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Open Up! FDA Unveils Transparency Proposal

In an effort to help consumers and stakeholders understand how the agency operates and makes decisions, the U.S. Food and Drug Administration’s (FDA’s) Transparency Task Force yesterday released 21 draft proposals and invited the public to comment.

“Governmental decisions, particularly regulatory decisions, should be based on publicly available information,” said former FDA commissioner Donald Kennedy, in 1978. With that premise, the agency charged with regulating a quarter of the gross national product–everything from lipstick to frozen pizzas to pacemakers–is making moves to be more transparent.
The draft proposals, which will be published in the Federal Register this week, are part of the second phase of the FDA’s Transparency Initiative launched last summer by FDA Commissioner Margaret Hamburg in response to the Obama Administration’s commitment to “an unprecedented level of openness in Government.”

fda-proposals-public-comment.jpg“Our goal is to facilitate transparency that promotes public health and

innovation,” said Joshua Sharfstein, FDA principal deputy commissioner

and chair of the Transparency Task Force. “These proposals reflect a

careful balancing of the importance of transparency with the importance

of protecting trade secrets and confidentiality.”

Sharfstein and Afia Asamoah, Director of the FDA’s Transparency Initiative, discussed the transparency initiative in yesterday’s New England Journal of Medicine (NEJM).  (See graphic, right, for an outline on key proposals).  The full report is available here.

Most of the proposals seem to directly impact drug regulation–nowhere in the document will you find “Salmonella” or “E. coli.”

The suggestions most related to the proposal involve illuminating enforcement efforts.  One example of a draft proposal for public comment highlighted in the NEJM article is, “The agency should disclose the name and address of the entity it inspected, the date or dates of inspection, the type or types of FDA-regulated product involved, and the final inspection classification–official action indicated, voluntary action indicated, or no action indicated–for inspections conducted of [among other things] facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed.”

It’s important to note that these are suggested draft proposals–not definite policy changes.

As Asamoah wrote on the FDA’s transparency blog yesterday, “FDA will not necessarily implement each of these ideas.  Some of the proposals require extensive resources to implement and some may require changes to regulations or legislation.”

In a statement yesterday, the agency said the new proposals already reflect the review of more than 1,500 public comments received by the FDA.

The FDA is seeking public comments on the proposals in the draft report for 60 days. According to the agency, “The task force will consider the comments received, their feasibility, resource requirements, and the priority of each proposal to arrive at recommendations for Commissioner Hamburg.”

During the last 11 months, the Task Force has held two public meetings, launched an online blog (http://fdatransparencyblog.fda.gov/) and opened a docket. The first phase of the transparency initiative was completed in January 2010 with the launch of a web-based resource called FDA Basics (http://www.fda.gov/fdabasics).

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