nature biotechnology • VOLUME 20 • JUNE 2002 • http://biotech.nature.com

BUSINESS AND REGULATORY NEWS

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Despite considerable conviction, wideningopportunities, and earnest willingness

among biotechnology companies to joinforces with the rapidly expanding, federallydirected bioterrorism countermeasuresbuildup, a good deal of frustration continuesto beset participants on both sides of this con-certed effort. Although several members ofCongress are proposing measures to overcomemany of the assorted stumbling blocks, nei-ther legislative nor administrative strategiesfor expediting matters appear particularly wellsuited to solving problems quickly.

In March, Senators Ron Wyden (D-OR) andGeorge Allen (R-VA) introduced the “Scienceand Technology Emergency Mobilization Act,”S. 2037, which would authorize the creation ofa central clearinghouse for technology aimedat countering terrorism, including bioterror-ism. If enacted, it would provide a single feder-al entity where companies and agencies withinthe US Department of Defense (DoD;Arlington, VA), the US Department of Healthand Human Services (DHHS; Washington,DC), and other federal departments couldexchange know-how, information aboutpromising technologies or near-term prod-ucts, and ideas for meeting anticipated needs.The legislative proposal also seeks to establish a“test bed” for initial evaluation of ideas andtechnologies from the private sector.

“It’s bizarre to have [biotechnology compa-nies] traipsing all over the government to findout where they have to go,” Sen. Wyden saidduring a one-day conference, “BIO-Defenseand Homeland Security,” convened by theBiotechnology Industry Organization (BIO;Washington, DC) on April 30 and held a shortdistance from the Pentagon. “The govern-ment has got to be a better partner with you.Too often, biotech companies that want tosprint … have to run a marathon.”

Industry representatives generally agreethat a centralized federal technology clear-inghouse for recognizing and funding devel-opment of bioterrorism countermeasureswould be valuable. But they also see otherareas where similar centralizing effortswould be useful, if not essential.

For example, federal procurement prac-tices also should be centralized and mademore systematic and uniform, and the entireprocess (particularly at DoD) should be expe-dited, according to Leighton Read, generalpartner at Alloy Ventures (Palo Alto, CA),who also spoke during the BIO conference.Such changes are needed particularly “to help

small companies,” he says, noting that pro-longed contract negotiations and other moremysterious silent periods, during which pro-posals seem to disappear within the Pentagonor other federal bureaucracies, can prove dev-astating to research-based companies that areaccustomed to rapid-fire decision making.

Read also calls for the establishment of aNational Vaccine Authority, reinforcing rec-ommendations in a recent report from theInstitute of Medicine (Washington, DC).Although details for the design of such a bodyare vague, the idea is to centralize authorityover vaccine development and also to guaran-tee markets for certain vaccines, such as thosethat protect against anthrax, for which little orno independent demand exists outside of thatarising from the threat of bioterrorismattacks. Currently, federal vaccine develop-ment efforts are shared among several federalagencies within DHHS and in the DoD—whose efforts are particularly fragmented, hesays, citing a task-force report done for theDoD last year that reviewed its anti-bioterror-ism programs in place before September 11and the anthrax incidents that ensued.

Even before September 11, Pentagon offi-cials were seeking better ways to integrate biol-ogy into overall defense efforts and to forgestronger ties with the biotechnology industry,and those fledgling efforts have subsequentlyaccelerated, says BIO president Carl Feldbaum.BIO’s member survey from that period nettedmore than 400 positive responses from biotechcompanies regarding ongoing or forthcomingbiodefense capabilities, he notes.

“Prior to 9/11, only one or two dozen[biotech] companies dealt with DoD, a verysmall percentage,” Feldbaum says. “But after-ward, there was a surge of interest—perhaps atripling of companies getting involved—fol-lowed by a cooling off when companies real-

ized how difficult it is—some people com-plained bitterly of the lack of responsivenessfrom the Pentagon.” Some of the companiesare offering technology that goes beyond theexpected drugs and vaccines that aim rathernarrowly at countering bioterrorism attacks,he says. They are also working on, for instance,detection devices, new biopolymers, physiolo-gy- and performance-enhancing products,and schemes for producing energy.

But when it comes to biotech companiesand the Pentagon or other federal partnersactually working together, the would-bepartners more often than not face a clash ofcultures, according to Feldbaum and others.Biotech companies “are used to getting dealsdone,” he says. The companies are finding,however, that “defense contracting is a mys-tery and hindrance” and that “there is noclean way to plug all those ideas, projects, andproducts into the government, either at thePentagon or DHHS.”

Implementing Sen. Wyden’s proposals for acentral clearinghouse and other measures tocut through bureaucratic thickets would helpto bridge some of those cultural gaps,Feldbaum says. But other pending legislativeproposals also need to be implemented. Forexample, S. 1764, the “Robert Stevens,Thomas Morris Jr., Joseph Curseen, KathyNguyen, Ottilie Lundgren, and Lisa J. RainesBiological and Chemical Weapons ResearchAct,” which was introduced by Sen. JosephLieberman (D-CT) late last year, addressesseveral concerns facing biotech companiesthat seek to work with the Pentagon and otherfederal agencies on antibioterrorism projects.Specifically, it provides tax incentives, guaran-tees intellectual property rights, and protectsagainst certain product liability claims.

In addition to these legislative reforms, thesuccess of biotech-company collaborationswith DoD and other federal agencies willdepend greatly on new leadership at the Foodand Drug Administration (FDA; Rockville,MD), Feldbaum continues. Agency officialsare framing new rules for evaluating new vac-cines, such as those against smallpox, thatcannot ethically be tested for efficacy inhumans. Nonetheless, with such an array ofproducts to be evaluated, other organization-al reforms needed, and important legislativeissues pending, the president’s nominationfor FDA commissioner seems long overdue.“Recently we spoke with Vice President[Dick] Cheney’s people, telling them the dis-tance between the government and thebiotechnology industry is a chasm that we’vegot to bridge,” Feldbaum says, referring againto the gap in cultures that forestalls progressin meeting bioterrorism countermeasuresneeds. “It ain’t going to be easy, but it’s got tobe done.”

Jeffrey L. Fox, Washington, DC

US federal bureaucracy hampers progress in countering bioterrorism

Leighton Read says small companies wouldbenefit if federal procurement practices werecentralized and made more systematic anduniform, and if the entire process were expedited.

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