The Price of Progress or the Waste of Regulation?

The average cost of delivering a new therapy from laboratory to clinic is increasing at a fast pace, more than doubling since the turn of the century according to some studies, to stand at $2.5 billion or more. This is not driven by the work of research and development becoming more expensive: if anything, the price of the tools of biotechnology is in free fall, even as capacity increases by orders of magnitude. Biotechnology has gone through, and is still going through, its own echoed version of the computing revolution of recent decades. A mix of advances in computational power and materials science means that a graduate student of today requires six months of lab time and a few tens of thousands of dollars to accomplish what would have taken a full biotech company, five years, and tens of millions of dollars back in the 1990s. So what is going on here? Why, in the midst of a transformative revolution in life science technological capabilities, is the price of building new therapies spiraling ever upwards? Government is the answer, bureaucrats and their incentives, regulation that demands an impossible degree of removal of risk from what is an inherently risky activity. The regulators of the FDA and other, similar organizations only suffer censure when patient issues occur that are related to approved medicines. No such censure happens when they reject medicines that would have helped greatly, or when they raise the cost of development high enough for beneficial prog...
Source: Fight Aging! - Category: Research Authors: Tags: Of Interest Source Type: blogs