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

The Transparency Task Force’s First Question

The Transparency Task Force is actively seeking input from the public about issues related to transparency and will work to identify what information the public most wants FDA to be transparent about.  The public comments will inform the recommendations the Task Force will provide to the Commissioner about ways the agency can become more transparent.

To fully utilize this blog and help categorize and focus the conversations on it we will post a new question and/or topic every week until the Transparency Task Force public meeting is held on Wednesday, June 24, 2009. We will begin by posting, one at a time, the questions we asked in the Federal Register notice we published on June 3, 2008.

 

The first question is relatively general.  Still, we really would like to hear everyone’s initial thinking on it:

How can the agency better explain its operations, activities, processes and decision making?

Thank you.  We look forward to your input and participation.  We also encourage you to attend the public meeting and send comments to the “docket.” 

FDA Transparency Task Force

  1. Amir Vasilis
    June 4, 2009 at 6:20 pm

    It would be best for the FDA to start off by explaining ALL of it’s operations, activities, processes, and decision making.
    Based on the information that the Task Force provides, we the general public will then choose what is relevant or irrelevant to our education. If there is information that the FDA is incapable of disclosing, then we should know in advance (right now) to prevent undesirable situations that may arise suspicion.
    The FDA is hear for us, not itself, so we don’t feel the need to limit transparency by segmenting specific topics just yet. That would undoubtedly leave vital information out.
    This would at least be a starting point to open up discussions.
    Also, I think there should be an RSS feed to subscribe to the entire blog and not just the comments.

  2. Dan
    June 5, 2009 at 12:23 am

    How can you explain what motivates your administration’s activites, processes, and decision making? What is your etiology for accepting money from those you are suppose to regulate that transforms those you are responsible for regulating into clients of your administration? Because now, you as an administration wish to please your toxic clients in a Pavlovian manner, quite overtly, as you view your clients as such due to the quid pro quo your administration has with those you are suppose to regulate. Therefore, these gifters that you gladly receive of what they offer are in fact your clients and their needs are met, or adverse to often, the needs of public citizens. These citizens understandably are not confident in your attempt to metamorphosize, or regress, to your original purpose as our FDA. Prove us wrong.

  3. PharmaGossip
    June 5, 2009 at 2:45 am

    Welcome to the blogosphere.
    A great first step on the road to change for the better.
    Anything I can do to help……

  4. Dennis D, McDonald
    June 5, 2009 at 7:11 am

    I would appreciate seeing the names and faces of the people of the FDA staff who will be managing and moderating this process. Part of any transparency effort, I feel, is making clear who is responsible for managing the process; names and pictures — and contact information — will help in this regard.

  5. Don Schindler
    June 5, 2009 at 8:36 am

    I’m kinda surprised that you are only doing one blog. There are many of us out here that touch the FDA in different ways. I personally would like to see each piece of the FDA blogging so we would know who we are dealing with.

  6. Mark Senak
    June 5, 2009 at 9:56 am

    FDA’s DDMAC made a decision to issue 14 untitled letters about search engine advertising involving 45 brands. The agency has given no insight into its regulatory approach to the Internet, saying that it is the medium, not the message. Yet Internet use is fraught with nuance not present in broadcast, television or print media. Companies are left to guess if something is right or wrong and risk a Warning Letter. When asked why DDMAC made the decision to issue letters about such a long-standing practice, the agency refused to answer. What kind of transparency is that?

  7. Jennifer Reese
    June 5, 2009 at 6:35 pm

    Get the word out about this blog–maybe using all the online groups in support of Pres. Obama.
    But I think a major television/radio/print/online campaign is in order that lays out the basics of what the FDA does.
    I learned today that the FDA does not regulate fisheries, but they are a part of the Commerce Dept.
    We know so much about commercial products, but personally, I don’t know much at all about government agencies and how they work. We need a new, smart, all ages School House Rock for the administration as a whole.
    I agree with the other commenter who said to include names and photos of the individuals running the dept and this blog. Thanks. This is a start!

