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U.S. Response I: Biological Defenses Stall at Pentagon By David McGlinchey “That is not a happy story for me to have to tell to senior leadership,” said Anna Johnson-Winegar, deputy assistant to the U.S. defense secretary for chemical and biological defense, at a Dec. 16 meeting on the issue. New drug licensing rules, some bureaucratic restructuring and a new study underway all offer hope that problems will be solved, she said. Funding for Pentagon research on medical defenses such as vaccines increased more than 400 percent from 1996 to 2002, to more than $160 million, Johnson-Winegar said. The “complex and challenging” science needed to develop the medicines, however, hinders the quick results that Congress and defense officials want to see and congressional staffers have asked why the United States is funding the same efforts year after year, she added. A shortage of scientific researchers that have the expertise to develop vaccines and biological warfare treatments have also hampered efforts, according to Johnson-Winegar. Rules and Restructuring The future holds promise, however, especially in the form of new rules from the Food and Drug Administration, Johnson-Winegar said. In May, FDA officials announced a rule change that, in select cases, allows researchers to determine the effectiveness of a drug using only animal testing (see GSN, May 31). Previously, the agency required developers to test new drugs in human trials before licensing them, but it was often considered unethical to expose a person to a disease simply to test a vaccine. The new regulations “should help,” according to Johnson-Winegar. “We will rely heavily upon animal models” when developing vaccines, said William Raub, deputy assistant Health and Human Services secretary for planning and evaluation, during testimony to Congress in June. The rule change “creates a better defined path for the kind of evidence a sponsor would need with animal models in those instances where it’s unethical to expose humans to the actual disease,” he added. A proposal to realign the structure of the Pentagon’s chemical and biological management and acquisitions efforts presents another opportunity to make biological defense research more efficient, according to Johnson-Winegar. Pentagon officials plan to license a smallpox vaccine by 2006 and FDA licensing on military vaccines for botulinum toxin and tularemia is scheduled for 2012, she said. Study to Hasten Licensing Johnson-Winegar spoke Monday to a new committee that was established to hasten licensing processes for biological warfare medicines. The 2002 National Defense Authorization Act directs the Pentagon to aggressively accelerate biological research programs and to invest in new technologies against the most dangerous biological warfare agents, including anthrax. The Pentagon should take advantage of advancements and technology in the private sector, the legislation says. The legislation also calls on the Pentagon to establish a study through the U.S. Institute of Medicine and the National Research Council to investigate “review and approval processes for new medical countermeasures for biological warfare agents.” The 17 members of the Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents — including doctors, researchers, lawyers and consultants — gathered in Washington for the first time this week to begin that study. An interim committee report is planned for spring 2003, and a complete report, due in December 2003, is intended to suggest faster methods for biological research in the Defense Department, according to the legislation. The committee has also been asked to identify factors that are slowing the development of biological warfare drugs, the Institute of Medicine said in a statement describing the study’s scope. The study shows that the United States is turning its attention to the licensing process for biological defense drugs, and that effort now has the attention of “senior leadership in DOD [and the] interest and support of Congress,” Johnson-Winegar said.
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