FDA’s Warning Letter Database – Has Any Progress Been Made Since the FDA Website Update?

Some time ago, we highlighted the issues that we had been facing searching FDA’s Warning Letter database in the new FDA website (FDA’s Website Re-Design – Did Something Get Left Behind?).  We wanted to give you an update as to where the current status of this is.

Since drafting this post, we received some email from other “super users” of this database shortly after publication of our blog post, letting us know that the Closeout Letter column was back (yay!), but unpopulated (not helpful!).   At the AAM GRx+Biosims meeting in November 2019, we were lucky enough to run into a Health Communications Specialist and tell her about the situation.  She forwarded our communications with the CDER Ombudsman to a Government Information Specialist in the Division of Freedom of Information, who submitted our request into the Drupal team, and was advised that it was in development.  This final interchange was dated November 6, 2019.  So where do we stand today?  Has the Warning Letter database search functionality been restored?  The answer is, yes and no.

While it is true that a Search field is added back, and that it DOES search through more than the name of the firm that received a Warning Letter, unfortunately, it still does not search through the body of the Warning Letter.  This was demonstrated by looking for “OOS”, an issue near and dear to the FDA (especially invalidating OOS investigations without scientific justification!). Judging by presentations by FDA about their focus on this issue, the Warning Letter database should be rife with references to OOS.  However, this is not the case.

Searching for “OOS” in the search bar, we get three results.  From a quick review of the results, one hit had OOS as part of the name of the company, and the other two had “Tattoos” as the product type, in the header, before the body of the Warning Letter.

So, FDA has gotten further down in the record than the name of the company, but only so far as the product type!

So, dear readers, we aren’t there yet.  We hope that the Drupal team keeps working hard to move the Search field down through the Recipient fields and Issuing office sometime soon, and maybe we will be able to search through the actual content of the Warning Letter by this time next year!