By Len Monheit
If you build it, will they come? One would hope so – at least judging from the complaints about inefficiency, confusion and chaos in the current FDA NDI docket system.
I’m speaking about the searchable New Dietary Ingredients (NDI) database officially launched earlier this week, a collaborative effort between the American Herbal Products Association (AHPA) and NPIcenter. (http://ndi.npicenter.com/ )
For those of you who have never been on the FDA docket (http://www.fda.gov/ohrms/dockets/dockets/95s0316/95s0316.htm) for NDI’s (the website where the correspondence is posted), it’s probably worth a visit. There have been about 300 filings in the years since DSHEA was passed, so there is quite a bit of correspondence (back and forth and back again) with the eventual results being that some of the filings have been accepted by the FDA, while others have not. Getting to view and understand the outcomes has been a challenge, as has the navigation of the dockets in general, as submitters and potential submitters try to find out whether a company has been successful for a particular ingredient, what FDA feedback and concerns have been, and noting any patterns or trends. This information has simply not dropped out of the docket system.
In 2004, AHPA president Michael McGuffin and General Counsel Tony Young published an in-depth review of the NDI program through its first ten years in the June 2004 edition of the Food and Drug Law Journal. This analysis of the docket brought home the poor success rate in NDI filings, as well as the fact that a better system of organizing and presenting the information could save time and money, and perhaps even increase the rate of successful filings.
Mission: Build a searchable database
Over the past many months, the docket data has been evaluated and reorganized, outcome statements have been written and the infrastructure for a searchable database has been constructed.
As of this week, viewers can now easily locate individual notifications by searching for key terms including the generic and brand name of the NDI itself and the Latin name (genus) of herbal NDIs, as well as the name of the submitting firm or their counsel or other consultant or the report number assigned by FDA. AHPA has prepared an “outcome statement” for each notification to provide a short summary of FDA’s response to the submission, and the Database also provides direct links to all of the documents that make up an NDI notification, including all communications between the submitting firm and FDA and any attachments that have been made publicly available.
Earlier this year, FDA solicited comments on the NDI system, and indicated that the NDI submission process was of high importance. Industry groups responded to the comment request and the dialogue is ongoing. The importance of proper submission of New Dietary Ingredient notifications can only increase. Theoretically, the database should be a practical and useful tool for compliance. The data organization and construction of the searchable database also represents a proactive step on the part of industry in efforts towards self-management and compliance. One would think that ongoing use of this resource would fall into the same category.
Access to the database does require a subscription. (A special rate applies for AHPA members.) If it increases the probability of a successful filing by 5%, or shortens the time to successfully file by even a few weeks – well, how much is that worth?