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NIH Tests Faster Countermeasure-Development Grants By Joe Fiorill WASHINGTON — The U.S. National Institute of Allergy and Infectious Diseases wants to cut by more than half the time required between the identification of WMD countermeasure concepts and the awarding of grants to develop the drugs, director Anthony Fauci said today in an interview. Getting the funds out faster would involve reducing the time needed for lengthy, multiphase drug-concept reviews that now precede issuances of drug-development grants by the institute, which is part of the National Institutes of Health. Authorization of the faster reviews is one of three main effects of Project Bioshield, which President George W. Bush signed into law on July 21 (see GSN, July 21). Fauci said reviews could be cut to six months from the current 12 to 14 months, with the expedited process reserved for projects “that you need to move quickly enough, because there is a threat in which the time element plays an important role.” The benefits, Fauci said, are considerable, if difficult to quantify. “I can tell you it’s going to be faster, and that’s the critical thing,” he said. Just two days after Bush signed Bioshield, the institute announced two new grant initiatives it called “consistent with this new authority.” The institute said it was planning in fiscal 2005 to commit $10 million to accelerated development of therapeutic treatments for the most dangerous agents — smallpox, anthrax and others listed in Category A of the Centers for Disease Control and Prevention’s agent-classification system — and $4 million to development of immune-system protections against radiation. The projects would have taken place without Bioshield, said Fauci, but now are serving as test cases in the institute’s bid to achieve six-month turnaround times. The two initiatives chosen roughly illustrate the institute’s priorities for countermeasures, the director said. “They are priorities,” Fauci said, “but I wouldn’t say that absolutely these are the top two things.” Reviews can be accelerated at several points in the process, and the institute is endeavoring to gain time everywhere it can. An optional but customary “concept clearance” by an advisory council, for example, can be reduced from months to days by soliciting council members’ input by e-mail, rather than in person at a meeting. “You don’t want to cut corners on substantive issues, but you can get clearance by the advisory council by e-mail vote, and you don’t have to wait,” Fauci said. Other plans call for giving researchers less time to respond to grant announcements, convening special review groups as needed rather than waiting for scheduled meetings and paying out grants without waiting for final NIAID approval, which can instead be bestowed retroactively. “This just codifies in law what you can do under certain emergency circumstances anyway,” Fauci said. A representative of VaxGen, a drug maker that is in the running for a much-anticipated anthrax-vaccine contract under a separate provision of Bioshield, applauded the move to speed reviews. “Acceleration in the review process,” spokeswoman Kesinee Yip said today, “would certainly help industry to be able to be responsive to government and to government requests for countermeasures that are important for the national security.” Speeding drug development is an overriding theme of Bioshield, with some saying the law does not go far enough. Some Democrats in Congress have said the legislation does too little to shorten “bug-to-drug” time, the time required between identification of a new pathogen and availability of a corresponding drug (see GSN, May 5). Besides speeding the review process for new countermeasures, Bioshield creates a guaranteed government market for otherwise unprofitable existing countermeasures and allows for bypassing Food and Drug Administration drug-approval processes during any attack or other event declared to be an emergency by the Homeland Security, Health and Human Services or Defense department. Bioshield taps the National Institutes of Health to participate in deciding what countermeasures the government should buy and in determining when the approval-bypass authority should be invoked. “They want to make sure that there is a non-FDA scientific input into these decisions, just to help them out,” Fauci said of the latter role. Fauci called the new law generally “very important” for U.S. WMD defenses because it codifies the faster review methods and provides incentives for drug makers. “We have been trying to get industry interested in doing something that they may not have a great incentive to do,” he said.
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