FDA non impartiality letter to NY Times investigative reporter
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 xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxx
((no word back, come on guys put your armor on for christ sake))