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< 1 min reading time
It’s the situation we all dread: A device with an obvious market and strong evidence of effectiveness bogs down in a seemingly endless FDA approval process.
According to Colorado surgeon Dr. Robert Christensen, internal conflicts, biases, and even corruption were at play. Christensen’s 2012 book, FDA, You Were Wrong! tells the story of his 12-year battle to get the government to approve his implants for the reconstruction of a degenerated or missing temporomandibular joint (TMJ). While other orthopedic implants in commercial distribution before the 1976 Medical Device Amendment were approved, his orthopedic implants faced delay after delay.
Christensen said he wrote the book to illustrate ways in which a needlessly complex approval process hampers innovation.
Christensen’s viewpoint is echoed by Senator Rand Paul (R-Ky), whose new book, Government Bullies, describes the effects of excessive government regulation of business and industry.
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