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Too fast, too soon?

March 30, 2007

The US FDA is widely considered to be the best food and drug regulatory agency in the world. However, the withdrawal of Zelnorm begs the questions: Is the FDA moving too fast?

Also, Zelnorm was originally targeted to women. It is well known in the industry that the usual subjects of clinical trials tend to be young men. This new debacle also begs the question: Are women being short changed in clinical trials? Are we exposing them to risks without adequate testing?

2 Comments leave one →
  1. grownoldernotup permalink
    March 30, 2007 8:01 pm

    Women are not being short changed. Zelnorm was originally approved only for use in women because that is the group focused on in its clinical trials. Recently it has undertaken and completed clinical trials involving men and has been approved for use in men as well.

    The FDA is extremely sensitive to the applicability of clinical trials to the target audience and to the marketing of prescription drugs generally. Each clinical trial must target the exact indication for which the drug company is seeking approval. In many instances finding patients to populate a clinical trial is difficult because the disease or condition is not terribly wide-spread. In the case of some extremely rare diseases, there is a process by which the approval of a drug is shortened.

    This is only a snippit of the vast sea of regulation of pharmaceuticals in the US. The FDA definitely has its hands full, but as far as government agencies are concerns, I think it does a decent job.

  2. darshan1979 permalink
    April 17, 2007 12:03 am

    You raise some excellent points, and I do agree with you that all things considered, the FDA does an excellent job. I also agree that Zelnorm is only one of the hundreds of compounds that the over worked FDA must evaluate regularly.
    However, the Zelnorm situation made me wonder:
    1. How did the drug company decide to target women? Animal studies would have been poor indicators as to the specific use of the NCE in women since nothing in the animals could have suggested a preffered sex in humans. (I am unaware of genetic markers that are upregulated in women.)
    2. When it comes to the abbreviated drug approval process, it is unlikely that Zelnorm qualified since it was indicated for IBS which is neither rare (as required for orphan drug status) nor an epidemic (as may be available for drugs for AIDS or cancer.) So, the drug company should not have qualified for an abbreviated drug review process.
    3. Considering the use of the drug in women specifically: My initial point was that we can barely predict what a drug would do in adult human males despite having the most data on them. Currently, there is very little data on women since they are not the primary target of most studies. I therefore wonder: Is it smart for a drug company to try to qualify for an abbreviated drug review process, or even a regular drug review process. Isnt it best, when a drug primarily targets women, to require a longer review process since we know the least about that popullation?

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