In a message dated 2/22/99 12:59:11 AM, email@example.com wrote:
>John Clark said
>>Tim Bates firstname.lastname@example.org Wrote:
>>>The enormous bulk of this cost is for regulatory compliance and
>>>Ditch the regulations and hte cost is minimal
>>I hate the FDA as much as anyone but that is a huge exaggeration.
>I wonder if we could get some facts and figures on this? I will try and
>do some research on line.
Samuel Peltzmann wrote a book on this in the early 70's called "The Regulation of Pharmaceutical Innovation" or something like that. He concludes that the FDA increases the cost of pharmaceutical innovation but pharmaceutical innovation does have other substantial costs. I can't find my copy for an exact quote. From working in the medical device industry, I can tell you that regulatory compliance is a large portion of the costs, probably even the majority, but there are *definitely* expensive elements to medical device development other than regulatory requirements.