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

The Transparency Task Force’s Second Question

We want to know what information FDA could give to the public to better explain the agency’s work and its decisions. The second question is:

What specific information should FDA provide about agency operations, activities, processes, and decision making, including:

  • Enforcement Actions?
  • Product Approvals?
  • Recalls?
  • Other Actions?

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

FDA Transparency Task Force

  1. Henry Brown
    June 14, 2009 at 5:50 pm

    As a minimum, would suggest the first 3 and a POSSIBLE additional one would be the “meeting minutes” for the first 3

  2. german
    June 15, 2009 at 3:57 pm

    (Product Approvals)
    I personally think that all drug approvals (Branded and Generic) should be made available for Drugs (and to whatever extent possible for biologics). I think it is very beneficial for the public to be able to read the medical reviews (covering the safety and efficacy). It should also include any recommendations for studies made by the FDA and any correspondence from Drug sponsors that offer contrary opinions to FDA recommendations. In summary, it should include information that the public can review and see what specifc actions and steps the FDA has taken to ensure that the products are safe and effective for use in the general population. It should also include any review of the risk versus the benefit analysis. Since some of this information is supposed to be available on the Drugs@FDA website, this transparency measure could benefit from adequately supporting this initiative.
    (Enforcement Action) Since Warning Letters are available at the Freedom of Information webpage, listed by company and date, there doesn’t appear to be any improvement over that transparency measure, although, often times the company’s or sponsor’s response is not available to determine how the the company addresses the issue, unless there is a repeat offense.
    (Other Actions) Once the regulated product has left the sponsor’s warehouse/company warehouse, there is little transparency into how the products are handled at their intended destination (hospital, outpatient center, pharmacy, etc.) It would appear as though many administration errors occur at the point of use, regardless of the initiatives taken by the company/sponsor. The regulation of the ‘drug’ (biologic and device) companies can only do so much. What measures does the FDA have in place to highlight problems that arise in the healthcare workplace?

  3. Joelle Godfrey
    June 15, 2009 at 7:30 pm

    – I would agree with the previous comment.
    – Please also include rule changes – such as the recent rule change away from the Declaration of Helsinki to guide clinical trials outside the country to the Good Clinical Practice standard.
    – If any of this is appearing on CSPAN that also would be good to know ahead of time.

  4. TSC
    June 18, 2009 at 8:51 pm

    Your drugs@FDA is an invaluable resource and a great help in writing independent drug reviews. Because of the publication bias for company-sponsored trials, the FDA is the only source of objective information on new drugs. However, I would like to suggest the following improvements to your drug approval information.
    1. Until very recently the approval information on new and generic formulations has not been available online. But I notice that you began filling up these lacunae. For example, in January 2009 you added the full approval package on Zelapar (new formulation of Selegiline, NDA: 021479). Please keep up this important work.
    2. The information on the basis of approval for new indications and new patient population is often not available. For example, the medical review for the recent approval of Lexapro (NDA 021323) for adolescent depression is not available online; only the new Label and approval Letter are available. Surprisingly, Forest Labs is more transparent and provides summaries even for unpublished trials that formed the basis of approval (see studies SCT-MD-15, SCT-MD-32 and SCT-MD-2 at http://www.forestclinicaltrials.com/CTR/CTRController/CTRCompletedListStudies). As a result, in an online discussion I was forced to base my defense of your decision to approve Lexapro for adolescents on Forest’s data (see my comment signed TSC here http://www.furiousseasons.com/movabletype/mt-comments.cgi?entry_id=2166). I rather use a more authoritative and reliable FDA review.
    3. This may be harder to address then the first two points. I would hope that the FDA could provide more information on its reasons for a non-approval of an existing commercial drug for a new indication or population. This could go a long way in limiting off-label prescription for such a rejected indication. While companies may argue that this is a commercial secret, the society has an overriding interest in preventing harm from prescribing a drug for inappropriate population or indication. A case in point is the side reactions that resulted in a withdrawal of duloxetine application for SUI. The FDA position was a PR disaster (see for example an article entitled “Was Traci Johnson driven to suicide by anti-depressants? That’s a trade secret, say US officials” in The Independent http://www.independent.co.uk/life-style/health-and-families/health-news/was-traci-johnson-driven-to-suicide-by-antidepressants-thats-a-trade-secret-say-us-officials-494637.html). While the FDA site does not give out any information, Eli Lilly provides detailed summaries of all clinical trials of duloxetine for SUI here http://www.clinicalstudyresults.org/search/?company_id=8&drug_name_id=316&r=1&submitted=1&page=1. Again, I trust the FDA much more than Eli Lilly and would prefer to use FDA materials when writing a review on duloxetine.

