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

The Transparency Task Force’s Third 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 third question is:

 

What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information?

  • Internet tools?
  • Tools to improve targeting and effectiveness of communications, including risk communication?
  • Improvements to the Freedom of Information Act processes?
  • Other?

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

FDA Transparency Task Force

  1. Scott S
    June 18, 2009 at 9:42 am

    For one, the research provided to the FDA for a drug, biotechnology medcine or medical device should be made available via the National Center for Biotechnology Information’s PubMed website, especially after the U.S. Patent has expired.
    Incidentally, you should also be aware that since late 2007, scientists getting grant money from the National Institutes of Health (NIH) are required to to submit to the NIH a final copy of their research papers when those papers are accepted for publication in a journal. The NIH database then posts those papers, free to the public, within 12 months after publication. [http://www.ncbi.nlm.nih.gov/pubmed/%5D Taxpayers, who have already paid for the research, should not have to subscribe to expensive scientific journals to read about the results.
    As far as the FDA is concerned, the scientific papers and documents have remained hidden from public access, often for decades (or more) after a drug’s patent has expired and there can be no conscionable to keep these documents hidden from U.S. taxpayers, researchers and others. There should also be a policy of complete disclosure after patents expire.

  2. Scott S
    June 18, 2009 at 9:56 am

    By the way, the European Medicines Agency (EMEA) has documents listed under various headings and often in multiple languages, yet the FDA does not have comparable information on the very same drugs!

  3. Jane F. Rutter
    June 18, 2009 at 10:21 am

    All of the above ! ! ! And stop leaning so hard on alternative treatment. The only thing that helps is to keep the money flowing to the pharmacy giants
    Jane R

  4. Emily
    June 18, 2009 at 2:25 pm

    The Centers for Medicare and Medicaid Services (CMS) often hosts national provider conference calls and/or “open door forums” whereby providers can participate in a conference call style meeting on either a focused topic, such as the Physician’s Quality Reporting Initiative (PQRI), or hear general updates from the agency. Sometimes the agency will develop a slideshow that is downloadedable and providers and their staff can follow along. Once the presentation piece is over, the provider community/public can ask questions of subject matter experts. These calls are sometimes co-hosted with the professional medical socieites and sometimes CMS will host the cals on their own – it depends on the subject. These types of calls have served CMS very well. The transcripts from these calls are usually posted to CMS’ website so anyone who didn’t make the call can listen later. If FDA were willing to hosts calls like this, similiar to what they did when announcing the transparency initiative, it may go a long way in helping the public better understand what FDA does, as well as give the public a chance to ask questions and participate in FDA activities in meaningful way. Please give this idea serious consideration as it has worked well for those of us in the medical professional community and the provider communtiy who also monitor and work with CMS.
    In addition, it would be exteremely helpful if FDA could utilize internet streaming video/webcast applications for its drug and device panel meetings, so anyone who is unable to attend in person could watch and listen to the proceedings via the internet. The National Committee on Vital and Health Statistics (NCVHS) does this using the services of another government agency, the Department of Veterans Affairs. In addition, other quasi-government committees webcast their public meetings – for example, the HIT Policy Committee.

  5. Nancy Parker
    June 19, 2009 at 12:52 am

    For many patients, their best interface for drug information is the pharmacist. Doctors are poor communicators, and not many patients are motivated enough to search the Internet, if they have access at all. Getting more information in electronic printable form or in print to pharmacists will reach many people who will otherwise remain ignorant. Encouraging them to discuss this with patients is important because too many people DON’T READ LABELS OR INSERTS.
    More unbiased information needs to get to doctors, most of their ongoing “education” is drug company sales pitches thinly disguised.

  6. Melissa Langone, PhD, ARNP, CNS
    June 20, 2009 at 9:45 pm

    Since a large percentage of the population turns to the Internet as a source of information, creating a consumer website would be extremely helpful. I understand that the FDA already has a consumer website, but it really needs to be more user-friendly. As a health care provider, I find the site useful, but I think many people are turned off by the layout of the site. The site needs to be a place where people will turn to for information, think WebMD (where it is not just about the information provided, but how it is delivered). Once the site is user-friendly, it needs to be advertised and promoted as a source of reliable and helpful information.
    While, as I said, a large percentage of the population utilizes the Internet, there are those who do not have access. Alternative methods of communication are a necessity. With regard to recalls, If an individual is not reading or watching the news, he or she may not be aware that there is a problem with a particular food. The FDA should have a website for grocery stores where recall notices are posted. The grocery stores should be required to print the recall and post it in the area of the store where the product is sold, even if it has been removed from the shelf. If the product is simply removed, the consumer may just think the product has sold out and continue consuming a potentially contaminated product that is in their home.
    In addition, to allow for the prompt recognition of unsafe products, television scroll bars should be used to announce the recall. Having this information displayed on the bottom of the television screen during prime time hours would allow for a greater dissemination of important information.
    Drug and product recalls or changes in safety/efficacy of drugs and products should result in a consumer mailing regarding the product.
    If there is a local issue, such as isolated cases of illness from a particular restaurant, reverse 911 systems could be used to inform residents of the problem as well as a brief description of symptoms that may be experienced if consumption of a contaminated product had occurred and what action should be taken, if any. The same could be used to warn of local outbreaks of diseases.

