Terror-Response Drugs Put on a Faster Track
WASHINGTON -- Responding to the threat of anthrax and other forms of chemical and biological terrorism, the Food and Drug Administration adopted rules Thursday that will speed the approval of drugs that could protect people from attacks.
The agency said that in some cases it would allow companies to base applications on animal testing alone when assessing whether a drug is effective. Previously, a drug’s effectiveness had to be tested on humans before the FDA would allow it onto the market.
“The terrorist attacks of last fall underscored the acute need for this new regulation,” said Lester Crawford, the FDA’s deputy commissioner. “Today’s action will help make certain essential new pharmaceutical products available much sooner--those products that because of the very nature of what they are designed to treat cannot be safely or ethically tested for effectiveness in humans.”
The new rule, which was proposed in 1999 and took on a new urgency last fall, was likened Thursday to the FDA’s landmark decision a decade ago to approve AIDS drugs that had not been fully tested by previous standards. At that time, the FDA concluded that its standard review process was impeding the manufacture of potentially lifesaving drugs for people with AIDS.
Some consumer advocates said Thursday that they are wary of the animal-testing rule, contending that its use could expand to other less pressing concerns--just as the FDA’s “fast track” approval process for AIDS drugs was later used for many other medications.
But Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said use of the new rule, which the agency considers “urgently needed,” would be very limited.
Woodcock said the FDA has “been struggling in a number of cases to persuade applicants to go forward” with drugs to treat biological, chemical and nuclear attacks. “When they couldn’t ethically do human trials, it has been very difficult to move forward,” she said. “This rule addresses that obstacle.”
She said that it would still take a year or more for companies to design, undertake and complete their animal studies and that she “would not expect a flood of products based on the rule.”
Woodcock called the new rule “narrowly drawn,” saying that it would usually require two or more animal tests, and that it could be invoked only when all FDA testing standards are inappropriate. The agency estimates that the new rule will be applied infrequently, probably less than once a year.
