Bureau of National Affairs Army Researchers' Plan Seeks Exemption From FDA Experimental Product Safety Rules
By M. Alexander Otto
Under a plan proposed by U.S. Army human research regulators, the Department of Defense could ignore key Food and Drug Administration safety standards when administering experimental products to soldiers, according to an October memorandum recently obtained by BNA from the U.S. Army Medical Research Institute of Infectious Diseases Office of Human Use and Ethics. Under current FDA rules, experimental drugs and devices can only be used in well-controlled clinical trials that test safety and efficacy.
That means the principal investigator must supervise the administration of the product and serious side effects must be reported to FDA within seven days, neither of which are practical in combat situations, according to the memorandum, dated Oct. 11, 2002. Investigational products also must carry labels that state "Caution: New Drug-Limited by Federal (or United States) Law to Investigational Use."
"This label can lead the war fighter to question the safety and/or effectiveness of the product and may threaten operational objectives," according to the memo.
New FDA Category. The plan would exempt the military from the clinical trial requirement. Instead, a joint military and FDA panel would review the safety and efficacy of the agent, determine whether a clinical trial is feasible, identify ethical obligations, and approve the product under a new FDA category: "licensed for contingency."
The category would be reserved for "products unlikely to receive FDA approval under current rules but that have sufficient human safety and animal efficacy experience to permit military . use." The memo noted, however, that the military often fields products that have not been tested in humans "because of the great danger to individuals of conducting human clinical efficacy trials." "DoD should continue to conduct trials when ethically appropriate and when time and resources permit compliance with the [Federal] Food, Drug and Cosmetic Act," the five-page memo stated.
Some of the content for this position paper was added to the DOD Medical Department legislative agenda, Dr. Arthur O. Anderson told BNA. Anderson is chief of the USARMIID Office of Human Use and Ethics and Department of Clinical Pathology. He co-authored the memo with Chris Beardmore, an administrator in the Office of Human Use and Ethics.
Advocate Skeptical. The move would resolve ongoing conflict with FDA about the use of experimental products. Following the Gulf War and action in Bosnia, DOD was criticized for failing: to report adverse events, to properly label and track investigational products, and to ask soldiers' permission before administering experimental agents.
Dr. Meryl Nass, an advocate for soldiers injured by anthrax vaccine, botulinum toxin, nerve gas antidote, and other experimental products, takes a dim view of the initiative. "It is part of an ongoing DOD campaign to free the military from basic human subject protections," she said. Soldiers are subject to military discipline if they refuse an experimental product. Those injured have no recourse; soldiers cannot sue DOD for injuries received while in the service, Nass noted.
Under a plan proposed by U.S. Army human research regulators, the Department of Defense could ignore key Food and Drug Administration safety standards when administering experimental products to soldiers, according to an October memorandum recently obtained by BNA from the U.S. Army Medical Research Institute of Infectious Diseases Office of Human Use and Ethics. Under current FDA rules, experimental drugs and devices can only be used in well-controlled clinical trials that test safety and efficacy.
That means the principal investigator must supervise the administration of the product and serious side effects must be reported to FDA within seven days, neither of which are practical in combat situations, according to the memorandum, dated Oct. 11, 2002. Investigational products also must carry labels that state "Caution: New Drug-Limited by Federal (or United States) Law to Investigational Use."
"This label can lead the war fighter to question the safety and/or effectiveness of the product and may threaten operational objectives," according to the memo.
New FDA Category. The plan would exempt the military from the clinical trial requirement. Instead, a joint military and FDA panel would review the safety and efficacy of the agent, determine whether a clinical trial is feasible, identify ethical obligations, and approve the product under a new FDA category: "licensed for contingency."
The category would be reserved for "products unlikely to receive FDA approval under current rules but that have sufficient human safety and animal efficacy experience to permit military . use." The memo noted, however, that the military often fields products that have not been tested in humans "because of the great danger to individuals of conducting human clinical efficacy trials." "DoD should continue to conduct trials when ethically appropriate and when time and resources permit compliance with the [Federal] Food, Drug and Cosmetic Act," the five-page memo stated.
Some of the content for this position paper was added to the DOD Medical Department legislative agenda, Dr. Arthur O. Anderson told BNA. Anderson is chief of the USARMIID Office of Human Use and Ethics and Department of Clinical Pathology. He co-authored the memo with Chris Beardmore, an administrator in the Office of Human Use and Ethics.
Advocate Skeptical. The move would resolve ongoing conflict with FDA about the use of experimental products. Following the Gulf War and action in Bosnia, DOD was criticized for failing: to report adverse events, to properly label and track investigational products, and to ask soldiers' permission before administering experimental agents.
Dr. Meryl Nass, an advocate for soldiers injured by anthrax vaccine, botulinum toxin, nerve gas antidote, and other experimental products, takes a dim view of the initiative. "It is part of an ongoing DOD campaign to free the military from basic human subject protections," she said. Soldiers are subject to military discipline if they refuse an experimental product. Those injured have no recourse; soldiers cannot sue DOD for injuries received while in the service, Nass noted.
