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Transparency to Regulated Industry: How Can FDA Improve Its Guidance Development Process?
The Task Force is collecting information on how to improve FDA's transparency to regulated industry. We held three listening sesions with members of regulated industry on January 21, 27, and 28. Transcripts and summaries of those listening sessions are available online and we are seeking comments from the public on the issues raised in those sessions, or other suggestions related to FDA's transparency to regulated industry.
Our next question is:
What changes, if any, should FDA make to its guidance development process?
We look forward to your ideas.
Transparency Task Force
What to do to increase transparency? A series of mandates must be enforced. FDA needs more authority in terms of ordering recalls on products of jurisdiction and requiring inspection information (whether negative or positive for Salmonella/ E-Coli…etc) from slaughterhouses, processing factories, manufacturers, and other companies. The FDA needs more experts and personnel to enforce the mandates. FDA needs its inspectors and attornies’ presence in establishments with previous bacteria/virus outbreaks. Communication with the FDA must be mandated. Often times FDA will rely on a company’s State Department of Health regulations and procedures to carry out the necessary precautions or even punishments.
And Congress is the legislative body who may grant FDA its wishes. It just breaks my heart that major actions take place in the wake of some nation wide epidemic or bacterial infection. Congressmen are not necessarily scientists or experts in the field of public safety but we must catch their attention. Mandates of communication and unveiling of the inspection results will bring about transparency.
I agree with the above comment, although, I believe the FDA already has the authority. I believe that the FDA (and this really is not based on fact that I can reference) takes politics into too much consideration. Really, I also believe the FDA is doing their job well. Making sure the public is well informed of these new “cure-all” drugs’ side effects that take longer to list then what the drug actually is supposed to do. There really is not much critisizm that I can give..
Hmm i agree with the first post on FDA needs more qualified personal on their side. The more people they have running on the field the less the chances are of a disaster. My 2cents of thought
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I don’t completely 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
I think it needs to improve its transparency. FDA needs to communicate more and better.
Mandates of communication and the unveiling of the inspection results will or should bring about transparency.
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Yes i agree that the FDA will require greater authority in order to impliment changes that will result in greater industry transparancy.
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