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U.S. Response: Official Urges Funding for Project Bioshield By David Ruppe A House bill proposed by the White House, the Project Bioshield Act, would authorize $5.6 billion in funds to be spent over 10 years to induce the U.S. pharmaceutical industry to increase investment in vaccines and treatments for biological weapons diseases through multiyear authorization of funding and liability-limiting provisions (see GSN, April 7). “The intent of asking for mandatory funding is to provide assurance to big industry that large dollar amounts would be there,” according to Philip Russell, senior adviser for vaccine development and production in the Health and Human Services Department’s Office of Public Health and Preparedness. In using the term “mandatory,” Russell was referring to bill language designating the $5.6 billion as a “special reserve fund,” from which the homeland security secretary could draw through 2013 to procure vaccines and other medical products after declaring a state of emergency. He told a conference here today that the purchase of vaccines and drugs would require “very large numbers” of dollars, so “we opted for mandatory funding because we thought it was the best way to assure industry that we were truly serious and that the money would be there.” The bill, notably, would permit the homeland security secretary to declare a national emergency and authorize release of a drug or device not approved by the Food and Drug Administration for use in an emergency, would provide government compensation for injuries resulting from smallpox vaccinations, and would guarantee procurement of certain vaccines. The House Government Reform Committee approved a version of the legislation last month and the bill will now be considered by the Homeland Security Committee. A Senate version awaits floor action. The legislation has been criticized by some lawmakers who have questioned the need and the wisdom of atypical multiyear funding authority, and whether the bill’s focus on developing vaccines and drugs for anthrax, smallpox and botulinum toxin might drive potential terrorists to focus on agents that cause other diseases. The Congressional Budget Office, furthermore, published a report in April concluding the bill’s cost could actually be $2.5 billion more than the $5.6 billion the Bush administration has estimated and the bill would authorize (see GSN, May 9). DynPort Vaccine Company, attending the conference, provided a chart showing that most progress has been made developing vaccines for smallpox and anthrax, which are considered by officials to be the potentially most dangerous bioterrorism diseases. Two anthrax vaccines are available in the U.S. stockpile and a smallpox vaccine and treatment for complications should be ready in three to four years, it indicated. The chart indicated the length of time it takes to develop, test and bring a vaccine into production. Vaccines for plague, tularemia, botulinum toxin, and multivalent Venezuelan equine encephalitis, and a next generation anthrax vaccine, are in the technology development stage, which could last four to eight years before moving into a system development and demonstration phase prior to production that could take three to four years, it said.
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