The FDA is Stifling Innovation and Hurting Patients
This David and Goliath story takes place in the medical field in the land of the FDA. During the course of a ten-year battle, a small medical device company spent upwards of 8 million dollars as a much-needed medical implant product was taken off the market.
Told with objectivity and an appreciation for the beneficial aspects of regulatory agencies, the authors graciously acknowledge the dedication of government employees and the various branches that are vital to the safety of the American public. Nonetheless, this story recounts a good doctor’s plight when guidelines for proven TMJ devices that were beneficial to many for fifty years became intrusively restrictive after the Medical Device Amendment was established in 1976.
The unusual requests of the Center for Devices and Radiologic Health, the branch of the FDA, which approves and oversees medical devices and drugs, were so outlandish for a pre-amendment device that the cost factors eventually forced the production company and Dr. Christensen into bankruptcy. These essential implants are no longer available for purchase, depriving patients of the care which they so needed.
Dr. Bob emerges a champion, not a victim, and his story will inspire you to persevere for worthwhile causes, no matter the giants you may face.
