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Monday, August 24, 2015

The Duchesnay and FDA Runaround

As some of you may know, I became intrigued by the whole Kim Kardashian promotion of Diclegis on her Instagram account a number of weeks ago. My interest peaked when Diclegis manufacturer, Duchesnay employee, Danny Martel, wrote me on Twitter, basically telling me to "educate myself." (Back story)

If you're up to speed on the whole Kardashian promotion you'll know that recently the FDA became involved. They told Kardashian to remove the advertisement and wrote to Duchesnay to inform them that they had violated certain rules in as much that they cannot advertise the benefits of a product without listing the risks of the said drug. The letter, addressed to Eric Gervais, Executive Vice President Duchesnay, Inc. can be viewed here.

Bravo to the FDA for monitoring social networks.

Here's where is gets a tad worrying.

The FDA gave Duchesnay until August 21 to respond to the warning letter, they wrote...

OPDP requests that Duchesnay immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce. Please submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. 

Well, we are three days over the deadline and still I see nothing on either the FDA or Duchesnay websites that suggest that a response has been made - so, I wrote to the FDA, who told me that they  "are  not able to comment on an ongoing compliance action, as this information may be privileged confidential information. I’d recommend asking the company if they would be open to sharing information with you."

So, I wrote to Duchesnay and asked them the following...

I am writing to ask if Duchesnay are prepared to share their letter of response they wrote to the FDA regarding the Diclegis promotion (Kim Kardashian) warning letter.
I have wrote directly to the FDA who, in turn, suggested I write directly to you.

Duchesnay's response is bizarre, to say the least...

We will share information once it is publicly available. We do not have that information at this time. 

Share the information when it's publicly available?

Um, I'm not nitpicking but shouldn't it be Duchesnay making this information public? I mean, what, or who are they waiting for?

The last paragraph of the warning letter sent to Duchesnay reads...

Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice. 
I think it's fair to say that this is a matter of public interest. Something which I pointed out to the FDA who then went on to tell me...

You could submit a Freedom of Information Act request. FDA Office of Media Affairs does not process FOIA requests. 

Seems a kinda half-arsed way to get an answer to a pretty simple question.

Bob Fiddaman.

Back Stories

Kim Kardashian on the Pharma Payroll

When Pharma Use the Defence of the FDA

Diclectin and the Redacted Adverse Events

Is It Just Kim Kardashian on the Duchesnay Payroll?

Duchesnay's Payments to Bendectin "Expert"

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