Study: FDA Oversight Of Drug Tests Is Lax
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(CBS/AP) An inspector general’s report of the Food and Drug Administration’s oversight of clinical drug trials says such tests — which involve millions of patients using experimental drugs and medical devices — are inadequately monitored by the government for patient safety, according to a report released Friday. Over a six-year period, the FDA inspected just one of every 100 trial sites, or one percent, raising questions about the agency’s ability to ensure the safety of study participants, according to the report by Health and Human Services Department inspector general Daniel Levinson. Even when clinical trials do get inspected, the report found that its often after they’ve been completed — too late to help participants who might have been put at risk, reports CBS News correspondent Nancy Cordes. Hampered by the lack of a comprehensive catalog of clinical trials, the FDA is unable to even identify all trials, the estimated 350,000 study sites, and the institutional review boards that oversee each study to ensure they meet scientific, ethical and legal obligations, the report says. Those limitations hinder the FDA’s ability to ensure participants are protected from unreasonable risks, Levinson said. More : cbsnews.com |