Speaking of Complete Response Letters

Here I am – speaking of Complete Response Letters.  What follows is a short tutorial on the communications aspects of CRLs.    

NOTE ADDED OCTOBER 19, 2010 - There has lately been a great deal of interest in this video from investors of a company with a drug candidate that has received a CRL from the FDA.  A note of clarification about the video.  It was created for communications professionals to help understand the communications ramifications of the change from the old way the FDA responded to NDAs – with an approval, an approvable or no approval, to the way it is today – an approval letter or a complete response letter.  A CRL lays out a pathway for approval by stating the requisites the FDA wants to see fulfilled before it might grant approval.  Whether or not a company does, or even can meet those requisites, is another matter.  The company may find that the pathway laid out is not possible or desirable.  



And an approval …

Also, yesterday Abbott received FDA approval for Trilpix.  Trilpix (fenofibric acid) is a delayed-release capsule for use with diet to lower triglycerides and LDL cholesterol, raising HDL cholesterol in patients with lipid problems and is the first and only fibrate approved for use in combination with a statin.  

That updates our chart as follows:Approvals v CRLs12-16-08
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5 Responses to Speaking of Complete Response Letters

  1. milan blecha says:

    I have a question about CRLs.
    From your video I infer that the content of CRL is proprietary. But does FDA at least announce that it made a decision and sent CRL to the company? Or is it at discretion of the company to reveal that they got CRL? Other question – CRL is orinary mail, so it takes a day or two before the recipient have it in the hand? Thank you for the answers.

  2. Mark Senak says:

    Hi there – thanks for your questions. The FDA does not announce that it has sent a CRL to a company – the contents and the fact that it was sent are within the company’s domain. That said, if a reporter calls FDA because they know your PDUFA date and asks if the FDA made a decision, they would likely refer the inquiry to the company. And the arrival of the CRL would be by fax, not snail mail.

  3. Milan Blecha says:

    Dear Mark,thanks for clarification.
    So we have secret CLR and its up to companies PR what will be presented…
    Would FDA object if company made a (grossly) misleading press release about the contents of the complete response letter? Thank you.

  4. Mark Senak says:

    I would never counsel a company to do such a thing, but do not know what the FDA would do in response. Sorry – but don’t like to speculate.

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