A key Senate committee Tuesday approved legislation that would create a new agency to direct government biological defense research and provide several new types of incentives that proponents say would encourage more private sector investment into countermeasure production.The Health, Education, Labor and Pensions Committee approved by voice vote the Biodefense and Pandemic Vaccine and Drug Development Act of 2005 despite Democratic objections. A Senate floor vote could come next week. There is no such legislation in the House."We must ensure the federal government acts as a partner with the private sector, providing the incentives and protections necessary to bring more and better drugs and vaccines to market faster," the legislation's author, Senator Richard Burr, R-N.C., said in a statement after the vote.Enacting the bill would mean "that we as a nation are prepared for a variety of threats that include natural, deliberate and accidental threats," said committee Chairman Mike Enzi, R-Wyo.The bill is intended to add incentives beyond those approved in the "Project Bioshield" law passed last year, which was designed to encourage the private sector to invest in drug and vaccine production where the U.S. government would probably be the only buyer. Burr and others have said the law did not go far enough to encourage private sector investment.Burr, who chairs the committee's Bioterrorism and Public Health Preparedness Subcommittee, said potential liability exposure and other factors have left companies reluctant to invest in new biodefense and flu countermeasures.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.New Agency, Industry IncentivesThe bill specifically would create a "Biomedical Advanced Research and Development Agency" within the Health and Human Services Department. The new agency would act "as the single point of authority" within the federal government for research and development of medical countermeasures against bioterrorism and natural disease outbreaks. 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.Doesn't Address Flu Threat, Democrats SayCommittee Democrats said they support the general aims of the bill and many of its provisions, including creating the new agency. Democrats said, though, that the bill - targeted at longer-term research and development - does little to improve the country's near-term preparedness for responding to an avian flu outbreak. That would include funding the stockpile of antibiotic drugs and improving the public health infrastructure and surge capacity."Congress may wait for regular ordeals to deal with the pandemic flu, but the flu virus will not wait while we delay," said Sen. Edward Kennedy, D-Mass."We need the capacity to develop the vaccines now. We need to appropriate money now," Harkin said. "We need emergency funding right now, probably to the tune of several billion dollars to begin to get grants out there right now … to build the vaccine manufacturing facilities for flu vaccines. … We need to get these facilities built in the next six or seven months."Burr said including such provisions in the bill would have greatly delayed the measure. He said there is "ample time" to prepare such legislation and that the committee would soon begin work on it for passage next year.Other ObjectionsDemocrats said they also objected to how the liability provisions were written. Company liability protections should only apply when a product is used in an emergency, and not for other situations, Harkin said.Kennedy said the liability protections should be accompanied by a "strong [federal] compensation program" in the bill, because "the rules should not be stacked against patients."Sen. Hillary Clinton, D-N.Y., criticized the market exclusivity provision for preventing public sale of generic versions of new drugs and vaccines for use as countermeasures against dangerous diseases.Clinton praised the proposed agency creation as "a good idea," but asked how it, as a coordinating agency, would "have more direct control than all the other coordinating positions have had."Chairman Enzi said the committee would try to address Democrats' concerns by possibly amending the bill, but said mutually agreed upon changes would be made by Thursday at the latest.There remain "fundamental differences" between Republicans and Democrats "that we have to work out," Burr said.Democrats said they might seek to amend the bill on the Senate floor.Some nongovernmental organizations have taken a harsher view of the bill's implications than the committee Democrats.It "basically eradicates regulatory safeguards against the production of unsafe vaccines, drugs and devices that the government determines to be for pandemic, epidemic or bioterrorism/security countermeasure use, and then wipes out liability for any drug company or health care provider that makes or dispenses them," the Center for Justice and Democracy in New York said in a recent press release.As a result of the liability provision, the advocacy group said, families or victims of defective countermeasures could "have no recourse, no ability to file a claim or lawsuit, no way to collect any compensation even if the drug company or health care provider was negligent, reckless or in some cases intentionally harmful."
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