For those of us in the regulated industry, we rely on FDA’s website for many different things. FDA.gov has historically been not the most intuitive website, with all of the Centers running their own pages, and inconsistencies occurring as a result of having many “chefs in the kitchen”, as the saying goes. On April 26, 2019, FDA launched a new website. In some ways, the new website is great; critical information can be found on the landing page, pages load much faster, and the graphics are higher resolution. However, we recently discovered a glitch in the re-design resulting in a huge difference in search functionality between the old website and the new one and wanted to notify our readers.
In the consulting business, it is very important for us to keep an eye on FDA’s directions with regards to enforcement actions. As a result, we pay a lot of attention to the Warning Letters database on FDA.gov. Every week, we (actually, me) at Lachman download the Warning Letters that FDA uploads (every Tuesday, in case you didn’t know that). We analyze them, parse out the data, and we use this information in industry presentations, in client strategy sessions, and in business development. In addition, when we are looking for overall trends in enforcement, it is important to have not only the full text of the most recent Warning Letters at our fingertips, but to be able to review historical enforcement actions going back a few years, for specific terms (I’m looking at you, OOS investigations). That way, we can know for sure that what we thought might be signal is, in fact, that.
However, since the relaunch of FDA.gov, on the Warning Letters landing page, the search function no longer works. I am showing an example in the snip below, where I am searching for the phrase “data integrity” in any Warning Letter given at any time by any issuing Office.
Those of us in the industry who pay attention to enforcement actions know that there are likely at least a hundred Warning Letters mentioning “data integrity” in their body, but the new search functionality no longer picks them up. It appears that, with the re-design, there was a change with regards to where in the record the search looks. I do not believe that it looks through the body of the Warning Letter any longer, and, I believe, looks only at the name of the firm. We have seen this when we do a search for the term “China” in the new Warning Letters database. There are hundreds (if not thousands) of Warning Letters across all of the Centers given to manufacturers in China, yet this search gave me only 2, and they both have the term China in their company names. (Try it for yourself and see.) If the search was looking in the body of the letter, which includes the address, it should have picked up many more Warning Letters, but it did not.
We have communicated this issue to FDA, and they have been very responsive. I am sure that they will work with the designers of the new website to fix the underlying issue, and that all of the data that was available on the old Warning Letter website will be migrated over to the new one, and we in the industry will once again have access to a very valuable historical resource. After all, the phrase “how can you know where you are going if you don’t know where you have been” applies to enforcement actions as well as real life!
Have any of our readers noticed any functionality changes with FDA’s new website? Write to us and let us know!
