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U.S. Response: FDA Alters Rules to Speed Medical Treatments The U.S. Food and Drug Administration yesterday announced a new rule to help speed development of drugs designed for treating illnesses related to an attack with biological, chemical or radiological weapons (see GSN, April 17). In some circumstances, the rule would allow companies assessing the effectiveness of a drug to base evaluations solely on tests on animals, the Washington Post reported. Previously, applicants have been required to test new drugs in human trials before the FDA would allow them to be marketed. The new rule would only apply when human testing of the new drug would be considered unethical. Because it is considered unethical to expose test subjects to potentially lethal or disabling agents, it is nearly impossible to test a drug’s effectiveness against WMD agents in humans, according to the Post. The FDA’s use of the new rule would be limited, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. In a majority of applications, pharmaceutical companies would still have to demonstrate that their new drugs are safe for human use, Woodcock said. Such a determination can often be done without exposing test subjects to risks that could be considered unethical, she added. The FDA has had difficulties encouraging medical companies to move forward on treatments for WMD agents, Woodcock said. “When they couldn’t ethically do human trials, it has been very difficult to move forward,” she said. “This rule addresses that obstacle.” Pharmaceutical and biotechnology industry spokesmen welcomed the new FDA rule yesterday. “This is a very important and valuable development because it offers some consistent rules for how products will be evaluated,” said Michael Friedman of the Pharmaceutical Research and Manufacturers of America. “That’s been the big difficulty for years. You have diseases that are untestable in humans,” he said. “There are medicines out there that we have every expectation would be effective against anthrax ... but there’s been no consistent way to test them” (Marc Kaufman, Washington Post, May 31). Might Not Speed Development The new FDA rule, however, does not solve all the problems with testing new drugs designed to counter WMD agents, Friedman said. There are often long waits at the small number of laboratories that are allowed to test lethal agents on animals and there are some biological agents for which there are no animals that can be used for testing, he said. A shortage of research monkeys to be used in tests is another problem, said Charles Bailey, a former commander of the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md. U.S. officials are examining ways to address the monkey shortage, he said (see GSN, Jan. 24). The small likelihood of an attack using biological, chemical or radioactive agents could also lower the incentive for drug companies to develop treatments, according to the New York Times. “This is a niche market,” said Frank Young, director of the pharmaceutical company EluSys Therapeutics. Pentagon Benefits Most The U.S. Defense Department, more than any pharmaceutical or biotechnology company, could be the biggest beneficiary from the new FDA rule, the Times reported. The Pentagon has already expressed interest in obtaining FDA approval for a drug that has been shown to allow mice to survive lethal doses of radiation. The U.S. Army also has several vaccines designed to protect against biological agents that have never been given approval but instead are used as experimental drugs to protect military researchers who handle deadly pathogens, according to the Times. “Now both the civilian population and the military population will be able to get these products out in a straightforward fashion,” said Arthur Anderson, USAMRIID chief ethics officer (Pollack/Broad, New York Times, May 31).
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