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Perhaps unbeknownst to some folks, the FDA as a regulatory body is funded in large part now by Congress but by GDUFA and PDUFA which allows the agency to collec
by rajman187 7y ago
Perhaps unbeknownst to some folks, the FDA as a regulatory body is funded in large part now by Congress but by GDUFA and PDUFA which allows the agency to collect user fees for both brand and generic drugs from the drug makers themselves, in essence being funded by the industry it is meant to regulate. So it is then understandable why a lot of the guidelines become flexible (note that the FDA cannot enact laws, that is the duty of Congress)
- conistonwater 7y agoThis 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.
- loceng 7y agoThis is one place where I would like to see an immutable blockchain database used, as a custody of records for decisions made.