  8. Michael G.
    June 6, 2009 at 12:06 pm

    1.) Create short videos that explain what the FDA does. First bifurcation should be differences between Food and Drug regulation; can also have a print & screenshot companion piece for accessibility (For best practices, see “Twitter in Plain English” at http://www.youtube.com/watch?v=ddO9idmax0o and the Krop.com “Creative Database Screencast” at http://www.krop.com/creativedatabase/screencast/).
    2.) Send an RFP to all ad agencies and design houses to come up with an overall approach, including FDA website overhaul. Approach should include two direct-to-consumer campaigns that enable the American public to report on drug and food safety issues. (think of it as the FDAs own version of “1-800-BAD-DRUG” and “1-800-BAD-FOOD”). This initiative could help bolster CDC’s more rigorous efforts in this regard. Current capabilities for patients to self-report adverse events are so constrained by medical, legal and political forces that they are effectively nonexistent. Approach should also include special attention to Clinical Trials Registry and Comparative Effectiveness study results.
    3.) If money is tight, offer tax breaks for in-kind services donated by the agencies rather than a traditional contract; this is done all the time for non-profit groups
    Good luck!

  9. girish
    June 6, 2009 at 1:26 pm

    hope the transperancy shall include the following in the policy
    Policy
    State intent and direction for:
    • guidance for provision of services
    • conformance with regulatory requirements
    • a planned and systematic program for monitoring quality and appropriateness of services
    • planning for quality of services
    • evaluating effectiveness and efficiency of the quality system of Services

  10. girish
    June 6, 2009 at 1:31 pm

    after policy next step is the process devolopment for transperancy which will be
    Describe activities that transform the intent into action
    • Develop a mission, vision, and code of ethics
    • Define the scope of authority and responsibility for the quality manager
    • Identify levels of authority and responsibility throughout the organization
    • Create a team of executive management and staff to maintain and regularly review the quality system
    • Allocate sufficient resources to operate, review, improve, and maintain the quality system
    • Involve all persons in the facility in quality

  11. Rebecca
    June 8, 2009 at 6:46 am

    I would like to see the FDA “faces behind the curtain” and what their jobs are.
    Who IS the FDA and HOW does it work? Make it simple but not dumbed down.
    Make it easy for the public to comment and give opinions on upcoming drug or food regulations.

  12. Edward Murray
    June 8, 2009 at 12:09 pm

    CVM ADE STATISTICS
    In the fall of 2007, CVM stopped publishing the number of events listed in their product by product listing of adverse drug events. At the time, we were told by Linda Grasse, Director of Communications, that this was a temporary change while efforts were underway to improve the presentation of the data.
    Then, a few months later, the remaining statistics (the total number of reports and the number of deaths) were dropped.
    This renders the data far less useful than it was when the full statistics were being published.
    A related issue was that the agency and manufacturers were quick to challenge the use of any of the published data noting that the reports were based on the raw submitted ADE’s, not the evaluated data.
    That being the case, then the agency should be publishing the evaluated data, not criticizing the public for using the only data available.
    While it is hard to see the banishment of this data as being anything other than cowtowing to manufacturers who no doubt are not happy to see these statistics being made public, if the agency believes there are valid reasons for withholding this information from the public, then it should publicly make it’s case.

