Hey rodman - well stated - as you know, I've long suspected something is up.
My belief, for a long time and posted here, has been that the FDA, after it admirably, honestly and transparently admitted it needed to hire and train more horsepower in its devices division, and did so, then determined that all the bureaucracy surrounding the SWD / SWT / whatever, devices was partially nonsensical as to side-effects and invested thousands of man hours in its Proposed Rule "on it own initiative" and "a a result of new information" - all taking u to February of this year. It called for public comment by May 21st, got 'em and reviewed 'em within a month.
I've read 'em, solid efficacy, no negative side-effects and lots of common sense on the Special Controls and label content aspects. like, pacemakers, kiddies and don't eat the ActiPatch!
So, I think more and more, that the FDA gets it completely that our toasters when unplugged represent a bigger issue because they could fall off the kitchen counter and land on a foot. FDA staff are some of the brightest minds in our country and they had the courage to initiate the Proposed Order, totally contrary to the interests of big pharma and the pill makers and sellers. Did anyone notice that there were no negative comments from big pharma when the FDA asked for public comments, except one cowboy who was singin in the wind, all chats and no facts?
My sense is that big pharma players have already commenced diversification of manpower and many tens of millions of capital to devices; look at J&J, its' CEO is the ex-Director of its' devices division, making them likely M&A players for BIEL, or, at the very least, marketing and sales partners.
Is the delay in publishing the Final Rule in the Federal Register because the FDA sees all of the light that BIEL type devices are totally safe and efficacious, with the exception of the Special Controls and label text I mentioned above? Of course they have, or they would not have published the Proposed Order in February in the first place. Remember, some of the brightest minds in the world! And, did anyone notice that some of those brilliant FDA Staffers advised posters here that they are aware of all the issues, aware of the public and safety aspects of the drug and chemical issues and that they are working diligently and want to complete this in a timely fashion, the only impediment being their workload? This is all factual folks, I have the e-mails and so do numerous posters here. Thank goodness for iHub. When the Final Rule will happen is the speculative part, not if it will happen!
The only political aspects I see in all this, are, that, because the cat was let out of the bag by the FDA on BIEL type devices with the Proposed Order in February, this train is already moving down the track and the Dems have an opportunity to regain some lost popularity by openly supporting the FDA in its quest in reducing a lot of the outrageous, yet legal over-prescribing Rx analgesic drug abuse and addiction that are killing tens of thousands of Americans every year and harming many millions more.
To both parties, want to win federal, state and local elections? Get behind this and get 'er done because our country is fed up with the drugs that we poison ourselves with each and every day to combat pain with simple devices staring us in the face! Anyone against it is un-American in my opinion. Go BIEL.
