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Wednesday, June 10, 2009

Missing Warning Letters Prove that FDA is an Internet Dunce!

UPDATE: See "Missing FDA Letters Found. More Questions."

On April 2, 2009, FDA's DDMAC sent 14 warning letters to 14 different pharmaceutical companies regarding sponsored search engine ads that it said violated FDA regulations regarding presentation of fair balance (see "FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!").

The 14 companies receiving these letters were:
  1. Biogen Idec
  2. Cephalon
  3. Forest Laboratories
  4. GlaxoSmithKline
  5. Sanofi-Aventis US
  6. Bayer Healthcare Pharmaceuticals
  7. Johnson & Johnson Pharmaceutical Services
  8. Pfizer
  9. Novartis Pharmaceuticals
  10. Genentech
  11. Boehringer Ingelheim Pharmaceuticals
  12. Merck & Co
  13. Eli Lilly and Co
  14. Hoffman-LaRoche
Today, you will find only 9 letters on the FDA's Website (here). The letters sent to the first 5 companies on the list are gone and not to be found. It's not just that these letters were removed from the warning letter list, the letters are gone altogether.

In the post I cited above I provided a link to the Biogen Idec warning letter: ie, http://www.fda.gov/cder/warn/2009/Biogen 20Letter.pdf, which now leads to a "Page Not Found" error.

Fortunately, I saved the letter that was sent to Sanofi-Aventis US -- find it here -- plus the promo material -- find it here -- that shows the violative ad discussed in the letter.

What happened to these 2 and the other 3 missing letters?

A Director of Search Engine Marketing at a major healthcare advertising agency, in a comment posted to another blog, suggested that the Yahoo! Plavix "sponsored ads" cited by the FDA were not paid ads: "What's interesting is the FDA letter to Sanofi about Plavix. It actually talks about 'sponsored links' but references natural search engine results NOT paid search ads. Could it be a mistake since these are not sponsored ads and these results cannot be bought?"

UPDATE: See "Missing FDA Letters Found. More Questions."

P.S. Some people attribute the missing letters to recent changes FDA made to its web site; ie, to broken links (see comments). However, there are NO broken links! The links simply are no longer there within the April 2009 section of the web page, whereas they were there previously. Whole rows in the table are missing. This means that the page was edited manually to REMOVE those links. I note that the page was edited on 6/8/2009.

For the record, I captured the Warning Letters page directly from the FDA website on 11-June-2009. You can find the pdf file here.

According to Mark Senak at EyeOnFDA, "I've never seen a retracted [FDA] letter." Well, of course! You cannot see it once it's been retracted! But I know what you mean, Mark. This does not bode well for FDA's new transparency initiative!

P.P.S. Crystal Rice from the FDA's trade media office returned my call and tried to explain why the 5 letters were no longer on the FDA site. You can listen to that conversation here. Afterward, via email Ms. Rice said: "I have confirmed with DDMAC that the five company letters you inquired about were not retracted. They were inadvertently dropped off the site during the recent FDA website migration. The web team is working to repost them as soon as possible."

I understand how some files (eg, warning letters) can be inadvertently "dropped" when migrating a web site, but how does a table on an HTML page mysteriously lose 5 rows? When you "migrate" you move the whole page, you do not edit the contents of the page except perhaps for navigation links.

To believe the "migration ate the 5 letters" excuse, you would have to believe that not only did the letters (ie, PDF files) go missing, but simultaneously, the rows in the table containing the links to these letters also went missing. Seems more like a deliberate edit job than a "migration" mishap!

For now I will suspend my disbelief and wait and see if the five letters are returned.

UPDATE: See "Missing FDA Letters Found. More Questions."

20 comments:

  1. Anonymous8:08 PM

    There was yet another letter that has suddenly disappeared from the Warning Letters/NOV site. An NOV to GSK for a Treximet banner ad (that was issued in March, posted in April) is no longer posted on the site. Anyone notice this new message on the FDA site?: "Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter."

    ReplyDelete
  2. Yes, but I never heard of FDA purging warning letters after corrective action was taken. they are supposed to remain available as a matter of public record. If the FDA purges a letter it must have rescinded the notice of violation; ie, it was not a violation in the first place. So at least 4 or 5 of these letters were sent in error -- an error made by the FDA. I haven't heard of such a thing before.

    ReplyDelete
  3. Anonymous11:25 PM

    Paid keywords for your drug and how it appears in a search can also be considered "sponsored" for purposes of triggering the regulatory requirements of drug name + use = disclosure of important safety information.
    While this most definitely makes me more than curious - I would have to say we are probably looking at an IT glitch when FDA website redesign took place (that actually made finding things much harder not easier) rather than a wholesale withdrawal of a numbr of NOV's. I could find no distinguishing characteristics among the letters to justify the 5 (or 6 if you count Treximet) letters that were removed as compared to those that are still on there. There is precedent for "I take it back", at least once that I know of - however this is not public knowledge (until now).