  13. german
    June 8, 2009 at 2:40 pm

    The initiative to become transparent obviates the need to understand the FDA’s roles, responsibilites, and non-proprietary knowledge. The Code of Federal Regulations (CFR) is the layman’s main source to understanding compliance with Food and Drug Law. The public is open to read and become knowledgable on the activities required to maintain compliance with Federal Regulations. Upon reading the Titles and sections associated with Food and Drug law it should be apparent that the FDA is a vast and complex organization. Its capacity for change is limited for many reasons. I’d like to consider some of the challenges facing this initiative and begin the discussion from that point of view:
    1. Who is going to pay for the changes required to make the FDA transparent? These changes will most likely require upgrades to their information technology infrastructure and communication mechanisms. Where will the funds come from to support and maintain these initiatives?
    2. The Food and Drug industries lure many employees away from the FDA due to principles inherit of capitalism. This leaves the Agency to be back-filling many of their positions and also creates for the loss of technical expertise, historical knowledge, and efficiency. How is the FDA going to be able to compete with industry in maintaining their workforce in order to maintain these transparency initiatives?
    3. The FDA is only as good as the information it receives from the Food and Drug industries. If the Food and Drug industries are to be more regulated, thereby leading to greater transparency, this will require larger workforces for both FDA and Industry. Both of which are sure to drive up the cost of food and drugs.
    4. Any initiative to create greater transparency may also take away from the ability of the Agency to work efficiently. Any delays in their ability to process the work they already have is going to be passed on to the public.
    5. There are a number of systems already in place that are supported by the FDA (electronic and non-electronic). Is the Agency capable of keeping up with these current initiatives? Might ensuring that the current systems in place be adequately supported be a starting point?

  14. Larry Minikes
    June 8, 2009 at 3:26 pm

    The Mobile Platform
    To make the FDA more transparent, collaborative, participatory and open it needs to stay on the technology curve. The mobile platform is increasingly becoming a vital part of many lives as a primary tool for communication and content delivery.
    While the Transparency Task Force considers these questions over the next few weeks, development of a mobile portal and a series of initiatives that will index, organize and reconfigure information delivery to simplify accessibility for citizens should be part of the discussion and your decision-making process going forward.

  15. CMCguy
    June 8, 2009 at 6:32 pm

    Q: How can the agency better explain its operations, activities, processes and decision making?
    My A: One approach to help present information is to outline and overview “case studies” that follow FDA actions and interactions over time. This can be used to show the lifecycle and key review and decision points as a “chronological” map and where different groups/functions are participating. Akin to college course(s) or training programs by companies need “modules that cover specific topics” but also must link together (and show cross connections between various levels). Need to start out General however certain steps should be magnified or expanded in great detail and addressed in more dedicated fashion. There are many “FDA Presentations” that already exists that could be coordinated and supplemented to build such a consolidated picture from. It can’t be dry “facts & figures” and “guidance quotes” but must elaborate on the current rational and influences applied to tasks (and uncertainty that are present). My preference is to see a “hard copy” but advantages in Multi-media (Papers, Videos, Blogs) to help spread info and allow people to access by their own most preferred option. A daunting challenge regardless on how attempt to convey and wish you luck.

  16. Dennis McDonald in Alexandria VA
    June 9, 2009 at 2:33 pm

    I think it would be very useful to explain how this blog relates to the other communication channels the FDA has available to it that are specified in the Federal Register for upcoming agency events. I address this suggestion — hopefully in a constructive manner — in my own blog post “How Transparent is the New FDA transparency Blog?” which is located here: http://www.ddmcd.com/fda.html

  17. TSC
    June 10, 2009 at 7:57 am

    I notice that your Transparency page (http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm#taskforce) sets a time limit for this blog: “The blog will run for the next six months (June through November 2009)” On the other hand, President Obama’s Jan. 21, 2009 memorandum (http://www.whitehouse.gov/the_press_office/Transparency_and_Open_Government/) implies that the government transparency should be a permanent thing. To better comply with the President’s Directive, it is desirable that this blog is made permanent. It would be ideal if a relatively high profile person with a reasonable level of independence runs it (see for example, Atlanta Fed Blog at http://macroblog.typepad.com/ which is run by David E. Altig
    Senior Vice President and Director of Research) and the persons responsible are identified in the postings (again see Atlanta Fed Blog)

