My Confusion about Postmarket Requirements & Study Commitments

FDA has a database of postmarket requirements and study commitments (translation: "we're going to approve your drugs, but you have to promise to run these additional trials after we approve").

This database is updated quarterly and FDA even provides its own search engine to mine this database.

I've only been indexing their collection of data for a couple of quarters, but with the most recent update (April 30), I noticed something that I hadn't realized before.

Specifically, each new quarter's data *wipes out* the previous quarter's data. For example, the January 31 update contained 3381 postmarket requirements that could be searched via FDA.

In contrast, the April 30 data release contains only 1910 requirements. So, it looks like the FDA removes commitments that have been satisfied (I'm not 100% sure about the precise commitments that are removed each quarter, but this seems like the most reasonable explanation).

In practice, this means that you can't use FDA's search-engine to get a historical look at the types of commitments/requirements that were mandated by the FDA.

For example, if you search the FDA's postmarket requirements database for Zoladex you get no results. If you search using FDAble, you'll see that Astrazeneca UK had 3 requirements relating to Zoladex that were fulfilled in 2008.

I imagine that this historical information would be useful to many people (clinicians, persons performing competitive intelligence & strategy regarding drug development, etc.).

FDA's web-facelift

The FDA revamped much of its website last week (e.g., http://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm).

Can you guys give me a heads-up next time you do something like this (;-))? It's like when my mother-in-law comes over and moves all the drinking glasses to a new cabinet.

At first glance the change appears to be largely cosmetic, but it's a nice touch--what with the drop-shadows and all.

Aaaaaaaand we're back

the horror is mostly over.

I Committed a Cardinal Sin of Software Development

Well, if I can critique the FDA, I sure as hell better be able to critique myself--and I blew it big time.

Cardinal Sin? Hard-wiring potentially variable data into an application (especially when you have no control over when the data is changed).

As my assiduous readers know (all 3 of them), I developed an iPhone app called FDA Mobile News. It's a glorified RSS reader for FDA news feeds.

The app contains the URLs for each RSS feed hard-wired into the application itself, meaning that if the FDA ever bothered to change those URLs, my app would no longer work.

Well, by my calculation, FDA had not changed it's RSS URLs in over 1.5 years, but guess what happened 1 day after my app was approved and put on the app store? Yep, FDA changed the URLs for most of those feeds and got rid of some of them altogether.

I woke up on Saturday morning to find my app throwing more errors than a drunken Derek Jeter. Now, it will take a week (hopefully less) to get the new version out the door.

I knew I shouldn't have hard-wired those addresses into the app, but I figured "hey, what's the likelihood that the URLs will change before I get around to making each app 'phone-home' to a central repository where I can change the addresses at will?"

"How long would I wait to do it the 'right way'?", you ask? As my wife pointed out...I was probably going to get caught up in other work and let it slide until it *did* become a problem--which in my case was all of 36 hours.

Bad Bad Move on my part.

(more on FDA feeds and other stuff later, though)

FDA Mobile News App Just Got Accepted into Apple's App Store

Like everyone else on the planet looking to score 99 cents (70 cents after commission), I developed an iPhone app: FDA Mobile News.

Basically it's a glorified RSS reader devoted to FDA's RSS feeds and I charge a whopping $0.00 for it (I get 70% of that--so who's the fool, now?).

It still has some problems that need to be worked out (as my only reviewer pointed out--someone who goes by the name of "Saddam Hussein's Lost Car Keys" [WTF?] it isn't particularly clear that the globe icon that I use is actually a hyperlink to the full RSS article).

Well, the way the App Store is these days, I wouldn't be surprised if my parents were toiling away in their basement crafting some "newfangled iAARP contraption for that iTelephone store where everybody gets rich"--70 cents at a time.

Things I Like About FDA Informatics

Sometimes me conscience gets to me. And lately I feel like I've been bashing the FDA data releases too much.

So today, I reverse course and list 2 IT-related thingies pushed out by the FDA that I like (sort of).

I'll go back to bashing the FDA later this week.

Thing # 1. The Peanut Product Recall Widget. This is a small Flash box (widget) that anyone can place onto a web-site. You just place a small snippet of code in your HTML and you get access to what looks like *all* FDA-related product recalls (not just the peanuts).

Why then, do they call it the Peanut Product Recall Widget? I have no idea, but bad branding isn't a felony.

The styling of the widget lies somewhere between "design by Stevie Wonder" and "absolutely horrendous", but as mentioned above--not...a...felony.


Thing #2. the MedWatch widget. Same principle applies as with the Product Recall Widget. Small bit of code and you get 4 links to MedWatch information. The utility of this widget is a tad suspect, as all it does is provide a collection of 4 hyperlinks. The Product Recall Widget has a search function, thereby vaulting it to a higher echelon in the pantheon of widgets.

But there you have it. 2 examples of the FDA reaching out on the informatics front and doing a good job.

AERS & VAERS Reporting Frequency has Approximately Tripled since their Inceptions

A little bit of navel gazing today, but I decided to plot the # of reports submitted to the AERS and VAERS systems vs. Time today. There are small bits of information in the graphs shown below that might warrant further examination.

e.g., The # of reports submitted to AERS has almost tripled from 1998 to 2008 (11 years).

Is this a big increase?

I can't really say with any certainty, but it feels like an inadequate increase given the concomitant increases in the use of information technology over that period (e.g., the interwebs).

[Aside: Wolfram Alpha is being of no use in trying to find the change in internet usage over the years to serve as a comparison---okay wikipedia is telling me that internet usage from 1997 to 2007 has gone up almost 6 fold in the developed world...so I think my feeling is probably correct.]

Also...what's going on with those dips in the # of reports in the early 2000s?

Note that 1997 only includes data for Q4 of that year so it's artificially low.

VAERS
As far as VAERS is concerned, it looks mostly like a flat-line from 1991 to 2006 (okay it doubled, but that's over 16 years) and then there's a HUUUUGE spike over the past 2 years.

Is VAERS being "marketed" better all of a sudden, or is it The Jenny McCarthy/ Autism effect? Or both?