FDA Is Expanding Transparency Efforts To Focus On Industry Questions

Full article reprinted from "The Gray Sheet" - November 16, 2009

FDA has expanded its transparency initiative to cover an area that was unanticipated, Deputy Director Joshua Sharfstein said: explaining how the agency works to the industry it regulates. Read more...

FDA Is Expanding Transparency Efforts To Focus On Industry Questions

Full article reprinted from "The Gray Sheet" - November 16, 2009

FDA has expanded its transparency initiative to cover an area that was unanticipated, Deputy Director Joshua Sharfstein said: explaining how the agency works to the industry it regulates.

Creation of the still unfurling Transparency Task Force was one of Commissioner Margaret Hamburg's first actions after becoming head of the FDA. So far the task force has held two public meetings, created an open public docket as well as a blog, and received more than 900 comments (The Gray Sheet' Nov. 9, 2009).

Speaking at the Nov. 12 FDA Risk Communication Advisory Committee meeting, Sharfstein explained that FDA has divided its transparency efforts into three parts. The first two were the anticipated efforts to foster understanding of the agency fundamentals and explore what can be made public about the reasons behind FDA's decisions on regulated products.

"The third part is something that I can't say we totally anticipated at the beginning, but we've heard pretty loud and clear that industry is very interested in transparency of how the agency works, for its own application," he said.

The "Transparency for Regulated Industry" - the official name given to the specific section of the agency's transparency initiative - will address a variety of concerns industry has voiced recently, including questions about ambiguous FDA rules, how to schedule meetings with FDA and what FDA has to do to justify changing its standards.

"There are a whole bunch of questions that they don't understand, and we've decided to make that a third part of the effort," Sharfstein told the advisory committee.

For the first part of the transparency effort, the agency is getting ready to launch "FDA 101" - a Web site that will address basic questions about the agency. It will also include interactive and video components.

The second transparency effort will address what FDA should disclose about information in its possession as the basis for its decisions on regulated products. The agency aims to answer a variety of questions, from what the agency typically discloses about ongoing applications to how FDA communicates safety problems once they emerge.

- Lauren Smith

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