January 22, 2014The Washington Post (1/22, Dennis) reports the FDA’s certifications of medicines being “safe and effective” are based on widely varied data, citing an analysis by researchers at Yale University’s School of Medicine. Nicholas Downing, the lead author of the study, “which examined nearly 200 new drug approvals between 2005 and 2012,” said, “Not all FDA approvals are created equally.” For instance, the study says, the FDA required that many new medicines “prove themselves in large, high-quality clinical trials,” however, about a third received approval based on one clinical trial, while “many other trials involved small groups of patients and shorter durations.”

USA Today (1/21, Szabo) reports the study, published in a series of articles in the Journal of the American Medical Association, found that many heart devices “have been approved through” a FDA “process that assumes newer models are safe and effective based on the approval of earlier versions.” Devices such as implanted defibrillators undergo “rigorous review” when they receive initial approvals but subsequent changes, however, “are often made through a ‘supplemental’ review process that doesn’t necessarily require them to be tested in clinical trials in humans.”
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