Warning Letters Part II

FDA provides a web-page where you can Search Warning Letters by Issue Date and Export to Excel. Previously, I wrote about how the output of this information is not actually Excel, but here's something cute.

When you actually select a range of dates and download the "Excel" file, you get a file named something like this:

fda_wl_search_results_06302009110030.xls
the digit "code" at the end of the filename isn't that difficult to crack

fda_w[arning]l[etters]_search_results_MONTH DAYYEARHOURMINUTESECOND.xls

But what happens when 2 people request results within the same second? This will probably never happen, but it's a bad idea to dynamically name files like this.

FDA Mobile News Back on Sale in iTunes App Store

errors fixed.

prices slashed in half (we're practically giving it away!!) !

get it here!!!

FDA Search Graduation Day

I posted earlier about creating a plugin for Mozilla's Firefox that allowed users to search the FDA and CDCwebsites and FDAble's search engines by right-clicking on a highlighted word.

Turns out that you can submit a plugin, but it's considered experimental until you've received reviews.

You also have to write a short justification of why your plugin is worthy of release to the public at large.

I'm happy to announce that, as of today, the FDA Search plugin has graduated from experimental to public.

How to use it?

1. download the plugin.
2. if you're on a web-page that contains a drug name or other health related term, highlight the term
3. right-click on the highlighted term and choose whether you'd like to use the term to search, the FDA, CDC or FDAble search engines.

That's it!

Warning Letters Upgrade – a jumbled bag of some good but mostly bad

This picture pretty much sums up how I feel the more I look at the FDA’s most recent upgrade of its warning-letters & responses search-engine.

First, some background:

FDA used to have a collection of web-pages that allowed you to search the warning letters and responses that it had issued to various food & drug scofflaws and ne’er-do-wells all the way back to 1996.

There were certainly some strange choices made with the old system that they used. For one thing, they separated the “old” warning letters (those > 1 year old) from the new ones (<= 1 year old) and you had to use a separate search engine for each collection of reports.

With the new search engine, they’ve combined old and new so that both can be searched from one form. However, this appears to be the only thing that they got right with the upgrade.

Another peculiarity was that if you used the old system to download an Excel table of warning letters filtered by date, you got a CSV file that was mistakenly tagged with an .xls extension. This transgression is no big deal as CSV will be read easily by Excel even if it’s mis-tagged, but whoever built the new version seems to have taken the mislabeling one step further (see below).

If you dig deeper into the web-pages, you find all sorts of weirdness.

First, your searches are capped at 1,000 results no matter how big the true size of results. The search-form doesn’t say that it will only return the first 1,000 results, but it does. And this initially led to confusion on my part because I was trying to see if the system would retrieve all 9,000+ warning letters that should be in the system. It only returned 1,000.

This is a bit dangerous b/c if a user searches for all warning letters from 1996 to 2009 s/he may mistakenly conclude that there have only been about 1,000 reports issued. What’s the deal? I seriously doubt they’re low on computing power.

The same holds true if you try to download an Excel table of the warning letters (you only get 1,000 results) no matter what you try.

And here’s the really strange bit. Remember how I said that the old system delivered a CSV file that was mis-labeled as an xls file?

Well, the *new* system again lets you download what is ostensibly an Excel file, but it’s not an xls file. It’s also not a CSV file like the old system. And no, it’s not one of those new-fangled Microsoft Office 2007 xlsx files. It’s a file marked with an xls extension, but if you open it up with notepad, you’ll find that it’s HTML !




Specifically, they’ve packaged the HTML table that is returned when a user searches their web-interface for warning letters and passed it off as Excel. Why? I have no explanation, except sheer laziness.

Finally, this section of the FDA’s website is titled “Warning Letters and Responses”[emphasis mine] and there used to be a way to search the responses to the warning letters…and the downloadable 'csv' file would list the location of letters received by the FDA in response to their warning salvos.

This information is no longer provided. As an example, this response letter can be found by using the FDAble search engine and searching for aquaculture (see result # 22). It can’t be found with the FDA’s search engine.

Also, they moved the URLs for all of the html versions of their warning letters, thereby breaking all of the fdable warning letter links. It’s not like the FDA is legally obligated to inform me of these changes, but when they do stuff like this they end up breaking the links for anyone/everyone who has ever bothered to link to their warning letter data. (time for me to get back to work…).

FDA Dings Zicam & Matrixx

FDA just issued an advisory about a potential link between certain Zicam products and the loss of sense of small (anosmia).

What's flabbergasting about this is that this information has been around for more than 4 years in the AERS system.

Here you can see that there have been 390 cases of anosmia reported to FDA where Zicam was also mentioned.

Here you can see that, by 2008, adverse event cases for Zicam reported anosmia ~1,000-fold more often than anosmia was reported in all other cases for all other drugs.


This signal is present as far back as Q3 of 2004.

FDA cleans its robots.txt file

In Late April I posted about how the FDA's robots.txt file had various peculiar sections, including a note indicating that one section was added at the request of Bristol Myers Squibb. Well, FDA recently (probably late May when they revamped the entire site) tidied up the robots.txt file removing most of the peculiarities (like "area 51").

The comment about Bristol still stands. The rest is now vanilla.

See for yourselves.

#Added for Bristol-Myers on Sept 2005
User-agent: vspider
Disallow: /

#For all other crawlers
User-agent: *
Disallow: /Management/ # don't crawl healthcheck
Hit-rate: 30 # wait 30 seconds before starting a new URL request default=30
Visiting-hours: 23:00EDT-05:00EDT #index this site between 11PM - 5AM EDT
Concurrent-hits: 2 # limit concurrent active URLS to 2 for each index server

FDA's RSS Feeds -- they're batting .555

The FDA provides a collection of 9 RSS Feeds for its various sub-domains.

5 of the 9 feeds are actually useful (Consumer Health Info, MedWatch Safety Alerts, News Releases, Recalls, What's New @ CDRH).

The other 4 are borderline pointless. It's not that the topics are pointless. Hell, I'd be interested in actually getting a glimpse as to what's new @ CDER & CBER. But take a look at the Feeds.

Enforcement Reports is simply a running list of when the FDA releases its weekly enforcement report, but there's no summary information provided in the feed itself. The content of each weekly report should be a feed itself.

What's New @ CDER & CBER aren't much better.

What's New @ the Center for Food Safety has a whopping single entry over 1 month old.

Why don't we just get rid of the food feed and put a little more meat into the others?