Recent decisions by the FDA have left me with the conclusion that they do not act at all times in the best interest of the consumer (but with NON-IMPARTIALALITY with newer technologies threating current drugs on the consumer market). Most recent case involves a company called Bioelectronics (BIEL). BIEL Mfg products involving PEMF technology. PEMF has been tested by NASA and hundreds of other professional bodies and found to be safe and effective. BIEL has one product approved (class 3) for post operative eye swelling.
Most recently they have been denied class 2 approval (which would have made the product available for OTC market like Tylenol, etc.), on their “Allay” product (used for womens menstrual pain). After a very lengthy review, (2nd time, 1st for DeNovo approval) the FDA said the product did not meet the thermal characteristics to be approved for DeNovo, when in fact BIEL had submitted all the necessary data proving thermal heat signatures, etc. BIEL has enlisted help from “ Senator Barbara Mikulski, D-MD, to try to help move the FDA. She wrote to FDA Commissioner Margaret Hamburg. We have now been informed that FDA Commissioner Hamburg has forwarded our complaint up to the Inspector General of Health and Human Services. We hope that this action will rationalize the review process” http://finance.yahoo.com/news/bioelectro...
I honestly believe that BIEL is being targeted by the FDA with non-impartiality regarding this disruptive technology ( to the extent of favoring large pharma ?, I don’t know, but something does not seem right. BIEL’s products produce more thermal heat than some other products that have already been cleared class 2 OTC by the FDA. As they say, something stinks in Denmark !
Please pass this information onto one of your investigative reporters, as I believe a story is about to unfold. I’d be glad to offer any assistance if you want to contact me.
Thank you, Michael DeMunbrun 314-808-0105
***But in addition, the FDA chief has one meeting with a NY senator and a new energy product is instantly looked into: ""Not just big pharma: FDA influence:
Well, so this is all it takes to get FDA resources reallocated, one meeting between the FDA Commissioner-Margaret Hamburg and a senator (who has connections with Rodale Inc.-brands include men and womens health, diet books, etc). Sen.Schumer recently met with Ms Hamburg and she agreed to review the safety and legality of a inhale caffeine product called Aeroshot. (if you notice the term efficacy is not brought into play here) Ask yourself why ? Would not a product like this be a threat to diet plans (the product is labeled for diets, like many of the other high caffeine products on the market, but appearantly these do not give Sen. Schumer the same concern ? Interesting) Sen. Schumer probably is sincere about his actions here, but it just goes to show how easily the FDA can be influenced. Biel (Bioelectronics Corp.) is in for more of a battle than I had even imagined...I just wonder what influences could be approaching the FDA regarding PEMF technology ??? Large drug pharma...?
(Does the Senator have a real concern here or just self interest due to his involvement with Rodale Inc. ???)