  18. June 11, 2009 at 10:15 am

    This comment is in response to FDA’s first blog question: “How can the agency better explain its operations, activities, processes and decision making?”
    As a member of the trade press, it would be helpful to have the agency prepare an upcoming calendar of events that would list where agency officials are making presentations and the topics being covered.
    Also, FDA should reconsider making presentations at meetings that are conducted by, or sponsored by, for-profit organizations that often discourage the press from attending by charging fees to hear FDA presenters. FDA should adopt a policy of restricting FDA presentations to organizations that have policies for open press coverage.
    For example, an upcoming GMP conference conducted by the for-profit group Pharmaconference (http://www.pharmaconference.com/pharmaceutical_conferences/p_conf_brochures/AugMD09.pdf is off limits to the press unless they pay a $1,945 registration fee. The conference has 19 agency employees scheduled to make presentations. Providing agency presentations and GMP interpretations to a small closed audience is not very transparent and a poor use of scarce agency resources.
    David McFarland
    FDA Webview (www.fdaweb.com)

  19. June 13, 2009 at 2:52 am

    Welcome to the blogosphere.
    A great first step on the road to change for the better.
    Anything I can do to help……

  20. June 16, 2009 at 7:49 pm

    The FDA covers a wider and more diverse range of areas than most federal agencies, which creates a unique challenge. To foster the open, collaborative approach to providing information and receiving feedback, in place of a single portal for public information consider creating a series of hubs or sub-portals. From these hubs create a series of nodes to focus on specific areas of interest. This approach will allow the agency to better explain its operations, activities, processes and decision-making.
    An example is this blog. Instead of filtering all information through a single blog in the future, the agency would have a series of blogs dedicated to the information hubs or nodes such as food safety, medical devices, medicines, etc. This will allow for better information management, citizen input and information dissemination.

  21. Ginny Riker
    June 18, 2009 at 5:43 pm

    I would like to see a list of former employers for all FDA decision makers, along with the already suggested typical information and a photo.

  22. June 28, 2009 at 1:36 pm

    In response to David McFarland Comments on the GMP conference he references. The University of Rhode Island, College of Pharmmacy has sponsored various types of GMP training for the FDA for decades. Pharmaconference is a contractor to the University and IS NOT the sponsor of these programs. When requested, The College of Pharmacy make these conferences fully available to trade press AT COST, the same rate charged to non speaking FDA representatives. Programs of this nature require extensive resources. Open FREE access for any trade press who requested it would not be possible or responsible for our NON PROFIT University. We have made arrangements for Mr. McFarland and other trade press to attend our conferences at our cost for some time and we will continue this policy.
    Ronald P. Jordan, Dean
    The University of Rhode Island
    College of Pharmacy
    http://www.uri.edu/pharmacy

  23. SEO
    July 20, 2009 at 5:27 pm

    It would be nice to see all the members who will be responsible for this and who they will report to.

