The FDA NDA dates can change; yet the FDA does not post any information to the public what the new estimated date will be... With Transparency, if the FDA would post these date changes; it would help the investor community.... We have seen multiple attacks by reporters making comments and suggestions as to an outcome.... without any basis to draw their basis of thought. The FDA just by posting the new estimated dates would help.

Why should the FDA be allowed to hold companies and their investors hostage just because they can't get their act together? I think at a minimum the FDA should be required BY LAW to provide a public reason as to why they delay approval decisions, how hard is that? I am not asking for the world, but I think in the fairness of transparency they need to be accountable for why they are so slow with our tax dollars at stake. No matter how sublime the reason!

I was think FDA TV, a cable channel focused on FDA issues, perhaps partnering with sister agencies, CDC, for coherent message regarding public health-e.g. H1N1 will return this fall and having an FDA cable channel as a source of information to all USA would be great. You could also create FDA101, FDA102, FDA103 courses to educate people about the complexity and issues (risk/benefit) that are so important to all.
I would recommend new resources for a television production team to create a new FDA cable channel followed by courses to educate. Huge variety of good things could come from FDA TV.

1. First, a few housekeeping items.

a) The link to the meeting agenda (http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm168618.htm) in your posting is broken.

b) Steaming video is a good format for the immediate communication, but it is not the most convenient format for archiving a 5-hour meeting. I would hope that providing a transcript should not be very difficult as you already have the transcript in the streaming format under the video.
c) Dr Grifo was omitted from the list of participants on Panel 2 on the meeting website http://wpc.0172.edgecastcdn.net/000172/fda/062409/FDA062409archive.htm#.

2. Jeffry Francer from PhRMA on the first panel was very good, and I would like to echo his sentiment that FDA’s drug approval process is already quite transparent.

3. Panel 3 was the strongest and the most interesting to me. I was pleasantly surprised that they repeated many of the concerns I already raised in this blog. Ms Patrick-Lake came across as a very intelligent person, and I hope there will be a place for her as the patients’ representative on the cardiac advisory committee. It was interesting to watch the exchange between Dr Sharfstein and Mr Findlay of the Consumers Union. Dr Sharfstein appeared to be surprised by Mr Findlay’s assertion that the current laws give the FDA enough authority for a fuller and earlier disclosure of pre-clinical and clinical trial results. In response to Dr Sharfstein’s questions Mr Findlay insisted that there is no need for legislative change. Strangely, FDA’s Counsel Jack Sanger, who was present there, did not comment. That raises questions about the readiness of FDA Legal Department for the impending change.

4. The apparent lack of mutual understanding between the freelance journalist Ms Foxhall from panel 5 and the FDA officials was a good illustration to the usual media complaints about the FDA as a “black box”. It did not help Ms Foxhall’s case that she did not clearly formulate her wishes. It seems to me that Ms Foxhall desired that middle and lower-rank FDA officials would be more available for “unofficial” and “off-the-record” comments to journalists without the involvement of the Press Office similarly to the more political parts of the Government such as Office of the President. I do not know how realistic that is, but something could certainly be done in that direction. By their inclination, journalists are ready to take the side of the FDA in any regulatory action that protects the public. So what that they like to have access and to be pampered and cultivated? It is relatively easy to do that, and it pays large dividends. For example, Economics Nobelists and pundits Paul Krugman and Joseph Stiglitz were scathing about President Obama’s economic policy until they were invited to meet the President and his economic advisers. After the meeting Krugman and Stiglitz have actually become quite supportive.

I will try to write something about the following panels later, as I watch the video.

If you have only 15 minutes to spare, watch the panel 6 discussion.

You will see that not only consumers (Ms Patrick-Lake, panel 2) and freelance reporters (Ms Foxhall, panel 5) but also the established and respected non-profits are frustrated with the almost complete absence of response to their inquires from the FDA. The FOIA requests are so often ignored that the National Research Center for Women (Dr Zukerman) no longer bothers submitting them. If the there is a reply, the information may be redacted so drastically as to render it unusable (Dr Lurie from Public Citizen). Once upon a time, a request to the FDA from a member of Congress could turn up the necessary information, but in the recent years even letters from key members of Congress were ignored (Dr Zukerman). In response, the FDA representatives Drs Durnham and Cook seemed to agree that there must be something wrong with the agency policy and indicated that things are changing – an important and encouraging sign.

It is uncanny that both Mr Francer from PhRMA (panel 2) and Dr Zukerman from National Research Center for Women insisted on the same thing. When the FDA decision to approve or reject a medication/device contradicts the decision of the advisory committee and other information available from the FDA, there must be a detailed public explanation.

Drs Zukerman and Lurie also raised a few of the points I brought up on this blog. More information should be available on drugs during the pre-approval process and for rejected indications. A new balance should be found between the public interest in disclosure and the commercial interest in secrecy. FDA scientists should be encouraged to publish their own analyses as to counteract the publication bias from the sponsors’ publications.

Other press and blog coverage of the Transparency meeting.

*** A positive post on the meeting from OgilvyPR blog:
"[They have been] demonstrating a willingness to listen that many are unaccustomed to receiving from the FDA. Most importantly, they heard the criticisms from yesterday (for the most part) without feeling the need to get defensive or justify things they are currently doing.
On more than one occasion during the session members of the task force asked for opinions, guidance and help from those presenting. It was a telling moment that will likely do more than anything to reduce the perception of the FDA as a closed organization."
Read in full here http://blog.ogilvypr.com/2009/06/signs-of-hope-for-the-transparent-future-of-the-fda/

*** A balanced but cursory report from WSJ, see here http://online.wsj.com/article/SB124588492308150255.html

*** A review from an anti-pharma blogger, who concentrated on critical comments. The most notable quote:

"One ex-FDA reviewer recommended that all new molecular entities have advisory committee meetings in spite of their problems. Dr. Sharfstein probed this and it was suggested that when FDA reviewers can't speak and all the questions are answered by industry or FDA senior people, a different picture may emerge. However when reviewers who know the data are allowed to speak, the committee members can get more nuanced and detailed answers which they can probe and in that reviewer's experience this in one case he was involved in changed the likely Advisory Committee "yes" vote to a "no" vote by the Committee."
Read in full here http://shearlingsplowed.blogspot.com/2009/06/salmons-insights-on-yesterdays-fda.html

The new transparency committee would be wise to reevaluate how it deals with investigations of drugs.The investigation into adverse reaction reports could be better handled by the media, if the FDA would be more transparent in their communicating how to report adverse reactions.When an Early Communication is released it is vague on the FDA"s end to say the least.That leaves the door wide open for the Pharmaceutical company to spin the tale of how rare the events that warrented the Early Communication are.Well, the FDA could be more precise in releasing their statements in regards to how important postmarketing reports are to evaluating the drugs.Even if the drugs have been on the market a long time, some side effects get treated as primary illnesses and go undetected.Stressing this important information can be key to stepping up the role the FDA is suppose to play in public safety.

i like it. nice post,thanks " Erik P. Mettler, MPA, MPH "