Ground Rules for June 24 Public Meeting on Transparency
- This public meeting is about transparency at FDA, how the agency can make understandable and useful information available to the public. Comments should be limited to this topic.
- Comments should be limited to 5 minutes to permit adequate time for questions from the panel and to allow time for an open comment session later in the day. During the open comment session, attendees who did not register to speak can make comments.
- Registered speakers will be organized into panels of three. We have attempted to group registered speakers thematically, based on the brief description each speaker provided when he or she registered to speak. Admittedly, this is an imperfect science and speakers in some groups may be speaking on different topics.
- FDA panelists may ask questions to the panel after all three speakers finish delivering their comments.
- We are looking forward to a respectful discussion and exchange of ideas.
- Under no circumstance shall a speaker be interrupted by another attendee at the conference.
- Personal attacks or disparaging comments will not be permitted.
- Comments to the panel should be made only when at a microphone and you have been recognized by the Chair of the meeting.
- The public meeting is being webcast and there will be a verbatim transcript of the meeting publicly available. Do not share or reveal information you would not want to be public.
- In addition to the public meeting, there are other ways to provide comments to the task force. You can post comments to this blog, submit written comments to the Division of Dockets Management, or submit electronic comments to Docket No. FDA-2009-N-0247 at www.regulations.gov. Information about submitting comments to the task force can be found in the June 3, 2009 Federal Register Notice.
We look forward to your participation at the public meeting on June 24.
Afia Asamoah, JD, MPP
Public Meeting Coordinator
It would be helpful if FDA could be more accurate about approval dates, and more specifically delays. Example at present: Hemispherx BioPharma, Inc (HEB) was due for an FDA approval/rejection decision for their drug Ampligen by May 25th. FDA then advised HEB via phone that there would be a 1-2 week delay, due purely to staff restructuring. It is nearly a month later and still not a word from the FDA. BDSI is in a similar position.
This has caused havoc with shareholders and has effected most in a negative manner, both by keeping capital tied up and by increased speculation that the drug will not be approved. This is also directly harming the company itself as they cannot take further steps in manufacturing plans, sales etc. In addition there is a shareholder meeting on the 24th of June with some issues being voted on that will be based on the FDA decision. Shareholders cannot make informed choices otherwise and could very definitely be adversely effected.
While I acknowledge this is not the FDA’s responsibility, it is however a direct result of the FDA’s actions (or lack thereof). If you advise 1-2 weeks delay, stick to it, or at least update accordingly!
Your last sentence was so true!
I would like to access the webinar for this meeting. Please provide a link for this.
Thank you,
Jaymie
FDA is an agency of US government and it is paid and supported by Tax payers.
FDA should have strict rules with specifically delineated deadlines for companies in releasing the DRUG approval or denial decisions in a timely manner. If drug approval decision is kept confidential between FDA and the particular pharmaceutical company then the taxpayers including the company’s investors are in a way excluded from the impact of these decisions. In some instances, investors (in this case tax payers) can be victims of stock news related manipulations which can lead to unreasonable amount of money in their investments.
When a investor loses money used to support a particular pharmaceutical company’s research and development the eventual loser in the US government with decreased TAX revenues!
FDA must regulate the time line for public release of news related to new drug approvals and denials to allow more transparent drug approval process!
Can you please provide a link for the webinar for this meeting
I agree with this: “It would be helpful if FDA could be more accurate about approval dates, and more specifically delays”
I am looking for a link please
Have the FDA ever really helped anyone
When a investor loses money used to support a particular pharmaceutical company’s research and development the eventual loser in the US government with decreased TAX revenues!
FDA must regulate the time line for public release of news related to new drug approvals and denials to allow more transparent drug approval process!
When is the next one?
Another public meeting has not been planned.
It was interesting to know the results of the meeting.
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