  24. Karen P.
    October 12, 2009 at 1:36 pm

    I read the 6/15/09 article “New commissioner aims to open FDA’s ‘black box’”, http://findarticles.com/p/articles/mi_hb4365/is_12_42/ai_n32147623/ , where Dr. Hamburg was reported as saying “If we make more information available, there may be fewer Freedom of Information Act requests and citizen petitions”.
    I am writing as a citizen who has already filed a FOIA request and is considering submitting a petition asking FDA to regulate the allergen sesame. I know FDA is not considering individual issues like the regulation of sesame here in this blog, but I am using this issue as an example of how FDA could better explain its operations, processes, and decision making.
    From a scientific standpoint, it is clear that sesame should be regulated:
    1) The foods most likely to cause anaphylaxis are peanuts, tree nuts, shellfish, and sesame. (Reference: Robert A. Wood, MD and Joe Kraynak, Food Allergies For Dummies (Hoboken: Wiley Publishing, Inc., 2007), p. 49.).
    2) Sesame is “clearly one of the six or seven most common food allergens in the U.S.”.
    (Reference: Sesame Allergies on the Rise in U.S.: Sesame Seed Allergy Now Among Most Common Food Allergies, by Charlene Laino, available at http://www.webmd.com/allergies/news/20090316/sesame-allergies-on-the-rise-in-us ).
    3) The European Commission (EC) and the Canadian Food Inspection Agency both include sesame in their allergen lists. (Reference: Gangur V., Kelly C., Navuluri L. (2005). Sesame allergy: a growing food allergy of global proportions? Annals of Allergy, Asthma and Immunology. 95, 5.).
    Looking in at the FDA from the outside, it appears that FDA has not decided on standardized criteria that will be used to determine when additional allergens will be regulated using the authority granted in the FALCPA. Instead, from the references below, it seems that FDA is not prioritizing the risk that different allergens pose to the public health, and is too overworked and underfunded to do so.
    1) The 2005 Policy Advisor to CFSAN’s Director of the Office of Regulations and Policy stated that “We’ve got enough to deal with right now with the eight major allergens.” (Reference: Laura E. Derr, When Food is Poison: the History, Consequences, and Limitations of the Food Allergen Labeling and Consumer Protection Act of 2004, 61 FOOD & DRUG L.J. 65, 141 (2006).)
    2) In the prepared remarks of Dr. Eschenbach’s March, 2008 FDLI conference speech, it is explained that there are significant problems at FDA like a lack of “planning, precision, or prioritization”, a workforce that is “aging, volatile, overextended, and equipped with inefficient tools”, and that FDA may “fail in its mission to protect and promote the health of every American”. (Reference: Andrew C. von Eschenbach, M.D (Commissioner of Food and Drugs), Prepared remarks for “The FDA Amendments Act: Reauthorization of the FDA” speech, Annual Conference of the Food and Drug Law Institute (March 26, 2008), available at http://www.fda.gov/NewsEvents/Speeches/ucm051550.htm ).
    In many cases in which FDA is given authority by Congress, it would be both possible and helpful for FDA to explain to the public the criteria and decision-making processes FDA plans to use as it decided whether and when to use such authority.

  25. Philip in Silver Spring
    November 16, 2009 at 10:43 pm

    I believe the FDA can become more transparent to the public in three ways: 1) update the FDA website, including adding a more intuitive search feature, 2) provide useful, active links to the federal register and the code of federal regulations, and 3)design a web page providing users information on what new rules FDA has proposed, how to comment on those proposed rules and,where to comment on proposed rules.
    My recent endeavor to traverse the FDA website in search of Food Allergen Labeling information convinced me the FDA search engine is a black hole of information. Not only will you not find what you need, but you will be lured into clicking link after link of unrelated information.
    As a concerned citizen and student looking for information for a project, I needed to find specifics about FDA’s rules/regulations regarding food allergen labeling on food products. After two hours of searching I realized that FDA would greatly benefit from a single portal guiding the public to a list of all current notices of proposed rules with links to the actual Federal Register/Code of Federal Regulations text, along with links to current legislation.
    Not only would this type of summary page for each topic be helpful for students like myself conducting research, but it will also be a valuable resource for those who want to track the status of FDA’s role in public policy formation. Additionally, those wishing to comment on proposed rules and play a more active role in the rule making process would benefit as well.
    In FDA’s renewed commitment to crack down on deceptive food labeling (including the “smart choice” labeling on cereal), this experimental type of summary page, listing the notice of proposal/rulemaking time frame with active links, could become a great way to involve the citizenry.

  26. E-Cigarette
    November 19, 2009 at 4:22 am

    Why exactly is the FDA trying to create an image of transparency. What government or private organization pressured the FDA to do this? Its not very common for a government agency to willfully disclose all of its operations to the public. Seriously, can someone tell me who put the FDA up to this, and can anyone verify how we know this transparency act isn’t just a facade to create a sense of trust?

  27. pariuri
    January 13, 2010 at 8:46 am

    It would be best for the FDA to evaluate continuously what best meets their needs and to develop better ways of doing things. In this way, a process will evolve for accelerating medical solutions in an increasingly effective manner.

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