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RedditOn September 1, 2004, a patient with type O blood died at a hospital and blood bank in Ponce, Puerto Rico, after being mistakenly given two units of type A blood. Upon investigation, Food and Drug Administration inspectors discovered that before the fatal accident, Hospital Damas had come close to killing two other patients under similar circumstances. Even afterward, Hospital Damas still failed to verify critical medical data or properly train its employees.
Five months later the FDA's San Juan district office recommended that the agency issue a warning letter, which is supposed to be a company's last chance to eliminate a hazard before being sued or having its product seized. But despite abundant evidence that patients at Hospital Damas were in danger, even this relatively minor enforcement action--routine in previous administrations--was never carried out. Instead, the FDA's Center for Biologics Evaluation and Research, which oversees blood banks, claimed there was no evidence of systemic problems.
The decision was far from surprising. Over the past five years warning letters have become an endangered species at the FDA. According to a recent report by Representative Henry Waxman, the number of such letters issued under Bush-appointed FDA chief counsel Dan Troy plummeted from 1,154 in 2000 to 535 in 2005. Seizures of mislabeled, defective or dangerous products, another key measure of enforcement activity, dipped 44 percent. Waxman's investigators found a disturbing pattern of laissez-faire managers overuling field agents trying to discipline wrongdoers--even when deaths had resulted.
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