Can You Say Loophole?
A friend of mine, who happens to be an attorney, loves to
curl his lips as he rolls the words, “litigious” and “loophole” off his tongue. He is so cheerful when he enunciate these
terms; you would think that he is preparing for a singing role in a opera. His
favorite phase is, “We live in a litigious and loophole society”.
Well, he is partly right on this matter. These days you can
file a lawsuit against a lightning bug (Lampyridae aka firefly), if the bug’s
flashes her light too often for your liking. The problem is lawsuits often get tangled up for years before being
resolved or settled. This brings me to the theme of this post – confusing
FDA and NIH Mind Merge
Just recently, I was reading that the future of commercializing
a promising stem cell research finding for blindness and age-related muscular
degenerative may be held up due to loopholes and legal red tape involving two
governmental agencies. The hold up has to do with proactive versus reactive
(after the fact) testing of potential embryo disease HIV, hepatitis and
infectious microorganisms that may be laying dormant.
It seems that the National Institutes of Health’s (NIH)
research rules and guidelines do not match up with the Food and Drug
Administration’s (FDA) regulations for embryonic stem cell research and
Why is this important? It’s important because the
consequence may mean that the research findings can end up not moving beyond
the researcher’s lab bench onto the market place which is the ultimate goal.
I’ll keep you posted if a resolution between NIH and FDA
occurs in the near future.