CLINICAL TRIALS: FDA Cracks Down on Research Violations
Engaged in a nationwide inquisition of clinical study programs, the FDA slapped California researchers with nine of the 22 reprimands issued since the beginning of 1999 for violating regulations that protect volunteers from exploitation and undue harm, the Los Angeles Times reports. The written warnings cover a variety of infractions, including poor record keeping, lax supervision of junior researchers and alleged fraud. While patient advocates hail the crackdown, the warning letters "frustrate and anger" researchers who claim that their "goal is to help humanity, not placate Washington bureaucrats." Facing increased public scrutiny, the FDA has bolstered the number of inspections on research projects in recent years. According to Dr. David Lepay, director of investigations for the agency's drug and research center, there also has been an "upward blip" in the number of warnings and other official FDA actions. He notes, however, that "American clinical research is in very good shape." Patient advocate groups and some scholars contend, however, that the FDA continues to do "too little." Dr. Peter Lurie, co-director of health research at Public Citizen, said, "[T]here are large residual amounts of research activity out there that the agencies are not willing to take action against." Under FDA rules, the agency issues a warning, one of its most serious actions, after field officers inspect a clinic, interview research staff and audit study records. In addition to California's nine violations, the FDA issued three warnings to Texas facilities, two in Wisconsin, and one in eight other states (Monmaney/Westphal, 6/5).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.