Eisai Gets Thumbs Down Action Letter

J0385349_2Another action from the FDA today that gives a thumbs down to an investigational drug.  Today Eisai announced that it had received a non-approvable letter for the investigational compound fospropofol disodium injection which has been in review at the FDA for use as an intravenous sedative-hypnotic agent for sedation in adult patients undergoing diagnostic or therapeutic procedures.

The interesting part of this rejection is that it goes against advisory committee recommendation, which is supposed to be rare, but seems to be occurring with increased frequency in today’s environment. 

Eisai was not as forthcoming as Vanda Pharmaceuticals was earlier today regarding their receipt of a non-approval letter and did not state the reasons for the FDA’s non-approval of the drug.  The only thing the company did say in the subtitle of the press release was that the FDA’s letter did outline a path to approval.  Eisai decided not to share what that path might be. 

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5 Responses to Eisai Gets Thumbs Down Action Letter

  1. In this new era of ambiguous FDA letters, here comes the confusion. Because FDA letters are not public domain, the company can release whatever it chooses. I am sure the PR folks are loving this; however, this provides way too much insider control over a path forward from a position like this.
    While the FDA is making a conscious effort to provide more information regarding their outcomes, it is wrapped in the secrecy of the corporate spin machine. How long will it take Congress (or the SEC) to force FDA letters out in the open?

  2. Mark Senak says:

    Hmmm, I’m not sure why you think PR professionals are loving it. As a public relations professional, I can only speak for myself, but the vagueness gives me no thrill. But I don’t think that the proprietary nature of these communications is about to change.

  3. Well, is it now not up to the PR function in each company to communicate the FDA’s opinion however they see fit?
    Look at the latest example in the most recent posts on this blog:
    “Eisai was not as forthcoming as Vanda Pharmaceuticals was earlier today regarding their receipt of a non-approval letter and did not state the reasons for the FDA’s non-approval of the drug. The only thing the company did say in the subtitle of the press release was that the FDA’s letter did outline a path to approval. Eisai decided not to share what that path might be”
    Obviously that was an arbitrary decision by the Investor Relations or PR team at Eisai on how they thought they should communicate the outcome. Here you have two companies receiving the same notification from the FDA & sharing different levels of detail with the public.
    I can imagine no better validation for the ambiguity we can now expect when there is a corporate filter on the information coming from the FDA.

  4. CMC guy says:

    Corporate Filters have long existed although different companies handle by various mechanisms, with majority hesitant to provide extensive details in a press release. I understand certain motivations (although think more info is usually the better course): Often IR/PR image concerns will determine what is released as one never knows what public or media attention will spawn. Plus there is a general unwillingness to provide information that could possibly aid a competitor’s strategy (or be used by them against you). Likewise, companies conscious that must walk softly in dealing with FDA in public arena so as to not poison future interactions. Then there is the reality is that when something like this occurs it can take considerable review and planning to figure what to do (although if FDA as proposed CRLs do provide a potential path that should help assuming other aspects of money, time, people can be lined up).
    Are there any way you know to get the complete stats on the FDA actions vs AC recommendations? I have looked but only found individual examples going with/against ACs so would be a chore to compile.

  5. Mark Senak says:

    Hi – that is a really good question and one that has come up before, but sadly I don’t know of a resource that has compiled a track record of the instances where the FDA has acted against the recommendation of an advisory committee.