[GerryW]

Building a 21st Century FDA - Reason.com

Would you support these changes in the FDA's drug approval process if it meant substantially cheaper medicines brought to market much quicker?

[johnt]

GerryW asks:

"Would you support these changes in the FDA's drug approval process if it meant substantially cheaper medicines brought to market much quicker?"

Yes, but the devil is in the detail.

Let's look at just one of the issues raised: the delay in getting a therapy to market caused by having to climb over regulatory hurdles. Just suppose, and I know it's not possible, that you knew a therapy was safe and efficacious without testing it, then not only are the direct costs of testing wasted, but the delay caused by the testing costs lives.

But, is the years of extra life a suitable metric for PD therapies? Using the wrong metric can lead to the wrong decisions being made. I think for PD that quality of life needs to be taken into account. Would you accept a drug that reduced your life expectancy, but increased your quality of life?

John