Anti-Terror Drugs Get Test Shortcut

By Andrew Pollack and William J. Broad-
New York Times

May 31, 2002

Departing from longstanding practice, the Food and Drug Administration will allow some drugs and vaccines designed to counter biological, chemical and nuclear terrorism to be approved without being tested in people to prove they work.

In an announcement yesterday, the agency said the new rule could spur development of drugs for use against biological, chemical and radioactive substances by eliminating a major stumbling block, the ethical barriers to exposing people to deadly substances like smallpox or nerve gas simply to prove that a drug works.

"We've been stymied for some products figuring out a way to show human efficacy, given the ethical issues," said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the F.D.A. "One of the reasons there wasn't commercial interest was that people were not at all certain their drugs could be approved if they developed them."

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