Q1 2009 AERS data released today

FDA released the Q109 AERS data today.

Initial upload into FDAble looks like everything was okay.

Interestingly, there are ~111,000 reports in this release compared to ~121,000 for the previous quarter. Not sure how significant this decrease is (is it seasonal? is it just noise? is FDA weeding out duplicates?). Will take closer look later....

FDA Responds about its warning letters search engine

Got this from "Webmail (L)" today. Love the personal touch. If I had to guess, some contractor who is now long gone implemented the actual warning letters search engine and now they have to either get that person back there to fix it or try and untangle someone else's spaghetti code themselves. Just a guess, but probably not fun for them either way.

Mr. Danese,

Thank you for your feedback. Our technical team is working hard to
resolve the remaining issues. Thank you for sending us emails about the
problems you encountered. We expect them to be resolved very soon.
Please don't hesitate to contact us when you have a question, suggestion
or any issues with our site. We are constantly working to improve the
site and appreciate your feedback.

Thank you,
Webmail (L)

The Food and Drug Administration isn't able to reliably determine how much money it needs

WOW. Sister-in-law sent this to me...

By JENNIFER CORBETT DOOREN

WASHINGTON -- The Food and Drug Administration isn't able to reliably determine how much money it needs to regulate medical products because, among other things, its staff can't track all the adverse-event reports it handles, according to the Government Accountability Office.

Full story here.

Drums fingers on table...

I just emailed the FDA asking them for an update regarding their warning letters search engine.

From what I can determine, they have fixed the issue of certain missing warning letters. However, 2 other significant issues (at least) remain. 1. the date filter is still malfunctioning (see previous post here) and the excel document dump is still outputting html (see previous post here).

"More Eyeballs on AERS"

That's what the Nature Biotechnology editors titled it.

Our correspondence to Nature Biotech regarding AERS data came out yesterday. I can't post the article due to copyright restrictions, but I'm sure you can pick up a copy at your local newsstand.

Warning Letters Update: FDA makes 1 fix

FDA has fixed the "beef northwest" issue described in yesterday's post (i.e. if you search for warning letters for "beef northwest" the search engine now returns 1 result (click here for same link as yesterday, but now with correct result).

I don't yet know whether all of the missing warning letters have been restored, but it's a start.

Where have all the warning letters gone?

I’ve written a couple of posts on FDA Warning Letters (here and here), but today’s post seems particularly important.

The FDA’s Warning Letter Search Engine is Seriously Flawed.
There are at least 2 things that are wrong (in addition to the flaws I outlined earlier).

• Certain warning letters that were in the old database have vanished.
• The warning letters that are returned when searching by date are often inaccurate.

Allow me to elaborate.

Certain warning letters that were in the old database have vanished If you use the FDA’s Warning Letter Search engine to search for “beef northwest”, you get 0 (zero) results [update: fda has fixed this error--see here]. But there is a warning letter issued to Beef Northwest Feeders LLC issued on August 21, 2007 (see here for the letter). You can also search the FDA’s Warning Letters by Company Name and the record does not show up.[update: fda has fixed this error--see here]


By my estimate there are almost 2,000 missing warning letters (I wrote a small bot that systematically went through the current FDA search engine and recorded warning letter results issued every day from January 1, 1996 to the present day and it returned ~7,700 warning letters, whereas the FDAble Warning Letter Database, made from the FDA’s old search engine, contains ~ 9500 letters).

Warning letters returned when searching by date are often inaccurate If you use the FDA warning letter search engine to search for all warning letters issued from 11/1/1996 to 10/31/1997 you get 152 results.

If you expand your search by 1 day (11/1/96 - 11/1/97) you get 876 results. Here’s a hint: The FDA did not issue 724 warning letters on 11/1/97- it was a Saturday.

I don’t know why the first search yields only 152 results, but it’s clearly wrong, and to be honest, given the errors throughout I’m not confident in the 876 results returned in the 2nd search-The FDAble database says there were 1,008 warning letters issued from 11/1/96 and 11/1/97.


To summarize all 3 posts we have the following problems with FDA Warning Letters Search Engine.

1. Certain warning letters that were in the old database have vanished.
2. The # of warning letters returned when searching by date is often inaccurate.
3. Warning Letter Responses also appear to be missing from the new database.
4. Downloadable Results are presented as Excel files, but are actually HTML.
5. Warning Letter results return a maximum of 1,000 records, but this limit is not explicitly noted on the web-site.

I have an email in to FDA asking them to repair and notify others who may have been led astray.