[w10-1]

Even as the article states, the problem is the risk-aversion of private actors to regulation. I can assure you, the scientists are happy to have the administrators handle regulatory affairs. To get approvals, administrators do the comparative analysis to show that a similar risk was accepted with similar constraints.

The real problem is the advantage this gives to repeat players. Then innovators have to sell out to the majors before market validation, so there's been little significant change in the identity of the key players, even though there have been huge (finance-driven) changes in organizational and market structures (with wider profit margins).

It also amplifies first-mover advantage. Not only do first movers capture customers, they set the regulatory standards others have to beat. If they are a key technology (like Illumina's NGS short-read sequencing), it's a perfect set-up for the monopoly to tie sale of one product to another (e.g., the one-time hardware to ongoing reagents or software services). This is amplified by the privacy of the regulatory submissions.

How can it be changed? It can't. Big pharma is a trillion-dollar golden egg is a nest of the FDA's making, and no rational humanistic discourse or broad-based health-care financing issues are going to dislodge those investments.

The best we can hope for is to keep the profiteering reasonably discreet. By being somewhat unpredictable, the FDA gives each administration leverage to extract some concessions for each generation.