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 OMB Rulemaking on 'Peer Review'

There is also concern about government-wide rule changes proposed by the White House or Congress that would alter the way the federal government gathers and reviews scientific and technical information. Such a rule change has recently been proposed by the White House’s Office of Management and Budget (OMB), and, if adopted, promises to have dramatic effects on the promulgation of new government regulations.

The new rule proposed by OMB would centralize control of review of scientific information relied upon in policymaking at federal agencies, even though OMB fails to identify any inherent flaws in the review processes now being used at these agencies.

The proposed rule would prohibit most scientists who receive funding from a government agency from serving as peer reviewers, but would permit scientists employed or funded by industry to serve as reviewers (unless they had a direct financial interest in the issue under review). These provisions would create a serious imbalance in the selection of peer reviewers, giving regulated industries much greater influence over the formulation of new regulations.

Both individual scientists and scientific associations have expressed concerns that this would lead to increased costs and delays in promulgating new health, safety, and environmental regulations. According to Dr. Anthony Robbins, professor of public health at Tufts University School of Medicine, co-editor of the Journal of Public Health Policy, and former director of the National Institute for Occupational Safety and Health, OMB’s proposed rule change “would radically restrict access to scientific advice at the government agencies on whom we rely to protect public health. The White House could restrict open discussion and tilt the balance of residual discussions towards commercial interests. In the hands of the Bush administration,” Robbins warns, “these could be the tools that could ultimately destroy integrity in science as we know it.”76

Dr. Bruce Alberts, president of the National Academy of Sciences, stated that “the highly prescriptive type of peer review that OMB is proposing differs from accepted practices of peer review in the scientific community, and if enacted in its present form is likely to be counterproductive.”77 Concerned about the impact on the FDA, the Pharmaceutical Research and Manufacturers of America told OMB that its proposed rule “would contribute little value and would add to the time and expense of a gatekeeper function that has historically been criticized for obstruction and delay”78

76 Author interview with Anthony Robbins, October 2003.

77 NAS comments

78 PhRMA comments online at

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