THURSDAY, May 30, 2002 (HealthDayNews) -- Citing the threat of future terrorist attacks, federal regulators are giving drug makers the right to develop and promote products that, for ethical or practical reasons, can be tested on animals but not on people.
The U.S. Food and Drug Administration first proposed the so-called "Animal Efficacy Rule" in 1999 during the Clinton administration as a way to speed the arrival of drugs that might help treat victims of biological, chemical, radiation or nuclear terror attacks. Its intent was to provide a route for new drugs to treat diseases so harmful -- such as anthrax or smallpox -- that human tests aren't possible.
"The terrorist attacks of last fall underscored the acute need for this new regulation," FDA Deputy Commissioner Dr. Lester M. Crawford said today in a statement.
"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," he added.
For most drug products, pharmaceutical firms must conduct several stages of studies in people before they can expect FDA approval. Yet sometimes -- in the case of anthrax, for example -- finding groups of patients or volunteers willing to risk infection or illness isn't feasible. The drug Cipro was approved to treat anthrax on the strength of animal experiments alone, because the disease is so rare and so deadly.
The new rule allows companies to gain approval for and market drugs based on how well they work in animals. But the manufacturers must still demonstrate that the products are safe in people and don't cause severe immune or other reactions. Regulators acknowledge that it will be difficult to assess whether a drug reacts badly with a toxin or agent in people if they only have animal tests with which to work.
The final rule, which will appear in the Federal Register tomorrow and take effect June 30, has few changes from earlier proposals. Perhaps most important, it allows companies to use data from a single animal species, provided that species is a good model for humans.
When the original rule was first offered, the agency fielded concerns about the marketing of drugs not tested in people. It even considered banning such ads.
But Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, told HealthDay today that regulators ultimately decided that such a ban would be unnecessary, potentially harmful to consumers and probably unconstitutional.
Woodcock said firms would be able to advertise their products approved under the animal-only rule. But they would have to disclose on the warning labels the absence of human studies for the products. She could not say, however, if the companies would have to make that disclosure in their advertising and marketing materials.
Stephan Lawton, vice president and general counsel for the Biotechnology Industry Organization, said his group supported the animal-only rule.
"We think it's an absolutely appropriate tool for FDA to use in the limited circumstances to which it would apply," Lawton said. "It's quite possible that down the road several of our companies would, in fact, be able to use it. We hope that things would progress to that level in a hurry."
Jeff Trewhitt, a spokesman for Pharmaceutical Research and Manufacturers of America (PhRMA), called the new rule "an important contribution" that would offer companies "a clear and orderly way for products to be evaluated that can only be tested in animals."
Trewhitt said "a number" of PhRMA's members have expressed interest in developing treatments under the regulation, and several already have such
products under way.
Also today, a Pentagon official said the military would share much of its stockpile of anthrax vaccine with the public in the event of a bioterror attack.
The official, David Chu, the undersecretary of defense for personnel and readiness, told the Associated Press that "the events of last fall were really a wake-up call for the country about the possibility of biological agents being used as a weapon of mass destruction, and therefore this is no longer just a military personnel problem. This is also a national problem."
The anthrax vaccine, made by BioPort of Lansing, Mich., is a good example of a product that would fall under the animal-only rule. The effectiveness of the shot has not been tested in people, but the military says it's convinced the vaccine is both potent and safe.
What To Do
For more on the animal-only rule, see this Food and Drug Administration statement. To learn more about the biotechnology industry, visit BIO.org.
