Home > Transparency Posts > The Transparency Task Force’s Sixth Question

The Transparency Task Force’s Sixth Question

We want to know how the FDA could provide information to the public to better explain the agency's work and its decisions. The sixth question is:

What metrics should FDA use to gauge the effectiveness of its transparency efforts?

Thank you and we look forward to your input and participation.

FDA Transparency Task Force

  1. June 25, 2009 at 1:33 am

    As an FDA employee, I agree that we should make our actions more transparent to the public. But please do not neglect the problems we have with internal transparency. There is a lot of activities and decisions that my coworkers and management should share, but they do not. There is perceived value in keeping things secret, as people think it enhances their position or value. It is very common for FDA employees to invest substantial time and effort on projects or situations, only to find out later that other people have already been working on the same problem. Some managers believe that virtually any internal discussion is too “sensitive” to allow other people in their group to also be in the know. For somebody who is working on a project within FDA, there is a fear that the involvement of other FDA employees will somehow make the project go south. This is particularly true of OIM (the IT group). They don’t like to communicate with users and learn about requirements or business processes for fear that their work will become more complicated and the users will mess everything up. There must be an effort to change the culture within FDA to make all of us more willing to share information with our colleagues. After that change occurs, only then will we be more willing to share information with the public.

  2. Emily
    June 26, 2009 at 3:52 pm

    FDA should gauge effectiveness in part by communicating with the medical specialty associations more regularly. The medical socieites represent the providers who prescribe drugs and employ devices approved by the FDA, and they communicate with respective members on a routine basis through a number of avenues. They also receive a lot of feedback from their members.
    Most physicians are not clear how the FDA has an impact on their day-to-day operations (not referring to the “practice of medicine”), so FDA should consider participating in national medical society meetings and engage in dialogue with providers about the relevance of FDA beyond just approving drugs/devices.

  3. June 28, 2009 at 4:55 am

    FDA should gauge effectiveness in part by communicating with the medical specialty associations more regularly. The medical socieites represent the providers who prescribe drugs and employ devices approved by the FDA, and they communicate with respective members on a routine basis through a number of avenues. They also receive a lot of feedback from their members.
    thanks

  4. Daniel A. Casciano
    June 30, 2009 at 10:57 am

    As a former employee of the FDA, I think that this question is quite simplistic. The FDA is an extremely complex organization and I think it would be a wonderful outcome if the new administration can stimulate effective communication between the various Centers including NCTR. Since the FDA has historically been woefully underfunded, there has been an inherent competition for the budget between the Centers that results in adversarial rather than cooperative relationships (of course there are exceptions, but they are minimal). I think if the culture can be altered or presented with adequate initiatives so a common theme could be agreed upon and communicated in plain language by the various Centers, perhaps the public could become more aware of the complex mission of the FDA and perhaps have a positive attitude toward it and perhaps even lobby for the FDA with congress and the president (ie. OMB). In my opinion, the audience of the FDA has never been the public but has been the congress or the white house. Mark Mclellan tried this by having the Commissioner’s office and the Center director’s offices expand on the simple phrase “the FDA’s Mission is to promote and protect the public health”. This is a simple motto that the public can understand and it would be easy for each center to weave their specific mission, goals and accomplishments around this phrase. This requires a commitment from the office of the Commissioner that requires short and long term planning. However, my experience is that this office becomes so enamored with the crises of the day and the particular agenda of the political administration in power that this type of planning is never accomplished. In my opinion this is critical before one can expect a useful communication and collaboration with the public. The public has to understand the message before one can measure it’s effectiveness.

  5. german
    July 6, 2009 at 3:10 pm

    I certainly agree that any measures that the Agency undertakes to become more ‘transparent’ should be measureable. However, from where I’m standing, the real question should be focused at is how is the public being protected by the transparency measures? How quickly is the FDA assessing the information it receives from food, drug, and device sponsors? There is a preception that the FDA has insight into problems long before the public can be made aware that there’s a potential for concern. If the transparency measures aim to still protect the sponsor and ultimately protect the American public, the balancing of those tasks becomes, on the outside looking in, very dangerous. By dangerous, I mean to imply that the public health is the foremost important factor and not company sales or wall-street concerns. However, if an agreement can be reached by sponsors and the Agency that the Agency can be a conduit/portal for publishing information – and only information regarding the information it receives, then maybe the real metric could be a website counter? How many Americans are checking the FDA website to be educated and/or warned? After that measure is tested (or perhaps it already has been), then other measures can be explored?
    However, as the first poster noted, before there can be evidence of transparency from the outside, there neeeds to be adequate checks and systems in place to streamline the flow of information inside the Agency in order to be able to keep up with the fast pace of the industries and public it is intended to support and protect. Resources need to be adequately positioned to react and respond without fear or concern that upon copmletion of their work, they learn that their work was duplicated or is no longer needed.

  6. July 11, 2009 at 2:38 pm

    For example, it is known that the FDA has created a work group to determine whether or not this organization should regulate Electronic Health Records (EHR) or not.
    There is no way to know what is being discussed. I’ve searched the FDA site and the Internet to no avail.
    Who’s participating? What’s the agenda? These are only two of many questions that many of us have.
    From my experience of working with the FDA in other technologies I can say that if EHRs fall under regulation this will be the demise of the modernization of the American healthcare system. It costs millions of dollars to get past the hurdles that are imposed and many months if not years of tedious work and most of it is to unravel the intricate bureaucratic processes imposed.
    The FDA is not transparent and most likely it will never be. They couldn’t justify their existence if they were.
    It’s the only regulatory organization in the world that acts in this way. Neither Europe nor Canada impose such strict regulations that only help perpetuate the monopoly controlled by giant healthcare technology organizations.
    Any transparent answers to this?

  7. July 23, 2009 at 1:47 pm

    You must wait before that. Public with a useful communication and collaboration is important. To measure the effectiveness of the public that the message has a priority to understand.

  8. Esther Annies
    November 4, 2009 at 10:25 am

    The comments are quite nice. FDA should make actions more transparent to the public and the same time keep the process private too. Such a great comment section available here. thanks

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  9. evden eve nakliyat
    November 17, 2009 at 4:17 pm

    You must wait before that. Public with a useful communication and collaboration is important. To measure the effectiveness of the public that the message has a priority to understand….very good realy thanks.

  10. Colon Cleanse
    December 12, 2009 at 3:40 am

    somebody who is working on a project within FDA, there is a fear that the involvement of other FDA employees will somehow make the project go south. This is particularly true of OIM (the IT group). They don’t like to communicate with users and learn about requirements or business processes for fear that their work will become more complicated and the users will mess everything up. There must be an effort to change the culture within FDA to make all of us more willing to share information with our colleagues. After that change occurs, only then will we be more willing to share information with the public.

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    April 25, 2012 at 6:55 pm

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