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.”
The Wall Street Journal (1/22, Loftus, Subscription Publication) provides a response from the FDA, which said it set specific requirements for each individual medicine but applies the same standards in giving the green signal for safety and efficacy of all medicines. The Federal agency also said it has set higher standards for approval of major modifications to some implantable cardiovascular devices over the past few years, including new studies aimed at finding any problems with devices.
Modern Healthcare (1/21, Rice, Subscription Publication) notes the authors said “the purpose of the study” was “not to suggest that the FDA is not rigorous in its approach to drug reviews.” One of the authors, Dr. Joseph Ross, assistant professor of general internal medicine at Yale University School of Medicine, said “the regulatory flexibility allows for a customized approach, and the agency can rapidly approve potentially effective therapies for life-threatening diseases.”
Bloomberg News (1/21, Edney), Forbes (1/21), New Haven (CT) Register (1/21), Medscape (1/22) and AFP (1/22) also cover the study.
Article courtesy American Medical Association
Speak Your Mind