The upcoming 2012 elections and the continued debates have shown that the flawed process of governmental regulatory practices is still very much in existence today. These inconsistent practices threaten the advancement of America’s small business future
Denver, Colorado (PRWEB) January 05, 2012
Dr. Robert W. Christensen and Lynn M. Watwood, Esq. are the authors of a well-documented account about how the Food & Drug Administration (FDA) has had the ability to interrupt thriving and successful small businesses through the means of governmental policies and regulations put into place.
Dr. Christensen was the innovator of surgical implants that had been successfully used for nearly 40 years when, according to book, the FDA attempted to curtail their use. These implants had been a main surgical technique used at the Mayo Clinic for a dozen years. The Christensen Partial TMJ Implant is the only very successful implant treatment for Internal Derangement of the TMJ. There is no other such partial joint implant in the nation and perhaps in the world.
In “FDA, You Were Wrong”, it is stated that “The primary law governing medical devices was enacted in 1976, and it established a flexible review process intended to tailor FDA oversight of new and improved devices to a level of regulatory control sufficient to provide a reasonable assurance of safety and effectiveness.”
As documented in the book, part of this process required companies to apply through an approval process for inclusion in the amendment. The TMJ implant Dr. Christensen pioneered was to be included and approved under a grandfather clause. It WAS indeed, approved, and not long after, the rights of the company were taken away without, it seems, any due reason. Now, these essential implants are no longer available for purchase, depriving patients of the care which they so needed.
"The upcoming 2012 elections and the continued debates have shown that the flawed process of governmental regulatory practices is still very much in existence today. These inconsistent practices threaten the advancement of America’s small business future, as well as patients’ health. This has profound consequences for the future of medical device regulation," says Dr. Christensen.
This comprehensive book provides actual documentation and the ongoing correspondences between Dr. Christensen, members of Congress, and others. It provides a thoughtful analysis of the events leading to his companies’ demise due to government agency practices.
To view Dr. Christensen’s book visit Amazon or learn more by going to his website at http://www.DrBobChristensen.com . For an interview to discuss his controversial book please email Dr. Christensen at tmjsurgeon(at)gmail(dot)com or call 303-549-6674.