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.