FDA waives informed consent

New rule permits experimental in vitro diagnostic testing in emergencies

By | June 15, 2006

The Food and Drug Administration (FDA) last week authorized US laboratories and clinics to perform investigational in vitro diagnostic testing without patients' informed consent in case of a declared or suspected public health emergency, such as a bioterrorist attack or avian flu pandemic. But some health policy experts say the provision could endanger patient privacy and is subject to abuse by devious medical device companies. The FDA's interim final rule, published in the June 7 Federal Register, allows health care and laboratory workers to use investigational in vitro diagnostic devices (IVDs) to identify chemical, biological, radiological, and nuclear agents without informed patient consent in case of a potential terrorism or other public health emergency. "I hope this rule is hypothetical, theoretical, and never used," said Steve Gutman, director of the FDA's Office of In Vitro Diagnostics. "But in some cases, it might be life saving," he told The Scientist. In a suspected emergency, the FDA worries that hospitals and clinics would not have time to track down earlier patients to get permission to run diagnostics on stored blood and tissue samples. "The consequences of delay could be catastrophic for subjects and for public health in general," the rule states. Lab and public health workers could run IVD tests without consent as long as they received advance approval from a physician not participating in the clinical investigation and from an institutional review board (IRB). These approvals could be granted retroactively within five days if the investigator believes he or she lacks sufficient lead time. Disclosure that tests had been run and results would be sent to the patients' health care providers for follow-up treatment, if warranted. Because determination of an actual or potential health emergency rests with the laboratory or clinic, "the FDA action is potentially amenable to abuse," said Robert Sprinkle, associate professor of public policy at the University of Maryland-College Park. Private companies developing screening tests "might be tempted to cut corners" in clinical or preclinical testing, he told The Scientist. "Another concern about unauthorized testing is the leaking of risk-revealing information -- such as genetic information or lipid levels -- to insurance companies and employers," Sprinkle said. Nevertheless, "it would be a perversion of informed consent reasoning to decide that such investigations should not be done" because of these concerns, Sprinkle said. "An imagined civil liberties concern is not the place to start." IVDs include instruments, reagents, and other tools to diagnose diseases and other conditions. Most investigational IVDs to identify potential bioterrorism agents and specific chemical agents have been developed by the Centers for Disease Control and Prevention (CDC) and the U.S. military, the rule states. "In most instances, these are the only devices available? although they may not have been approved or cleared by FDA," the rule states. Because they are experimental, "there is a risk of false positives and false negatives," said Nancy King, professor of social medicine at the University of North Carolina Medical School in Chapel Hill. "But it's not like giving anybody an experimental intervention, like an anthrax vaccine," she told The Scientist. Still, erroneous results can be harmful. "If it's the first such test available for some indication it might be overly sensitive or insufficiently specific to be a good screening test," said Sprinkle, who is also editor of the journal Politics and the Life Sciences. "If overly sensitive, the patient is informed he needs other procedures to follow in what might be a red herring. If it's insufficiently sensitive, it might be falsely assuring. You could cause real harm by not using a good test." While the FDA rule went into effect June 7, the agency will receive comments until Aug. 7. "We welcome criticism," Gutman said. "We appreciate it even more if we get criticism with suggestions on how to improve things." Ted Agres tagres@the-scientist.com Links within this article "Medical Devices; Exception from General Requirements for Informed Consent," (21 CFR 50.23(e)), Interim Final Rule, June 7, 2006, Federal Register/ Vol. 71, No. 109, p 32827-34 http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2006_register&position=all&page=32827 Overview of IVD regulation (FDA) http://www.fda.gov/cdrh/oivd/regulatory-overview.html T. Agres, "Controversial blood trial continues," The Scientist, May 8, 2006. http://www.the-scientist.com/news/display/23397/ Robert Sprinkle http://www.publicpolicy.umd.edu/facstaff/faculty/sprinkle.html Bioterrorism Agents/Diseases (CDC) http://www.bt.cdc.gov/agent/agentlist-category.asp Chemical Emergencies (CDC) www.bt.cdc.gov/chemical Nancy King http://www.med.unc.edu/wrkunits/2depts/soclmed/FACULTY&STAFF/King_profile.html Politics and the Life Sciences http://www.politicsandthelifesciences.org/ FDA comment link www.fda.gov/dockets/ecomments

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