Senate panel backs bill to create biodefense agency
By David Ruppe, Global Security Newswire
....."Critics say the new bill would do nothing to address the potential near-term threat of a deadly avian flu outbreak and that its provisions could drive up the cost of certain drugs and vaccines and greatly reduce the public's legal recourse for defective products.
"I hope ... that people don't think that this is going to solve the problem of the possible avian flu pandemic that is on our doorstep," Sen. Tom Harkin, D-Iowa, said...."
"....Burr's legislation would also provide incentives that proponents said are needed to encourage the biotech and pharmaceutical industries to invest more for drugs and vaccines for biological defense and naturally occurring disease protections."
"For instance, the bill would allow Health and Human Services to sign exclusive sales contracts with particular manufacturers for a particular product. It would forbid government purchases of generic versions of such new drugs or vaccines as well as public sales of the products for use as countermeasures."
"The bill would also provide companies with liability protections for new countermeasures not yet licensed by the Food and Drug Administration, so that a company producing products for epidemics or biodefense could only be sued if the Health and Human Services secretary finds clear and convincing evidence it willfully engaged in misconduct that caused the injury."
"The bill would provide rebates or grants to encourage companies to manufacture vaccines, medical countermeasures, and pandemic or epidemic products within the United States and would allow the government to help pay the costs of establishing domestic manufacturing facilities."
"Burr's proposal would provide a "limited antitrust exemption" for the Health and Human Services secretary and the BARDA director that would allow them to collaborate and consult with industry on developing new countermeasures."
"It also would exempt the new agency from standard Freedom of Information Act and Federal Advisory Committee Act requirements for public transparency and would exempt certain federal cost oversight requirements."
"Less controversially, the bill also would compensate first responders for countermeasures they purchase and would provide money to encourage development of animal models on which countermeasures could be tested against diseases too dangerous to test on humans."