Congress to hold them accountable."

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Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

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