After a long delay, the US Senate last week (May 19) unanimously passed the "Project BioShield Act of 2004" (S 15), the White House's plan to accelerate development and production of new vaccines and countermeasures against bioweapons. The House, which had passed a similar bill last year, is expected to reconcile differences quickly and send the measure to President Bush for his signature.

BioShield will allow the government to spend $5.6 billion over 10 years to develop and purchase "huge amounts" of vaccines or drugs to treat smallpox, anthrax, botulinum toxin, Ebola, plague, and other pathogens. The measure will also give the National Institutes of Health (NIH) new authority to bypass traditional procedures when awarding grants and contracts for bioterrorism research and will allow the Food and Drug Administration (FDA) to sidestep usual approval processes to distribute experimental drugs in case of a bioterrorist attack or other emergency.

Despite bipartisan support in Congress, BioShield had generated controversy in the scientific community ever since President Bush proposed it in January 2003. Some senior scientists have contended that BioShield funds might be squandered or wasted since there is no straightforward way to create vaccines or antimicrobials. Others have noted that because bioweapons are likely to employ modified strains of biological agents, vaccines and treatments developed in advance would not be effective. Instead, they urge funding to increase the public health capacity to care for infected individuals.

After the House passed the bill last summer, BioShield was stalled in the Senate by a few lawmakers concerned about technical oversight and funding mechanisms. Several private companies developing countermeasures put their projects on hold. "This delay has had a sobering effect within the industry, causing doubt that any investments made to develop new countermeasures against potential bioterror agents will ever pay off," wrote Claire M. Fraser, president of the Institute for Genomic Research, last month in Science.

As a stopgap, Congress authorized $890 million in BioShield funds this fiscal year. But BioShield found renewed receptivity this month after sarin, a deadly nerve agent, was found in a roadside bomb in Iraq.

The pharmaceutical and biotech industries praised Senate passage of BioShield, but noted that measures to protect companies from liability were still needed. "The BioShield bill is an important step forward in protecting Americans from bioterrorism," said the Pharmaceutical Research and Manufacturers of America in a statement. "We have urged, and still hope for, the enactment of additional measures, such as meaningful product liability protection," he said.

Thomas A. Schatz, president of the nonprofit Citizens Against Government Waste, cautiously endorsed the BioShield legislation. "The question is whether any of these companies would do this work without this act. But under the circumstances, it seems to me that something like this makes sense," he told The Scientist last week. "We just have to track it carefully and make sure it's doing what it's supposed to do."