Replies to post #51493 on Biotech Values

[zipjet]

>> Like any large bureaucratic organization, the FDA does many things that can be criticized.

I love that statement.

People are so screwy.

I know well a large and prestigious international consulting company. Top management was involved in every aspect of the design of a new enterprise computer system. Among the many tasks that the computer system does is the billing of clients - a task of great importance and which is done monthly for most clients.

These brainy consultants have made the billing process so complex it is taking 6 times as many hours to do each bill as it did under the old system. And bills that could be out the same day are taking a week to 10 days to complete the process.

While working on bills the consultants are unable to do the work they bill for because of the time this is taking.

Sound stupid? It is. And these guys are brilliant. But they lost sight of the real objective.

I think FDA in their well intentioned scientific rigor have lost sight of the goal - to provide safe and effective medications for our people. And I would add "efficiently". Forcing up costs needlessly or inefficiently, burdens the consumer of these needed drugs. BTW - I have never met a researcher that could not find the need to do another study. :-)

Respectfully,

ij

[p3analyze]

"I find it notable that the industry pros on this board do not buy this anti-FDA propaganda. And these pros were, almost without exception, highly skeptical of DNDN’s BLA. "

I am willing to bet that if the mechanism of action were clear, many of the PROS would overlook the type I error bullshit, as would FDA. But this also means that setting aside issue of MOA, most of these PROS could care less about type I error. Yet the main criticism was the statistical technicality when FDA has approved numerous applications with worse violations.

US FDA probably is as good an institution as a bureaucracy can be. It protects the welfare of American consumer and patients with due dilligence. There is no doubt about it. But what yous said sounded almost like the following:

When German Nazi first invaded, in many European countries, upper echelons almost without exception were highly skepitcal of resistence put up by underground guerilla. Their pessimism were well justified, but that does not make Nazi right, does it?