Who gets to write these Press Releases?

I've gotten a handfull of these emails (below) recently from the FDA. It's serious business and I'm glad they're being vigilant, but do you think there are fights over who gets to write these press releases?

Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient

Glow Industries, Inc. Issues Nationwide Recall of Mr. Magic Male Enhancer from Don Wands Amended

Glow Industries, Inc., Perrysburg, OH, announced today that it is initiating a voluntary nationwide recall of the company's product sold under the name of Mr. Magic Male Enhancer from Don Wands. Glow Industries, Inc. is conducting this voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found the Mr. Magic Male Enhancer from Don Wands capsules to contain Hydroxythiohomosildenafil and Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making Mr. Magic Male Enhancer an unapproved new drug. These active ingredients are not listed on the product label. Product manufactured containing lot numbers 9041401, 251209 and 8121904 are included in this recall...

I had always assumed these types of companies simply sold snake oil. I never considered the possibility that they were getting their hands on bona-fide analogues of sildenafil and the like. Weird and scary all at once.

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.