PDUFA was enacted 13 years ago and passed by Congress as a way of providing the FDA with more funds. This way, it could hire more physicians and other scientists to review drug applications so drugs could be approved more quickly.
You see, every day a drug is held up from being marketed to you they lose about $1 million to $2 million. Yes, you read it correctly, $1-2 MILLION for every DAY the drug is held up from being approved.
So the obvious incentive is to approve drugs as quickly as possible and not stand in the way of profit-making.Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared towed the approval of drugs and 20 percent is for everything else. Drug safety is a measly 5 percent. This speaks loads about their priorities. It is NOT about protecting you -- it is about approving drugs as quickly as possible so the drug companies can reap their profits.