FDA Proposes Broadening Access to Experimental Drugs
I discover this article originally from Mark Senak over at Eye On FDA blog. This FDA proposal would allow for greater access to experimental drugs as reported in the New York Times.
FDA Proposes Broadening Access to Drugs - New York Times
I am a backer of allowing greater access to experimental drugs but feel that the key in this is the word “appropriate”. While no one would object to this with regard to life threatening conditions such as cancer it is unclear how other situations would be dealt with. One of the point in the proposed rule states that:
modernize applicable regulations to include all circumstances under which access to experimental drugs is permitted.
This seems to be a little overly optimistic to me. I find it hard to believe they could define ALL CIRCUMSTANCES in which this may be appropriate. What about someone who has a respiratory ailment that makes breathing difficult and they have tried all approved therapies without positive results? Maybe it keeps them from being mobile and getting out of their home. If there is an experimental drug that could significantly improve their quality of life would this be allowed? The question basically boils down to what is appropriate and this could indeed vary with regard to aliment and even for given patients having a certain condition. I think rather than trying to state all conditions it might be better to define the process allowing for the use of experimental drugs.
One of my other concerns in this involves the fact that our society today seems to be very litigious. Seems anytime something goes wrong, we look for someone else to hold responsible or to sue. I firmly believe that if a company deliberately withholds information concerning dangers or concerns then they should be held liable. However, in the case of an experimental drug, little may be known and opening it to what use to be called compassionate use may be opening a can of words. I firmly believe individuals should be held accountable for their decisions provided it is an informed decision. I’m not sure how this would be worked out, but I’m sure that this will be an item for discussion.
Technorati Tags: drug safety, FDA, experimental drugs
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