The FDA's take on transparency

By Dr Nicola Davies

In 2009, the US Food and Drug Administration outlined steps to improve its transparency program in three phases.1

Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter notes that Phase I, FDA Basics, launched in January 2010, is an online platform where members of the public are granted access to information concerning the FDA and its activities.2 FDA Basics for Industry was also launched to provide information on the design, manufacture, labeling, marketing, and testing of products.3 In May of the same year, Phase II, a report which provided information on products and firms regulated by the FDA, was released. This was followed in 2011 by Phase III, a report on the transparency operations and decision-making process of the FDA.4 While transparency is a significant concern for the FDA, many feel the Administration’s transparency initiatives fall short of where they could be.