The FDA approved the smallest number of medicines since 2007 last year and let only 21 new drugs into the realm of approved medicines. Is this a failure, triumph or funding shortfall?
One would have to have attended all of the FDA committee meetings to make a reasonable comment--yet from information gleaned in attending three meetings, it appeared that data presented was not sufficient AND that a new conservatism and scrutiny of benefits and risks has emerged. Data failures to support previously agreed to criteria are NOT the fault of the FDA, but rather shift to the burden on a company trying to gain approval.
It is simple to point fingers at the FDA and say it is a failure, yet triumph of reason over heart felt appeals from patients suffering from a disease must be the challenge that the FDA rises to. If there is a failure, it is in the present level of funding and staffing for the FDA. Looking at the prior funding, present funding and burden and backlog of drug applications, a stronger budget certainly appears warranted.