Strides in Scientific Integrity at FDA Hindered by Special Interests

Strides in Scientific Integrity at FDA Hindered by Special Interests

Staff Survey Shows Political, Corporate Interference Still Prevalent

March 7, 2012

Although scientists at the Food and Drug Administration (FDA) feel their leaders are working hard to boost scientific integrity at the agency, persistent interference by special interests continues to hinder their work, according to survey results released by the Union of Concerned Scientists (UCS) today.

"Despite the Obama administration's improvements in scientific integrity, political and corporate influence over the FDA's scientific work persist," said Francesca Grifo, director of the Union of Concerned Scientists' Scientific Integrity Program. "When inappropriate influence clouds scientific judgment at the FDA, public health and safety suffer."

A total of 997 FDA scientists responded to the survey, conducted last summer. Of those surveyed, hundreds of scientists reported that political and corporate interests frequently and excessively influence science-based regulatory decisions. For example, 265 scientists (30 percent of respondents) felt that political interests had "a lot of weight in the FDA's final decisions" and 485 scientists (55 percent) thought such influence was "too high."

"It used to be that administrations would come and go and we could go about the business of protecting the public using scientific and legal principles," wrote one scientist, a 40-year veteran of agency. "Now the lawyers and politicians seem to run the show and think they know better."

The results also showed:

    --338 different scientists reported personally experiencing interference in their work at least once in the previous year.
    --253 scientists reported "frequent" or "occasional" experience with members of Congress forcing the withdrawal or significant modification of an FDA policy or action designed to protect consumers or public health.
    --A similar number -- 238 scientists -- reported the same kind of interference from corporate interests.
    --244 respondents feeling they could not "openly express any concerns about the mission-driven work of [their] agency without fear of retaliation" – just a 10 percent decrease over 2006.

The 2011 survey, which asked many of the same questions as a 2006 UCS survey of the agency's scientific workforce did find significant improvement in terms of agency leadership.

The survey found:

    --652 respondents—more than double the number in 2006—agreed that "the agency is moving in the right direction."
    --582 scientists in 2011 agreeing that their "direct supervisor stands behind scientists who put forth positions that may be controversial" -- a 21 percent increase over the 2006 survey.
    --743 respondents agreed that "the FDA is acting effectively to protect public health" – a 25 percent increase

These improvements may be due to increased agency independence. In 2007, in light of numerous product recalls and congressional scrutiny of FDA scientists whose work was suppressed and censored, Congress approved the Food and Drug Administration Amendments Act. That law required that the FDA be more transparent in its drug approval process, and directed the agency to reduce the number of experts on its advisory panels who have financial stakes in panel recommendations.

The survey comes in the wake of the unprecedented emergency contraception decision, in which the Secretary of Health and Human Services (HHS) overruled the FDA commissioner and ordered her to refuse over-the-counter access to the contraceptive drug known as Plan B. Both the FDA and HHS have since released scientific integrity policies, but failed to open the policies to a public comment period, missing the opportunity to significantly improve them.

This year, Congress is again considering major FDA legislation, part of its must-pass reauthorization of the Prescription Drug User Fee Act and the Medical Device User Fee Act. The fragile progress that the FDA has made, as evidenced by this survey, would be harmed by legislative proposals now pending before lawmakers, which would relax conflict of interest standards and make science at the agency significantly more vulnerable to special-interest pressures. One legislative proposal would actually change the FDA's mission to include job creation, diluting its core obligation to protect American families from unsafe drugs, food, and medical devices.

"While the FDA is taking steps to protect science within its walls, Congress is attempting to tear those walls down," said Grifo. "From drugs to medical devices to food to vaccines, Americans rely on the FDA to use science to protect them. Congress and private industry shouldn't get in the way."

This is one in a series of surveys of government scientists designed to measure influence on and interference in their work. For more information, go to www.ucsusa.org/surveys.

The Union of Concerned Scientists is the leading U.S. science-based nonprofit organization working for a healthy environment and a safer world. Founded in 1969, UCS is headquartered in Cambridge, Massachusetts, and also has offices in Berkeley, Chicago and Washington, D.C.

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