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May 31, 2002

U.S. IMMUNIZATION NEWS

"Antiterror Drugs Get Test Shortcut"

New York Times (www.nytimes.com) (05/31/02) P. A1; Pollack, Andrew; Broad, William J.

In the United States, the Food and Drug Administration (FDA) has decides to allow some vaccines and drugs to be approved without being tested beforehand on people to make sure they work.  The vaccines and drugs in question are those designed to counter chemical, biological and nuclear terrorist attacks.  According to Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, many companies up until now have been reluctant to develop such drugs and vaccines because they were not certain they would be approved.  This is because the FDA normally requires three phases of clinical trials in human beings to ensure a drug is effective and safe.  However, drugs designed to counter chemical, biological, and nuclear attacks could not be properly tested, because it would have meant exposing people to deadly substances like nerve gas or smallpox, something that was ethically unacceptable.  Under the new rules, animals would be used to test the effectiveness of new drugs, providing there was no morally acceptable way to test them in human beings.  The drugs themselves would, however, be tested on human volunteers to check for side effects and safety, because this involves exposing human beings only to the drug, not to the disease or other deadly agents.  One of the biggest beneficiaries of the new ruling will be the U.S. Department of Defense, which has numerous vaccines for biological agents that it has never been able to obtain approval for in the past.

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