Change for the Better at the FDA

David Mittleman

Attorney
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Food and Drug Commissioner, Dr. Margaret Hamburg, signaled a major shift away from the old ways of business at the FDA. In a recent article published in the New England Journal of Medicine, co-authored by Deputy FDA Commissioner Joshua Sharfstein, Dr. Hamburg stated that she views the FDA as a public health agency that should measure its success by promoting health and preventing illness, not by how successful it is in helping the food and drug industry market their products.

In the past, drug and device makers stalled on important post-market studies designed to protect consumers by identifying dangerous products. 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.