The FDA’s Move Towards Increased Transparency Could Threaten the Confidentiality of Submitted Data

June 03, 2009
In furtherance of a transparency directive from President Obama, the Food and Drug Administration announced this week the creation of a “Transparency Task Force” to make recommendations on making certain information and FDA processes more available and understandable to the public. The FDA also announced that it will hold a public meeting on June 24, at which interested parties may express opinions on the subject. This update explains that entities required to submit confidential, trade secret, and/or private information to the FDA, such as pharmaceutical companies that submit confidential test data, should track and participate in this move towards transparency.