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David Mittleman
David Mittleman
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Change for the Better is Coming to the FDA

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Food and Drug Commissioner, Dr. Margaret Hamburg, signaled a major shift away from the quid pro quo attitude of the FDA of the past. In a recent article published in the New England Journal of Medicine, co-authored by Deputy FDA Commissioner Joshua Sharfstein, Dr. Hamburg explained that the FDA as a public health agency that should measure its success by how well it promotes health and prevents illness, not by how successful it is in helping the food and drug industries market their products.

In the past, drug and device makers purposefully stalled on post-market studies meant to protect consumers from dangerous products. Their excuse was often that such studies were too expensive and the FDA looked the other way. This may soon be a habit of the past. Hamburg and Sharfstein emphasized the greater authority given to the FDA by H.R. 3580, the Food and Drug Administration Amendments Act of 2007, of which they plan to take full advantage. Specifically, their article highlighted the agency’s power to restrict medication at the time of FDA approval and to demand post-market studies. The rewards could be greater for medicine makers who do show they are involved in scientifically valid post-market studies: Hamburg and Sharfstein hinted at quicker approvals of other products that are not yet on the market.