Swift Approval For Bio-Terror Antidotes

FDA To Allow Approval Of Some Drugs Without Human Testing

(AP)  The Food and Drug Administration is set to allow approval of some drugs based on animal studies in cases where it wouldn't be possible or ethical to test them in humans.

The rules finalized Thursday will help in the development of bio-terrorism antidotes to treat or prevent the potentially lethal or disabling toxicity of chemical, biological or nuclear substances. Traditional human testing of the drugs would be impossible.

"This isn't some kind of pass we're giving to these drugs," cautioned FDA drug chief Dr. Janet Woodcock, who said manufacturers will have to do several rigorous studies in animals and provide other supporting data.

"We have been struggling" with how to evaluate such drugs as nerve-gas antidotes under traditional FDA rules, she said.

Two years ago, the FDA based its approval of Cipro to treat anthrax largely on animal data - a military study that found the antibiotic saved the lives of monkeys who inhaled the deadly spores. But the FDA was able to use some human data in making that decision: It knew Cipro was safe because people used it to treat other infections, and it could extrapolate the dose needed to fight anthrax in humans from the level needed in monkeys.

In 1999, when the FDA first proposed the new regulation, its scientists already were warning that they eventually would have to consider antidotes for nerve gas, smallpox or other agents for which there might be far less, if any, human data.

After the Sept. 11 terrorist attacks, the FDA finished revising the proposed regulation, which will take effect June 30.

The rule should be used very rarely, cautioned Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, an FDA watchdog.