Enhancing Transparency at the US Food and Drug Administration: Moving Beyond the 21st Century Cures Act

Source: Sharfstein JM and Stebbins M. JAMA. 2017;317(16):1621-1622. doi:10.1001/jama.2017.2481

Transparency rules…. at least for those of us in the pharmaceutical and medical device industries. The increased cry for transparency over the past decade has led us to modify many of our practices to ensure that what we do, how we do it, and what we publish is fully transparent.
A “Viewpoint” article in the April 25, 2017, issue of JAMA shares interesting and timely information about a proposed blueprint designed to increase transparency at the FDA. The authors note: “The US Food and Drug Administration (FDA) has primary responsibility for oversight of every drug, biologic, and medical device sold in the United States. Yet the FDA is far more than a regulator. It is also an agency dedicated to public health, with the expertise of thousands of scientists and access to enormous amounts of information from clinical trials and other studies. Greater transparency can allow FDA not only to better meet its many obligations but also to advance the scientific enterprise needed to develop safe and effective medical products.”

The blueprint contains 18 recommendations in 5 principal areas, and “sets out an approach to leverage the regulatory process to advance scientific understanding, patient, care and public health.”
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