The Corpus Callosum

Changes in the Drug-Approval Process

I know, it is a lame excuse.  But I just found this article,
and am too tired to blog about it.  It should be a fertile
inspirational source for someone, though, if someone else wants to get
to it before me.

From the August 10, 2006 New England Journal of Medicine:
Proposal for Radical Changes in the Drug-Approval Process
, by
Alastair J.J. Wood, M.D.

Sometimes, articles of particular interest to public policy are made
available on an open-access basis.  This is one of them.
 Usually, such articles are worth reading.


  1. #1 Doc Bushwell
    August 11, 2006

    Indeed, this was quite a worthwhile read. Thanks for calling attention to this, Joseph. Wood’s proposals pertaining to first-in-class drugs are exciting and definitely needed. Believe me, many of us discovery bench monkeys chafe at the overcautiousness of our Big Pharma employers when it comes to new targets. Not to say that there are not new targets which are the objects of intense research, but incentives for more are needed.

    I believe you have just inspired a blog entry for the Refuge, that is, once I finish putting together a plethora of Powerpointery today.

  2. #2 Joseph j7uy5
    August 11, 2006

    Great. I will look forward to reading it. I am on call this week, meaning frequent nightnight phone calls, plus going in to the hospital on Saturday and Sunday. Even so, I might be able to put together some comments of my own.

  3. #3 Greg P
    August 11, 2006

    One of the biggest deficiencies I see in these reforms is that nowhere is the high cost of drugs addressed. We have drifted into a time when drug companies are gambling with vast sums of money, since they have found that they are allowed to charge ever-increasing amounts for approved drugs.

    Some of the so-called reforms will only make this worse. If we seriously deincentivize me-too drugs, there will not be the price pressure of the me-too drug to help control the cost of the me-first drug. And sometimes the me-too drug ends up being better and safer than the me-first drug.

    These are reforms that to a large extent Big Pharma would like to see — any opportunity to lengthen patents is good for them. Soon, the 2-3 winning companies buy up all the rest.

    What I think we need to do is to set limits on profits, perhaps in exchange for tax incentives for drug development. At some point you have to look at what a given drug costs to produce from its components and base its retail price in some relation to that, rather than just on some inflated “cost” of its development and “what the market will bear.”

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