Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: A Misguided Approach

In June 2014, the US Food and Drug Administration (FDA) for the first time issued draft guidance for the pharmaceutical industry on distributing scientific and medical publications about the risks of approved prescription drugs and biological products.¹ In my view, the draft guidance, which is open for public comment until August 25, 2014,² has the potential to undermine the FDA’s drug safety laws and regulations and should be changed.