FDA Advisers Usually Recommend Approval
A recent article came across my desk and I thought it misrepresented the facts and wanted to make some comments on it. The article was in the Signs on San Diego site.
The article implies that something improper may be occurring with the process of having external experts make recommendations on drugs and devices I would point out that the whole drug development process involves weeding out those candidates that do not preform well at early stages. It is in the best interest of the company developing the drug that they be able to make a go-no go decision as soon as possible. Therefore, only the drug candidates that have a very high potential to be approved make it to the point of filing an new drug application (NDA). It is not surprising to me that the majority of those get approved. It should also be noted that just because an expert panel recommends approval, does NOT necessarily mean it will be approved.
While I do acknowledge that there have been some conflicts of interest that were not made transparent in the past, I think there has been some progress made in this regard. I just hope that reason prevails and this isn’t used as another bullet against the FDA.
Technorati Tags: drug development, FDA
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