  5. Nancy Parker
    June 19, 2009 at 12:46 am

    ALL trial data, whether positive, negative, or neutral, should be made publicly available. Companies should not be allowed to withhold or “spin” data to make drugs look better than they are.
    Recent actions treating foods and nutrients as “unapproved new drugs” just because they are good for human health are ludicrous. Nature took out the patents on those items a long time ago. If you had to explain yourselves fully to the public on these actions, just how would you look?
    We will never control health care costs in this country until we learn to use the simplest tools first and that means diet, exercise, rest, etc. Quit fighting our best hope!

  6. Sue
    June 20, 2009 at 3:26 pm

    We should be able to search your site by product name (all names), product category (such as drug classification), and enforcement actions (such as all recalls, most recent first).

  7. Sara, Heart Implant Patient
    June 22, 2009 at 1:37 pm

    I think the FDA needs to be more transparent about how it decides which drugs or devices it approves for use by the general public. I have a specific example. I would like to know why heart implant devices have still not been approved for Patent Foramen Ovale (PFO) closure. They have been approved for another type of “hole in the heart,” the Atrial Septal Defect (ASD), but not for PFO closure. As a heart patient, I would like to know why not. I know there have been several trials done and I would also like to know where one could find the results of these studies in a user-friendly format. Additionally, I would like to know why approval takes so long for certain conditions and not for others, as exemplified once again by ASD closure vs. PFO closure. I am perplexed by the lack of approval of heart implant devices for PFO closure and I would really like to know why this is. Is there a purely medical reason or is there a profit-loss motive involved?

  8. Robert Pestronk
    June 23, 2009 at 6:55 pm

    I’d like to suggest disclosure to local health departments of the names and addresses of retail and wholesale businesses involved in voluntary food recalls. This information is not now routinely available from FDA or other sources and epidemiological investigation and other follow up in local communities by local health departments across the country would be greatly aided if this information were quickly available.

  9. Angela Davis
    July 1, 2009 at 11:12 am

    I dont understand how companies like discovery laboratories can spin shareholders for months on approvable letters and fda meetings that cant be access. Until this is changed, there is nothing transparent about the process. At least, shareholders should know when the minutes of meetings are typed. 30 days is too long to wait for typed minutes. This is a contradiction to the SEC regulations on making information known to the public in a timely manner. Deals are being made on information that is withheld from shareholders. The common shareholder is being squeezed. The guidelines governing the availability of this information cant event be located on the FDA website.

  10. July 5, 2009 at 11:09 am

    Following suggestions relate to food and feed
    1. All EIRs should be made available on-line automatically and in a timely fashion (with proprietary information deleted, of course) so that consumers can inform themselves of the compliance history of companies whose products they are considering purchasing.
    2. Genetic fingerprint results of all outbreak-related isolates should be made available on-line.
    3. ORA Import refusals should be searchable data base. The new format is not useful at all. One should be able, for example, to search the refusal database for “Salmonella” or multi-year by country. The refusals should not be limited to the most recent 12 months only. Historical data should be readily available.

  11. Acai
    September 27, 2009 at 6:35 pm

    I agree for the most part with the suggestions provided above. It think that in general people are unaware of the process a new product needs to go through with the FDA to being approved. There are also a lot of misconceptions about the benefit of FDA approval in general. Many products non-drug related are being sold online without FDA approval and many of these companies are touting that it is irrelevant, because the ingredients themselves are approved by the FDA. This can lead to some false assumptions being made on the part of the consumer. I know the FDA is cracking down on some of the claims being made, especially online, but more awareness is still needed to safeguard the consumer. Thanks letting us make these suggestions!

  12. Karen P.
    October 8, 2009 at 4:09 pm

    The investigative Chicago Tribune article “Children at risk in food roulette: Mislabeling, lax oversight threaten people with allergies” by Sam Roe shows that FDA needs to share more information with the public regarding undeclared allergens in food.
    The public should be notified of all recalls for products with undeclared food allergens.
    Even if there is no official recall, if FDA confirms that there are undeclared allergens in a product (food, drug, etc.), this information needs to be shared with the public.

  13. Resveratrol
    December 12, 2009 at 3:45 am

    It would appear as though many administration errors occur at the point of use, regardless of the initiatives taken by the company/sponsor. The regulation of the ‘drug’ (biologic and device) companies can only do so much. What measures does the FDA have in place to highlight problems that arise in the healthcare workplace?

  14. September 24, 2010 at 10:28 pm

    I don’t totally agree on the post, but regardless a very well written post – I’ll link back from my Robert Zapppone blog in the links area on my next blog post

  15. Dr.Schwartz
    December 9, 2010 at 3:31 pm

    Thank you for this helpful information!

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