The FDA “Transparency Task Force” (what a name) will hold a public meeting announcing: “FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible.” For more information on the November 3rd meeting go to the FDA website at http://www.fda.gov. FDA says the topics for the meeting are:
1. Early communication about emerging safety issues concerning FDA-regulated products
2. Disclosure of information about product applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval
3. Communication of agency decisions about pending product applications.
Unfortunately, the organizations that know how to mobilize articulate representatives for public FDA meetings like this are not always the organizations with FDA’s best interests at heart. FDA is a large, complex organization and it can be a little intimidating to think about speaking in public about any specific concerns. Also, some of us don’t live within driving distance of Washington, DC (its on the wrong coast). FDA has set up a “Transparency Blog” where it might be easier to make a contribution. FDA is actually doing a lot of listening these days so please, speak your mind, you just might have something useful and understandable to say.
Link to the FDA Transparency Blog: on Blogroll under FDA Transparency Blog
UPDATE: The FDA issued a press release on 12 March 2010 that said in part:
“As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.”
It continues:
“For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:
~ Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
~ The guidance development process
~ Maintaining open channels of communication with industry routinely and during crises
~ Providing useful and timely answers to industry questions about specific regulatory issues
Electronic comments may be submitted to:
http://www.regulations.gov
Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA–2009–N–0247.”
Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.”
Read the FDA Press Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm204236.htm
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Posted by GxP Perspectives 
FDA discusses product recalls on new website feature
October 14, 2009FDA has started a major campaign to explain product recalls to the public. In an extensive article and video called, “FDA 101: Product Recalls – From First Alert to Effectiveness Checks,” FDA explains the process in clear language for the general public. Go to http://www.fda.gov to view for yourself.
During the time that I worked as an FDA field investigator I would sometimes perform “recall audit checks.” I would go to a hospital, health product distributor, or pharmacy to find out if they had received a recall notice from the manufacturer of the recalled product. Sometimes they had taken prompt action to remove the product from their shelves. Sometimes they would just shrug their shoulders and say they didn’t remember or that they threw away such notifications. There is little FDA can do in that situation because the system is basically voluntary except for the most serious situations. For many, if not most recalls, a voluntary recall system is OK. They are not serious enough to utilize significant agency resources. However, when there are serious public health risks FDA needs the authority to take action.
Hopefully Congress will tmove forward soon with legislation to give FDA the authority it needs to enforce product recalls of significant public health concern.
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