Science  07 Dec 2007:
Vol. 318, Issue 5856, pp. 1537

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  1. Scientific Deficiencies at FDA

    Twelve months after U.S. Food and Drug Administration Commissioner Andrew von Eschenbach asked for an assessment of FDA's science, the results are in: It's dismal. In a 300-page report by agency advisers and outsiders, 33 experts from industry, academia, and government conclude that FDA is suffering from “serious scientific deficiencies.” Those include an inability to adequately monitor the food supply and medical products.

    “It certainly sounds consistent” with previous analyses of FDA, says epidemiologist Bruce Psaty of the University of Washington, Seattle, who has criticized the agency's drug-safety record. But the new report released this week is striking for its breadth, says Psaty, covering the vast range of responsibilities at the agency. Among the recommendations: Beef up the agency's work force and form an “incubator” that, among other things, could help define personalized medicine. “This is the science that FDA really has to take the lead on,” says Eve Slater, a senior vice president at Pfizer, who helped create the report.

  2. Endangered Rulings Reversed

    Seven decisions on endangered species made on the watch of a controversial political appointee should be revised, the U.S. Fish and Wildlife Service (FWS) has decided. Julie MacDonald, former deputy assistant secretary for Fish and Wildlife and Parks, resigned in May after the Department of the Interior's (DOI's) inspector general found that she had inappropriately “reshaped” the science behind decisions related to the Endangered Species Act (Science, 6 April, p. 37). House Natural Resources Committee Chair Nick Rahall (D-WV) then asked DOI to review those actions.

    FWS has concluded that seven of eight decisions it recently reviewed should be revised, including the choice not to consider listing the white-tailed prairie dog as an endangered species and to withdraw the Preble's meadow jumping mouse from the list. FWS will also reexamine critical habitat designations for the Canada lynx, a toad, a frog, and 12 species of Hawaiian flies. In a statement, Rahall now says the turnaround leads him to “question the integrity of the entire program under [MacDonald's] watch.” Others have already come to that conclusion; last month, the Center for Biological Diversity, an advocacy group based in Tucson, Arizona, sued FWS over decisions involving 55 other species.

  3. Lab Project Launched

    A massive biomedical research facility in London received a green light this week when British Prime Minister Gordon Brown announced that one of his government's departments had agreed to sell a key 1-hectare plot to a coalition composed of the U.K. Medical Research Council (MRC), two medical charities—the Wellcome Trust and Cancer Research UK—and University College London. The coveted downtown site was “absolutely critical” for the planned UK Centre for Medical Research and Innovation, says Mark Walport, director of the Wellcome Trust, which will contribute about £100 million to the estimated £500 million project.

    Cancer Research UK would transfer its London Research Institute to the new center. And MRC would relocate the government's largest biomedical research outfit—the National Institute for Medical Research (NIMR)—to the site, which may end a long battle over its future (Science, 20 April, p. 353).

    Paul Nurse, president of Rockefeller University in New York City, will lead a committee charged with developing the scientific plans for the center. Local residents seeking affordable housing for the site may try to block the project, however, as may those who fear that the new labs, which will include NIMR's World Influenza Centre, could expose London to biosafety risks.

  4. Lab Review Panned

    The U.S. National Institutes of Health (NIH) did a shoddy job in reviewing the risks of a controversial high-security biosafety lab being built in Boston, according to a new report from a National Research Council (NRC) panel.

    The $178 million Boston University lab in the city's densely populated South End will include biosafety level 4 (BSL-4) facilities for studying the deadliest pathogens, such as Ebola virus. In response to a request from the state of Massachusetts, NRC reviewed an NIH draft study of alternative sites outside Boston and of worst-case scenarios if a pathogen escaped (Science, 11 August 2006, p. 747). The NRC panel labeled the study “not sound and credible,” faulting NIH's modeling and its failure to consider the escape of highly transmissible agents such as avian influenza and SARS. Construction on the lab will continue as NIH sifts through the NRC report and other comments. But the pending risk assessment could delay resolution of federal and state lawsuits opposing the operation of its BSL-4 suites.