Hey 7-up.
The publishing of this letter and the heretofore erroneously inferred as 'Confidential' comments, simply because the word 'Confidential' was printed as standard protocol for all correspondence, is not, in my opinion, by accident. It is now public knowledge that yet another corporation submitted intelligent and scientifically supported comments in complete endorsement of FDA's proposed reclassification of these devices to Class II. The comments also lead one to the obvious conclusion that such devices warrant immediate OTC designation. There is growing curiosity in various sectors as to why the reclassification is taking so long.
Seems to me that any written comments submitted in response to a government agency public request for public comments would automatically become public knowledge, but I support the FDA respecting the word 'Confidential' on the commentor's stationery. I express greater support to those who finally realized that the comments were not intended to remain confidential. Now that they are appropriately in the public domain, could we please now proceed with publication of the Final Order in the Federal Register? Doing so will allow American manufacturers to produce analgesic devices, instead of analgesic drugs for controlling chronic pain, for tens of millions of Americans. Have our people, our biggest assets, not been harmed and dumbed down, addicted and side-effected enough by drugs yet? Have analgesic drugs, from the Tylenols to the oxis, not killed enough Americans yet? Time to get 'er done. An FDA approved analgesic with no negative side-effects, no one.
Would that not be another American first we can share with the world? If so, then we should be all over it.
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