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Transparency Public Meeting Structure and Format

We are seeking advice on the best way to structure the June 24, 2009 public meeting on transparency.

The agency typically organizes public meetings by the order in which presenters submit their speaking requests to the agency.  This approach has varied results as it can be difficult to locate a particular meeting or to review comments associated with a particular topic after the meeting.  We have come up with additional options below for organizing the June 24 public meeting and we are interested in your input.

  • By Product (e.g., drugs/biologics, medical devices, foods, cosmetics, dietary supplements)
  • By Agency Action (e.g., review of product applications and product approvals, enforcement actions, recalls, public education and outreach to stakeholders)
  • By Question posed in the Federal Register notice

Thank you in advance for your help and advice.

FDA Transparency Task Force

  1. Harriet C. McCleary
    June 9, 2009 at 7:30 pm

    The process for submitting a comment is CUMBERSOME and UNCLEAR. I have clicked on many different possibilities before finding this posting place. I am not confident you are going to receive this.
    I suggest using the internet to relay your transparent information. However, based on what I saw as I was trying to comment, someone needs to test the information displayed with many different people (100-1000) from all walks of life to see if they understand what is being reported or asked.
    Since transparency is vitally important, you need to make sure people actually understand what you have written. In fact, I would suggest that this part of the process is just as important, or more so, as the transparent information you are reporting.
    As a normal consumer, I would like to see the information, how the information was gathered, who gathered it, if there is scientific backing (if appropriate), what the information means and where to find more information, should it be necessary or requested.
    Thank you.

  2. Bill Budris
    June 10, 2009 at 9:33 am

    Perhaps too late for this meeting to arrange, but why aren’t these meetings being offered to the public live via webcast. No better way to be more inclusive and reach that transparency goal simultaneously.

  3. Mark Pine
    June 10, 2009 at 3:26 pm

    I’d really like to see the meeting on transparency web cast. In regard to transparency, it would be really useful to have the Medwatch adverse reaction database online in an easily usable form (redacted of identifiers, of course.)

  4. PharmaWatcher
    June 10, 2009 at 4:41 pm

    General blog idea – why not have a tool by which people reading comments can recommend a comment? I.e. if I see a comment that I agree with, I can click on a thumbs up button and recommend it. That way you can see how many people that read this blog support other’s views without having to repeat.

    • como ficar rico
      May 26, 2014 at 5:38 am

      What’s up to all, how is all, I think every one is getting more from this web page, and your views are good designed for new visitors.

  5. anne juhlmann
    June 11, 2009 at 8:17 pm

    Having witnessed a family member experience the worst possible outcome from a drug adverse event, due to current legislative constraints that limit transparency, as well as astonishing weaknesses in the current approval/regulatory process, I truly appreciate that the FDA is seeking public advice. However, I think it is critical that there be more effort to publicize this blog.
    I read the newspaper and listen to TV national news each day. I also likely have my eyes far more open to looking for FDA news than the average person. Yet there has been little about the transparency task force and today was the first I learned of this specific blog through an emailed FDA Digest Bulletin.
    My guess is that the vast majority of Americans do not subscribe to FDA newsletters and do not frequent the FDA website. I urge you to make a truly concerted effort to get the word out via the many forms of media available. Otherwise, you will get a very slanted sampling of advice – one that is not representative of our population and the many “FDA experiences.”
    Finally, greater than 70% of Americans do not have a level of health literacy adequate for understanding or navigating the health care system. I recommend that you bring the readability level down when you pose questions and make it simpler to understand how to access the blog and post comments.
    I understand your resources are limited and time is inadequate. Perhaps you could offer an internship to some college students. They’d appreciate the experience and be able to help get the word out to as many media sources as possible. I’m sure one of the first things they’d recommend is that you use social media to direct people to this blog.
    In summary please intensify your effort to widen your audience.

  6. Rocco Paul
    June 13, 2009 at 10:55 am

    The FDA needs to revamp itself. It is a slow and bureaucratic organization. They lack the resources and technology to deal with medical and food related issues in the 21st century. Just look at the number of drug approvals, they have declined significantly. This due to a cumbersome process and heavy regulation placed on pharmaceutical companies. With this they not only stifling INNOVATION, but they are harming patients the people they are their to SERVE. There are fewer options of therapy for patients. The FDA is in a quite a sorry state of affairs, they need some real leadership for CHANGE. For instance, Alzheimer’s disease is one of the most unmet medical needs of our time. However, the FDA has not been able to come together with Industry to get a disease modifying therapy through the clinic. Why? Because of the cumbersome rules in a post Vioxx era. They want to see large, long clinical trial results which cost hundreds of millions. If this is the path the FDA continues on, some of the biggest medical challenges of our era will never be adressed.

  7. June 15, 2009 at 7:49 pm

    On June 24th, I suggest you consider an agenda which:
    1. Describes the problem to be solved by the transparency initiative. Perhaps it would help set the stage to state the current and historical mission of the agency and list some of the more widely held perceptions and misconceptions among the FDA’s interested parties.
    2. Have each of the Centers – including NCTR – and the Office of the Commissioner give a presentation of the most successful 3-5 methods they have they have used historically to enhance public awareness about the workings of their part of the agency. (e.g. CDRH Studio webcasts, “FDA Consumer”, “Enforcement Story”, scientific publications, and of course press releases and Federal register notices).
    3. Speakers requesting to be heard should be identified as to whether they represent for profit industry or consumers and an attempt should be made to ensure that 50% of floor time is given to consumers.
    4. Establish taht measurable goals are to be met by any transparency effort. (Budget for statistically relevant random public and industry surveys would be good).
    5. Propose a preliminary timeline to meet those goals with scenarios and budgets.
    This is a worthy effort and one I hope the agency embraces whole heartedly. Having worked with FDA for many years, I have long felt the it is an exemplar of how taxpayer dollars can be spent for the people. Hopefully this will improve the way FDA takes and incorporates input by the people.

  8. Jacqueline
    June 16, 2009 at 7:46 am

    1. I would like to see the agency form a task force to proactively pay visits to pharmacuetical companies that are running phase III clinical trials on the early stage of the trial before the pharma company files for BLA as well conduct visits to the investigators sites participating in the respective clinical trial.
    2. The agency should request from the biotech/pharma to provide a summary of ongoing trials every six months. Provide protocol deviations details, AEs, SAEs, dropout rate, and enrollment targets.

  9. June 19, 2009 at 1:05 am

    I agree that meetings such as this should be open to the public since the talk would concern all of us anyway.

  10. Colon Cleanse
    December 12, 2009 at 3:45 am

    The FDA is in a quite a sorry state of affairs, they need some real leadership for CHANGE. For instance, Alzheimer’s disease is one of the most unmet medical needs of our time. However, the FDA has not been able to come together with Industry to get a disease modifying therapy through the clinic. Why? Because of the cumbersome rules in a post Vioxx era. They want to see large, long clinical trial results which cost hundreds of millions. If this is the path the FDA continues on, some of the biggest medical challenges of our era will never be adressed.

  11. September 24, 2010 at 11:00 pm

    Wonderful blog, would really like to see a bit more media though! One of my favorite subjects… Then again my site hasn’t many posts either – Great post anyway, added your XML feed! Cheers

  12. September 17, 2011 at 9:36 am

    Transparency is vital for every organization. But even more for FDA. Congratulations for making this aspect one of your major areas of improvement!

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