FDA Task Force Seeks Public Input on Ways of Increasing Transparency with Industry

The Food and Drug Administration (FDA) has requested public comments on how the agency can increase transparency in its interactions with regulated industry. According to a March 12, 2010, FDA press release, the agency regulates products responsible for approximately 25 percent of the U.S. gross national product, as well as overseeing the industries that manufacture these items, which include foods, veterinary medicines, human drugs, and medical devices. FDA’s Internal Transparency Task Force, which already held public meetings in 2009, is developing “recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while protecting confidential information.”

Representing FDA’s third and final phase of its transparency initiative, the latest request particularly seeks ideas on how the agency can (i) improve training and education for regulated industry about its regulatory process in general and about specific new requirements, (ii) strengthen the guidance development process, (iii) maintain open channels of communication with industry routinely and during crises; and (iv) provide useful and timely answers to industry questions about specific regulatory issues. FDA has requested public comments by April 12, 2010. See Federal Register, March 12, 2010.