4 ms·
This is a very common complaint, but the other side of the coin is that FDA needs resources to do its job and any time the number of submitted drugs changes the
by conistonwater 7y ago
This is a very common complaint, but the other side of the coin is that FDA needs resources to do its job and any time the number of submitted drugs changes the FDA would need less/more funding from congress if it was funded only by congress. Collecting fees means the size of FDA's funding is correlated with the amount of work it has to do. The proper way to determine whether FDA is unduly influenced by this is to look at the actual decisions it makes, which is something I remember reading medical researchers already tried to do.
- rajman187 7y agoGDUFA guarantees a decision within 10 weeks, which is considerably better than the running average before and even extreme cases such as 13 years before addressing applications. There are unfortunately many cases that have been decided on the basis of finances rather than clinical justifications. I don’t envy the agency, stuck between the disdain of the public, pressure from industry, and continually having to justify their existence to Congressional committees.