  7. TSC
    June 20, 2009 at 11:05 pm

    1. Provide easy links to the FDA regulatory reviews of drugs. Maybe make industry to place a web link on their prescription information brochure to the corresponding page of Drugs@FDA and to any safety alerts.
    2. Make all FDA publicly accessible documents in searchable PDF format. Your recent advisory committees documents are searchable and that is nice. However, the drug approval documentation is not searchable, even for the most recent drugs, e.g. iloperidone. Allow (or make it easier for them, if it is allowed) Google to search all of your public documents. Somehow this feature is inconsistent. For example, when I search for a question from a recent PDAC “Has Seroquel been shown to be effective for the treatment of schizophrenia in pediatric patients ages 13-17″. Astra-Zeneca’s website comes up first. Some of the PDAC materials also come up but not the most important document — the clinical review.
    3. Encourage the FDA scientists to publish articles based on their regulatory reviews. It is important to provide a counterweight to biased publications from the companies. The public and most of the doctors will not trawl your site in the search for objective information, as I do. An example of such publication is a paper by Hammad, Laughren, and Racoosin on Suicidality in pediatric patients treated with antidepressant drugs (http://archpsyc.ama-assn.org/cgi/content/abstract/63/3/332) based on their PDAC presentation which has been immensely popular. It was cited 220 times! (based on Google Scholar)
    Another example of a less high profile work is a review on “Clinical Pharmacokinetics and Pharmacodynamics of Selegiline” by Iftekhar Mahmood (Clin. Pharmacokinet, 1997, 33, 91-102) and a series of works by the same author on the scaling of pharmacokinetics parameters from animals to humans. A similar review on a rejected drug or indication could avoid the legal issues related to commercial secrets. It could ostensibly be based on the publicly available trial data from companies’ websites but would require only minimal changes from the already existing internal review. At the same time, a standard disclaimer that it does not reflect the official view of the FDA would indemnify the agency.

  8. Matt J.
    June 21, 2009 at 2:42 pm

    I noticed you have links for Digg and Del.icio.us, how about adding some others such as reddit, stumbleupon, etc. Having some extras could help increase the dissemination of info to the public, as well as increase public response to issues.
    Thanks for all this effort to help the public, you’re off to a great start!

  9. Bray Patrick-Lake, patient
    June 21, 2009 at 11:43 pm

    •Establish in all FDA approved clinical trials patient voice starting from the period of trial design to the final FDA submission of trial results.
    •Provide a confidential blog-type mechanism for patients in clinical trials to communicate directly with a patient advocate at the FDA similar to the idea of an interactive MedWatch, thus collecting valuable insights and feedback that may not be gleaned from patients during the regular clinical trial monitoring process. Patients could be given a unique code of access to an FDA moderated website upon enrolling in trials.
    •Require the establishment in trial protocols a visible plan of response to poor outcomes, including what type action will be taken and when. The current generalized sponsor statement “we will provide you care” has proven to be insufficient.
    •Print a patient-friendly brochure to be distributed during the pre-enrollment of all clinical trials that clearly articulates patients’ rights, identifies appropriate routes to address concerns, and visibly illustrates how patients can become partners with the FDA in the development of new medical therapies.
    •Encourage the release of all data obtained in clinical trials even if the trials are not completed and device companies are protected under the current loopholes of the law, so as to allow the American public the ability to make more informed medical decisions.

  10. Bray Patrick-Lake
    June 26, 2009 at 9:16 pm

    I don’t know Melissa Langone, but I think you guys should hire her. She has lots of good things to say. As for her idea about the consumer website, I completely agree. Additionally, the language of the website should be in the casual register instead of the formal register. Try moving away from a stodgy, government-type website toward something fresher and more engaging in feel.

  11. June 29, 2009 at 1:38 pm

    “What tools, techniques, processes, or other mechanisms should FDA use to be more effective in providing useful and understandable information? Internet tools?”
    I think a very effective way for the FDA to get real-time collaboration from the public would be the creation of a wiki. Users can edit, suggest, comment or just read the available information.

  12. June 30, 2009 at 9:47 am

    There used to be two categories of media – earned and paid. Today there are four – earned, paid, owned (Web site) and shared (social media). In the fourth category, the FDA has taken absolutely no action in spite of the fact that it is a primary means of disseminating news today. While FDA has a small Twitter presence and a disorganized YouTube presence, it does absolutely no online editorial outreach to bloggers. The agency would benefit greatly by developing such relationships, just as one would with reporters.

  13. Susan J. Bliss, RPh, MBA
    July 17, 2009 at 9:38 pm

    The website is greatly improved, much more readable now and FDA is headed in the right direction! I would add a clear site map of the website–reviewed and market tested by a group of physicians, a group of pharmacists, a group of nurses, and members of the public–to ensure that readers can find what they seek.
    FDA could create a “road show” to take to all major medical, pharmacy and nursing conferences, providing some CE content and Q & A sessions. Information presented could include: navigation/teaching how to use the website, disseminating the latest information, and collecting input from practitioners.
    Some instruction for mid-career practitioners on how to set up and receive pod casts, RSS feeds, etc. would be sensible.
    More internships and experiential rotations for students, in communications (not just technical issues), and hiring more communications professionals with journalism training would also help to ensure clarity (although the current communications staff is excellent!).
    Finally, the new website and move towards transparency makes it clear that FDA is our partner in patient care. Thank you!
    Susan J. Bliss, RPh, MBA

  14. Colon Cleanser
    December 12, 2009 at 3:32 am

    the European Medicines Agency (EMEA) has documents listed under various headings and often in multiple languages, yet the FDA does not have comparable information on the very same drugs!

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