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Law Passes Retooling Effort on Bioterror

By Renae Merle, Washington Post Staff Writer

The House and Senate have passed legislation that will revamp the Bush administration's $5.6 billion effort to counter bioterrorism threats, reorganizing management of the program and providing struggling companies with periodic cash infusions to help fund their research and testing.

"It's a relief," Sen. Richard Burr (R-N.C.), one of the measure's principal backers, said yesterday. "We're a little further ahead of the fear of bioterrorism and pandemic because we've got a solid plan in place."

The House passed the legislation early Saturday morning and it passed the Senate last Tuesday. President Bush intends to sign the legislation, but a date has not been set, according to the White House.

More than a year in the making, the legislation was considered by many to be an effort to salvage the two-year-old Project BioShield, which has been marked by delays and operational problems. Sen. Harry M. Reid (D-Nev.), the incoming majority leader, listed it among his priorities for Congress's lame-duck session.

"I think it's already made a difference," Burr said of the legislation, which was also pushed by Sen. Edward M. Kennedy (D-Mass.). "We have more people, more companies, more academic institutions, that have looked at this legislation and planned how they can plug into it. It has brought more people to the table interested" in the program.

The legislation creates the Biomedical Advanced Research and Development Authority, within the Health and Human Services Department, to manage the effort. It also allocates $1 billion over three years for research not funded by a Project BioShield contract or the National Institutes of Health and attempts to pump more government money into the private sector sooner.

Under current law, participating companies are not paid until they deliver the drugs. The legislation would speed up the development cycle by allowing Health and Human Services to pay companies up to 5 percent of their contract's value when they reach certain milestones.

The legislation "complements important work that HHS has already begun to improve the BioShield program," Christina Pearson, an HHS spokeswoman, said in a statement.

"Passage [of] this bipartisan legislation supports much needed late-stage research-and-development funding. . . . It also supports our efforts to improve coordination of preparedness and response programs across the department."

The program's most significant investment, a nearly $1 billion effort by VaxGen to develop an anthrax vaccine, has been in limbo since the Food and Drug Administration held up human testing last month because of concerns about the drug's reliability. After threatening to end its contract, HHS gave the firm until Dec. 18 to resolve the concerns and begin human testing.

"It is regrettable that we have been unable to engage HHS in a productive discussion regarding how to ensure that this program moves forward," said Lance Ignon, VaxGen's vice president for corporate affairs. "We need to engage in a true partnership or we risk losing all the work on this vaccine and undermining our nation's biodefense programs."