NEW YORK (GenomeWeb News) – On Capitol Hill yesterday, biosecurity analyst Brad Smith told congressional staffers that the US does not have sufficient countermeasures to bioterrorism and the outbreak of a major pandemic, and that the federal government has inadequately funded programs aimed at helping companies develop biothreat responses.
The Bush Administration and Congress have insufficiently supported the Biomedical Advanced Research and Development Authority, Smith said, and are sending a signal to firms that make biothreat detection and deterrence technologies that the government may not be committed enough to biosecurity to help them get products through the regulatory process.
Congress authorized $1.07 billion to fund BARDA over the fiscal years 2006-2008, but so far has only appropriated $99 million of that. With the Department of Health and Human Services budget for 2008 stuck in gridlock because of a spending squabble between Congress and the White House, BARDA is not living up to its promise to extend a hand to diagnostics and drug companies, said Smith, who is a senior associate at the University of Pittsburgh Medical Center’s Center for Biosecurity.
In 2006, HHS said BARDA would be used to supplement Project Bioshield, which was appropriated over $5.6 billion to spend between 2004 and 2012. But according to Smith, Project Bioshield also has been unable to address specific concerns that the federal government might leave companies high and dry after they have made substantial investments in diagnostics or drugs.
The new authority was created by Congress as part of the Pandemic and All Hazards Preparedness Act, which was designed to lay the foundation for America’s ability to manage and react to biothreats singled out by the Department of Homeland Security.
Smith told GenomeWeb Daily News today that the money isn’t flowing, probably because this is “a difficult budget year.”
Even before the HHS budget, which the President vetoed recently and sent back to Congress to be trimmed, BARDA appeared to be a thinned version of what the PAHPA law called for, Smith said.
In the president’s proposed 2008 federal budget, the White House requested $189 million for BARDA. Congress then cut more of its funding before passing it back to the executive branch, Smith said, asking for $149 million for the authority.
If those numbers represent the budget that eventually passes, Smith contends, that will represent a “significant gap,” with the federal government’s contribution between 2006 and 2008 totaling around $250 million. Although the $1.07 billion number Congress authorized for BARDA is not an appropriation, the disparity of $820 million marks quite a different level of commitment from the government to companies working under Project Bioshield.
The difficulties of developing diagnostics and drugs for security are enormous, and the risk may be greater than it is for medical drug developers serving other functions, explained Bill Hall, a spokesman for HHS, in an interview with GenomeWeb Daily News earlier this year.
Hall described the case of the drug company Vaxgen, which spent $175 million out of its own pocket developing a drug for anthrax under Project Bioshield, only to have the deal die because the agreement called for the company to have a working product ready to roll out before it would get the contract money. When the drug failed, the HHS funding never materialized.
BARDA was designed to help companies cover R&D costs that arise between the period when National Institutes of Health funding ends and funds from Project BioShield or from commercialization begins — a three- to five-year period some call the “valley of death.”
BARDA, Hall said, would authorize more spending to help with such situations.
However, if the money is not appropriated, “What incentive do companies have to take the risk and venture across that valley alone?” asked Smith.