All things being equal, the FDA needs more money.
But shouldn't more money be tied to what my colleague Peter Pitts calls for: "responsible and predictable behavior on the FDA's part?"
We have heard the complaint that FDA is under-funded for decades. But all bureaucracies say that if they had more money, they could do more. The question is, what is FDA doing with the money they have. Or as Lincoln once observed: "Be what you are. But be a good one."
The FDA is spending way too much time and money on regulatory science that does nothing to encourage the use of biomarkers in clinical trials.
Instead of following the critical path, it is more inclined to apply the precautionary principle to product approvals.
By framing its decisions on relative risk it has raised the bar for product approval in ways that make even helpful products unavailable. And by shifting standards for post market review of drugs like Avastin it demonstrates that it cannot always be trusted with the money it has...
The FDA should show how it will get back on the track it was taking before Vioxx before it asks for money. It should show it will be something different, not a smaller version of what it currently is.
Or as Steve Martin put it: A day without sunshine is like, you know, night.
But shouldn't more money be tied to what my colleague Peter Pitts calls for: "responsible and predictable behavior on the FDA's part?"
We have heard the complaint that FDA is under-funded for decades. But all bureaucracies say that if they had more money, they could do more. The question is, what is FDA doing with the money they have. Or as Lincoln once observed: "Be what you are. But be a good one."
The FDA is spending way too much time and money on regulatory science that does nothing to encourage the use of biomarkers in clinical trials.
Instead of following the critical path, it is more inclined to apply the precautionary principle to product approvals.
By framing its decisions on relative risk it has raised the bar for product approval in ways that make even helpful products unavailable. And by shifting standards for post market review of drugs like Avastin it demonstrates that it cannot always be trusted with the money it has...
The FDA should show how it will get back on the track it was taking before Vioxx before it asks for money. It should show it will be something different, not a smaller version of what it currently is.
Or as Steve Martin put it: A day without sunshine is like, you know, night.
