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Critics Question Proposed Countermeasures Agency

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Science  04 Nov 2005:
Vol. 310, Issue 5749, pp. 755
DOI: 10.1126/science.310.5749.755

Spurred by worries about avian influenza, a Senate panel has come up with an idea to speed the development of new drugs and vaccines against urgent public health threats such as pandemic flu and bioterror weapons. But its solution—a new research agency within the Department of Health and Human Services (HHS)—has put scientific groups on alert. They worry that its work would be secret and could duplicate existing efforts at HHS. “The creation of a new agency raises many issues,” says Janet Shoemaker, public affairs director of the American Society for Microbiology in Washington, D.C.

The proposal is part of S. 1873, a bill passed on 18 October by the Senate Committee on Health, Education, Labor, and Pensions. Sponsored by Senator Richard Burr (R-NC), the legislation is in part meant to address gaps in the BioShield law passed in 2004 that provides $5.6 billion to drug companies over 10 years for procurement of biodefense drugs and vaccines. Few companies have applied for BioShield funding partly because of concerns about liability. S. 1873, which some are calling BioShield II, would protect companies from lawsuits and also offers sweeteners such as exclusive markets for countermeasures.

Perhaps the most controversial part of the legislation is its creation of the Biomedical Advanced Research and Development Agency (BARDA). Burr says the agency is modeled on the Defense Advanced Research Projects Agency, which acts quickly to fund high-risk, high-payoff research that might not pass peer review at other agencies. BARDA's focus, however, would mainly be on providing funding and coordination to reduce the time between basic research and final product.

BARDA would fund research and development on countermeasures for bioterror agents, chemical and nuclear agents, and infectious diseases that could cause natural outbreaks. In addition, it would coordinate research on biodefense and infectious disease countermeasures across the federal government—a role that no agency now f ills. Although Burr's staff says BARDA's budget is still being worked out, the bill stipulates it would start out with $1 billion in 2006 from unspent BioShield 2004 funds. The legislation also calls for the National Institutes of Health to fund animal models for countermeasures research and for NIH to absorb some parts of the Armed Forces Institute of Pathology, which is to be disbanded as part of the latest defense base closings (Science, 2 September, p. 1472).

Top-down approach.

A proposed federal agency would fund research on drugs and vaccines against natural disease outbreaks and potential bioterror weapons such as anthrax.

CREDIT: JOHN SOMMERS/REUTERS

Scientific groups are worried about where BARDA's funding would come from at a time when research budgets are already being squeezed. The Federation of American Societies for Experimental Biology wrote Burr that it is “troubled” that the bill doesn't clarify how BARDA would differ from biodefense and infectious disease programs at NIH's National Institute of Allergy and Infectious Diseases (NIAID) and at the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia. It's not clear whether the bill “will help” develop drugs and vaccines or “just adds a layer of complexity,” adds Shoemaker. Observers also note that the bill does not spell out how research proposals would be reviewed or what the necessary expertise for BARDA's presidentially appointed director would be.

Another concern, say scientific and other groups, is that BARDA and a new oversight board would be exempt from the Freedom of Information Act and open-meetings laws. “Transparency is both appropriate and necessary,” particularly for developing infectious-disease countermeasures, writes the Center for Arms Control and Non-Proliferation in a letter recommending that information be withheld only in cases of a threat to national security.

Burr's press secretary Doug Heye says BARDA would have “a much different role” from that of NIAID which focuses on basic research and that its reports would be public except in certain situations. Security expert Gerald Epstein of the Center for Strategic and International Studies, who testified at two hearings earlier this year on the bill, says scientists'” almost allergic reaction” to secrecy doesn't make sense in a world in which “there are folks looking at this stuff to kill us rather than help us.” BARDA's overseers “can't guarantee that they'll never have to” withhold information about, say, devices to detect bioterror agents, he suggests.

An NIAID spokesperson said the institute could not comment on pending legislation. Burr, who was still revising the bill, hoped it would reach the Senate floor for a vote as early as next week. It's not clear how soon the House will take up the measure. It's also possible that the bill will be merged with measures focused on pandemic influenza, such as a provision passed last week by the Senate that would give CDC nearly $8 billion in 2006 for pandemic preparedness and President George W. Bush's new pandemic flu plan (see ScienceScope, p. 759).

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