    ReplyDelete
  4. The FDA changed its website and was unaware that links to warning letters and guidances did not work until they were pointed out by our reporters. I do not believe warning letters were purged, because FDA spokespeople took to task to do damage control and repair many broken links. They said they were working on this problem but did not set an official deadline for its resolution, which means the link repair is still a work in progress. They seemed genuinely surprised that links did not work, which raises another issue I will not comment about concerning the agency's communication. I would check back periodically for the links.

    ReplyDelete
  5. Nicholas,

    You talk like you have some inside knowledge, but your profile is not available for me to determine who you are.

    Regardless, there are NO broken links! The links simply are no longer there within the April 2009 section of the web page, whereas they were there previously. Wholes in the table are missing. This means that the page was edited manually to REMOVE those links. See http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM055773

    ReplyDelete
  6. Eric T.12:23 PM

    Just another instance of shady and corrupt marketing by large pharma companies. They will try to saturate any new media that pops up with their drugs, and the FDA is always a couple steps behind in regulating it.
    Eric T. http://www.jazdlifesciences.com/pharmatech

    ReplyDelete
  7. Anonymous1:52 PM

    johnny mack:
    You are so removed from FDA regulatory world. An average reporter/journalist would have asked FDA for comment and you would have been told it's the new remake of the web site that is causing so much trouble.

    sincerely,
    a non-conspiracy therorist

    ReplyDelete
  8. Dear Anonyramous:

    Just to amuse you, I called FDA's press office and here's what they said:

    http://www.blog.pharma-mkting.com/ContactingFDA.WAV

    ReplyDelete
  9. Anonymous4:04 PM

    It's me (the "idiot") again. I forgot to suggest that you should also record the audio of you eating crow when FDA finally gets back to you.

    ReplyDelete
  10. I updated the audio file -- someone from FDA did call me back -- same URL: http://www.blog.pharma-mkting.com/ContactingFDA.WAV

    You decide who's eating crow now.

    P.S.Sorry I called you an idiot, but you did goad me on with your "so far removed" comment. You probably do not recall that I was the only person who suggested that the "one-click" rule violated FDA regulations.

    ReplyDelete
  11. Anonymous4:28 PM

    Eat your crow with some hot sauce and a beer... it goes down much easier. The girl on the phone tried to tell you it was the web site remake but you cut her off with some conspiracy theory dribble. The fact is FDA's old links are all screwed up because of the remake and it is common knowledge.

    Another fact... If FDA wrote a letter alleging violations that were later determined to be inaccurate, there would still not be any retraction. That letter is part of the official record. This actually happens all the time with manufacturing deficiencies.

    I'm not sure I want to accept your apology until you acknowledge FDA's new web site is whacked. If you spent any real time on it you'd already know this.

    ReplyDelete
  12. Well, the FDA website may very well be "whacked" as you say, but then I should get credit for calling attention to the fact that an important piece of public information was missing from the site. What else may have been "inadvertently dropped" as FDA says (see below) may never be known (unless some other conspiracy nut like me speaks up, even if he has to eat crow. BTW, I love hot sauce!).

    Crystal informed me that the letters will be put back:

    "I have confirmed with DDMAC that the five company letters you inquired about were not retracted. They were inadvertently dropped off the site during the recent FDA website migration. The web team is working to repost them as soon as possible."

    She didn't thank me, however.

    ReplyDelete
  13. Anonymous4:47 PM

    You always seem to want credit for being "first in your mind" to acknowledge something in your small circle. These web site problems with warning letters and other information have been discussed extensively by other media outlets for about two weeks. So if first to you is really like being 20th or later, then Ok you can have credit for being the first to point this out on PharmaMarketingSmog. Sorry to burst your bubble....

    I will now accept your apology for calling me an idiot if it is still open.

    ReplyDelete
  14. The apology is still open.

    I first learned about the missing letters from one of my Twitter pals. So, I was NOT the first to notice this -- what I said was I was the first (to my knowledge) to notify the FDA, and was instrumental in getting them to fix the problem.

    BTW, if you did not goad me on to call the FDA, this all would not have happened. Thanks for being part of the PharmaMarketingSmog! Is that trademarked?

    ReplyDelete
  15. Anonymous5:52 AM

    wrt to the links missing from a table on the page, therefore suggesting something had been "manually" removed - it is entirely possible that any data on a table on the page is database backed. In fact for a website as large as the FDA's it is more than likely. The fact that the letters vanished along with the references in a table would suggest to me a database migration error, rather than human intervention.

    ReplyDelete
  16. I thought of that too. While we can now say that this all was caused by the migration, it is problematic in that we now do not know what else might be missing.

    ReplyDelete
  17. I am interested in a required Pharma company response to a warning letter. Are those available online or is a FOIA request required?

    Any advice is appreciated.

    Thanks,

    SteveM

    ReplyDelete
  18. Steve,

    That's a good question. I will contact FDA and ask them!

    ReplyDelete
  19. Thanks John!

    SteveM

    ReplyDelete
  20. First, DDMAC warning letters are of no real concern from a legal paradigm for drug companies. They equate such letters with toilet paper.

    Yet for reasons such as competitor or media knowledge, they likely bribe those in the FDA not to release the warning letters, just has other big pharma bribed federal prosecutors not to release a settlement agreement to the media.

    ReplyDelete

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