Your chance to comment!
If you or your company is in any way affected by the way the FDA handles your pre- or post-approval activities, then you should be interested in the information technology plan that it plans to use over the next five years.
The draft plan was released on December 27th, 2007. Comments are due to the FDA by Friday, February 22, 2008. The Docket number for this plan is 2007D-0481.
Having read this 37 page document, I can tell you that it will be no easy task to either understand what they want or to collect your thoughts. Never the less, submitting your comments should be a priority. With this post, it is my intention to make it a bit easier to get through the comment process.
First, here are the relevant links:
As a background primer, take a look at the FDA Strategic Plan. This is optional reading but helpful.
For the Docket itself, go to the PDUFA IV Information Technology Plan. This is the PDF version.
Next, to submit your comments, choose one of the following methods:
- Send a printed document to: Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852
- Fax comments to: 301-827-6870
- Call the FDA public room for assistance at: 301-827-6860
Make sure you put the Docket Number on the envelope or the fax cover sheet in big bold letters!
Unfortunately, there is no way to submit your comments electronically. At least, not for this docket.
What to Comment On
As I noted in my introduction, it is difficult to tell what types of comments the FDA is looking for. For example, there is no section specifically written to give the reader any guidance. Even the due date for comments is missing!
To confuse matters further, the document gives a lot of historical information mixed in with the future plans. Then, there are plans that are specifically related to PDUFA and others to broader FDA IT strategies and plans. I, for one, can't figure out whether they want comments on everything or only on the PDUFA related plans. Based on this confusion, I would suggest that the field is wide open and you should comment on anything that strikes your fancy.
The document is also divided into two major parts: Pre-market Activities and Post-Market Activities. As the Docket tells you, this is somewhat of an arbitrary division since the FDA is striving for inter-divisional synergies and will prefer to implement common processes and systems as much as possible.
A Summary of the IT Initiatives
A more important division is made between technologies and standards. Here again, the reader must keep in mind that the standards will be implemented using information technologies. You will thus need to determine for yourself how the standards will impact FDAs current and proposed systems.
Related to the above is the most important table in the document which I am reproducing here:
Please click on the image to see a larger version. To see it in a separate window, hold the CTRL key while clicking.
Since you will find it hard to read this table here, I suggest that you open the PDF file referenced above and go to this table on page 33.
In brief, this table maps the proposed systems and standards against the FDA IT and Drug Safety goals. If, for example, you are interested in the MedWatch adverse events submission system, then the table will tell you to read sections XIV A.1.g and VIII A and D.
Systems and Standards
The IT plan presents several tables that enumerate the key systems and standards initiatives that fall under PDUFA IV. I found these tough to read and inconsistent in presentation. For example, planned release dates are given for some of the systems but not all of them. Some initiatives have very specific goals while others are very vague (to put in kindly). Dates for most of the standards initiatives are not given at all. Just to get my head around the list of initiatives, I created a spreadsheet for myself that you can download here: fdapdufa_iv_it_plan.pdf .
If you look at the spreadsheet, you will note that they are now in alphabetical order. I have also streamlined the text and tried to make it easier to see when the specific goals are intended to be completed. Since I took editorial license, please remember to check the original FDA document to get the whole story.
Strategy and Process
The IT Plan is encouraging since the FDA has recognized that systems should only be implemented once you have a strategy and have understood and defined the required processes. This approach has to be tempered by the fact that the FDA already has systems in place or are in the middle of developing them. So, the reality is that the new thinking and approaches to information systems will be tough to apply to the initiatives that have already left the station.
With that as a preamble, it will be important for you to review the future state architectures that are also included in the plan. For example, you will find before and after diagrams for "Pre-market Submission Tracking and Archiving" (page 19) and "Post-market Submission Tracking and Archiving" (page 27).
I should also mention that reading pages 3 - 7 will give you the context within which the IT initiatives are being performed. The tough part here will be to determine which statements are important and relate to the specific initiatives discussed in the rest of the document.
Where to from here
For a moment I was tempted to give you some of the comments that I plan to submit to the FDA. I quickly changed my mind since focusing on them right now would further delay my pushing the PUBLISH button on this blog post.
It's my fervent hope that you will take it from here...